Saturday, November 7

Real-Time Observation Sheds New Light On Multiple Sclerosis

In diseases such as multiple sclerosis, cells of the immune system infiltrate the brain tissue, where they cause immense damage. For many years, it was an enigma as to how these cells can escape from the bloodstream. This is no trivial feat, given that specialized blood vessels act as a barrier between the nervous system and the bloodstream. Until now, tissue sections provided the sole evidence that the immune cells really do manage to reach the nerve cells. Now, a team of scientists from the Max Planck Institute of Neurobiology, the University Medical Center Göttingen, and other institutes, has witnessed the movements of these cells "live" under the microscope for the very first time. In the process, they discovered several new behavioural traits of the immune cells. The consolidated findings mark a significant step forward in our understanding of this complex disease. (Nature, 14 October 2009) .....full report in Medical News Today

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[Pathogenetic treatment of multiple sclerosis: the present and the future] - In this review, we present results of studies of drugs modifying the MS course which have been approved for MS treatment and those that are in the stage of clinical trials and expected to enlarge possibilities of MS treatment. - Zh Nevrol Psikhiatr Im S S Korsakova. 2009;109(7 Suppl 2):90-9. in PubMed

[Brain atrophy and neurological impairment in patients with multiple sclerosis] - An aim of the study was to investigate a relationship between global and local brain atrophy with neurological impairment (motor dysfunction) in multiple sclerosis (MS) patients with different levels of disease severity. - Zh Nevrol Psikhiatr Im S S Korsakova. 2009;109(7 Suppl 2):32-7. in PubMed

The effect of war stress on multiple sclerosis exacerbations and radiological disease activity. - Our study shows that exposure to war-related events is likely to lead to an increase in both clinical relapses and MRI disease activity in patients with MS. - J Neurol Sci. 2009 Nov 3. [Epub ahead of print] in PubMed

Magnetic resonance imaging characteristics of children and adults with paediatric-onset multiple sclerosis. - The purpose of this study was to compare the clinical and quantitative magnetic resonance imaging metrics of paediatric-onset multiple sclerosis to adult-onset multiple sclerosis. - Brain 2009 Nov 5. [Epub ahead of print] in PubMed

The diagnostic value of earlier and later components of Vestibular Evoked Myogenic Potentials (VEMP) in multiple sclerosis. - Abnormal VEMP imply the presence of lesions undetected by MRI neuroimaging, which verifies the diagnostic value of the method. Unilateral absence of n34p44 complex was related with sensorineural hearing loss, supporting the hypothesis that n34p44 is of cochlear origin. - J Vestib Res. 2009;19(1-2):59-66. in PubMed

Molecular profiling of glatiramer acetate early treatment effects in multiple sclerosis. - Our findings demonstrate that GA treatment induces alternations of immunomodulatory gene expression patterns that are important for suppression of disease activity already at three months of treatment and can be used as molecular markers of GA activity. -Dis Markers 2009;27(2):63-73. in PubMed

The impact of disability, fatigue and sleep quality on the quality of life in multiple sclerosis. - In conclusion, it may be said that MS patients had poor and moderate quality of mental and physical health. The quality of life was impaired as seen by PSQI, EDSS, and FSS. It is our suggestion that these patients require the attention of health care professionals, to be observed for the need of possible psychological support. - Ann Indian Acad Neurol. 2008 Oct;11(4):236-41. in PubMed

Optic neuritis--more than a loss of vision. - Aust Fam Physician 2009 Oct;38(10):789-93. in PubMed

[Multiple sclerosis at the time of world-wide use of disease modifying treatment] - The review discusses issues of multiple sclerosis (MS) management at the time of world-wide use of effective treatment - disease modifying treatment including the influence of the time of treatment start and adherence to treatment on its results, monitoring and treatment strategy of neurodegenerative disorders, problems of new trials, changes in MS course and significance of symptomatic treatment and rehabilitation. The discussion of many aspects is based on the data presented in the articles published in this special issue of the journal. - Zh Nevrol Psikhiatr Im S S Korsakova. 2009;109(7 Suppl 2):4-9. in PubMed

[Genetic predisposition to multiple sclerosis as a polygenic autoimmune disease] - The biological properties of the MS-associated genes support the notion that autoimmune inflammatory processes play an important role in MS, whereas an existence of mainly non-overlapping subgroups of patients bearing different predisposing genetic factors is consistent with the MS genetic heterogeneity. - Zh Nevrol Psikhiatr Im S S Korsakova. 2009;109(7 Suppl 2):16-22. in PubMed

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MS Patients Need More Comprehensive Training

Self management training for people with multiple sclerosis shouldn’t be limited to patient education. It needs to include a comprehensive range of techniques for skill building and getting the resources they need.

That’s one conclusion of a “white paper” recently released by the Consortium of Multiple Sclerosis Centers. The paper comes from a panel chaired by Robert Fraser of the University of Washington Rehabilitation Research and Training Center in Seattle.

“Work in multiple sclerosis has chiefly been related to physical conditioning and we need a more holistic perspective on a wellness intervention,” suggests Fraser, who has optained a research and training grant to develop the “Self Management Consensus Conference” being held April 2010 in Seattle.

The panel says patients need to be prepared for more than the changes the disease brings. They need to be prepared for the challeges of rehabilitation and disease-modifying therapies.
Go to www.mscare.org for more information. ...... this story found in TheLedger.com

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Thursday, November 5

FDA delays ruling on Acorda’s MS drug until 1/2010

HAWTHORNE, N.Y. (AP) – Acorda Therapeutics Inc. said Thursday the Food and Drug Administration delayed a ruling on its multiple sclerosis drug candidate Fampridine-SR by three months.

The agency was due to make a decision by Thursday, but the ruling is now due by Jan. 22, 2010.
Acorda said the FDA extended its review because it recently submitted new information on its risk evaluation strategy for the drug.

Acorda sent in the additional information following a meeting with an FDA panel on Oct. 14. The panel recommended that Fampridine-SR receive FDA approval.

MSNewsToday

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Multiple Sclerosis: What Part Do Relapses Play In Severe Disability?

People with multiple sclerosis (MS) who have relapses within the first five years of onset appear to have more severe disability in the short term compared to people who do not have an early relapse, according to a new study published in the November 4, 2009, issue of Neurology®, the medical journal of the American Academy of Neurology. The study is one of the first to examine how MS relapses affect people during different time periods of the disease.

Research shows that 85 percent of people with MS begin by having the relapsing-remitting form of the disease and the majority of these people later develop secondary progressive MS. A relapse is defined in the study as worsening of neurological symptoms for more than 24 hours, without a fever or infection. Because relapse-related symptoms often improve within a few weeks, it's been unclear how much disability comes from relapses, and how much from progression.

For the study, scientists reviewed the medical records of 2,477 people with MS who experienced relapses in British Columbia, Canada. The study looked at whether the participants had disability severe enough to require the use of a cane for walking and whether this was related to relapses occurring within five years, five to 10 years, or more than 10 years after onset of symptoms. The participants were followed for an average of 20 years. During that time, the group experienced 11,722 relapses.

Scientists found that people who had a relapse within five years of disease onset were at a 48 percent higher hazard (a measure of relative risk) of needing a cane to walk within five years of disease onset than those who did not have an early relapse. Importantly, the impact of the early relapse lessened over time. Those with early relapse who did not need a cane after five years were at only a 10 percent higher hazard (a measure of relative risk) of needing one 10 years after disease onset than those without early relapses.

"Our findings may represent an important message to people diagnosed with MS today. Those who have a history of relapses could potentially be offered reassurance that as time goes on, these relapses will have a diminishing effect on their everyday lives," said study author Helen Tremlett, PhD, with the University of British Columbia in Vancouver. "In addition, our study calls upon the need for new medications that target axonal degeneration, which is suspected of causing permanent disability, especially for people who have had MS for many years or who are older at diagnosis."

The impact of relapses that occurred later, either at five to 10 or more than 10 years after the start of the disease, also waned over time and became insignificant after long-term follow up. Relapses in people under 25 had a longer impact on disability compared to those over 35 years.

"There may be a longer window of opportunity for treating younger people with MS right away, changing the course of progression later on," Tremlett said.

The study was supported by the U. S. National MS Society.
Source: Rachel Seroka American Academy of Neurology .......full story in Medical News Today

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What's new for 'Multiple Sclerosis' in PubMed

Neuronal and BBB damage induced by sera from patients with secondary progressive multiple sclerosis. - Int J Mol Med. 2009 Dec;24(6):743-7. in PubMed

Type 1 diabetes mellitus and multiple sclerosis: common etiological features. - In this Review, we highlight the latest epidemiological and genetic findings, which have identified many features common to both disorders. - Nat Rev Endocrinal. 2009 Nov 3. [Epub ahead of print] in PubMed

Effect of neutralizing antibodies on biomarker responses to interferon beta: the INSIGHT study. - These data provide evidence that high titers of neutralizing antibodies abolish the in vivo response to interferon beta. - Neurology. 2009 Nov 3;73(18):1493-500. in PubMed

Effect of anti-IFN{beta} antibodies on MRI lesions of MS patients in the BECOME study. - High levels of anti-interferon beta (IFNbeta) antibodies, which result in diminished bioactivity, are correlated with reduced therapeutic efficacy of IFNbeta. -Neurology. 2009 Nov 3;73(18):1485-92. in PubMed

Resistance training improves muscle strength and functional capacity in multiple sclerosis. - Level of evidence: The present study provides level III evidence supporting the hypothesis that lower extremity progressive resistance training can improve muscle strength and functional capacity in patients with multiple sclerosis. - Neurology. 2009 Nov 3;73(18):1478-84. in PubMed

Time course transcriptomics of IFNB1b drug therapy in multiple sclerosis. - Autoimmunity. 2009 Nov 3. [Epub ahead of print] in PubMed

Progressive changes in the retinal nerve fiber layer in patients with multiple sclerosis. - Axonal loss in the optic nerve of patients with MS is greater than that expected in healthy subjects, regardless of the presence of a previous optic neuritis. - Eur J Opthalmol. 2009 Sep 30. [Epub ahead of print] in PubMed

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Tuesday, November 3

Biogen’s Tysabri Problems the Fault of European Docs?

As mentioned in my last BNET Pharma posting, Biogen Idec’s key multiple sclerosis drug Tysabri had been linked to 23 worldwide cases of a potentially deadly brain infection called progressive multifocal leukoencephalopathy, or PML — with most confirmed cases centered in Europe, in particular Germany. Could there be a link between the seemingly higher prevalence of Tysabri-related PML cases in Germany and lack of oversight?

Hard and fast data confirms that from July 2006 (when Tysabri marketing resumed) to September 8, 2009, thirteen worldwide cases of Tysabri-related PML occurred in patients being treated for MS with Tysabri monotherapy. Of these, only four cases were patients in the United States, according to an FDA Post-marketing Drug Safety report.

Germany is an important MS market for Biogen. Aside from the U.S., Europe is home to four of the top seven markets — Germany, Italy, UK, and Spain — in terms of commercial dollars spent on disease modifying drugs for use in MS, according to an analysis of the global MS market by the pharmaceutical research outfit Visiongain.

Patients receiving monthly Tysabri infusions in the U.S. must be enrolled in the TOUCH Distribution Program overseen by Biogen, which involves (i) extensive monitoring of all patients for signs of PML and (ii) education of all patients and providers, with strong emphasis communicated to all parties that the drug is contraindicated for use in MS patients taking any drugs that may increase their risk of opportunistic infections, including drugs that lower immune function (e.g., azathioprine, chemotherapy, cyclosporine) or immunomodulators, such as the interferon-based disease-modifying therapies.

Aside from voluntarily enrollment of patients in Biogen’s Phase 4 trial, TYGRIS (Tysabri Global Observation Program in Safety), which is a prospective 5-year, 5000-patient cohort observational study to further evaluate PML risk and overall safety of Tysabri therapy, there are few — if any — restricted distribution programs in place throughout Europe.

As mentioned, most of the other reported cases of PML are alleged to have occurred in Germany, where oversight is purportedly lax, especially in the monitoring of the presence of latent JC virus and a mandated prior “washout” phase required in patients recently removed from other immunosuppressant therapies, both high-risk factors for development of PML.

However, since late summer, German authorities have been working with the company to make sure “appropriate use of Tysabri is monitored and followed up with [patients],” Chief Executive Jim Mullen said on the third-quarter earnings call.

The duration of therapy in the newly diagnosed PML patients is unknown. That said, lax supervision in German — and other European — MS treatment facilities could be a contributing risk factor behind the higher incidence(s) and prevalence of reported PML cases.

In the last 12 months, Biogen has engineered relationships between academic reference centers and many of the larger MS clinics in Germany so that the prescribing of Tysabri can occur in a more structured environment — in compliance with a common protocol developed and published by the Medical Advisory Board of German MS, according to chief operating officer Robert Hamm. To date, 250 top German MS treatment centers are linked to 40 reference centers, he said on the call. This initiative should play out in the company’s favor as European regulators re-assess the risk-benefit profile of Tysabri.

View full post here: http://industry.bnet.com/pharma/10005010/biogen-idecs-tysabri-problems-may-be-fault-of-european-doctors/?tag=shell;content

This story taken from MS News Today

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Genetic Clue May Predict Multiple Sclerosis Severity

Biomarker May Have Potential to Help With Diagnosis, Treatment of Multiple Sclerosis

Oct. 19, 2009 -- A newly identified biomarker may be linked to the severity of multiple sclerosis and may one day help with diagnosis and treatment of the often frustrating and unpredictable disease.

Multiple sclerosis is a disease of the brain and spinal cord that affects more than 400,000 Americans. MS is believed to be an autoimmune disease because the body’s immune system attacks the protective myelin sheath around nerve fibers. This results in problems with nerve messages being conducted to and from the brain.

In a new study published in Nature Immunology, researchers identified short RNA molecules, known as microRNAs, that were linked to multiple sclerosis symptoms in mice, depending on their level of activity or expression. The researchers found that when expression of the microRNA called miR-326 was silenced, MS severity in mice was mild. When the microRNA expression was increased, disease severity was severe.

The researchers note that microRNAs have been linked to regulation of autoimmunity in mouse studies, but details about the specific microRNAs involved in autoimmune disease are unclear. ......full story in WebMD

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Results Published from Rituximab Study in Primary-Progressive MS

Primary Endpoint Not Reached but Subgroup Analysis Shows Evidence of Benefit in Younger Patients with Active Disease

A study of intravenous rituximab (Rituxan®, Genentech and Biogen Idec) in 439 people with primary-progressive MS has shown that the drug did not slow disease progression when compared with inactive placebo, the primary endpoint of the study. However, MRI scans suggested some benefit, and an analysis of subgroups within the study showed significant delays in patients younger than age 51 and with active disease observed on MRI scans. Early results from this OLYMPUS study were originally reported in a press release in 2008, and at the American Academy of Neurology Annual Meeting in 2009, and now Kathleen Hawker, MD (The Ohio State University Medical Center, Columbus) and colleagues have published their complete findings in Annals of Neurology (2009;66[4]:460-471) ....... read the full report National MS Society

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Update on Tysabri and PML: Company Releases Details of Cases and Risks

According to information released yesterday by Biogen Idec, there have been 24 confirmed cases of progressive multifocal leukoencephalopathy (PML, a viral infection of the brain that usually leads to death or severe disability) among people who have used Tysabri® (natalizumab, Biogen Idec and Elan Pharmaceuticals) after it became available for prescription in July 2006.

As of the end of September 2009, 60,700 people have used Tysabri worldwide. Although the absolute risk for PML in patients treated with Tysabri cannot be precisely determined, the sponsor has now released data suggesting that the risk increases with increasing time on therapy, starting out lower than the one-in-one thousand level that was estimated at the time of Tysabri’s re-approval in 2006, and rising after two years of infusions to about one in one thousand. There is insufficient information to determine the risk of PML in those who have been on therapy for three years or more. Right now only 2,000 people have been on the therapy for over three years.

This release followed an October 23 announcement from the EMEA, the European equivalent of the U.S. FDA, indicating that one of its advisory committees was launching a review of the risks and benefits of Tysabri in light of the increasing number of new cases of PML.

Signs of PML: Typical symptoms associated with PML progress quickly over days to weeks, and can include:
• personality or behavioral changes
• changes in thinking, memory, and orientation leading to confusion
• onset of seizures, clumsiness or progressive weakness on one side of the body
• disturbances of vision

If individuals taking Tysabri experience new, unusual symptoms, they should contact their prescribing physician immediately. Physicians who need guidelines on the protocol to follow when they have a patient on Tysabri who experiences unusual symptoms should contact Biogen Idec.

Details of Cases: According to the company, the 24 cases of PML have occurred in both men and women who had been given infusions of Tysabri every four weeks for a duration ranging from one year to three and a half years, with an average of two years.

16 of the cases occurred in Europe, and 8 in the United States

4 of the 24 died

The degree of disability in the 20 survivors is a wide spectrum: at the milder end, some have recovered enough to return to work, and at the other extreme, some are confined to bed, requiring extensive assistance with activities of daily living, and others were in between this range. Further details of their condition were not provided.

It appears that when PML is detected and treated early, it generally improves outcomes. It is important that individuals taking this drug and their doctors be vigilant in monitoring for any occurrence of new, unusual symptoms that might indicate PML.

Based on these cases, the sponsor stressed that, contrary to prior information, the presence of gadolinium-enhancing lesions on MRI does not exclude the possibility of PML. Likewise, the absence of JC virus DNA in the spinal fluid does not exclude PML.

There has been no characteristic among those who have developed PML that would give substantial clues to who might be more likely to develop it, except that half of the cases had prior histories of having been on immunosuppresive therapies, such as mitoxantrone, and less commonly, azathioprine and methotrexate.

Right now there is no test that can predict who is more likely at risk for developing PML while using Tysabri; in a large company-sponsored study, testing of blood cells, plasma, serum and urine for the causative JC virus in people before and after 48 weeks of Tysabri therapy (Rudick et al. ECTRIMS 2009) did not show any differences in the presence of the virus in those fluids.

The results of these studies, performed at the U.S. National Instituties of Health, differ somewhat from an earlier study (N. Engl. J. Med., 361:1067, 2009) suggesting higher virus levels after treatment.

When PML was suspected, Tysabri infusions were halted. There is no specific therapy to treat PML, but the best hope is to reconstitute a person’s immune responses. In most of the 24 cases, once PML was confirmed, Tysabri was removed from their systems with the blood-cleansing treatments of either plasma exchange or immunoadsorption.

During the aftermath of PML, as the immune system begins to recover, a condition called IRIS (immune reconstitution inflammatory syndrome) usually occurs about 4 weeks after the removal of Tysabri from the system. The sponsors suggested that some of the treating physicians found that prompt use of intravenous steroids to treat this brain inflammation led to improvement.

The FDA provides post-marketing safety warnings on Tysabri at this link, although the updated information above is not currently provided.

Read the report at National MS Society

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Facet Biotech Reports Third Quarter 2009 Financial Results

REDWOOD CITY, CA--(Marketwire - November 3, 2009) - Facet Biotech Corporation (NASDAQ: FACT) today reported financial results for the third quarter ended September 30, 2009.

"We are executing on our development programs while remaining vigilant on cost containment and expense management," said Faheem Hasnain, president and chief executive officer of Facet Biotech. "We expect our lead program, daclizumab in multiple sclerosis, to enter a second registration-enabling study in the first half of 2010, triggering a $30 million milestone payment to us from Biogen Idec. Our four development-stage oncology programs continue to progress, and for our elotuzumab and TRU-016 oncology programs, we remain on track toward achieving important development milestones in the coming year. Our strong balance sheet enables us to support our programs through these and other future critical milestones to the end of 2012. We possess a focused and promising pipeline and have never been more confident in the future growth prospects for Facet Biotech." ....... full financial report in Marketwire

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Modifying Neural Stem Cells Improves Their Therapeutic Efficacy

Stem cells isolated from the brain of adult mice (adult neural stem cells [aNSCs]) have shown very modest therapeutic effects in a mouse model of the chronic inflammatory neurodegenerative disease multiple sclerosis. But now, Guang-Xian Zhang and colleagues, at Thomas Jefferson University, Philadelphia, have developed an approach to enhance the therapeutic effects of aNSCs in this model of multiple sclerosis. Specifically, the researchers genetically engineered aNSCs to express the anti-inflammatory molecule IL-10 and found that these cells induced more extensive functional and pathological recovery from ongoing disease than did nonengineered aNSCs. Importantly, the IL-10-aNSCs mediated their effects in multiple ways, suppressing immune system attack of nerve cells, promoting nerve cell repair, and promoting production of the nerve cell protective sheath. The authors hope these results might increase the chance that aNSC-based therapies might one day be developed for clinical use. ...full report in Medical News Today

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ACG: New Pain Relievers Cause Less GI Injury

SAN DIEGO -- Two investigational pain relievers demonstrated superior gastroprotection when compared with a conventional nonsteroidal anti-inflammatory drug (NSAID) in clinical trials reported here. ....... full report in MedPage Today

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What's new for Multiple Sclerosis in PubMed

Progressive changes in the retinal nerve fiber layer in patients with multiple sclerosis. - Axonal loss in the optic nerve of patients with MS is greater than that expected in healthy subjects, regardless of the presence of a previous optic neuritis. - Eur J Ophthalmol. 2009 Sep 30. [Epub ahead of print] in PubMed

Retinal nerve fiber layer thickness and spatial and temporal contrast sensitivity in multiple sclerosis. - MS is accompanied by visual function alteration even in the absence of acute optic neuropathy. The important correlation between functional and anatomic aspect confirms the value of OCT to appreciate the subclinical involvement of the optic nerve. Associated with tests exploring visual function, the OCT could reveal itself pertinent in evaluation of the different therapeutics used in MS ON. - Eur J Ophthalmol. 2009 Jul 24. [Epub ahead of print] in PubMed

Thickness of retinal nerve fiber layer correlates with disease duration in parallel with corticospinal tract dysfunction in untreated multiple sclerosis. - J Rehabil Res Dev. 2009;46(5):633-42. in PubMed

Integration of genetic risk factors into a clinical algorithm for multiple sclerosis susceptibility: a weighted genetic risk score. - The inclusion of 16 susceptibility alleles into a wGRS can modestly predict MS risk, shows consistent discriminatory ability in independent samples, and is enhanced by the inclusion of non-genetic risk factors into the algorithm. Future iterations of the wGRS might therefore make a contribution to algorithms that can predict a diagnosis of MS in a clinical or research setting. - Lancet Neurol. 2009 Oct 28. [Epub ahead of print] in PubMed

Sleep disorders in patients with multiple sclerosis. - This paper reviews the association of sleep disorders with MS, and discusses the association of sleep disruption with MS fatigue. - Sleep Med Rev. 2009 Oct 28. [Epub ahead of print] in PubMed

Optic neuritis: a review. - Since there is evidence of early axonal damage in acute demyelinating ON, disease-modifying drugs should be considered in patients at high risk of developing MS in the future as prophylaxis against permanent neurological impairment. - Int MS J. 2009 Sep;16(3):82-9. in PubMed

Spotlight on alemtuzumab. - In this review we summarize our experience; describing how this prototypical, "bench-to-bedside" therapy continues to inform basic science, revealing aspects of the pathogenesis of MS and lymphopeniaassociated autoimmunity. - Int MS J. 2009 Sep;16(3):77-81. in PubMed

Early psychiatric manifestation in a patient with primary progressive multiple sclerosis. - Multiple sclerosis can create a variety of somatic, cognitive, and behavioral symptoms. Here we report a patient with early psychiatric symptoms including depression, dementia, and catatonia, who was eventually diagnosed as having primary progressive multiple sclerosis. - Arch Iran Med. 2009 Nov;12(6):595-8. in PubMed

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Sunday, November 1

New Tool To Accelerate Discovery Of Autoimmune Disease Mechanisms And Therapies

Currently, 5 - 8% of the U.S. population is afflicted with an autoimmune disease. Many of these are chronic and require life-long care. Moreover, different autoimmune diseases aggregate within a single family, suggesting they are caused by disruptions in common biological pathways.

To help researchers investigate these common pathways, The Jackson Laboratory has published Pathways to Discovery: Autoimmune Diseases .... full report in Medical News Today

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Multiple Sclerosis difficult to diagnose

With more than 50 symptoms linked with multiple sclerosis, all which can vary in severity, duration and disability, it is not surprising that Cathy Sanchez went several years without a diagnosis.

"MS is difficult to diagnose going on your symptoms because the symptoms can be the same as a lot of other diseases and conditions," says Sanchez, who is a dispatcher for the Hale County Sheriff’s Office.

She admits that to exacerbate the situation — symptoms come and go and can vary in degrees of severity.

"I would be in the middle of a relapse, then by the time I got to a doctor it would be over. I got to where I thought I was crazy."

Eventually, with perseverance and a strong determination to find out what was going wrong with her body, Sanchez was told that tests showed she had two or three lesions in her brain that could indicate multiple sclerosis.

With a partial diagnosis in hand, she went to a specialist in Houston where she had what she called a "better MRI.

"The results were that I had 10 lesions in my brain."

In multiple sclerosis, lesions, also known as plaques, are patches of inflammation in the central nervous system.

Sanchez says the simple explanation of multiple sclerosis is to compare human nerves to an electric cord.

"I use an electric cord to a lamp as an example," she says. "Nerves are coated with a myelin sheath (a coating of fatty proteins that surrounds, insulates and protects the nerves), and with MS, the immune system attacks the myelin coating until the nerve is exposed. Like the electric cord that is cracked or damaged, when you go to turn on the light, it may work or it may not.

"That’s what MS does to the nerves. Each attack on the myelin leaves damage and scars. The next attack goes for a new place and, over time, those nerves are so scarred that they don’t work."...... full story in MyPlainville.com

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Saturday, October 31

Diagnosing and managing multiple sclerosis.

The most common form of MS is relapsing remitting MS (RRMS). This is now a treatable condition and early diagnosis is becoming increasingly important in order to guide management decisions. After several years, RRMS may evolve into a slowly progressive deterioration in neurological function, known as secondary progressive MS. In 10-15% of people with MS, the condition follows this pattern of slow deterioration from onset, without relapses or remissions. This is primary progressive MS. It is difficult to predict prognosis in an individual patient. Factors associated with a favourable prognosis include female sex, onset with optic neuritis or sensory symptoms (rather than weakness or ataxia) and a long interval between initial relapses. RRMS is most commonly diagnosed in white women in their 20s. The first attack is known as a 'clinically isolated syndrome' reflecting inflammation in a single location. Common sites and symptoms are: optic nerve; spinal cord; sensory symptoms; Lhermitte's symptom and brainstem. The time course of symptoms is often helpful, as it is characteristic of inflammation. Patients tend to deteriorate over days, remain at a nadir for a week or two, and then recover over weeks. Recovery may be incomplete. Question patients directly to find out if there is a past history of any of the other common symptoms and perform a full neurological examination. Primary progressive MS should be suspected in patients presenting with a progressive spastic paraparesis or cerebellar syndrome. The diagnosis of MS should be made by a specialist and patients with a syndrome suggestive of MS should be referred to a neurologist. The mainstays of pharmacological treatment in RRMS are still the beta interferons and glatiramer acetate. These drugs reduce the rate of relapse by about a third and are therefore indicated for mobile patients with at least two relapses in the past two years. - Practitioner. 2009 Sep;253(1721):25-30, 2-3. in PubMed

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More Tysabri Problems; Time for a Biogen-Idec Credibility Check

Unsubstantiated whisperings about Biogen Idec and its controversial multiple sclerosis drug took an ugly turn to the truth on Thursday when Europeon regulators disclosed another new case of progressive multifocal leukoencephalopathy, a serious brain infection known as PML, in a relapsed MS patient receiving Tysabri (natalizumab) infusions. With 11 new cases in two months, Biogen is going to face some awkward questions that will challenge the credibility of the company — and its promising MS franchise:

What did they know?

How long have they known it (more PML cases)?

And, how safe are other drugs in the MS pipeline?

In response to an email I wrote to the FDA inquiring as to how many confirmed cases of PML were on file — and were more reports to be expected — spokeswoman Sandra Walsh would only say:

"Yes, there are 24 confirmed cases of PML (since Tysabri re-marketing in 2006). The FDA is still receiving and reviewing follow-up information on cases of PML so we cannot yet comment further.

We’ll keep you posted as we learn more."

The global press will likely scapegoat Biogen management, accusing officials of withholding clinical data on side effects culled from Tysabri-treated patients. Before criticizing chief executive Jim Mullen & Co., however, the American public needs to remember that all current and emerging biological therapies for immune-mediated diseases, such as rheumatoid arthritis, Crohn’s disease, and MS, are imperfectly understood at best. The actual mechanism by which most of these drugs work is often murky, and they can cause unknown side effects as well:

Increasing numbers of invasiv e fungal infections are being reported in patients who have autoimmune inflammatory diseases and are being treated with newer immunosuppressive drugs, such as the well-known tumor necrosis factor (TNF)-alpha antagonist Enbrel (Etanercept), the anti-CD52 antibody Campath (alemtuzumab), or the interleukin-2 receptor antibody Simulect (basiliximab). [Current Infectious Disease Reports, 2009 Nov; 11(6): 435-8]

Or, as Ralf Gold, a well-respected neurologist in residence at Ruhr-University, located in Bochum, Germany, pointed out in a paper published in the New England Journal of Medicine:

“new MS drugs unfortunately have new side effects that can sometimes be fatal. Currently Natalizumab is the focal point of interest throughout the world, but [that] other new drugs, such as Alemtuzumab or anti-CD20 antibodies may soon follow.”

Still, all stakeholders, especially MS patients, have the right to feel both betrayed and angry, as Biogen management appeared to be both evasive and equivocal when answering queries from biotech analysts on the October 20 third-quarter earnings call. For example, as up to 17 worldwide cases of PML had been reported prior to third-quarter end, Eun Yang, biotech analyst at Jeffries & Co, asked management about emerging data suggesting there was a link between duration of Tysabri therapy and increased risk of developing PML.

“When you look at the patients who have been on the treatment for 24-months or longer, PML rate runs around 1 in 800, which is higher than what is in the [prescribing] label,” said Yang. “So, my question to you is what do you think would be the critical threshold of a PML rate where physicians or regulatory agencies would become more cautious on Tysabri?”

“I don’t want to speculate what makes regulators want to do things,” responded chief operating officer Bob Hamm, “but I can assure you that our current thinking is that the risk of PML even in that third year beyond 24-months is within the currently implied risk in the label.”

The current rate of PML in patients who had received at least 24 infusions ranges from 0.4 to 1.3 per 1,000 - patients, according to an FDA Safety Alert Update posted on September 16.
Management also downplayed any safety advantage to “drug holidays” for long-term Tysabri users. Specifically, when asked to comment on the proportion of patients in Biogen’s database where providers implemented drug holidays, senior researcher Al Sandrock tersely replied: “From the data we have — we are seeing very, very isolated cases of that.”

As I referenced in an earlier BNET Pharma posting, about 13,400 patients receiving monthly infusions (or approximately 29 percent of all patients taking the drug) had been on Tysabri therapy for more than two years — paying, on average, $28,500 per year for 13 infusions. It’s easy to do the math, subtract number of infusions and units sold decline.

Short-term, in my opinion, physician and patient distrust could lead to Tysabri (once again) losing market share to Teva Pharmaceutical’s (non-interferon) immunomodulator Copaxone (glatiramer acetate), with harmless injection-site reactions the most annoying of reported adverse events. Data from a 15-year ongoing Copaxone prospective study demonstrating patients treated for 10 and 15 years with the drug had significant reduction in disease severity should stimulate growth in sales, too.

“To stumble twice against the same stone is a proverbial disgrace, ” said the great Roman statesman Marcus Cicero. Not that Jim Mullens need give a Richard Nixon-like Checkers speech: “My fellow Americans.” The goal of Biogen management, nonetheless, is the same as Nixon’s was 50 years ago — damage control with humility. Admit (without admitting liability) that PML is more prevalent than original surveillance data suggested and move forward, working with MS interest groups and the FDA and European regulators to strengthen distribution and monitoring programs at Tysabri infusion centers worldwide. Also, Mullens should remind providers that the drug’s demonstrated 67 percent reduction in the relapse rate tips the risk-benefit scale in Tysabri’s continued favor.

The importance to Biogen of retaining credibility cannot be understated, as the company is racing against European drugmakers Merck KGaA (cladribine) and Novartis AG (fingolimod) to introduce the first oral pill for MS to market. Biogen agreed back in July to pay up to $510 million to market Fampridine SR (sustained-release), an oral tablet owned by Acorda Therapeutics, outside the United States.

The FDA’s Peripheral and Central Nervous System Drugs (PCNSD) Advisory Committee voted 12 to 1 that clinical data on Fampridine-SR 10 mg twice daily, which will sold under the brand name Amaya, has demonstrated substantial evidence of effectiveness as a treatment to improve walking in MS patients. Most experts agree that the drug could likely be on pharmacy shelves in the U.S. by the second quarter of 2010.

Biogen Idec expects to file for approval by the European Medicines Agency (EMEA) in early 2010. However, an unknown here and abroad is whether the therapy will receive a boxed warning for seizure risk (side effect looks to be dose-related). Consequently, the key issue to early adoption by physicians of Fampridine SR will likely, once again, turn on credibility — do neurologists trust Biogen Idec?

Story in BNET

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Disease progression among multiple sclerosis patients before and during a disease-modifying drug program: a longitudinal population-based evaluation

Randomized controlled trials have demonstrated the efficacy of disease-modifying drugs (DMDs) in persons with relapsing–remitting multiple sclerosis (MS) and secondary progressive MS with superimposed relapses. ........Multiple Sclerosis 2009, doi:10.1177/1352458509350307 in Sage Journals Online

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Senators push for pardon of Franklin man with MS charged with growing marijuana

SOMERSET COUNTY — As he gets ready to go to trial for growing marijuana in back of his rented Franklin, Somerset County, home, John Ray Wilson has garnered some influential support.

Wilson suffers from multiple sclerosis and was trying to alleviate the pain of the disease with home-grown marijuana. But growing marijuana in New Jersey can lead to harsh penalties and the law make no concessions for people like Wilson.

This week state Sen. Nicholas Scutari and state Sen. Raymond Lesniak, both D-Union, called the prosecution of Wilson a "severe, inappropriate, discompassionate and inhumane application of the letter of the law."

They are seeking a pardon from Gov. Jon S. Corzine for the man on the first-degree charge of maintaining or operating a drug manufacturing facility. It can bring a sentence of up to 20 years in prison.

A four-year plea deal is on the table. But Lesniak said even that could ensure that Wilson would die behind bars.

Prosecuting people like Wilson "wasn't the intent of the legislation," of the drug manufacturing statute, Lesniak said. "It was designed to go after drug kingpins. This is hardly the case."

Wilson is facing two other charges, a second-degree manufacturing charge and a third-degree possession offense. The second-degree charge can bring five to 10 years in prison; a third-degree offense, three to five years.

Lesniak said they have not sought an outright pardon since Wilson must face consequences if found guilty. Community service would be a more appropriate sentence, Lesniak said.
A tentative trial date has been set for Dec. 14.

"We're moving ahead with the case," said David Wald, spokesman for the state Attorney General's office.

Robert Corrales, spokesman for Corzine, declined to discuss the request for the pardon.
"It would be inappropriate for us to comment on an ongoing investigation," he said. ... full story in myCentralJersey.com

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Europe Takes Closer Look At Tysabri

A European panel has started a review of the controversial multiple sclerosis drug Tysabri, sold by Biogen Idec Inc. and Elan PLC, citing a higher rate of a rare brain infection than previously disclosed.

The additional cases are important because they may increase the drug's risk profile and raise questions about the companies' responsibility in updating the market on the safety record of Tysabri, a product that generates nearly $1 billion in yearly revenue.

The European Medicines Agency's Committee for Medicinal Products for Human Use, known as CHMP, reported there have been 23 cases of progressive multifocal leukoencephalopathy, or PML, ... full story in TheWall Street Journal

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European panel reviewing infections linked to Tysabri

Shares of transatlantic biotechnology partners Biogen Idec Inc. and Elan Corp. tumbled yesterday after European regulators said they were examining 23 cases of patients who developed potentially fatal brain infections after taking the companies’ multiple sclerosis drug Tysabri. That is twice as many cases as previously reported.

The European Medicines Agency, which regulates drugs in Europe, said it will review the risks and benefits of Tysabri and discuss whether added measures are needed to assure safety.

Biogen Idec spokeswoman Jennifer Neiman said the incidents of the brain infection, progressive multifocal leukoencephalopathy, remain extremely rare - well within the range of one in 1,000 cases noted on the drug’s label.

“Tysabri is a very compelling option for the treatment of multiple sclerosis,’’ Neiman said, “and overall, the benefit-risk profile for the product continues to be very favorable.’’ She said Tysabri is the only MS therapy that has been shown to stop - and in some cases reverse - the progression of the disease.

Al Sandrock, senior vice president and head of neurology research and development at Biogen Idec, said the company was discussing with global regulators a change to the wording on Tysabri’s label that would reflect an increased risk the longer patients took the drug. ...full story in Boston.com

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Teva rivals advance on oral MS drug: Merck KGaA and Novartis have completed Phase III trials of their drugs, and are filing for approval.

Oct 01, 2009 (Globes - McClatchy-Tribune Information Services via COMTEX) -- TEVA Quote Chart News PowerRating -- The ring around Copaxone, Teva Pharmaceutical Industries Ltd.'s (Nasdaq: TEVA; TASE: TEVA Quote Chart News PowerRating) treatment for multiple sclerosis, is tightening. Yesterday, two of Teva's main rivals developing oral treatments for the disease announced that they were applying for approcval of their drugs by the US Food and Drug Administration (FDA). Teva is also trying to develop an oral version of Copaxone.

Germany's Merck KGaA (XETRA: MRK) filed for approval of its multiple sclerosis pill cladribine, two months after filing for EU approval, and Switzerland's Novartis AG (NYSE:NVS; LSE: NOV; SWX: NOVZ) is seeking approval for its drug, FTY720, in both the US and Europe.

Copaxone generates 30-35 percent of Teva's net profit. The drug is administered by injection, and is considered a safe drug. Teva is undergoing a Phase II clinical trial for oral Copaxone.
Novartis announced successful results of the Phase III clinical trial of FTY720.

The company said that the drug delayed development of multiple sclerosis by two years, but that there were dangerous side effects if the drug was taken in high dosages, including high blood pressure, and skin cancer.

Merck KGaA has completed its Phase III clinical trial, which showed in January that cladribine reduced the number of relapses per year in patients with some forms of multiple sclerosis by 58 percent, compared with a placebo. However, the drug is considered as risky as FTY720. Market sources believe that cladribine will come on the US market in the second quarter of 2010, and European market launch in the fourth quarter of 2010. ....full story in TradingMarkets.com

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Luteolin as a therapeutic option for multiple sclerosis

Multiple sclerosis (MS) remains without an effective treatment in spite of intense research efforts. Interferon-beta (IFN-beta) reduces duration and severity of symptoms in many relapsing-remitting MS patients, but its mechanism of action is still not well understood.

Moreover, IFN-beta and other available treatments must be given parenterally and have a variety of adverse effects. Certain naturally occurring flavonoids, such as luteolin, have anti-oxidant and anti-inflammatory effects, including inhibition of activated peripheral blood leukocytes from MS patients.

Luteolin also inhibits mast cells, as well as mast cell-dependent T cell activation, recently implicated in MS pathogenesis. Moreover, luteolin and structurally similar flavonoids can inhibit experimental allergic allergic encephalomyelitis (EAE), an animal model of MS in rodents.

An appropriate luteolin formulation that permits sufficient absorption and reduces its metabolism could be a useful adjuvant to IFN-beta for MS therapy. ...story in 7th Space

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Avanir's Zenvia Reports Good Trial Results; Shares Jump

Avanir Pharmaceuticals Inc. (AVNR) disclosed late-stage trial data which showed its drug Zenvia met all secondary endpoints in treating the psuedobulbar effect in patients with underlying multiple sclerosis. ......full story available through the Wall Street Journal

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Fluid-Attenuated Inversion Recovery Magnetic Resonance Imaging Detects Cortical and Juxtacortical Multiple Sclerosis Lesions

FLAIR can detect many cortical and juxtacortical lesions in MS, which were appreciated previously in autopsy studies but usually missed by magnetic resonance imaging during life. Cortical and juxtacortical plaque formation may contribute to cortical atrophy in MS. - Arch Neurol. 2001;58:742-748.

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Two-year data confirm efficacy of novel MS drug

A new type of immunomodulator could be the first orally administered treatment for multiple sclerosis, if an approval application expected later this year is successful.

Fingolimod, which is being developed by Novartis, binds to sphingosine 1-phosphate receptors on lymphocytes. The drug effectively ‘traps' lymphocytes in lymph nodes, reducing the number of cells circulating in the bloodstream and thereby lessening nerve inflammation.

Recently released data from a two-year Phase III trial show that fingolimod significantly improved two key disease measures in 1272 patients with relapsing-remitting multiple sclerosis. In the FREEDOMS study, fingolimod reduced annualised relapse rates by up to 60% and cut the risk of disability progression by as much as 32% compared with placebo.

The two doses of fingolimod tested, 0.5mg and 1.25mg once daily, exhibited comparable efficacy. However, investigators observed fewer adverse events at the 0.5mg dose than the 1.25mg dose. The lower dose is likely to be the focus of the drug's approval application.

"FREEDOMS reinforces the potential for fingolimod as a significant breakthrough in the future treatment of relapsing-remitting MS," said study investigator David Bates, Professor of Clinical Neurology at the University of Newcastle upon Tyne. "These results mean that a patient who would have had an attack every three years might expect one only every six to seven years. This, in itself, reduces the degree of disability."

In an earlier one-year Phase III study (TRANSFORMS) in relapsing-remitting multiple sclerosis, fingolimod reduced relapse rates significantly more than interferon beta-1a.

A third pivotal study of fingolimod (INFORMS) is ongoing in patients with primary progressive multiple sclerosis.

Story in healthcarerepublic.com

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Thursday, October 29

More PML Troubles for Biogen, Elan MS Drug: Biobuzz

CAMBRIDGE, Mass. (TheStreet) -- European regulators confirmed that 24 multiple sclerosis patients treated with Tysabri have contracted a serious brain infection. Four of those patients have died, according to the investment bank UBS.

The new disclosure concerning the link between Tysabri treatment and progressive multifocal leukoencephalopathy, or PML, pushed shares of Biogen Idec (BIIB Quote) and Elan(ELN Quote), makers of Tysabri, lower in Thursday trading.

Last week, European regulators launched a new safety review of Tysabri after it was disclosed that 23 multiple sclerosis patients treated with Tysabri had contracted PML since the drug was relaunched in 2006. The number of PML cases tied to Tysabri was much higher than investors had previously known.

The 24 cases of Tysabri-linked PML and four patient deaths was disclosed Thursday in an email sent by European regulators to UBS drug analyst Martin Wales, who was seeking more information about the link between Tysabri and PML cases. The email has been circulated across Wall Street trading desks this morning. A copy of the email, obtained by TheStreet, states:

"We can confirm that to date, 24 confirmed cases of PML have been reported worldwide since Tysabri has been on the marked in the EU in 2006.[Fourteen] of these ocurred in the EU, 8 in the US and 2 in Switzerland. Four patients died. Most of the cases were reported in patients who have had 24 or more infusions of Tysabri.

Story in TheStreet.com

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Data points out paths to Tysabri rehab

The news that 23 Tysabri patients had developed the brain malady PML hit Biogen hard earlier this week. Some analysts now say that the estimated risk of developing PML--1 in 1,000--might actually be more like 1 in 400. But two new possibilities for fighting PML have emerged, raising hopes that the potentially fatal brain infection can a.) be better prevented, and b.) better treated.

As BNet Pharma reports, a disproportionate number of PML cases have occurred in Germany. Why might that be? Well, oversight isn't quite as rigorous there as it is in the U.S., where Tysabri use is governed by a strict risk management program. By contrast, European distribution goes largely unrestricted. Also, Germany reportedly has been lax about making sure patients get completely free of other immunosuppressants before going on Tysabri, among other things. Biogen has been working with German clinics and academic medical centers to change that.

Meanwhile, a researcher at Elan--which discovered the drug--tells Forbes he's working on a diagnostic test that could screen patients for their risk of developing PML (progressive multifocal leukoencephalopathy). Tysabri suppresses the immune system, which can allow a dormant pathogen--the JC virus--to go into overdrive, causing PML. Previously, researchers thought 90 percent or more of us were infected with that virus, but Elan's Ted Yednock says his team has discovered an infection rate of 50 percent.

A diagnostic test could identify those patients who aren't infected, and thus are free and clear for Tysabri treatment. And those who have the virus could be closely monitored for symptoms.

Read more: http://www.fiercepharma.com/story/data-points-out-paths-tysabri-rehab/2009-10-28#ixzz0VOCZAWP3

Story in FiercePharma

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What's new for Multiple Sclerosis in PubMed

Does Functional Electrical Stimulation for Foot Drop Strengthen Corticospinal Connections? - The large increases in MVC and MEP suggest that regular use of a foot-drop stimulator strengthens activation of motor cortical areas and their residual descending connections, which may explain the therapeutic effect on walking speed. - Neurorehabil Neural Repair. 2009 Oct 27. [Epub ahead of print] in PubMed

Cochlear implantation in a profoundly deaf patient who also suffers from multiple sclerosis - a case study. - Cochlear Implants Int. 2009 Oct 26. [Epub ahead of print] in PubMed

A cross-sectional study of bone health in multiple sclerosis. - Patients with multiple sclerosis (MS) often have multiple risk factors for osteoporotic fractures. Many patients with MS with low bone mass or previous fractures are not taking supplemental calcium or vitamin D, suggesting a potential area of improvement in care. - Neurology. 2009 Oct 27;73(17):1394-8. in PubMed

Autologous haematopoietic stem cell transplantation for secondary progressive multiple sclerosis: an exploratory cost-effectiveness analysis. - We conclude that HSCT could potentially achieve an acceptable level of cost-effectiveness. However, caution should be exercised as large, high-quality RCTs comparing HSCT versus mitoxantrone are necessary to validate these findings.Bone Marrow Transplantation advance online publication, 26 October 2009; doi:10.1038/bmt.2009.305. - Bone Marrow Transplant 2009 Oct 26. [Epub ahead of print] in PubMed

The effectiveness of choline citrate infusions monitored by lymphocyte transformation test (LTT) in multiple sclerosis. A new approach to the diagnosis and treatment of the disease. - Neuro Ebdocrinol Lett. 2009 Aug 26;30(3):331-334. [Epub ahead of print] in PubMed

Taking aim at novel vaccines market. - Hum Vaccin. 2009 Oct 4;5(10). [Epub ahead of print] in PubMed

Gene therapy in autoimmune diseases: Challenges and opportunities. - The recent success of Phase I/II clinical trials of gene therapy in rheumatoid arthritis and multiple sclerosis, development of cutting edge technology in target identification, as well as gene delivery systems have now set the stage for a more thorough and vigorous pace in the near future to advance this exciting field. - Autoimmun Rev. 2009 Oct 24. [Epub ahead of print] in PubMed

Autoimmune diseases induced by biological agents A double-edged sword? - In this review, we analyze the clinical characteristics and outcomes of autoimmune diseases developing after biological therapies through a baseline Medline search as one of the objectives of the BIOGEAS project, created by the Spanish Society of Internal Medicine. - Autoimmun Rev. 2009 Oct 22. [Epub ahead of print] in PubMed

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Tuesday, October 27

Biogen's Tysabri Disclosure Policies Raise Questions

NEW YORK (Dow Jones)--Biogen Idec Inc.'s (BIIB) refusal to disclose new cases of a severe brain infection among multiple-sclerosis patients taking its Tysabri drug has raised questions about its disclosure policies.

The Cambridge, Mass., biotech company believes those developments aren't material news because the risk profile for developing progressive multifocal leukoencephalopathy, or PML, is well defined, and providing such information isn't beneficial for patients, physicians or investors unless that profile changes. As the company notes, the drug's label implies a risk rate of one in every thousand patients.

However, knowing the risk rate didn't prevent Biogen shares Friday from dropping more than 7% and shares of Elan Plc (ELN) ??? the drug's co-marketer ??? from falling almost 18% when the number of confirmed PML cases since its 2006 relaunch jumped to 23 from 13.

Some investors and analysts argue that Tysabri's significant role as the key growth driver for the companies makes any such developments vital in making a decision in investing in either company, and should be disclosed accordingly.

"It is hard to understand how they wouldn't have deemed it necessary to communicate such material information as soon as it was available to them," Geoffrey Porges, analyst with Sanford Bernstein, said. "I think the company will have to revisit its disclosure policies in light of this."

News of the sharp increase in PML cases didn't come from Biogen or Elan, neither of which have commented on the figure, but rather from U.S. and European regulators.

Although the companies consult with each other, Biogen takes the lead on releasing information on Tysabri related to MS. Elan's stock is more sensitive to related news because the drug is its biggest seller.

Biogen was keeping Wall Street updated on new cases until July, the third anniversary of Tysabri's relaunch, when it believed the risk profile would be clearer. It hasn't provided any information since that time.

"We are confident we are in full compliance with all disclosure requirements," Biogen spokeswoman Naomi Aoki said.

While the company contends that the PML-related information doesn't help physicians or patients, Morgan Stanley analyst Steven Harr notes that Biogen's decision to stop reporting cases, just as evidence of accelerating risk was developing, may in fact cause increased concern.............

Aoki said the company uses "statistically acceptable measurement of risk" that incorporates the number of patients exposed along with their duration of use.

On a conference call last week, Biogen executives defended the rate, which "even in that third year beyond 24 months, is within the currently implied risk in the label" ......full story in The Wall Street Journal

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Europe to review risk of Biogen/Elan drug Tysabri

BOSTON, Oct. 23 (Reuters) - European regulators said they have begun a review of the multiple sclerosis drug Tysabri in light of 23 reports of a potentially deadly brain infection known as progressive multifocal leukoencephalopathy, or PML, since the drug has been on the market.

Tysabri is made by the U.S. biotechnology company Biogen Idec Inc (BIIB.O) and Elan Corp Plc (ELN.I) (ELN.N) of Ireland. It was temporarily withdrawn from the market in 2005 after being linked with PML. It was reintroduced with stricter safety warnings in July 2006.

The European Medicines Agency said it has initiated the review to discuss any additional measures necessary to ensure the safe use of Tysabri.

Biogen's shares fell 6 percent to $44.45 in early trading while shares of Elan fell nearly 17 percent to $5.36. (Reporting by Toni Clarke, editing by Gerald E. McCormick) ... story in Reuters UK

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Gentle Touch May Aid Multiple Sclerosis Patients

While gripping, lifting or manipulating an object such as drinking from a cup or placing a book on a shelf is usually easy for most, it can be challenging for those with neurological diseases such as multiple sclerosis or Parkinson's, or for people who had a stroke. For them, the tight gripping can cause fatigue, making everyday tasks difficult.

A team of University of Illinois at Chicago physical therapists report this month in the journal Neurorehabilitation and Neural Repair that persons with multiple sclerosis use excessive force when they are lifting objects. In an earlier finding reported in the journal Clinical Neurophysiology, they reported that regaining control and coordination may be as easy as applying a gentle touch to the affected hand from a finger of the opposite hand. .... full story in Medical News Today

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Multiple Sclerosis Researchers To Meet In Boston To Design Largest-Ever Vitamin D Study

On Saturday, October 17, leading MS researchers from around the country will meet at the Hyatt Regency, Boston to evaluate the feasibility of conducting what would be the largest clinical study ever undertaken to explore the role that Vitamin D play in Multiple Sclerosis. The meeting will be led by Dr. Benjamin Greenberg, deputy director of the MS program and director of the new Transverse Myelitis and Neuromyelitis Optica Program at University of Texas Southwestern Medical Center, and is being organized under the auspices of the nonprofit organization Accelerated Cure Project for Multiple Sclerosis.

Vitamin D is of particular interest to MS physicians and researchers, since previous epidemiological and laboratory studies have produced strong evidence that low vitamin D levels may play a role in causing MS. The purpose of this meeting is to discuss the feasibility of designing a large-scale study around vitamin D supplementation to evaluate its potential effects early in the course of the disease. This study would also result in the banking of thousands of additional blood samples into the Accelerated Cure Project's MS sample and data repository for future use in understanding the causes and disease mechanisms of MS.

The Accelerated Cure Project for MS has spent the past three years building the world's largest shared multidisciplinary collection of biological samples and data from people with MS and other demyelinating diseases, as well as control subjects. In addition to supporting individual research efforts around the world with these samples, the Accelerated Cure Project is committed to orchestrating studies such as this one that it believes can "accelerate the cure by determining the cause. ....full story in Medical News Today

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Possible New Underlying Cause Of MS Investigated By Neurologists

Neurologists at the University at Buffalo are beginning a research study that could overturn the prevailing wisdom on the cause of multiple sclerosis (MS).

The researchers will test the possibility that the symptoms of MS result from narrowing of the primary veins outside the skull, a condition called "chronic cerebrospinal venous insufficiency," or CCSVI. (For more details on the study, go to http://www.bnac.net/?page_id=496.) ....full story in Medical News Today

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European Drug Agency To Weigh Risks/Benefits Of Tysabri -- Cites 23 Cases Of PML

Today the EMEA, the European equivalent of the U.S. Food and Drug Administration, released a statement indicating that one of its advisory committees was launching a review of the risks and benefits of Tysabri® (natalizumab, Biogen Idec and Elan Pharmaceuticals) in light of 23 confirmed cases of PML that it says have occurred since the drug has been on the market. PML (progressive multifocal leukoencephalopathy) is a viral infection of the brain that usually leads to death or severe disability. (This number of cases is still within the anticipated frequency of 1 in 1,000 indicated in the drug's labeling.)

Unlike the situation in the U.S, there is no unified risk management strategy in place across Europe for the administration of Tysabri. In the U.S., the drug is administered only to patients registered with the company's TOUCH program.

The National MS Society will follow the European panel's deliberations on the safety of Tysabri and any new thoughts they might have on balancing the risks and benefits of this therapy for people with MS. .... full story in Medical News Today

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26 New Research Projects Launched Totaling $9.2 Million To Propel Multiple Sclerosis Research

The National MS Society has just committed $9.2 million to launch 26 new MS research projects as part of its comprehensive research program and commitment to move research forward. This investment comes despite a challenging economic environ¬ment, and is the latest in the Society's relentless research effort to stop MS, restore function, and end this disease forever.

The new projects include a clinical trial testing a type of physical therapy to improve function in people with progressive MS, and a project searching for gene variations that may explain why MS affects more women than men. Read summaries of all these new projects.

There are FDA-approved drugs that can impact the underlying disease course in people with the more common forms of MS. However, none of these drugs can stop or cure the disease. The National MS Society funded basic research that helped lead to the development of each of these drugs, and continues to be a driving force of MS research. Read more about how far we've come in MS research. .... full story in Medical News Today

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FDA Panel Endorses MS Drug that Improves Walking

WASHINGTON -- An FDA advisory panel has voted to recommend approval of an investigational drug to increase walking speed in patients with multiple sclerosis, despite an increased risk of seizures.

The Peripheral and Central Nervous System Drugs Advisory Committee voted 12 to 1 that Acorda Therapeutic's fampridine (Amaya) was effective, and 10 to 2, with one abstention, that the drug can be used safely.

However, fampridine has a dose-dependent connection to seizures, so the panel voted 12 to 1 that Acorda should test doses lower than the proposed 10 mg twice-daily dosage. .... full story in MedPage Today

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What's new for Multiple Sclerosis in PubMed

Autologous haematopoietic stem cell transplantation for secondary progressive multiple sclerosis: an exploratory cost-effectiveness analysis. - We conclude that HSCT could potentially achieve an acceptable level of cost-effectiveness. However, caution should be exercised as large, high-quality RCTs comparing HSCT versus mitoxantrone are necessary to validate these findings. - Bone Marrow Transplantation advance online publication, 26 October 2009; doi:10.1038/bmt.2009.305. in PubMed

The effectiveness of choline citrate infusions monitored by lymphocyte transformation test (LTT) in multiple sclerosis. A new approach to the diagnosis and treatment of the disease. - Neuro Endocrinol Lett, 2009 Aug 26;30(3):331-334. [Epub ahead of print] in PubMed

Taking aim at novel vaccines market. - The World Vaccine Congress Washington 2009 was held in Chantilly, VA USA April 20-23(rd). The importance of collaboration among academic institutions, industries and philanthropic foundations for developing markets was also emphasized. - Hum Vaccin. 2009 Oct 4;5(10). [Epub ahead of print] in PubMed

Endogenous opioids regulate expression of experimental autoimmune encephalomyelitis: a new paradigm for the treatment of multiple sclerosis. - These results imply that endogenous opioids, evoked by treatment with LDN and acting in the rebound period from drug exposure, are inhibitory to the onset and progression of EAE, and suggest that clinical studies of LDN are merited in MS and possibly in other autoimmune disorders. - Exp Biol Med (Maywood). 2009 Nov;234(11):1383-92. in PubMed

Gene Therapy in Autoimmune Diseases: Challenges and Opportunities. - The recent success of Phase I/II clinical trials of gene therapy in rheumatoid arthritis and multiple sclerosis, development of cutting edge technology in target identification, as well as gene delivery systems have now set the stage for a more thorough and vigorous pace in the near future to advance this exciting field. - Autoimmun Rev. 2009 Oct 22. [Epub ahead of print] in PubMed

[Wilson's disease and multiple sclerosis :] - Although Wilson's disease and multiple sclerosis are known as distinct diseases with a completely different pathophysiology, symptoms and results of evoked potentials overlap, and they share a common historic background. Similarities and differences of both disorders are discussed. - Nervenarzt. 2009 Oct 23. [Epub ahead of print] in PubMed

Rituximab in patients with primary progressive multiple sclerosis: Results of a randomized double-blind placebo-controlled multicenter trial. - Although time to CDP between groups was not significant, overall subgroup analyses suggest selective B-cell depletion may affect disease progression in younger patients, particularly those with inflammatory lesions. - Ann Neurol 2009;66:460-471. in PubMed

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Sunday, August 2

Dirucotide Does Not Meet Primary Endpoint In Phase III MAESTRO-01 Trial In Secondary Progressive Multiple Sclerosis

Eli Lilly and Company (NYSE: LLY) and BioMS Medical Corp. (TSX: MS) announced that dirucotide did not meet the primary endpoint of delaying disease progression, as measured by the Expanded Disability Status Scale (EDSS), during the two-year MAESTRO-01 Phase III trial in patients with secondary progressive multiple sclerosis (SPMS). In addition, there were no statistically significant differences between dirucotide and placebo on the secondary endpoints of the study.

The data also showed that dirucotide was generally well tolerated. There were no unexpected safety or tolerability issues. The most common side effect reported was injection site reaction. More details of the MAESTRO-01 study results are expected to be presented at a medical conference later this year. ... full report in Medical News Today

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MS Society Responds To Debbie Purdy Ruling - Clarification On The Law Of Assisted Suicide, UK

The MS Society has responded to today's Law Lords ruling concerning the case of Debbie Purdy, who has sought clarification on the law of assisted suicide.

Debbie, 46, who was diagnosed with Primary Progressive multiple sclerosis (MS) in 1995, wanted to be assured that her husband would not be prosecuted on his return to the UK, if he accompanies her to the Dignitas clinic in Switzerland.

It is now thought that the Law Lords will ask the Director of Public Prosecutions to set out when prosecutions would happen.

Simon Gillespie, Chief Executive of the MS Society, said: "Debbie Purdy's victory has pushed MS into the spotlight but there is far more to living with MS - even in its more severe forms - than planning how to die. "

There are 100,000 people with MS across the UK and most will live about as long as any of us. The key to living well with MS is access to the right care and support, including palliative care when it's needed.

"Most palliative care resources are focused on cancer and cases like this show why the Government's end of life care strategy is so important." ... full report in Medical News Today

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Cognitive Testing, Gender And Brain Lesions May Predict MS Disease Progression Risk

Cognitive testing may help people with inactive or benign multiple sclerosis (MS) better predict their future with the disease, according to a study published in the July 29, 2009, online issue of Neurology®, the medical journal of the American Academy of Neurology. Gender and brain lesions may also determine the risk of progression of MS years after diagnosis.

By current definition, people with benign MS are those who remain "fully functional" after 15 or more years from disease onset. However, people with benign MS occasionally develop renewed disease activity or progression, and can experience severe symptoms. .... full report in Medical News Today

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What's new for "Multiple Sclerosis" in PubMed

Gender disparity in the rate of partner abandonment in patients with serious medical illness. - Female gender was found to be a strong predictor of partner abandonment in patients with serious medical illness. When divorce or separation occurred, quality of care and quality of life were adversely affected. - Cancer. 2009 Jul 30. [Epub ahead of print] in PubMed

[Quality as management tool. Actions to improve efficiency in neurological care.] - The changes in clinical practice to improve the quality of care have been associated with improvements in the efficiency indicators but not in patient satisfaction. The improvement in the perceived quality probably requires specific actions. - Neurologia. 2009 Jun;24(5):292-296. in PubMed

Neuropsychological and MRI measures predict short-term evolution in benign multiple sclerosis. - Cognitive assessment and MRI metrics can predict short-term disease evolution in benign multiple sclerosis (B-MS). This information can be useful to correctly identify patients with B-MS. - Neurology. 2009 Jul 29. [Epub ahead of print] in PubMed

In vivo imaging of cortical pathology in multiple sclerosis using ultra-high field MRI. - Seven-tesla MRI detected different histologic cortical lesion types in our small multiple sclerosis (MS) sample, suggesting, if validated in a larger population, that it may prove a valuable tool to assess the contribution of cortical MS pathology to clinical disability. - Neurology. 2009 Jul 29. [Epub ahead of print] in PubMed

Risk of deep venous thrombosis (DVT) in bedridden or wheelchair-bound multiple sclerosis patients: A prospective study. - Thromb Res. 2009 Jul 27. [Epub ahead of print] in PubMed

One-Dimensional-Ratio Measures of Atrophy Progression in Multiple Sclerosis as Evaluated by Longitudinal Magnetic Resonance Imaging. - All four normalized ratios showed uniform atrophy progression, suggesting a consistent rate of atrophy over long-term disease duration independent of MS course. Disability status correlated with 1D measures, suggesting that serial evaluation of Evans and bifrontal ratios might contribute to the radiological evaluation of MS patients. - Acta Radiol. 2009 Jul 28:1-9. [Epub ahead of print] in PubMed

A Comparison of Mood and Quality of Life Among People with Progressive Neurological Illnesses and Their Caregivers. - The findings suggest that educational and intervention programs need to be developed to help both patients and their caregivers to adjust and cope with these illnesses, particularly caregivers of people with MND and HD. - J Clin Psychol Med Settings. 2009 Jul 29. [Epub ahead of print] in PubMed

Epstein-Barr virus infection is not a characteristic feature of multiple sclerosis brain. - Our finding that CNS EBV infection was rare in multiple sclerosis brain indicates that EBV infection is unlikely to contribute directly to multiple sclerosis brain pathology in the vast majority of cases. - Brain. 2009 Jul 28. [Epub ahead of print] in PubMed

Addressing the need for increased adherence to multiple sclerosis therapy: can delivery technology enhance patient motivation? - Few studies have directly addressed adherence to MS therapy and further clarification is required. Adjustments to drug formulation, provision of patient education and improvements to injection devices may all contribute indirectly to improved adherence in the future. - Expert Opin Drug Deliv. 2009 Jul 29. [Epub ahead of print] in PubMed

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Wednesday, July 29

Judge: Ill Franklin man charged with growing marijuana can't tell jury about medical use

SOMERSET COUNTY — John Ray Wilson was diagnosed with multiple sclerosis in 2002, had no health insurance and was unable to afford drugs to treat the disease, according to his attorney.

So Wilson, now 36, sought natural alleviation from the pain with a therapy involving the use of substances including bee venom and marijuana, the attorney said.

Wilson started growing his own marijuana, according to court documents, but his plan fell apart.

On Aug. 18, 2008, a helicopter pilot spotted his marijuana patch on Skillmans Lane in Franklin behind his rented home and township detectives arrested him, authorities said.

The 17 marijuana plants they confiscated, some 6 feet tall, brought Wilson a charge of operating a drug manufacturing facility, an offense that can bring up to a 20-year prison sentence if there's a conviction.

Under a judge's ruling in Superior Court, Somerville, on Monday, a jury won't hear Wilson's account of why he grew the marijuana.

Judge Robert Reed ruled that Wilson cannot use his medical condition as a defense or mention it to a jury. The reason follows the argument that led to the rejection of Wilson's motion for the dismissal of the indictment.

Since there is no legislatively permitted exemption for personal use in operating a drug manufacturing facility it cannot be used as a legitimate defense, state Deputy Attorney General Russell Curley argued and Reed agreed.

Mentioning multiple sclerosis would amount to an emotional appeal to the jury, Curley argued.
Reed wrote in his opinion that medical marijuana is a matter for lawmakers.

"If medical marijuana use is to be recognized to an exemption from our criminal law, the legislative process must produce that result," Reed wrote. "Defendant's assertion of a personal use defense is not permitted under our present law."

Allowing medical marijuana use for certain patients is being weighed by the state Legislature.

The most recent version of a bill permitting it, which cleared an Assembly committee in June, recognizes multiple sclerosis as a qualifying disease, but would not allow patients to grow their own. ... full story in My Central Jersey

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Does Eating Animal Brains Cause Multiple Sclerosis?

A case-control study to investigate possible risk factors for MS in Brazilian people found that individuals who had consumed animal brains were 3.4 times more likely to have MS than people who had never eaten animal brains.

Honestly, I do not know what is going on here, but it is an interesting question to ponder. Interestingly, a Mexican study did not find an association between eating cow or pig brains and MS risk. ... full story and comments in About.com: Multiple Sclerosis

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Cooking for your health Good nutrition tastes better than you think

We all know we should eat healthy — lower our intake of fat and salt, avoid junk food and empty calories. A healthy diet adds years to our lives, increases mental sharpness, lowers cholesterol, creates energy, gives us glowing skin and hair, and helps us maintain a healthy weight.

Good nutrition is about giving your body what it needs and if you have a health problem, nutrition is an essential element in how your feel from day to day.

Changing your eating habits is not a simple thing. It takes commitment to stick to a plan and say no to foods you love. But you don't have to give up everything and don't feel guilty if you slip now and then. As your habits change and you see how much better you feel, you will be more motivated to stick with it. ... full story in kdhnews.com Killeen Daily News

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11th Tysabri Patient Develops PML

An 11th patient taking Biogen Idec's multiple sclerosis (MS) drug Tysabri has developed a potentially deadly brain infection.

In the latest confirmed case of progressive multifocal leukoencephalopathy, or PML, the patient took Tysabri for 29 doses, continuing the trend of the last six reported cases of the infection, where each patient had therapy for two years or longer.

The latest patient was located in the USA, the third American to have developed the infection. Of the 11 reported cases, one patient has died.

The PML incidence rate remains below the long-projected risk rate of one in 1,000 patients for those patients receiving the therapy for 12 months or 18 months.

The drug was temporarily withdrawn in 2005 after it was linked with PML, but was then brought back in 2006 with stricter safety warnings.

Tysabri continues to receive strong support from patients and doctors, however, because of the drug's perceived effectiveness. That support has remained steady because patients are made well-aware of the PML risk before they start taking Tysabri for MS.

This is the last case of PML that the company plans to announce on its website. In future any new cases will be reported by word of mouth to medical professional and patient groups. .... full report in Medical News Today

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Diabetes Drug Shows MS Potential

A small trial testing the benefits in multiple sclerosis (MS) of a drug used to treat type II diabetes, in combination with beta-interferon-1a, has been shown to potentially prevent brain cell loss.

The results of the trial in 21 people investigating the effects of pioglitazone (also known as Actos) were published last month in the Journal of Neuroimmunology.

Although the results of the trial showed some evidence of less damage in the brains of people with MS, there were too few people in the study to determine whether this effect was real.

Dr. Susan Kohlhaas, Research Communications Officer at the MS Society said, "These results suggest that pioglitazone may have some benefit in combination with beta-interferon for people with relapsing remitting MS, but this trial is not large enough to determine exactly what that benefit will be.

She added, "A larger clinical trial is needed to decide whether or not pioglitazone will be of benefit to people with MS." .... frull report in Medical News Today

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Experimental MS Drug Withdrawn From Trial

An experimental treatment for multiple sclerosis (MS) has been withdrawn from clinical trials after it failed to delay progression of the condition in a late-stage trial.

Dirucotide, manufactured by Eli Lilly and Co and BioMS Medical Corp, had earlier failed to meet a main goal in a mid-stage study, which tested whether the drug prevented symptoms returning among patients with relapsing remitting MS.

The drugmakers, which have been collaborating since late 2008 on dirucotide, said the latest negative results were seen in a study of the drug that involved 612 patients with secondary progressive (MS).

Patients in the study were divided into groups that received either dirucotide or a placebo intravenously every six months for two years.

In addition to failing its primary goal of delaying the time it took for the condition to worsen in patients, the drug also failed a number of secondary goals.

"We are obviously disappointed by this result and will be working closely with our clinical team to evaluate these data," BioMS Medical Chief Executive Kevin Giese said in a statement. report in Medical News Today

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Mercury In Dental Fillings Not Harmful But Still Subject To Control, FDA Rules

The US Food and Drug Administration (FDA) issued a final regulation today, Wednesday, saying that at the levels dentists use for tooth cavity filling, elemental mercury in dental amalgam does not harm patients, although adverse health effects are known to occur at higher exposures.

Dental amalgam is made by combining mercury with other metals such as silver, copper and tin.

Under the new regulation, dental amalgam is classified as Class II, denoting moderate risk. Devices in Class II can be made subject to special FDA safety and effectiveness controls (in addition to the manufacturing standards required of all medical devices regardless of their risk level).

The announcement has received a mixed response. While the American Dental Association said they agreed with the FDA decision, a consumer group that is against using mercury in dental fillings said it showed contempt for children and the unborn. ... full report in Medical News Today

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Neurologic Complications Seen with Swine Flu

LITTLE FALLS, N.J., July 23 -- Clinicians encountering children with flu-like symptoms accompanied by neurologic symptoms should consider infection with the pandemic H1N1 (swine flu) virus in the differential diagnosis, researchers said.

Since April, the Dallas County health department has detected four cases of neurological complications in children with confirmed H1N1 infection, Jane Siegel, MD, of the University of Texas Southwestern Medical Center in Dallas, and colleagues reported in the July 24 issue of Morbidity and Mortality Weekly Report.

When encountering children with flu-like symptoms and unexplained seizures or mental status changes, clinicians should begin antiviral treatment immediately -- especially in hospitalized patients -- and send specimens for viral testing, the researchers said.

Neurological complications, including seizures, encephalitis, encephalopathy, and Reye syndrome, had previously been associated with seasonal influenza viruses but had not yet been described in connection to the new pandemic strain. ... full report in MedPage Today

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Improved Way to Identify 'Benign' MS Suggested

WHEELING, W.Va., July 29 -- Regular neurocognitive screening and MRI scans may be able to spot patients with so-called benign multiple sclerosis who will soon develop significant disabilities, researchers said.

Among 63 patients diagnosed with benign MS at baseline, 29% developed disabling symptoms during mean follow-up of five years, reported Maria Pia Amato, MD, of the University of Florence, Italy, and colleagues online in Neurology.

They found that T1-weighted brain lesion volume detected on MRI scans, the number of neurocognitive tests failed at baseline, and male gender, were each significantly predictive of disease progression.

A model combining all three predictors distinguished those who progressed with an accuracy of 82%, the researchers reported. ... full report in MedPage Today

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What's new for "Multiple Sclerosis" in PubMed

Optical coherence tomography helps differentiate neuromyelitis optica and MS optic neuropathies. - Optical coherence tomography (OCT) shows more severe retinal damage after optic neuritis (ON) episodes in neuromyelitis optica (NMO) than in relapsing-remitting multiple sclerosis. Identification of substantial retinal nerve fiber layer loss (>15 mum) after ON in a non-multiple sclerosis patient should prompt consideration of an NMO spectrum condition. OCT may be a useful tool for the evaluation of patients with NMO. - Neurology. 2009 Jul 28;73(4):302-8. in PubMed

A population-based case-control study on viral infections and vaccinations and subsequent multiple sclerosis risk. -The aim of the present study was to clarify whether these infections or vaccinations, and two other infections, varicella and infectious mononucleosis, influence MS risk. We performed a population-based case-control study in Gothenburg that included 509 MS cases and 2,067 controls, born 1959-1986. - Eur J Epidemiol. 2009 Jul 26. [Epub ahead of print] in PubMed

MRI characteristics of patients with antiphospholipid syndrome and multiple sclerosis. - Therefore, the aim of this study was to investigate the differences in MRI measures among patients with PAPLS, MS and normal control (NC) subjects. We also explored non-conventional MRI measures in APLA+ and APLA- MS patients. - J Neurol. 2009 Jul 26. [Epub ahead of print] in PubMed

B-type natriuretic peptide as a marker of subclinical heart injury during mitoxantrone therapy in MS patients-Preliminary study. - The aim of this study was to evaluate the plasma level changes of B-type natriuretic peptide (BNP), biochemical marker of heart failure, and echocardiographic parameters during mitoxantrone treatment in 22 multiple sclerosis (MS) patients (8 males, 14 females, mean age 37.1+/-6.6). - Clin Neurol Neurosurg. 2009 Jul 24. [Epub ahead of print] in PubMed

Complementary and alternative medicines and dietary interventions in multiple sclerosis: what is being used in South Australia and why? - This study reports frequent use of CAM/dietary intervention amongst SA people with MS. The majority of users did so in conjunction with conventional treatments. - Complement ther Med. 2009 Aug;17(4):216-23. Epub 2009 Apr 21. in PubMed

Potential of a unique antibody gene signature to predict conversion to clinically definite multiple sclerosis. - If confirmed, signature prevalence would be a novel genetic diagnostic tool candidate for patients with early demyelinating disease of the central nervous system. - J Neuroimmunol. 2009 Jul 22. [Epub ahead of print] in PubMed

Matrix metalloproteinase-9 genotypes and haplotypes are associated with multiple sclerosis and with the degree of disability of the disease. - J Neuroimmunol. 2009 Jul 22. [Epub ahead of print] in PubMed

Breaking bad news: Communication around parental multiple sclerosis with children. - This study investigates the relation of communication around parental multiple sclerosis (MS) to family dysfunction and mental health problems of the children in Greek families. - Fam Syst Health. 2009 Mar;27(1):64-76. in PubMed

Killer immunoglobulin-like receptor ligand HLA-Bw4 protects against multiple sclerosis. -Carriage of the ligand of the inhibitory KIR3DL1 receptor, HLA-Bw4, was found to protect against MS in an HLA-DRB1 independent manner. - Ann Neurol. 2009 Mar 18;65(6):658-666. [Epub ahead of print] in PubMed

Activities of the enzymes that hydrolyze adenine nucleotides in platelets from multiple sclerosis patients. - Our results suggest that the alterations in NTPDase, E-NPP, 5'-nucleotidase and ADA may have contributed to the alterations in platelet function in MS by altering the levels of nucleotides and nucleosides in the circulation. -J Neurol. 2009 Jul 24. [Epub ahead of print] in PubMed

Parent-of-origin of HLA-DRB1*1501 and age of onset of multiple sclerosis. - J Hum Genet. 2009 Jul 24. [Epub ahead of print] in PubMed

PARP-1 deficiency increases the severity of disease in a mouse model of multiple sclerosis. - Together, our results indicate that PARP-1 plays an important role in regulating the physiological immune composition and in immune modulation during EAE, and our finding identifies a new aspect of immune regulation by PARPs in autoimmune CNS pathology. - J Biol Chem. 2009 Jul 23. [Epub ahead of print] in PubMed

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Sunday, July 26

Facts and Myths about Generic Drugs

Today, 7 in 10 prescriptions filled in the United States are for generic drugs. This fact sheet explains how generic drugs are made and approved and debunks some common myths about these products. .... F.D.A. - U.S. Department of Health and Human Services

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Biogen Reports New PML Case In Final Weekly Tysabri Update

NEW YORK (Dow Jones)--Biogen Idec Inc. (BIIB) reported another case of a rare brain infection in users of the multiple sclerosis drug Tysabri in the company's final weekly update Friday.

The latest patient represents the 11th case of progressive multifocal leukoencephalopathy, or PML, since the drug's relaunch in July 2006 and the fourth announced over the past seven updates. Tysabri - sold with Ireland's Elan Corp. (ELN) - was pulled from the U.S. market in 2005 because of PML concerns.

The total amount of cases remains below the risk rate on Tysabri's label, Biogen has said. However, the recent increase raises questions as to whether now is the time to stop the updates and adds to concerns that patients may stop taking Tysabri for a time to avoid developing the infection.

Duration of therapy is believed to play a role in Tysabri's PML risk, but such breaks - referred to as "drug holidays" - are opposed by Biogen and could hurt sales of a key growth driver for the company.

In the latest confirmed case, the patient took Tysabri for 29 doses, continuing a trend as those in the last six reported cases have each had therapy for two years or longer.

The latest patient was located in the U.S. This is notable because it's only the third such U.S. patient. Eight of the previous 10 cases have occurred overseas, and it's unknown why that has been the case.

The PML incidence remains below the long-projected risk of one in 1,000 patients developing the infection. After the previous case, a Jefferies & Co. research note last month put the revised PML incidence at one in 2,490 after 12-month Tysabri therapy; one in 1,400 after 18-month therapy; and one in 680 after 24-month therapy.

Tysabri receives strong support from patients and doctors because of the drug's perceived effectiveness. That support has remained steady because patients are well-aware of the PML risk before they start taking Tysabri for the otherwise debilitating disease of MS.

Nonetheless, the number of PML cases has frustrated Biogen's aim of making Tysabri into a blockbuster drug. The company has invested in treatments for PML and ways to mitigate the infection - once thought to be almost always fatal - and in persuading doctors that PML's risk in Tysabri patients is less severe and less likely. Of the 11 confirmed cases since the relaunch, one has died.

Biogen began issuing weekly updates in January after receiving criticism for its previous policy of disclosing new cases through 8-K filings with the Securities and Exchange Commission. From the start, Biogen had determined July 24 would be the final date because it was around the third anniversary of Tysabri's relaunch, by which time the company expected the risk/benefit profile to be clearer.

Tysabri was pulled from the U.S. market in 2005 after three initial cases, including two deaths.

The Food and Drug Administration allowed Tysabri to be reintroduced in 2006 because of the drug's effectiveness in fighting the degenerative disease, and under monitoring rules and a prohibition on using it in combination with other MS drugs. The system was aimed at reducing PML incidence.

Wall Street Journal

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Dangerous Devic's Disease, Attacks Nervous System and Spinal Cord - Is there any Cure?

Devic’s Syndrome is a disease that is related to multiple sclerosis and lupus, but is unique in that it presents itself before MS and lupus and it progresses much more rapidly. Devic’s Disease targets and affects the optic nerves, the sheath of the spinal cord, and causes in continence. .. more info in My Channel News

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Merck KGaA Submits Application For Cladribine Tablets As Multiple Sclerosis Therapy In Europe

Merck KGaA announced the submission of a marketing authorization application (MAA) to the European Medicines Agency (EMEA) for Cladribine Tablets, Merck's proprietary investigational oral formulation of cladribine, as a therapy for patients with relapsing-remitting multiple sclerosis (MS). Cladribine Tablets could become the first orally administered disease-modifying therapy available for patients with MS, as all disease-modifying therapies currently approved for the treatment of MS are injectable."

The submission of Cladribine Tablets to the EMEA brings us closer to the possibility of providing an oral short-course treatment to patients with multiple sclerosis and underscores our commitment to provide new options for the management of relapsing-remitting multiple sclerosis," said Roberto Gradnik, Executive Vice President Commercial Europe of the division Merck Serono. "We look forward to working with the EMEA and the European member states' authorities." The MAA submission is supported by results from the CLARITYa study, a two-year, randomized, double-blind, placebo-controlled Phase III trial of Cladribine Tablets in patients with relapsing-remitting MS. The CLARITY data were presented at the 61st Annual Meeting of the American Academy of Neurology (AAN) in April 2009 and at the 19th Meeting of the European Neurological Society (ENS) in June 2009.

Merck is currently submitting new drug applications for Cladribine Tablets in several other countries, including the United States in the current quarter. ... full report in Medical News Today

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Advances In Lab-Grown Motor Nerves Can Lead To Cures For Diabetic Neuropathy And Help Further Understand Multiple Sclerosis And Related Conditions

In the July issue of Biomaterials, published by Elsevier, researchers from the University of Central Florida (UCF) report on the first lab-grown motor nerves that are insulated and organized just like they are in the human body. The model system will drastically improve understanding of the causes of myelin-related conditions, such as diabetic neuropathy and later, possibly multiple sclerosis (MS). In addition, the model system will enable the discovery and testing of new drug therapies for these conditions.

MS, diabetic neuropathy, and many conditions that are caused by a loss of myelin, which forms protective insulation around our nerves, can be debilitating and even deadly. Adequate treatments do not yet exist. Researchers at the UCF have identified this to be a result of a deficiency in model research systems. ...full story in Medical News Today

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Functional Gene Mutation Associated with RLS Identified

WHEELING, W.Va., July 24 -- Sequencing of two genes associated with restless legs syndrome (RLS) revealed a functional mutation in some patients with the condition -- the first ever found, researchers said.

The mutation was found in the MEIS1 gene, a member of the homeobox gene family thought to play a critical role in development, reported Carles Vilariño-Güell, PhD, of the Mayo Clinic in Jacksonville, Fla., and colleagues in the July issue of Neurology.

Although the mutation appears to be rare, even among RLS patients, it was found in all affected members of one family, suggesting a causative role. ...full report in MedPage Today

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'Stigmatizing' Illness Is No Bar to Patient Cooperation in Research

WHEELING, W.Va., July 24 -- Patients with diseases that may expose them to discrimination were surprisingly willing to allow their personal and health information to be used for research purposes, researchers said.

Writing in the online journal BMC Medical Ethics, Dr. Willison and colleagues said fewer than 5% of such patients would refuse participation altogether and about 20% would demand specific permission for each use in studies like this.

On the other hand, patients were more likely to balk when the research was sponsored by for-profit companies or was intended for marketing purposes.

"Individual attitudes -- and concern about disclosure in particular -- were more predictive of consent choice than was one's health condition," the researchers wrote. .....full report in MedPage Today

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What's new for "Multiple Sclerosis" in PubMed

Prediction of acute multiple sclerosis relapses by transcription levels of peripheral blood cells. - We conclude that gene expression analysis is a valuable tool that can be used in clinical practice to predict future MS disease activity. Similar approach can be also useful for dealing with other autoimmune diseases that characterized by relapsing-remitting nature. - BMC Med Genomics. 2009 Jul 22;2(1):46. [Epub ahead of print] in PubMed

Suspected multiple sclerosis - what to do? Evaluation of a patient information leaflet. - Taken together, our findings demonstrate that early information about possible MS is warranted by patients and does not show negative side effects. Further studies on evidence-based patient information in early MS seem necessary. - Mult Scler. 2009 Jul 22. [Epub ahead of print] in PubMed

Multiple sclerosis risk: interaction between human leukocyte antigen and the environment in Sardinian population. - In the Sardinian population, an environment more prone and propitious to autoimmunity may contribute toward the rising incidence of MS or anticipate overt manifestation of the disease in genetically predisposed subjects. - Mult Scler. 2009 Jul 22. [Epub ahead of print] in PubMed

Foreign accent syndrome as a first sign of multiple sclerosis. - FAS may be the first symptom of MS. It could result from extensive disturbances of brain function involving the right hemisphere. - Mult Scler. 2009 Jul 22. [Epub ahead of print] in PubMed

Follow-up examination of linkage and association to chromosome 1q43 in multiple sclerosis. - We found preliminary evidence to suggest that common variation within the RGS7 locus may be involved in disease susceptibility. - Genes Immun. 2009 Jul 23. [Epub ahead of print] in PubMed

PARP-1 deficiency increases the severity of disease in a mouse model of multiple sclerosis. - Together, our results indicate that PARP-1 plays an important role in regulating the physiological immune composition and in immune modulation during EAE, and our finding identifies a new aspect of immune regulation by PARPs in autoimmune CNS pathology. - J Biol Chem. 2009 Jul 23. [Epub ahead of print] in PubMed

Parent-of-origin of HLA-DRB1*1501 and age of onset of multiple sclerosis. - J Hum Genet. 2009 Jul 24. [Epub ahead of print] in PubMed

Activities of the enzymes that hydrolyze adenine nucleotides in platelets from multiple sclerosis patients. - Our results suggest that the alterations in NTPDase, E-NPP, 5'-nucleotidase and ADA may have contributed to the alterations in platelet function in MS by altering the levels of nucleotides and nucleosides in the circulation. - J Neurol. 2009 Jul 24. [Epub ahead of print] in PubMed

Killer immunoglobulin-like receptor ligand HLA-Bw4 protects against multiple sclerosis. - Carriage of the ligand of the inhibitory KIR3DL1 receptor, HLA-Bw4, was found to protect against MS in an HLA-DRB1 independent manner. - Ann Neurol. 2009 Mar 18;65(6):658-666. [Epub ahead of print] in PubMed

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Thursday, July 23

The Right Messenger For A Healthy Immune Response

ScienceDaily (July 20, 2009) — Researchers from the Molecular Immunology group at the Helmholtz Centre for Infection Research (HZI) in Braunschweig, Germany have now shown that Beta-Interferon also plays a crucial role during an immune response: without Beta-Interferon immune cells are unable to show "wanted posters" of pathogens to other cells. As a consequence, these cells will not recognize the pathogen and the immune response does not start properly. ...read the full story in Science Daily

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First Model Motor Nerve System That's Insulated And Organized Like Human Body

ScienceDaily (July 22, 2009) — Researchers from the University of Central Florida (UCF) report on the first lab-grown motor nerves that are insulated and organized just like they are in the human body. The model system will drastically improve understanding of the causes of myelin-related conditions, such as diabetic neuropathy and later, possibly multiple sclerosis (MS). In addition, the model system will enable the discovery and testing of new drug therapies for these conditions. ...read the full story in Science Daily

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‘Biosimilars’ Are ‘Biodifferent’

'Biosimilar drugs are too dis-similar for fast-tracking'

WASHINGTON -- Hidden in the congressional fireworks bursting over health-care overhaul and cap-and-trade is another highly contentious consumer issue centered on a unique class of drug used to alleviate pain associated with the worst kinds of diseases, including multiple sclerosis and cancer.

The class of drugs at the center of the argument is biologics -- biologically produced drugs – and the legislative issue centers on how quickly biologics should be approved and moved to market. Congress faces a balancing act between maintaining product safety that comes from rigorous testing on one side, and on the other, fast-track approval to get generic copies of biologics to patients quickly.

The New York Times is the latest to explore the issue, July 22, 2009 in this article:
http://www.nytimes.com/2009/07/22/business/22biogenerics.html?hpw

Following commentary argues that biologics are too complex to be given quick passage through the FDA’s testing process.

By Dr. Richard Dolinar

“Biologics,” or biologically produced drugs, constitute a huge and growing segment of the medical marketplace. They include insulin and many vaccines.

In 2008, more than 600 new biotechnology medicines, for more than 100 diseases, were in development in the United States. More than 300 other biologics already had been approved for use by the federal Food and Drug Administration.

Because biologics are used to treat a wide range of diseases, including cancer, multiple sclerosis, and rheumatoid arthritis, legislators and medical professionals are interested in bringing less-costly “generic” versions to the marketplace. A bill proposed by Rep. Henry Waxman (D-CA), the Promoting Innovation and Access to Life-Saving Medicine Act (HR 1427), would allow for the manufacture and distribution of “biosimilars,” or generic biologic drugs, following standards similar to those governing generic chemical drugs.

In 1984, the Drug Price Competition and Patent Term Restoration Act, sponsored by Waxman and then-Rep. Orrin Hatch (R-UT), created an abbreviated approval process for generic chemical drugs.

Because the active ingredients in chemical generics are identical to those in the “innovator drugs,” or original name-brand medicines, it was possible to establish an approval process allowing generic manufacturers to piggyback on the research studies provided by the innovator companies. The ability to manufacture drugs that already had been extensively tested hastened the generic drugs’ entry into the marketplace, saving both time and money.

When chemical reactions are performed, the result is always the same. For instance: combining two hydrogen molecules with one of oxygen always produces water.

But that’s not the case with biologics, which are “grown” (biologically engineered), not created by a simple chemical reaction (e.g. Lipitor and Prozac). No two biologics created using different cell lines or different manufacturing processes ever turn out exactly the same.

That’s the problem with HR 1427. In mirroring the guidelines for generic chemical drugs, Waxman’s new bill assumes the copies of biologics made by follow-on manufacturers—though admittedly not identical—will be close enough to the originals to make extensive product testing before release unnecessary.

What is close enough for government work is not necessarily close enough for the treatment of patients. Small differences in drugs can have very profound effects on the body. Because biologics are huge, complex entities, predicting how small changes in them will affect safety, efficacy, and immunogenicity is not possible.

Perhaps follow-on biologics should be called “biodifferent” rather than “biosimilar.” It is the differences that are of concern, not the similarities. These differences, no matter how minute, can have major implications for patients.

Physicians and patients need to be confident that any biosimilar approved by the FDA has been subjected to the same rigorous clinical testing as the innovator drug. Waxman’s bill would not provide that security.

Dr. Richard Dolinar (drdolinar@dolinar.org ) is a practicing endocrinologist, has consulted for pharmaceutical companies, and is a senior fellow for health care policy at The Heartland Institute.

Read in The Heartland Institute

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Advances In Lab-Grown Motor Nerves Can Lead To Cures For Diabetic Neuropathy And Help Further Understand Multiple Sclerosis And Related Conditions

In the July issue of Biomaterials, published by Elsevier, researchers from the University of Central Florida (UCF) report on the first lab-grown motor nerves that are insulated and organized just like they are in the human body. The model system will drastically improve understanding of the causes of myelin-related conditions, such as diabetic neuropathy and later, possibly multiple sclerosis (MS). In addition, the model system will enable the discovery and testing of new drug therapies for these conditions.

MS, diabetic neuropathy, and many conditions that are caused by a loss of myelin, which forms protective insulation around our nerves, can be debilitating and even deadly. Adequate treatments do not yet exist. Researchers at the UCF have identified this to be a result of a deficiency in model research systems. ....full report in Medical News Today

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NIH Deepens Investment In Combination Study Of MS Drugs

The first large-scale "CombiRX" clinical trial testing the combined use of FDA-approved interferon beta-1a (Avonex®) and glatiramer acetate (Copaxone®) to treat relapsing-remitting MS has just received a $19-million renewal grant from the National Institutes of Health. This is the largest MS trial ever supported by the NIH, with a cumulative investment of more than $44 million. The long-term trial is led by principal investigator Fred Lublin, MD, (Corinne Goldsmith Dickinson Multiple Sclerosis Center at Mount Sinai School of Medicine, New York, NY).

The study is now fully enrolled, with more than 1,000 participants at 67 medical centers across the United States and Canada. Dr. Lublin is a member of the National Board of Directors of the National MS Society and the Society's National Clinical Advisory Board and the New York City Chapter Clinical Advisory Committee. ....full report in Medical News Today

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What's new for "Multiple Sclerosis" in PubMed

Diffusion tensor imaging of the cervical spinal cord of patients with relapsing-remising multiple sclerosis: a study of 41 cases. - We observed reduced fractional anisotropy in the demyelinating plaques and in the NASC of MS patients, corroborating the hypothesis that the histological extension of the MS lesions is more severe than the abnormalities seen in the conventional MRI sequences. - Arq Neuropsiquiatr. 2009 Jun;67(2B):391-5. in PubMed

Executive function and memory in patients with relapsing-remitting multiple sclerosis. - In contrast to the well known sensitive/motor deficits, the cognitive dysfunction has only been analyzed in the last few decades. - Psicothema. 2009 Aug;21(3):416-20. in PubMed

[Energy-saving strategies in the treatment of fatigue in patients with multiple sclerosis. A pilot study.] - Rev Neurol. 2009 Aug 16-31;49(4):181-5. in PubMed

The impact of regular physical activity on fatigue, depression and quality of life in persons with multiple sclerosis. - The participation in regular physical activity may positively influence fatigue, depression and quality of life scores in persons with MS. - Health Qual Life Outcomes. 2009 Jul 20;7(1):68. [Epub ahead of print] in PubMed

Injection anxiety remains a long-term barrier to medication adherence in multiple sclerosis. - Sustained adherence to DMT remains a challenge for a subset of individuals with MS well beyond the initial period of acclimation. Injection anxiety is an important and promising target of psychological intervention during all periods of medication use. - Rehabil Psychol. 2009 Feb;54(1):116-21. in PubMed

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Tuesday, July 21

Elan revenues up 14% in Q2

Pharmaceutical firm Elan has announced that its revenues rose by 14% ($66m) to $526m in the second quarter of the year.

The company attributed the increase to a 30% rise in income from Tysabri, which is used to treat multiple sclerosis and Crohn's disease, and a 10% increase in revenues from Elan Drug Technologies.

Commentinng on the results, Elan executive vice-president and chief financial officer Shane Cooke said that there had been a 55% increase in the net number of patients using Tysabri since the first quarter. ..full story in RTE Business

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What's new for 'Multiple Sclerosis' in PubMed

Differential micro RNA expression in PBMC from multiple sclerosis patients. - This work highlights the importance of miRNA expression in the molecular mechanisms implicated in the disease. Moreover, the proposed involvement of these small molecules in multiple sclerosis opens up a new therapeutic approach to explore and highlight some candidate biomarker targets in MS. - PLoS One. 2009 Jul 20;4(7):e6309. in PubMed

What multiple sclerosis could bring to cognitive neuroscience? - The early disseminated nature of brain lesions, their dynamic and unstable nature, the prevalence of white-matter lesions, and the alteration of non-modular aspects of cognition: all these arguments have discouraged neuropsychologists for a long time. Today, these very same specific properties of multiple sclerosis offer an extremely relevant model to explore cognitive dimensions of brain plasticity, to revivify the concept of disconnection in neuropsychology, and to evaluate some neuroscientific models of consciousness. - Rev Neurol (Paris). 2009 Jul 17. [Epub ahead of print] in PubMed

Inhibition of CXCR2 signaling promotes recovery in models of Multiple Sclerosis. - Our findings demonstrate the importance of antagonizing CXCR2 in enhancing myelin repair by reducing lesion load and functionality in models of multiple sclerosis and thus provide a therapeutic target for demyelinating diseases. - Exp Neurol. 2009 Jul 16. [Epub ahead of print] in PubMed

Does the DRB11501 allele confer more severe and faster progression in primary progressive multiple sclerosis patients? HLA in primary progressive multiple sclerosis. - This exploratory study raises new hypotheses for future research and emphasizes the need to investigate possible candidate genes other than HLA that may contribute towards heterogeneity in the course of the disease. - J Neuroimmunol. 2009 Jul 16. [Epub ahead of print] in PubMed

Effect of geranylgeranylacetone on optic neuritis in experimental autoimmune encephalomyelitis. - Neurosci Lett. 2009 Jul 15. [Epub ahead of print] in PubMed

Post-marketing of disease modifying drugs in multiple sclerosis: An exploratory analysis of gender effect in interferon beta treatment. - The results of this exploratory analysis seem to suggest that male patients do not respond to IFNbeta treatment in the same way of females. - J Neurol Sci. 2009 Jul 15. [Epub ahead of print] in PubMed

Capturing the costs of end-of-life care: comparisons of multiple sclerosis, Parkinson's disease, and dementia. - Studies of multiple sclerosis, Parkinson's disease, and dementia that have used this questionnaire are described in this article. What is clear is that the costs of providing end-of-life care can be high and that informal care from family members and friends accounts for a substantial amount of the overall costs. - J Pain Symptom Manage. 2009 Jul;38(1):62-7 in PubMed

Efficacy of natalizumab in second line therapy of relapsing-remitting multiple sclerosis: results from a multi-center study in German speaking countries. - Natalizumab is effective after insufficient response to other DMT and also in patients with high disease activity. - Eur J Neurol. 2009 Jul 9. [Epub ahead of print] in PubMed

Pregnancy, prolactin and white matter regeneration. - Here I discuss work that demonstrates that hormonal changes during pregnancy promote increased OPC proliferation and oligodendrocyte production in the maternal CNS. - J Neurol Sci. 2009 Jul 14. [Epub ahead of print] in PubMed

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Monday, July 20

Restrictions don't halt illegal use of drugs

I am concerned about Republican gubernatorial candidate Chris Christie's stance on New Jersey's medical marijuana bill, as stated on his Web site. I have had multiple sclerosis for the past 12 years and the New Jersey Compassionate Use Medical Marijuana bill would greatly benefit me if it is enacted into law.

After stating his concern for my suffering, he goes on to say that he cannot support this bill unless it is changed to enable it to do what New Jersey's total efforts against drug abuse have failed to accomplish. "I would only consider a bill which had sufficient safeguards in it to prevent the widespread use of this drug by people who do not really need it," he said.

We already have what he considers widespread use of marijuana in New Jersey, even though medical marijuana is not legal. The people he worries about getting legal medical marijuana — even though they were not qualified patients — are probably smoking pot as I write this. Legitimate patients should not suffer because Christie places unachievable goals on this bill.

There is diversion of virtually all opiate-based prescriptions, even with all of the restrictions placed on them. I'm glad Christie had no say in those restrictions or I would have no medicine at all. Medical marijuana is an integral part of my therapy for multiple sclerosis. ...story and comments on APP.com From the Jersey Shore to You

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Sunday, July 19

I suffer with Multiple Sclerosis. Can I get a prescription for Sativex?

Sarah Martin is a British Multiple Sclerosis sufferer who has found success in aleviating the symptoms of her condition by using cannabis. And whilst the government tries to enforce their way on the British population, by maintaining the illegal status of cannabis, in other global regions where cannabis use is permitted with a doctors note, the medical profession are lifting the curtain higher and higher, and in doing so they're making British patients feel like second class citizens.

Whilst American and Canadian MS sufferers may grow their own cannabis, here in the UK, seriously ill people are risking court cases and jail-terms in a bid to find some pain relief.

Make no bones about it, cannabis treatment is available in the UK right now, by way of a drug called Sativex. But it turns out you can only have it, if you can afford to pay for it. So some users are turning to growing their own medicine to fill the void.

http://pr.cannazine.co.uk/ : The political and financial wranglings surrounding the most emotive of pharmaceutical treatments has been turned into something of a soap-opera, as the UK government attempts on the one hand, to deny cannabis has any medicinal benefits to offer humanity, whilst on the other hand keeping cannabis out of the hands of those that need it most, using the police and the judicial system as their 'enforcers'. ..full story in PR.CannaZine

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Drug deal, R&D hike hit Biogen profit

Biogen Idec's profit for the second quarter was down significantly from the same period last year, due in part to the acquisition of a new experimental treatment for multiple sclerosis. The company included the acquisition as part of a 60-percent increase in year-on-year research and development costs.

The Cambridge, Mass.-based biopharmaceutical company reported net income of $144.9 million for the three months ending June 30, 2009, down from $208.1 million for the second quarter last year.

Revenue for the company was up for the second quarter, to $1.1 billion from $993 million during the second quarter of 2008. The increase was led by sales of the company’s two marketed treatments for Multiple Sclerosis, Avonex , which booked revenues of $591.2 million, up from $527.2 million and Tysabri, with sales of $187.6 million, up from $147.2 million. The increase in sales of Tysabri beat investors’ expectations.

Biogen paid $110 million to Accordia Therapeutics Inc. to licence the drug candidate Fampridine-SR.

Biogen’s (Nasdaq: BIIB) stock rose slightly on the news, during mid day trading on Thursday, to $47.06 from $46.67 at the previous close. .. story in the Boston Business Journal

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Biogen Idec 2Q profit falls on charge for MS drug

CAMBRIDGE, Mass. -- Biotechnology company Biogen Idec Inc. said Thursday its second-quarter profit fell on charges for a drug development deal with Acorda Therapeutics Inc., but sales of its multiple sclerosis drugs gained ground.

The company earned $142.8 million, or 49 cents per share, compared with profit of $206.6 million, or 70 cents per share, during the same period a year prior. Revenue rose 10 percent to $1.09 billion from $993.4 million. ... full story in Forbes.com

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ICAD: DASH Diet May Slow Cognitive Decline

VIENNA, July 15 -- A diet rich in fruits and vegetables and low in salt, sweets, and red meats -- the Dietary Approaches to Stop Hypertension (DASH) model -- appears to slow cognitive decline, researchers said here at the International Conference on Alzheimer's Disease. ...full story in MedPage Today

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Online Brain Game For People With Multiple Sclerosis Launched By Technology Collaborative

The MS Technology Collaborative has created a new way for people living with multiple sclerosis (MS) to exercise their brain power. The Collaborative, an alliance of Bayer HealthCare Pharmaceuticals, Microsoft, and the National Multiple Sclerosis Society, today announced the launch of MyBrainGames, a free suite of online games filled with cognitive challenges for the MS community.

Approximately 50 percent of people living with MS develop cognitive challenges, often in the areas of processing speed, working memory and complex attention. These challenges can involve difficulty in learning and remembering information; focusing, maintaining and shifting attention; and organizing, planning and problem-solving.

MyBrainGames, available for free at MyMSMyWay.com, are the first online games designed specifically for people with MS under the direction of a team of leading healthcare professionals specializing in MS and cognition, as well as members of the MS community. The games provide a series of fun and interactive cognitive challenges for the MS community. .... full report in Medical News Today

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Gene Regulates Immune Cells' Ability To Harm The Body

A recently identified gene allows immune cells to start the self-destructive processes thought to underlie autoimmune diseases such as multiple sclerosis (MS) and rheumatoid arthritis, researchers at Washington University School of Medicine in St. Louis have found.

Researchers showed that mice without the Batf gene lacked a type of inflammatory immune cell and were resistant to a procedure that normally induces an autoimmune condition similar to human MS. They plan to look for other genes and proteins influenced by Batf that could be targets for new treatments for autoimmune diseases. ..full report in Medical News Today

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MS Society Pleased With Government Recognition Of Crisis In Social Care

The government's Green Paper 'Shaping the Future of Care Together' has been welcomed by the MS Society as the radical step necessary to address the crisis in social care.

Announced on Tuesday, the bold proposals set out a vision for a care system as important as the NHS, billed as the 'National Care Service', which could potentially bring an end to the postcode lottery in care and improve its quality.

The Green Paper presents proposals for the long term funding of better care for the growing number of older people, and people with long-term conditions such as multiple sclerosis (MS). ...full report in Medical News Today

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What's new for 'Multiple Sclerosis' in PubMed

Impact of Immunomodulatory Treatment on Leukocyte Cytokine Production in Multiple Sclerosis Patients and Healthy Donors. -Treatment with interferon(IFN) beta, glatiramer acetate (GLAT) and intravenous immunoglobulins (IVIG) alters the cytokine production in multiple sclerosis (MS) patients. To date, it is not clear whether the effect on cytokines varies among these drugs. - Neuroimmunomodulation. - in PubMed

Is multiple sclerosis a mitochondrial disease? - In this article, we discuss the latest developments on MS research, including etiology, pathology, genetic association, EAE animal models, mechanisms of neuronal injury and axonal transport and therapeutics. In this article, we also focus on the mechanisms of mitochondrial dysfunction that are involved in MS, including mitochondrial DNA defects, and mitochondrial structural/functional changes. - Biochim Biophys Acta. Jul 13. [Epub ahead of print] in PubMed

Getting the balance right: A randomised controlled trial of physiotherapy and exercise interventions for ambulatory people with multiple sclerosis. -Data analysis will analyse change in each group, and the differences between groups. Sub group analysis may be performed if sufficient numbers are recruited. - BMC Neurol.. 2009 Jul 16;9(1):34. [Epub ahead of print] in PubMed

Cladribine: not just another purine analogue? - This review highlights pharmacological, toxicological and clinical data for the use of cladribine. It also discusses existing and new mechanisms that may contribute to its unique clinical activity. - Expert Opin Investig Drugs. 2009 Aug;18(8):1169-81. in PubMed

User Interface of a Teleradiology System for the MR Assessment of Multiple Sclerosis. - The aim of this study was to assess the image display of a web-based teleradiology system that uses a common web browser and has no need of proprietary applets, plug-ins, or dedicated software for DICOM display. - J Digit Imaging. 2009 Jul 15. [Epub ahead of print] in PubMed

Genetic polymorphisms, their allele combinations and IFN-beta treatment response in Irish multiple sclerosis patients. - The genetic mechanism of response to IFN-beta is complex and as yet poorly understood. Data mining algorithms may help in uncovering hidden allele combinations involved in drug response versus nonresponse. - Pharmacogenomics. 2009 Jul;10(7):1177-86. in PubMed

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Monday, July 13

Smoking May Speed Multiple Sclerosis Symptoms

Patients who smoke appear to progress to severe disease more rapidly, study finds.

MONDAY, July 13 (HealthDay News) -- In addition to the well-known hazards of smoking, research now suggests that the dangerous habit causes a more rapid progression of multiple sclerosis.

The new findings are from a study that included 1,465 multiple sclerosis (MS) patients, average age 42, who had had MS for an average of 9.4 years. There were 257 current smokers, 428 past smokers and 780 participants who had never smoked.

At the start of the study, current smokers had significantly more severe disease and were also more likely to have primary progressive MS (a steady decline in health status), rather than relapsing-remitting MS (alternating periods with and without symptoms).

The Boston researchers tracked a group of 891 patients for an average of three years to identify how many changed from relapsing-remitting MS to secondary progressive MS, which is a steady decline that develops after a period of relapsing-remitting MS. During the follow-up, this change was seen in 20 of 154 smokers, 20 of 237 ex-smokers and 32 of 500 never-smokers.

"The conversion from relapsing-remitting MS to secondary progressive MS occurred faster in current smokers compared with never-smokers, but was similar in ex-smokers and never-smokers," according to Brian C. Healy of Brigham and Women's Hospital, Harvard Medical School and Massachusetts General Hospital, and colleagues.

The study was reported in the July issue of Archives of Neurology .

The findings "support the hypothesis that cigarette smoking has an adverse effect on progression of MS as measured by clinical and MRI outcomes," the study authors concluded.

"Although causality remains to be proved, these findings suggest that patients with MS who quit smoking may not only reduce their risk of smoking-related diseases but also delay the progression of MS."

More information: The U.S. National Institute of Neurological Disorders and Stroke has more about MS. SOURCE: JAMA/Archives journals, news release, July 13, 2009

Story found in HONnews

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GTC Agreement Takes Aim At MS

Framingham-based GTC Biotherapeutics Inc. now has the rights to develop and commercialize a protein that could be used to treat multiple sclerosis and other autoimmune diseases.

The protein is recombinant human alpha-fetoprotein (rhAFP) and it has been in development by Cambridge-based Merrimack Pharmaceuticals in the milk of genetically modified goats at GTC's facilities. Under the new agreement, GTC will receive enough rhAFP from Merrimack for use in clinical studies and will assume control of the goats.

Financial terms of the deal were not disclosed.

Human AFP is a blood protein produced in very high levels in women during pregnancy. It plays a role in strengthening women's immune systems in order to protect gestating fetuses. Apart from pregnancy, AFP is produced in very low levels.

GTC plans to study whether human AFP produced by genetically modified goats can treat autoimmune diseases multiple sclerosis and myasthenia gravis.
Story found in Worcester Business Journal Online

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Biogen Idec Receives Fast Track Designation From FDA For PEGylated Interferon Beta-1a For Relapsing Multiple Sclerosis

Biogen Idec (NASDAQ: BIIB) announced the U.S. Food and Drug Administration (FDA) has granted PEGylated interferon beta-1a (BIIB017) Fast Track designation for relapsing multiple sclerosis (RMS). Biogen Idec is currently enrolling patients in a global Phase III study evaluating the efficacy and safety of either bi-weekly or once-monthly injections of PEGylated interferon beta-1a in this patient population.

"Early-stage clinical trials suggest that PEGylated interferon beta-1a has the potential to offer less frequent dosing without compromising efficacy, which would be a significant development for people living with multiple sclerosis," said Michael Panzara, M.D., M.P.H., vice president and chief medical officer of neurology at Biogen Idec. "We look forward to working closely with the FDA to expedite the compound's development and review process." ...full report in Medical News Today

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MS Society Appoints New Director

The MS Society has appointed Sue Farrington to its newly created role of Director of Information and Education. Sue was formerly Director of Corporate Affairs at CSV.

In her new role, which starts this month, Sue is responsible for the management of the MS Society's information for people affected by MS - through its website, annual conference programme and publications team. Sue will also be overseeing a drive to improve the Society's professional education programme. ...full report in Medical News Today

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Kineta Acquires Novel Drug Candidates From Airmid For Potential Treatment Of Multiple Sclerosis, Type 1 Diabetes And Other Autoimmune Diseases

Kineta, Inc. of Seattle and Airmid Incorporated of Redwood City, CA jointly announce an agreement in which a Kineta subsidiary has acquired exclusive commercial rights to a portfolio of novel therapeutic compounds from Airmid. The array of compounds holds extraordinary potential for the treatment of multiple sclerosis, type 1 diabetes mellitus and numerous other autoimmune diseases.

"This transaction is a significant milestone for Airmid. It places our peptidic Kv1.3 blockers into the very capable hands of Kineta's drug development team, sets Airmid on a path to provide substantial return-on-investment for our shareholders, and provides funding to enhance the value of Airmid's retained assets," said George Miljanich, Ph.D., CEO of Airmid. Under the terms of the deal, Airmid will receive upfront payments, development, regulatory and commercial milestones as well as sales royalties.

Airmid founder, K. George Chandy, MD, Ph.D., also applauded the announcement: "Kineta possesses both the scientific capacity and the track record of success necessary to advance these promising therapeutics toward the goal of conquering multiple devastating autoimmune diseases." ...full report in Medical News Today

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MS Society-funded Study Unlocks Part Of The Mystery Of Remyelination In MS

Researchers working in Cambridge and San Francisco have discovered clues about how stem cells promote myelin repair. The study, published earlier this week in the journal Genes and Development, was partly funded by the MS Society and took place at the MS Society Cambridge Centre for Myelin Repair.

Researchers looked at what factors are important for remyelination (the process by which damaged myelin is repaired by brain cells) in MS and discovered that a cell signalling pathway called the Wnt pathway is involved in remyelination.

Cell signalling pathways are complex processes in cells that, when turned on or off, can change the role of that particular cell in the body. The Wnt pathway is an important pathway for all stages of development, including development in the womb, and for this reason researchers have been studying it for years.

In this case, researchers have shown for the first time that the Wnt pathway is involved in remyelination - and that when it is not working properly cells cannot remyelinate properly. The study looked specifically at the Wnt pathway in oligodendrocytes (specialised brain cells that are responsible for making and repairing myelin). They found that if the Wnt pathway is over-active then remyelination is impaired, suggesting that the Wnt pathway is not functioning as it should in MS lesions. This is potentially a good therapeutic target to help promote myelin repair in people with MS. ....full report in Medical News Today

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Drug Manufacturer Receives Fast Track Designation From FDA

Pharmaceutical firm Biogen Idec announced that the American drug watchdog the Food and Drug Administration (FDA) has granted Fast Track designation for its multiple sclerosis (MS) drug PEGylated interferon beta-1a (BIIB017).

The company is currently enrolling patients in a global Phase III study evaluating the effectiveness and safety of either bi-weekly or once-monthly injections of the therapy in people with relapsing remitting MS.

If the trial reports promising results it means that people could inject their medication less often without sacrificing effectiveness. ....full report in Medical News Today

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MS Society-Funded Study Investigates Experiences Of Partners Of People With MS

An MS Society-funded study has highlighted the impact that MS has on partners' lives and demonstrates the need for support and services for partners of people with MS.

A study recently published in the journal Multiple Sclerosis has concluded that partners of people in the early stages of MS report feeling isolated and helpless. The study involved conducting telephone interviews with 15 people whose partners were recently diagnosed with MS and asking them a series of broad open-ended questions such as "Can you start by telling me all about what you thought and felt when your partner was first diagnosed with MS?" The interviews covered aspects of participants' lives that ranged from feelings when their partner was first diagnosed to the impact of MS on various aspects of their lives and also with how they cope with these challenges. ....full report in Medical News Today

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Smoking Speeds MS Progression

WHEELING, W.Va., July 13 -- Multiple sclerosis shifts from the relapsing-remitting form to steadily progressive disease more quickly in patients who smoke, researchers said.

The adjusted hazard ratio for advancing to secondary progressive MS was 2.50 for smokers relative to patients who had never used cigarettes (95% CI 1.42 to 4.41) over a median of 3.3 years of follow-up, reported Alberto Ascherio, MD, of Harvard School of Public Health, and colleagues in the July issue of Archives of Neurology.

Among 1,465 patients referred to the Partners MS Center in Boston, smokers were also significantly more likely to have primary progressive MS and to have worse disease compared with patients who never smoked, the researchers also found.

"Our data suggest that cigarette smoke has an adverse influence on the progression of MS and accelerates conversion from a relapsing-remitting to a progressive course," they wrote.

The findings conflict with a Dutch study published in 2007 that found no relationship between smoking and MS progression, but support earlier research suggesting such a link. (See: Tobacco Smoke Dispelled as Factor in MS Progression) ..... Full report in MedPage Today

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What's new for 'Multiple Sclerosis' in PubMed

Enhanced number and activity of mitochondria in multiple sclerosis lesions. - Our data indicate the occurrence of severe mitochondrial alterations in MS lesions, which coincides with enhanced mitochondrial oxidative stress. Together, these findings support a mechanism whereby enhanced density of mitochondria in MS lesions might contribute to the formation of free radicals and subsequent tissue damage. Copyright (c) 2009 Pathological Society of Great Britain and Ireland. Published by John Wiley & Sons, Ltd. - J Pathol. 2009 May 26. [Epub ahead of print] in PubMed

Sensory complaints of the upper extremities in multiple sclerosis: relative efficacy of nortriptyline and transcutaneous electrical nerve stimulation. - This study demonstrates that both nortriptyline and TENS can be effective in reducing the intensity of pain and/or sensory complaints in the upper extremities of people with MS. However given the side-effect profile of nortriptyline, TENS may have some benefits over nortriptyline. This modest reduction in the intensity of pain and/or sensory complaints suggests that physicians should carefully weigh the risk and benefits of nortriptyline and TENS in people with MS with pain and/or sensory complaints. - Clin J Pain. 2009 May;25(4):281-5. in PubMed

Headaches in the different phases of relapsing-remitting multiple sclerosis: a tendency for stabbing headaches during relapses. - The high frequency of PSHs in relapse was notable, and, to the best of our knowledge, PSH was not reported in relapsing-remitting multiple sclerosis before. Further studies with larger samples are recommended. - Neurologist. 2009 Jul;15(4):212-6. in PubMed

Interferon-beta(1b) Treatment in Neuromyelitis Optica. - In NMO patients, IFN-beta(1b) treatment was not effective in reducing the relapse number and the disability progression. - Eur Neurol. 2009 Jul 7;62(3):167-170. [Epub ahead of print] in PubMed

Adherence of adolescents to multiple sclerosis disease-modifying therapy. - In conclusion, adolescents in this cohort had difficulty adhering to disease-modifying therapies, and peers played an important role in mediating their adjustment to multiple sclerosis. Specific strategies are required to improve adolescents' adherence to treatment, including less intrusive options and enhancing peer support. - Pediatr Neurol. 2009 Aug;41(2):119-23. in PubMed

Immunotoxicity profile of natalizumab. - Overall, natalizumab was well tolerated in monkeys, demonstrated the expected pharmacologic effect on cell trafficking, and showed no adverse effect on immune cell function. - J Immunotoxicol. 2009 Jun;6(2):115-29. in PubMed

Treatment of seizures in multiple sclerosis. - Well-designed randomised controlled trials are needed to guide clinical practice. Such trials should preferably contain a head-to-head comparison of antiepileptic drugs in patients with MS. - Cochrane Database Syst Rev. 2009 Jul 8;(3):CD007150. in PubMed

Oral versus Intravenous Steroids for Treatment of Relapses in Multiple Sclerosis. - The trials reviewed support the hypothesis that no significant differences in clinical, radiological or pharmacological outcomes oral and intravenous steroids for MS relapses exist. However, with the small number of patients and methodological limitations, conclusions of equivalence are premature. - Cochran Database Syst Rev. 2009 Jul 8;(3):CD006921 in PubMed

Sustained release oral fampridine in the treatment of multiple sclerosis. - Fampridine-SR 10 mg twice a day has been shown to be safe and effective in improving the ambulation of patients with walking disability due to MS. It will probably find clinical application beyond this specific indication in a significant proportion of patients. - Expert Opin Pharmacother. 2009 Jul 8. [Epub ahead of print] in PubMed

Brazilian experience with two conditioning regimens in patients with multiple sclerosis: BEAM/horse ATG and CY/rabbit ATG - Studies have shown that autologous hematopoietic SCT (HSCT) can be used as an intensive immunosuppressive therapy to treat refractory patients and to prevent the progression of multiple sclerosis (MS). This is a prospective multicentric Brazilian MS trial comparing two conditioning regimens: BEAM/horse ATG and CY/rabbit ATG. Most (80.4%) of the 41 subjects in the study had the secondary progressive MS subtype and the mean age was 42 years. The baseline EDSS score in 58.5% of the subjects was 6.5 and 78% had a score of 6.0 or higher, respectively. The complication rate during the intra-transplantation period was 56% for all patients: 71.4% of the patients in the BEAM/hATG group and 40% in the CY/rATG group (P=0.04). Three subjects (7.5%) died of cardiac toxicity, sepsis and alveolar hemorrhage, all of them in the BEAM/ATG group. EFS was 58.54% for all patients: 47% in the BEAM/hATG group and 70% in the CY/rATG group (P=0.288). In conclusion, the CY/rATG regimen seems to be associated with similar outcome results, but presented less toxicity when compared with the BEAM/hATG regimen. Long-term follow-up would be required to fully assess the differences in therapeutic effectiveness between the two regimens. Bone Marrow Transplantation advance online publication, 6 July 2009; doi:10.1038/bmt.2009.127. - Bone Marrow Transplant. 2009 Jul 6. [Epub ahead of print] in PubMed

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Saturday, July 4

Biogen Idec and Acorda Therapeutics Announce Collaboration Agreement to Develop and Commercialize MS Therapy Fampridine-SR in Markets Outside the U.S.

CAMBRIDGE, Ma. & HAWTHORNE, N.Y.--(BUSINESS WIRE)--Jul 1, 2009 - Biogen Idec (NASDAQ:BIIB) and Acorda Therapeutics, Inc. (NASDAQ:ACOR) today announced that they have entered into an exclusive collaboration and license agreement to develop and commercializeFampridine-SR, a multiple sclerosis (MS) therapy, in markets outside the United States. Fampridine-SR is a novel, oral sustained-release compound being developed to improve walking ability in people with MS. The parties have also entered into a related supply agreement. The transaction represents a sublicensing of an existing license agreement between Acorda and Elan Pharma International Limited, a subsidiary of Elan Corporation plc (NYSE:ELN). ...full story in PharmaLive

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UCB And Biogen Idec Discontinue Phase II Clinical Trial Of CDP323 - Analysis Showed No Clinically Relevant Benefit For Patients

UCB and Biogen Idec announced today the discontinuation of the Phase II clinical trial of CDP323 for the treatment of relapsing multiple sclerosis (MS). Preliminary interim efficacy analysis showed that patients enrolled in this clinical trial did not benefit as expected from CDP323 compared to placebo after a six month treatment period. No cases of PML (progressive multifocal leukoencephalopathy) were noted.

CDP323 is an oral small molecule alpha4 integrin inhibitor that was being developed by UCB and Biogen Idec for relapsing forms of multiple sclerosis.

For UCB, results of this interim analysis trigger a re-valuation of the intangible asset "CDP323". UCB expects a non-cash, non-recurring impairment of a high double-digit million pre-tax euro amount. This will be more than compensated by cash, non-recurring capital gains, which resulted from the divestitures UCB made earlier this year. More information on the financial impacts of both the impairment and the capital gains will be included in the Half Year Report 2009 of UCB, due July 31, 2009. ...full report in Medical News Today

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Hard To Treat Diseases (HTDS) Clinical Trial Update On Therapeutic Effects Of Combined Treatment With Ribavirin And Tiazofurin

Hard To Treat Diseases (HTDS) Chief Scientist with its Slavica BioChem subsidiary, Dr. Sanja Pekovic provided updates on recent clinical trials with animal subjects in regards to the use of Ribavirin And Tiazofurin for the potential treatment of Multiple Sclerosis (MS).

Dr. Pekovic reported; "It is now well accepted that axonal injury begins at an early stage in MS, and likely accounts for clinical progression seen later in the disease course, suggesting that early, aggressive treatment is critical in order to suppress long-term disability progression. Researchers from IBISS group (a related research group) tested the effect of combined treatment with ribavirin (R) and tiazofurin (T) administrated during the effecter phase of disease.

Dr. Pekovic added: "We are hopeful, that with additional funding, we will be able to continue along this promising path, and continue researching the potential applications of a combination of ribavirin and tiazofurin in the treatment of MS." ...full report in Medical News Today

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Insight Into How Brain Stem Cells Develop Into Cells Which Repair Damaged Tissue

The joint research, funded by the National Multiple Sclerosis Society and the UK MS Society as well as the National Institutes of Health and Howard Hughes Medical Institute, was conducted by scientists at the University of California San Francisco (UCSF) and University of Cambridge and was published in the journal Genes and Development. ...full report in Medical News Today

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Mri Data Showing Tysabri® Promoted Remyelination Presented At The 61st Annual Meeting Of The American Academy Of Neurology

Biogen Idec (NASDAQ: BIIB) and Elan Corporation, plc (NYSE: ELN) announced results of a study demonstrating that TYSABRI® (natalizumab) promoted regeneration and stabilization of damage done to the myelin sheath, as measured by advanced MRI technology. Damage to the myelin sheath causes the symptoms of multiple sclerosis (MS). Additional posters will also be presented during the Congress highlighting the ability of TYSABRI, in some patients, to improve physical function and patient reported outcomes on cognition, quality of life, and fatigue. TYSABRI is the first approved MS therapy with reported data suggesting that some of the signs of disease progression can be stopped. The strong efficacy profile demonstrated in clinical trials is enhanced further from these data and may help redefine success in MS. ...full report in Medical News Today

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First Ten-Year Follow-Up Shows That Treatment With AVONEX® Leads To Long-Term Benefits In Early Multiple Sclerosis Patients

Biogen Idec (NASDAQ: BIIB) announced data results from the CHAMPIONS (Controlled High-Risk AVONEX (interferon beta-1a) Multiple Sclerosis (MS) Prevention Study In Ongoing Neurologic Surveillance) study, an open label follow-up to CHAMPS (Controlled High Risk Subjects AVONEX MS Prevention Study). Based on the CHAMPS study, AVONEX was granted approval for use in patients who experienced their first clinical MS episode with MRI findings. The CHAMPIONS ten-year follow up showed that patients treated immediately after their first episode had significantly less chance of experiencing a second attack versus those patients with delayed treatment. These results at ten years also indicate that 80 percent of patients taking AVONEX were below an expanded disability status scale (EDSS) score of three. These data were presented as a poster at the Annual American Academy of Neurology (AAN) meeting. ...full report in Medical News Today

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What's new for "Multiple Sclerosis" in PubMed

[Alterations in early auditory evoked potentials in multiple sclerosis patients.] -these findings stress the importance of looking at EAEP in cases where there is suspicion of demyelinating disease and in patients with a defined diagnosis for MS. - Braz J Otorhinolargol. 2009 Apr;75(2):177-181. in PubMed

Cognitive reserve moderates the negative effect of brain atrophy on cognitive efficiency in multiple sclerosis. - J Int Neuropsychol. 2009 Jul;15(4):606-612. in PubMed

Relationship between Psychosocial Factors and Onset of Multiple Sclerosis. - The psychosocial factors are closely associated with MS onset and may play important roles in the development of the disease. - Eur Neurol. 2009 Jul 1;62(3):130-136. [Epub ahead of print] in PubMed

Dose-dependent melanonychia by mitoxantrone. - Mult Scler. 2009 Jul 1. [Epub ahead of print] in PubMed

Gadolinium-enhancing or active T2 magnetic resonance imaging lesions in multiple sclerosis clinical trials? - Mult Scler. 2009 Jul 1. [Epub ahead of print] in PubMed

Autonomic dysreflexia in a man with multiple sclerosis. - This report emphasizes that AD can occur in MS. Somatic symptoms warrant thorough investigation before attributing them to psychosomatic causes. - J Spinal Cord Med. 2009;32(2):198-203. in PubMed

Using prior knowledge and genome-wide association to identify pathways involved in multiple sclerosis. - This and other pathway-based approaches are likely to continue to emerge in the GWAS literature, as they provide a powerful strategy to detect important modest single-locus effects and gene-gene interaction effects. - Genome Med. 2009 Jun 29;1(6):65. [Epub ahead of print] in PubMed

HHV-6 infection in multiple sclerosis. A clinical and laboratory analysis. - Human herpesvirus-6 infection may be an associated agent in some MS cases. Viral studies are needed to identify a possible viral etiology and give specific therapy. - Eur J Neurol. 2009 Jun 29. [Epub ahead of print] in PubMed

An exploration of anger phenomenology in multiple sclerosis. - The presence of an altered pattern of anger, unrelated to the clinical severity of MS, suggests that anger is not an emotional reaction to disease stress. An alteration of anger mechanisms might be a direct consequence of the demyelination of the connections among the amygdale, the basal ganglia and the medial prefrontal cortex. - Eur J Neurol. 2009 Jun 29. [Epub ahead of print] in PubMed

The role of natalizumab in hematopoietic stem cell mobilization. - The use of natalizumab alone or in combination with either cytotoxic drugs or other antibodies might be a new modality for stem cell mobilization and a therapeutic option for patients with hematologic malignancies. - Expert Opin Biol Ther. 2009 Jul 1. [Epub ahead of print] in PubMed

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Tuesday, June 30

Biogen Reports a 13th Sick Patient on MS Drug

Biogen Idec Inc.'s disclosure of a debilitating brain infection in a patient taking its Tysabri multiple-sclerosis medicine sparked a selloff in shares of the biotechnology company Monday.

The disclosure, made Friday evening, marks the 13th case of the infection, called progressive multifocal leukoencephalopathy or PML, in a Tysabri patient. Three of the patients have died.

Biogen's shares dropped 5.5% to close at $47.32 on the Nasdaq Stock Market, possibly making the firm more vulnerable to a takeover by a large pharmaceutical company. Earlier this month, the company lost a proxy fight with billionaire activist investor Carl Icahn, who won two ...
Story in the Wall Street Journal

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Saving Grace: Device gives walking help to those with disorders

Three lightweight, wireless devices have given Lubbock resident Frank Jones grace - something multiple sclerosis stole from him several years ago.

Jones, a Vietnam veteran who has retired from the Army and lives on a farm, still has bruises from his last fall. He tripped in his living room and banged his head against a closet door.

But the bruises will fade soon, and Jones hasn't had a bad fall since purchasing the NESS L300, a relatively new device that uses mild electrical stimulation to help people with neurological disorders and traumatic injuries walk.

Jones, 67, was diagnosed with multiple sclerosis in 2003, but he lived with the symptoms for 35 years before his diagnosis. The disease progressed to the point where several years ago he developed foot drop, a condition in which a person can't lift his or her toes when walking.

The L300 uses electrical pulses to lift a person's toes and foot while he or she is walking.

It's intended to help people with traumatic brain and spinal cord injuries, multiple sclerosis, cerebral palsy and other neurological disorders. Made by the Bioness company, the device received Food and Drug Administration clearance in July 2006.

It has a pressure sensor that goes under the heel, a stimulator that looks like a knee brace, and a control unit the patient can put in a pocket or wear around his or her neck. The three pieces work together wirelessly......full story in Lubbock Online

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Tysabri: Multiple Sclerosis Medication Linked to 13th Brain Infection Case

Biogen Idec Inc., a biotechnology company, announced Friday that another patient who was taking its Tysabri multiple-sclerosis medicine is infected with progressive multifocal leukoencephalopathy, or PML. Their announcement marks the 13th case of the infection in patients taking Tysabri. Three other patients have already died from taking the medication and contracting PML. PML is a serious brain infection that attacks the central nervous system and damages and inflames the white matter areas of of the brain. Immune suppressing drugs such as Tysabri put patients at serious risk for contracting PML and potentially dying as a result.
Story in InjuryBoard.com

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What's new for "Multiple Sclerosis" in PubMed

Vibration therapy in multiple sclerosis: a pilot study exploring its effects on tone, muscle force, sensation and functional performance. - Exercise may be beneficial to those with multiple sclerosis, but there is limited evidence that the addition of whole body vibration provides any additional improvements. Further larger scale studies into the effects of whole body vibration in people with multiple sclerosis are essential. - Clin Rehabil. 2009 Jun 26. [Epub ahead of print] in PubMed

Urinary dysfunction in multiple sclerosis. - We suggest that the assessment of urological symptoms and urodynamic evaluation is critical for evaluating quality of life in MS. - J Clin Neurosci. 2009 Jun 26. [Epub ahead of print] in PubMed

Aerobic Fitness is Associated with Gray Matter Volume and White Matter Integrity in Multiple Sclerosis. - In this study, we investigated the association between cardiorespiratory fitness and measures of gray matter atrophy and white matter integrity. - Brain Res. 2009 Jun 25. [Epub ahead of print] in PubMed

Multiple sclerosis associated fatigue during natalizumab treatment. - Fatigue and well-being improved after treatment initiation with natalizumab. A randomized controlled trial is necessary to come to definite conclusions as to a potential effect of natalizumab on fatigue in MS. - J Neurol Sci. 2009 Jun 25. [Epub ahead of print] in PubMed

Interferon-beta treatment in multiple sclerosis attenuates inflammatory gene expression through inducible activity of the phosphatase SHP-1. - In conclusion, interferon-beta treatment upregulates SHP-1 expression resulting in decreased transcription factor activation and inflammatory gene expression important in MS pathogenesis. - Clin Immunol. 2009 Jun 24. [Epub ahead of print] in PubMed

Identification of new sensitive biomarkers for the in vivo response to interferon-beta treatment in multiple sclerosis using DNA-array evaluation. - Eur J neurol. 2009 Jun 22. [Epub ahead of print] in PubMed

NITRIC OXIDE IN CELL SURVIVAL: A JANUS MOLECULE. - Antioxid Redox Signal. 2009 Jun 26. [Epub ahead of print] in PubMed

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Wednesday, June 24

TV personality's bike ride raises $500,000

Phil Keoghan, host of CBS' "The Amazing Race," raised $500,000 in his bicycle ride across the United States in the fight against multiple sclerosis.

The TV personality was sponsored by the General Nutrition Centers' chain in the 42-day trip, which made a stop May 2 in Robinson.

Tom Dowd, executive vice president of the chain, says $400,000 of the total came from donations to the National Multiple Sclerosis Society in stores along the route.
Tribune-Review

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A reflection of Multiple Sclerosis and dads on Father's Day

Men aren't as commonly afflicted with Multiple Sclerosis as women. In fact, twice as many women as men have this weird illness. And, some say it's hereditary, passed through the father. In fact, men are twice as likely to pass the illness on to their children than women.

But, on this Father's Day, it's still important to look at people's stories from dads with MS to kids who have dads with MS, and I've picked some of the best stories I could find. ....Full story in Examiner.com

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Disability 101: Changed and on my way to D.C

I am changed. I have just returned from the annual National ADA Symposium which was held in Kansas City, Mo., on June 8-10 and I am changed.

I think it's the contrast that hits me most. Let me start with some background.I was first a special education teacher. I have a college degree and I was the team leader for a group of Masters level and Doctoral level professionals. But then multiple sclerosis hit me and I couldn't teach any more because in the state of Colorado, teaching special education is pretty much a 60 hour a week job and I couldn't manage 60 hours a week with my MS......full story in Summit Daily News

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Rapid Beneficial Effects of New Interferon Formulation on MRI Outcomes in Multiple Sclerosis: Presented at ENS

MILAN, Italy -- June 23, 2009 -- Patients with relapsing-remitting multiple sclerosis (RRMS) show early benefit from a new formulation of subcutaneous interferon (IFN) beta-1a as measured by magnetic resonance imaging (MRI), according to a study presented here at the 19th Meeting of the European Neurological Society (ENS). .....full story in Doctor's Guide

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Continuous Disease-Modifying Treatment Without Interruptions Provides Better Long-Term Outcomes in Multiple Sclerosis: Presented at ENS

MILAN, Italy -- June 23, 2009 -- Patients with multiple sclerosis (MS) who adhere to their treatment with interferon (IFN) beta-1a without interruption have lower relapse and progression rates than patients who do not adhere to their medication as regularly, said researchers here at the 19th Meeting of the European Neurological Society (ENS). ......
Full story in Doctor's Guide

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What's new of 'Multiple Sclerosis' in PubMed

Potential risk factors for multiple sclerosis in Rio de Janeiro: a case-control study. - RESULTS of this study may contribute towards better awareness of the epidemiological characteristics of Brazilian patients with multiple sclerosis. - Arq Neuropsiquiatr. 2009 Jun;67(2A):229-34. in PubMed

Age of Onset in Concordant Twins and Other Relative Pairs With Multiple Sclerosis. - A maternal parent-of-origin effect on the age of onset in collinear generations was suggested. - Am J Epidemiol. 2009 Jun 22. [Epub ahead of print] in PubMed

Prediction of conversion from clinically isolated syndrome to clinically definite multiple sclerosis according to baseline MRI findings: comparison of revised McDonald criteria and Swanton's modified criteria. - In conclusion, Swanton's modified criteria are more sensitive and accurate (but not significantly so). However, Swanton's criteria are simpler to use and have equally high specificity and PPV. - J Neurol Neurosurg Psychiatry. 2009 Jun 21. [Epub ahead of print] in PubMed

MR Spectroscopy Indicates Diffuse Multiple Sclerosis Activity During Remission. - The absence of early tissue atrophy and apparent axonal dysfunction (NAA loss) in these RR MS patients suggests that both are preceded by diffuse glial proliferation (astrogliosis), as well as possible inflammation, de- and re-myelination reflected by elevated mI, Cho and Cr, even during clinical remission and despite immunomodulatory treatment. - J Neurol Neurosurg Psychiatry. 2009 Jun 21. [Epub ahead of print] in PubMed

Vitamin D, a neuro-immunomodulator: Implications for neurodegenerative and autoimmune diseases. - In this article, we review some of the mechanisms that may underlie the role of vitamin D in various brain diseases. We then assess how vitamin D imbalance may lay the foundation for a range of adult disorders, including brain pathologies (Parkinson's disease, epilepsy, depression) and immune-mediated disorders (rheumatoid arthritis, type I diabetes mellitus, systemic lupus erythematosus or inflammatory bowel diseases). Multidisciplinary scientific collaborations are now required to fully appreciate the complex role of vitamin D in mammal metabolism. - Psychoneuroendocrinology. 2009 Jun 20. [Epub ahead of print] in PubMed

Rasch analysis of the Multiple Sclerosis Impact Scale (MSIS-29). - Health Qual Life Outcomes. 2009 Jun 22;7(1):58. [Epub ahead of print] in PubMed

Cognitive deficits in multiple sclerosis patients with cerebellar symptoms. - These results highlight the importance of considering cognitive deficits associated with the presence of cerebellar symptoms in RR-MS. - Mult Scler. 2009 Jul;15(7):854-9. in PubMed

Measures in the first year of therapy predict the response to interferon {beta} in MS. - In RRMS patients treated with IFNbeta, the combination of measures of disease activity and the presence of new active lesions on MRI may have a prognostic value for identifying patients with disease activity in the second and third year of therapy. - Mult Scler. 2009 Jul;15(7):848-53. in PubMed

Cognitive impairment and its relation with disease measures in mildly disabled patients with relapsing-remitting multiple sclerosis: baseline results from the Cognitive Impairment in Multiple Sclerosis (COGIMUS) study. - Cognitive impairment occurs in approximately one-fifth of mildly disabled patients with MS and is associated with specific MRI disease measures. Assessment of cognitive function at diagnosis could facilitate the identification of patients who may benefit from therapeutic intervention with disease-modifying therapies to prevent further lesion development. - Mult Scler. 2009 Jul;15(7):779-788. in PubMed

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Tuesday, June 16

Brain Games for Multiple Sclerosis Patients

The cognitive effects of multiple sclerosis can be devastating. Chris Armistead was diagnosed with MS four years ago. He loved video games and has taken that love to create a Brain Game program for people with MS to help improve the brain processing speed of people living with MS. The game will be online and is sponsored by MSMyWay.

About.com: Multiple Sclerosis

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NYU Study May Find Better Treatments For MS

Doctors at New York University are conducting a medical study that may determine the best treatments to slow the advancement of multiple sclerosis. NY1's Health reporter Kafi Drexel filed the following report.

Full story with video at NY1 News

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What's new for 'Multiple Sclerosis' in PubMed

Genome-wide association study identifies new multiple sclerosis susceptibility loci on chromosomes 12 and 20. - Nat Genet. 2009 Jun 14. [Epub ahead of print] in PubMed

Meta-analysis of genome scans and replication identify CD6, IRF8 and TNFRSF1A as new multiple sclerosis susceptibility loci. - Nat Genet. 2009 Jun 14. [Epub ahead of print] in PubMed

Demyelination, inflammation, and neurodegeneration in multiple sclerosis deep gray matter. - The aims of this study were to determine the frequency and distribution of lesions and characterize the inflammatory and neurodegenerative changes in DGM of MS patients. Histochemistry, immunohistochemistry, and morphometry were performed on whole coronal sections of 14 MS and 12 control (6 normal, 6 from amyotrophic lateral sclerosis patients) brains. - J Neuropathol Exp Neurol. 2009 May;68(5):489-502. in PubMed

Sex-Specific Therapeutic Strategies Based On Neuroactive Steroids: In Search For Innovative Tools For Neuroprotection. - In particular in our introductory article, the possibility that sex differences in the levels or in the action of neuroactive steroids may represent causative factors for sex differences in the incidence or manifestation of pathologies of the nervous system is considered. - Horm Behav. 2009 Jun 11. [Epub ahead of print] in PubMed

Multiple sclerosis association study with the TENR-IL2-IL21 region in a Spanish population. - Tissue Antigens. 2009 Jun 11. [Epub ahead of print] in PubMed

Immunomodulatory and anti-inflammatory effects of chondroitin sulphate. - The review of the literature suggest that CS might also be of interest for the treatment of other diseases with an inflammatory and/or autoimmune character, such as inflammatory bowel disease, degenerative diseases of the central nervous system and stroke, multiple sclerosis and other autoimmune diseases. - J Cell Mol Med. 2009 Jun 11. [Epub ahead of print] in PubMed

[Perioperative anesthetic management of a patient with multiple sclerosis] - In conclusion, appropriate control of surgical stress and prevention of fever are important for perioperative anesthetic management of patients suffering from MS. - Masui. 2009 Jun;58(6):772-4. in PubMed

Redefining functionality and treatment efficacy in multiple sclerosis. - we believe that expanding on the traditionally accepted definitions of "functionality" and "efficacy" will allow for the adoption of a more holistic picture of MS and its impact. - Neurology. 2009 Jun 9;72(23 Suppl 5):S1-11. in PubMed

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Monday, June 15

Another Tysabri Patient Stricken with PML

Tysabri, a drug used to treat multiple sclerosis, has been linked to another case of progressive multifocal leukoencephalopathy, or PML. According to a report on Reuters.com, this latest case of Tysabri-associated PML was confirmed on June 10.

Tysabri is now available only to patients with relapsing multiple sclerosis (MS) or Crohn’s disease (CD) who are enrolled in the risk minimization plan called the TOUCH Prescribing Program. Under the TOUCH Prescribing Program, every Tysabri-treated patient is closely monitored and followed for the occurrence of PML and other serious opportunistic infections.

According to The Wall Street Journal, Biogen Idec has been posting a PML case update on the Internet every Friday. That will continue until July 24 - the third anniversary of the drug’s relaunch - by which time it expects the risk/benefit profile of Tysabri to be clearer. This is the eighth case of Tysabri-associated PML reported by Biogen Idec in the past year. Of those cases, one has been fatal.

Like all but two of those PML cases, this latest occurred in a patient overseas, the Journal said. Biogen Idec said this latest patient took 35 doses of the monthly medication, the most of any of the post-launch cases. According to The Wall Street Journal, some believe that duration of Tysabri therapy plays a role in the drug’s PML risk.

Last August, Biogen Idec announced that Tysabri had been associated with two other European cases of PML. One patient had been taking Tysabri for 14 months and the other for 17. But unlike others stricken with PML, those patients had been taking Tysabri as monotherapy - with no other drugs. It had been theorized that patients contracting PML had done so because of exposure to multiple medications and that monotherapy with Tysabri was less risky. ...complete story in NEWS Inferno.com

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MS Research Accelerated To Help Patients

WAKE COUNTY, N.C. - An estimated 200 Americans are diagnosed with Mutiple Sclerosis every week. Brian Cole knows what that feels like. The Wake Forest man was diagnosed with the disease 14 years ago.

Like most Multiple Sclerosis patients, Cole's disease is relapsing and remitting, meaning it comes and goes. He is able to keep his symptoms at bay with medication.

"The only medications for M.S. right now are injections," Cole said. "So for me that meant...an inch and a half needle that you stick in your leg."

There are only six approved drugs on the market for Multiple Scleroris. Cole is currently participating in a clinical trial for a new oral medication. But developing new drugs is literally a process of trial and error. Four out of five new drugs in clinical trials for M.S. fail.

Dr. Tim Coetzee is the director of Fast Forward, a program of the National Multiple Sclerosis Society that is working to get more drugs on the market by funding research in small biotech and pharmaceutical companies. ....full story & news video in Wake MyNC.com

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New Study Uncovers Mystery of Multiple Sclerosis

(ChattahBox)—A new study of the DNA of patients with Multiple Sclerosis, has discovered specific genetic markers pointing to the disease, which could one day lead to treatments that have the potential to stop the disease in its tracks. This new study for the first time, points to a genetic cause of MS, which has remained a mystery to scientists until now.

The groundbreaking study was led by a team of 40 researchers from Australia and New Zealand who are members of the of the ANZgene consortium. The scientists analyzed the DNA makeup of 1,618 patients with MS and compared their findings to a control group of 3,413 people without the disease. ....full story in ChattahBox.com

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Numbers Of People With MS Higher Than Previously Estimated

New research released by the MS Society has for the first time revealed an accurate estimate of the number of people living with a diagnosis of multiple sclerosis (MS) in the UK.

The results show that there is likely to be around 100,000 people with MS in the UK - a 20 per cent increase on previous estimates.

The new study of GP records - funded by the MS Society - was carried out by the London School of Hygiene and Tropical Medicine and updates previous estimates of 85,000.

The revised figure has major implications for health and social services and the study is a precursor to a pilot MS Register, which will provide much more information on exactly how MS affects individuals. ....full report in Medical News Today

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Tracking Down The Causes Of Multiple Sclerosis - New Discoveries In Immune Response

Over 2.5 million people suffer from multiple sclerosis world-wide. Despite intensive research, the factors that trigger the disease and influence its progress remain unclear. Scientists from the Max Planck Institute of Neurobiology in Martinsried and an international research team have succeeded in attaining three important new insights into the disease.

Commenting on the findings, Helen Yates, Multiple Sclerosis Resource Centre Chief Executive said, "These findings from the Max Planck Institute of Neurobiology provide yet more pieces of the MS 'jigsaw'. It has long been suggested in some areas that the current mouse model, EAE, is not a close enough match to the development of MS in humans, so to develop a new model in itself is a real step forward. The research also suggests a different weighting of the activity of B cells and T cells. We hope to see more research in this area." ....full report in Medical News Today

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MS Society Commends Federal Government's Research Investment In Neurological Diseases

The Multiple Sclerosis Society of Canada praised the government announcement of $15 million to study the impact of a wide variety of neurological conditions, including multiple sclerosis.

"The MS Society applauds the federal government's $15 million commitment to pursue a greater understanding of neurological diseases and injuries," said Yves Savoie, president and CEO of the MS Society of Canada. "In the field of MS, we anticipate the results of this work will help guide our efforts to fund the best research and deliver programs that positively impact quality of life." ..full report in Medical News Today

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Queensland Researchers Help Unlock Genetic Keys To MS

New genes discovered by Australian and New Zealand researchers may hold the key to new treatments for people with multiple sclerosis (MS).

Queensland scientists are part of a consortium that has discovered two genetic variants which increase the risk of MS and reveal links to other autoimmune disease.

The study was published today in the prestigious scientific journal Nature Genetics. ...full report in Medical News Today

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Aussie And Kiwi Researchers Make Double MS Genetic Discovery

Australian and New Zealand researchers have accelerated research into Multiple Sclerosis by discovering two new locations of genes which will help to unravel the causes of MS and other autoimmune disease.

Their findings will be published today in the prestigious journal Nature Genetics. ...full report in Medical News Today

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Long-Term Study Determines Early Predictors of Response to Interferon Beta-1a in Patients With MS

June 10, 2009 (Atlanta, Georgia) — In patients with relapsing-remitting multiple sclerosis (MS), progression of disability and higher relapse rates are early markers of long-term disease severity, while initiation of treatment with intramuscular interferon (IFN) beta-1a can delay this progression when initiated in patients with low disease burden, new findings suggest.

Richard Rudick, MD, director of the Mellen Center for Multiple Sclerosis Treatment and Research at the Cleveland Clinic Foundation, in Ohio, presented the results here at the Consortium of Multiple Sclerosis Centers (CMSC) 23rd Annual Meeting in a poster session. ...full report in MedScape Today

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Natalizumab Likely Associated With Peripheral Sequestration of Proinflammatory T Cells

NEW YORK (Reuters Health) Jun 12 - Treatment with the humanized monoclonal antibody natalizumab increases the percentage of activated leukocytes producing proinflammatory cytokines in blood, according to an exploratory longitudinal study by US researchers. The likely mechanism of this action is sequestration of these activated CD4+ and CD8+ cells in the peripheral circulation.

The study, conducted in patients with relapsing-remitting multiple sclerosis (MS), is reported in the June 2 issue of Neurology by Dr. Samia Khoury of Brigham and Women's Hospital, Boston and colleagues. ....full report in MedScape Today

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What's new for 'Multiple Sclerosis' in PubMed

Oligodendrocyte development and the onset of myelination in the human fetal brain. - In this review we discuss the spatial and temporal progression of oligodendrocyte lineage characterized by the expression of specific markers and transcription factors in the human fetal brain from the early embryonic period (5 gestational weeks, gw) until midgestation (24 gw). - Front Neuroanat. 2009;3:5. Epub 2009 Jun 1. in PubMed

Coping Strategy and Anxiety Evolution in Multiple Sclerosis Patients Initiating Interferon-Beta Treatment. - This study (ACSEPT) aimed to assess anxiety evolution according to coping strategy in patients with multiple sclerosis (MS) during their first months of treatment with interferon (IFN)-beta1a. Eur Neurol. 2009 Jun 12;62(2):79-85. [Epub ahead of print] in PubMed

Plasma Exchange Therapy in Steroid-Unresponsive Relapses in Patients with Multiple Sclerosis. - PE is an effective and well tolerated therapeutic option for steroid-unresponsive MS relapses. - Blood Purif. 2009 Jun 11;28(2):108-115. [Epub ahead of print] in PubMed

[Efficacy and safety of cyclophosphamide treatment in progressive multiple sclerosis.] - Our results suggest that the CPM is efficient in progressive multiple sclerosis; however, its place must be reconsidered before establishing an international consensus for treatment; open label studies are needed to validate the present findings. - Rev Neurol (Paris). 2009 Jun 9. [Epub ahead of print] in PubMed

New perspectives in human stem cell therapeutic research.- BMC Med. 2009 Jun 11;7(1):29. [Epub ahead of print] in PubMed

Recent patents in CNS drug discovery: the management of inflammation in the central nervous system. - In this review, the authors focus on disclosures from the patent literature to give a broad overview of the different approaches that are being taken to try and develop more effective and selective anti-inflammatory agents to manage acute and chronic inflammation in the CNS. - Recent Pat CNS Drug Discov. 2009 Jun;4(2):86-95. in PubMed

Parent-of-origin effect in multiple sclerosis. Observations from interracial matings. - Neurology. 09 Jun 10. [Epub ahead of print] in PubMed

[The latest world standards in the diagnosis of multiple sclerosis] - This report describes the evolution of MS diagnostic guidelines for physician in clinical practice with a focus on recent recommended criteria from the year 2005, called "Revised McDonald Criteria". - Klin Oczna. 2009;111(1-3):70-4. in PubMed

[Stem cells in therapy of multiple sclerosis] - Experimental evidence of corrective and protective effects on tissues by preneuronal cells differentiated from fetal and embryonal human stem cells has been obtained in an animal model. - Duodecim. 2009;125(9):965-73. in PubMed

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Thursday, June 11

What's new for 'Multiple Sclerosis' in PubMed

Vocal symptoms and acoustic changes in relation to the expanded disability status scale, duration and stage of disease in patients with multiple sclerosis. - Patients with MS may develop vocal symptoms irrespective of the EDSS score, duration and stage of the disease. Vocal fatigue and vocal breaks are more common than hoarseness. - Eur Arch Otorhinolaryngol. 2009 Jun 10. [Epub ahead of print] in PubMed

Immuno-Therapeutic Potential of Haematopoietic and Mesenchymal Stem Cell Transplantation in MS. - In this review we will summarize the current clinical and experimental evidence on HSC and MSC and outline some key questions warranting further investigation in this exciting research area. - Results Probl Cell Differ. 2009 Jan 23. [Epub ahead of print] in PubMed

B Cells and Antibodies in MS. - This chapter therefore aims to summarize the present knowledge and to outline future directions about the role of B cells and antibodies in research and therapy of MS and NMO. - Results Probl Cell Differ. 2009 Jan 22. [Epub ahead of print] ib PubMed

Assessing the Clinical Efficacy of Sildenafil for the Treatment of Female Sexual Dysfunction(July/August). - Although data suggest a possible role of sildenafil for the treatment of FSD, the information should be interpreted cautiously, as many of the studies included small sample sizes, used inappropriate statistical tests, and used nonvalidated assessment tools. A better FSD classification system and consistent use of validated assessment tools might help alleviate differences among clinical trials and provide a more cohesive foundation for assessing the safety and efficacy of sildenafil for the treatment of FSD. - Ann Pharmacother. 2009 Jun 9. [Epub ahead of print] in PubMed

Cost-Effectiveness of Disease-Modifying Therapies in the Management of Multiple Sclerosis for the Medicare Population. - Value Health. 2009 Jan 9. [Epub ahead of print] in PubMed

Effect of statins on clinical and molecular responses to intramuscular interferon beta-1a. - Statin therapy does not appear to affect clinical effects of IM interferon beta-1a in patients with relapsing-remitting multiple sclerosis or the primary molecular response to interferon beta treatment. - Neurology. 2009 Jun 9;72(23):1989-93. in PubMed

Risk alleles for multiple sclerosis in multiplex families. - Neurology. 2009 Jun 9;72(23):1984-8. in PubMed

Exclusive Breastfeeding and the Risk of Postpartum Relapses in Women With Multiple Sclerosis. - Our findings suggest that exclusive breastfeeding and concomitant suppression of menses significantly reduce the risk of postpartum relapses in MS. Our findings call into question the benefit of foregoing breastfeeding to start MS therapies and should be confirmed in a larger study. - Arch Neurol. 2009 Jun 8. [Epub ahead of print] in PubMed

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Could MS Doctors be Treating the Wrong Disease?

I ran across this while doing some research and, although it is a little old, thought it was interesting. Some experts think that the reason a cure for multiple sclerosis has not been found is because the understanding of multiple sclerosis that researchers and physicians have is fundamentally wrong. The alternative theory, upheld by Drs. Peter Behan and Abhijit Chaudhuri states that multiple sclerosis is not caused by the immune system attacking myelin (as is commonly believed); instead, multiple sclerosis is caused by cells (called astrocytes) malfunctioning.

The thinking goes like this: the animal model of multiple sclerosis (which is used for treatment and drug development) is very different from the human experience of multiple sclerosis. In the animal model, the MS-like condition (in which the myelin indeed is attacked by the immune system) leads to death or disability, while in people the course of multiple sclerosis is much more varible (and only rarely leads to death). Therefore, claim the researchers, these are really two different diseases (with the further proof that, despite extensive research, these animal-based treatments do not "cure" MS).

Reactions to this theory vary, but most consider it an oversimplification of things and recent evidence of the impact of MS treatments on multiple sclerosis itself leads most researchers and physicians to believe we are "on the right track." ...read in About.com

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UK: Adult Stem Cells Reverse Symtoms of Multiple Sclerosis

Chalk up yet another success for adult stem cell therapy!

According to the UK Telegraph, researchers in Britain have taken stem cells from a patient’s own body fat to stimulate the regrowth of tissue damaged by multiple sclerosis.

Last year experts suggested that stem cell therapy could be a “cure” for MS within the next 15 years.

Patients’ symptoms were still improving up to a year after the treatment, the new study shows. ... full story in Dakota Voice

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Bioenergy Life Project Announces Community Event to Document Benefits of Bioenergy on Parkinson's Disease and Multiple Sclerosis

LOS ANGELES, Calif., June 10 (SEND2PRESS NEWSWIRE) -- The Bioenergy Life Project announces the first community event to document the benefits of Bioenergy therapy on Parkinson's Disease and Multiple Sclerosis. The event will last from July 13th to 16th 2009 at the Marina Del Rey Hotel, Marina Del Rey, Calif.

The Bioenergy Life Project offers the public a free opportunity to experience a unique, safe and gentle alternative solution to long term, chronic illness.

By documenting the benefits and results of the Domancic Method of Bioenergy Therapy, the Bioenergy Life Project will raise awareness that Bioenergy is a safe, effective method for renewing and maintaining health. ...full story in Send2Press Newswire

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Breastfeeding Associated With A Reduced Risk Of Relapse In Women With Multiple Sclerosis

ScienceDaily (June 11, 2009) — Women with multiple sclerosis who breastfeed exclusively for at least two months appear less likely to experience a relapse within a year after their baby's birth, according to a report posted online today that will appear in the August print issue of Archives of Neurology, one of the JAMA/Archives journals. ...full story in Science Daily

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Tracking Down The Causes Of Multiple Sclerosis

ScienceDaily (June 10, 2009) — Over 100,000 people suffer from multiple sclerosis in Germany alone. Despite intensive research, the factors that trigger the disease and influence its progress remain unclear. Scientists from the Max Planck Institute of Neurobiology in Martinsried and an international research team have succeeded in attaining three important new insights into the disease.

It would appear that B cells play an unexpected role in the spontaneous development of multiple sclerosis and that particularly aggressive T cells are activated by different proteins. Furthermore, a new animal model is helping the scientists to understand the emergence of the most common form of the disease in Germany....full story in Science Daily

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Saturday, June 6

What's new for "Multiple Sclerosis" in PubMed

Fellow eye changes in optic neuritis correlate with the risk of multiple sclerosis. -The magnitude of latency prolongation and amplitude decline 12 months after the initial episode was proportional to the risk of MS. The prognostic significance of these changes as predictors of subsequent MS should be investigated longitudinally. - Mult Scler. 2009 Jun 4. [Epub ahead of print] in PubMed

Arterial Compliance in Multiple Sclerosis: A Pilot Study. - Arterial compliance is significantly compromised in young individuals with MS, compared with age-matched controls, but not for older individuals, suggesting a systemic effect of an inflammatory process that predominantly affects the CNS. - Angiology. 2009 Jun 3. [Epub ahead of print] in PubMed

Protective effects of progesterone administration on axonal pathology in mice with experimental autoimmune encephalomyelitis. - Brain Res. 2009 Jun 1. [Epub ahead of print] in PubMed

Cerebrospinal fluid and serum uric acid levels in patients with multiple sclerosis. - Our results support the significance of UA in the pathogenesis of MS. - clin Chem Lab Med. 2009 Jun 4. [Epub ahead of print] in PubMed

Updated prevalence estimates of multiple sclerosis in Texas, 1998 to 2003. - Patients in whom MS was diagnosed by a neurologist, who resided in the study areas, and who had an office visit between 1998 and 2003 were included in the study. - Tex Med. 2009 Jun 1;105(6):e1. in PubMed

Fatigue, depression and disability accumulation in multiple sclerosis: a cross-sectional study. - In patients with MS, fatigue and depression are strongly associated with each other but not with the degree of disability or the speed of disability accumulation. - Eur J Neurol. 2009 Mar 1;16(3):348-352. in PubMed

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Wednesday, June 3

Secretary Of State Backs MS Society Work Retention Project

Secretary of State for work and pensions James Purnell MP is lending his support to an MS Society-led project designed to help people with chronic and fluctuating health conditions remain in work.

Mr Purnell joins the MS Society and a range of charities, work organisations and leading UK employers and trade unions at a round table event at the Work Foundation in London today (2 June).

Simon Gillespie, chief executive of the MS Society, said: "All too often, people with multiple sclerosis (MS) and other fluctuating health conditions say they left work too soon, either voluntarily or due to pressure from an employer. We want to provide an information resource that can act as a safety net at the point at which someone's working life may be about to fall off a cliff. ....full report in Medical News Today

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What's new for 'Multiple Sclerosis' in PubMed

Comparison of MRI signatures in pattern I and II multiple sclerosis models. - These findings suggest that the observed signal changes reflect the convergent histopathology of the two models rather than the underlying mechanisms of the disease. - NMR Biomed. 2009 Jun 1. [Epub ahead of print] in PubMed

Imaging outcomes for neuroprotection and repair in multiple sclerosis trials. - At present, the three most promising primary outcomes in phase II trials of neuroprotective and/or reparative strategies in MS are: changes in whole-brain volume to gauge general cerebral atrophy; T1 hypointensity and magnetization transfer ratio to monitor the evolution of lesion damage; and optical coherence tomography findings to evaluate the anterior visual pathway. Power calculations show that these outcome measures can be applied with attainable sample sizes. - Nat Rev Neurol. 2009 May;5(5):256-66. in PubMed

Combining beta interferon and atorvastatin may increase disease activity in multiple sclerosis. - The combination of 40 or 80 mg atorvastatin with thrice weekly, 44 microg interferon beta-1a in persons with multiple sclerosis resulted in increased MRI and clinical disease activity. Caution is suggested in administering this combination. - Neurology. 2008 Oct 28;71(18):1390-5. Epub 2008 Jun 4. & Comment in: Neurology. 2008 Oct 28;71(18):1286-7. & Neurology. 2009 Jun 2;72(22):1965-6. in PubMed

Natalizumab treatment is associated with peripheral sequestration of proinflammatory T cells. -Natalizumab treatment increases the percentage of activated leukocytes producing proinflammatory cytokines in blood, presumably due to sequestration of activated cells in the peripheral circulation. - Neurology. 2009 Jun 2;72(22):1922-30. in PubMed

Remyelination capacity of the MS brain decreases with disease chronicity. - In summary, our data demonstrate that remyelination is a frequent event in early multiple sclerosis lesions. Furthermore, the anatomic localization of a lesion might influence the extent of remyelination. - Neurology. 2009 Jun 2;72(22):1914-21. in PubMed

Spontaneous relapsing-remitting EAE in the SJL/J mouse: MOG-reactive transgenic T cells recruit endogenous MOG-specific B cells. - J Exp Med. 2009 Jun 1. [Epub ahead of print] in PubMed

[Part II: Implication of the blood-brain barrier in neurological diseases.] - This review will focus on the recently described BBB dysfunctions presumably involved in various neurological diseases. - Rev Neurol (Paris). 2009 May 30. [Epub ahead of print] in PubMed

Loss of AMPK exacerbates experimental autoimmune encephalomyelitis disease severity. - Our study identifies AMPK as a down regulated target during disease in all immune cells and possibly restoring AMPK may serve as a novel therapeutic target in autoimmune diseases like multiple sclerosis (MS). - Biochem Biophy Res Commun. 2009 May 29. [Epub ahead of print] in PubMed

Lack of Interferon-beta bioactivity is associated with the occurrence of relapses in multiple sclerosis. - Treatment failure to Interferon-beta (IFNbeta) in multiple sclerosis (MS) can only partly be explained by anti-IFNbeta neutralising antibodies (NAb)........Our results suggest that a lack of IFNbeta bioactivity is associated with the occurrence of relapses and therefore can be useful as a biomarker for unresponsiveness to IFNbeta. - Eur J Neurol. 2009 May 22. [Epub ahead of print] in PubMed

[Validation analysis of selected psychometric features of Polish version of Modified Fatigue Impact Scale - preliminary findings.] - Both the reliability and validity of MFIS are satisfactory; the scale seems to be a valuable tool to evaluate the impact of fatigue on quality of life of patients with MS. - Neurol Neurchir Pol. 2009 March-April;43(2):148-154. in PubMed

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Tuesday, June 2

MS Trial Alert: Investigators Recruiting Participants with MS for Study of Alemtuzumab - UPDATED

Investigators worldwide are recruiting subjects for a study of alemtuzumab (Genzyme Corporation) for the treatment of relapsing-remitting MS. In the CARE-MSSM II study, approximately 700 subjects at over 200 study sites will be randomly assigned to receive treatment with alemtuzumab or Rebif® (interferon beta-1a, EMD Serono and Pfizer). This study is funded by Genzyme Corporation and Bayer Healthcare Pharmaceuticals.

Rationale: Alemtuzumab is a humanized monoclonal antibody directed at CD52 (a protein on the surface of immune cells) that is currently approved by the U.S. FDA as a single agent for treatment of patients with B-cell chronic lymphocytic leukemia. Its ability to target immune cells has led investigators to test its potential as a treatment for relapsing-remitting MS. A phase 2 study compared two dose levels of alemtuzumab with Rebif in 334 subjects with relapsing-remitting MS who had never taken any other disease-modifying therapies. Those taking alemtuzumab had a 74% reduction in the risk of MS relapse compared with those on Rebif, and a 71% reduction in the risk for sustained accumulation of disability (New England Journal of Medicine 2008 359;17: 30-45). ..news from the National MS Society

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BioPartners GmbH Withdraws Its Application For Biferonex (interferon Beta-1a)

The European Medicines Agency has been formally notified by BioPartners GmbH of its decision to withdraw its application for Biferonex (interferon beta-1a), 6 million-international-unit solution for injection, prefilled syringes for subcutaneous administration.

Biferonex was expected to be used to treat patients with relapsing-remitting multiple sclerosis characterised by two or more exacerbations of neurological symptoms in the previous two years.

The application for the marketing authorisation for Biferonex was submitted to the Agency on 24 July 2007. On 19 February 2009, the Agency's Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation. Following this, the company requested a re-examination of the opinion, which was under review by the CHMP at the time of the withdrawal.

The company stated in its official letter that its decision to withdraw the application was based on the fact that the additional information provided in support of the re¬examination had not changed the Committee's view on the benefit-risk balance of Biferonex. ...full report in Medical News Today

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What's new for 'Multiple Sclerosis' in PubMed

Improving Compliance with Interferon-beta Therapy in Patients with Multiple Sclerosis. - CNS Drugs. 2009;23(6):453-62. doi: 10.2165/00023210-200923060-00001. in PubMed

Driving behaviors among community-dwelling persons with multiple sclerosis. - The results indicate the need to consider issues related to driving as MS severity progresses, and, given the progressive nature of MS and the concerns of the validity of the most common clinical driving assessment measures (the behind-the-wheel evaluation), repeated assessment of driving ability may be the most effective approach for identifying driving difficulties among persons with MS. - Arch Phys Med Rehabil. 2009 Jun;90(6):975-81 in PubMed

Assaying THE functional effects of demyelination and remyelination: Revisiting field potential recordings. - J Neurosci Methods. 2009 May 26. [Epub ahead of print] in PubMed

The mosaic of autoimmunity: the role of environmental factors. - In this communication, only the environmental factors are reviewed such as: infectious agents (represented by Epstein-Barr virus and cytomegalovirus), vaccines as triggers of autoimmunity, smoking and its relationship with rheumatoid arthritis, systemic lupus erythematosus, thyroid disease, multiple sclerosis and inflammatory bowel diseases. Some aspects of stress as implicated in causing autoimmunity and the processes leading to autoimmunity are reviewed as well. - Front Biosci (Elite Ed). 2009 Jun 1;1:501-509. in PubMed

Twin studies and the heritability of MS: a conclusion. - Overall the studies support a genetic contribution to disease; however, the imprecision of the heritability estimates and potential biases that they contain mean that very little inference can be drawn its exact size. - Mult Scler. 2009 Jun;15(6):661-667. in PubMed

T2 hypointensity in the deep gray matter of patients with benign multiple sclerosis. - Mult Scler. 2009 Jun;15(6):678-686. in PubMed

Efficacy of intramuscular interferon beta-1a in patients with clinically isolated syndrome: analysis of subgroups based on new risk criteria. - Mult Scler. 2009 Jun;15(6):728-734. in PubMed

Neurological disability, psychological distress, and health-related quality of life in MS patients within the first three years after diagnosis. - ConclusionsEarly stage MS patients significantly differ in their psychological distress when compared to healthy controls. Psychological distress in these patients is associated with neurological disability, but it is also present in patients with minimal to no neurological disability. Psychological distress was identified as an independent predictor for MS-related quality of life. - Mult Scler. 2009 Jun;15(6):752-758. in PubMed

Prominent brainstem and cerebellar involvement in multiple sclerosis with psoriasis. - Mult Scler. 2009 Jun;15(6):763-766. in PubMed

A New Therapeutic Approach for Autoimmune Diseases by the Sphingosine 1-Phosphate Receptor Modulator, Fingolimod (FTY720). - Patients who received FTY720 orally had a significant reduction in the clinical disease activity, the number of lesions in the central nervous system, and the relapse rates. Since FTY720 possesses a new mechanism of action that has not been observed with other immunosuppressive agents, it is believed that FTY720 provides a new therapeutic approach for autoimmune diseases including multiple sclerosis. - Yakugaku Zasshi. 2009;129(6):655-665. in PubMed

Update on inflammation, neurodegeneration, and immunoregulation in multiple sclerosis: therapeutic implications. - Clin Neuropharmacol. 2009 May-Jun;32(3):121-32. in PubMed

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Genzyme completes acquisition of worldwide rights for multiple sclerosis drug Campath - update

(RTTNews) - Biopharmaceutical company Genzyme Corp. (GENZ: News ) said Tuesday that it has completed the acquisition of the worldwide rights for Campath/MabCampath from German drug maker Bayer HealthCare (BAYRY.PK: News ).

Campath is currently used for the treatment of B-Cell Chronic Lymphocytic Leukemia or CLL, and indicated for multiple sclerosis or MS.

According to the deal, Genzyme has the primary responsibility to develop and commercialize Campath, or alemtuzumab in MS. However, Bayer can exercise an option to globally co-promote the product for MS, upon approval.

Genzyme said it is conducting two rapidly progressing phase 3 studies of alemtuzumab in relapsing-remitting MS patients.

Genzyme will also acquire a new, Seattle-area Leukine manufacturing facility for $75 million to $100 million and hire the plant's operating personnel following the 2010 anticipated FDA plant approval. ..full story in RTT News Global Financial Newswires

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MS Attacks More Than Myelin

Your brain can be though of as having two different types of stuff that it is made up of. This "stuff" is called gray matter and white matter. White matter is the "stuff" that connects neurons to each other, white matter is where the myelin is (actually, the myelin is what makes it white). We know that in multiple sclerosis, the body's own immune cells attack and damage myelin in the white matter.

Now here is some bummer news, some researchers now think that the immune system of people with multiple sclerosis also attacks the gray matter in the brain. The gray matter is made up of the actual neurons (the brain cells). Even more importantly, the damage to the gray matter may be the biggest factor in the level of disability of a person with multiple sclerosis.

We have always known that the nerve structures below the myelin often sustain damage from MS, and can be destroyed, resulting in "black holes" and generalized atrophy (shrinkage) of the brain and spinal cord. However, it was my assumption that this was just "collateral damage" that came from an overenthusiastic attack on the myelin.

What researchers have discovered is that the immune system in MS attacks a certain protein, called Contactin-2, that is produced by both the myelin and by neurons, which suggests that both types of brain matter may be actively targeted and attacked by the immune system in multiple sclerosis. They believe that Contactin-2 triggers the immune response in people with MS. So far, the research around this has been in the mouse model of MS, not in humans. ..full story in About.com Multiple Sclerosis Blog

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Diverse, bumpy roads converge at Tunxis

FARMINGTON — Yvonne Hill of New Britain has multiple sclerosis and dyslexia and is the single mother of a 10-year-old daughter. Edyta Bolek arrived in New Britain from Poland three years ago. But the two have something in common other than living in the same city.

On Sunday, Hill and Bolek both graduated from Tunxis Community College. Both majored in business administration and will further their education at four-year colleges. They are just two of the 350 people of all ages who received diplomas and/or certificates at Sunday’s commencement ceremony, held under a large tent in the college’s courtyard, with the new wing and library in the background. ...full story in The Bristol Press

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American Idol contestant to speak and perform at 2009 Woman Against MS Luncheon

Singer, songwriter and 2009 American Idol contestant David Osmond will headline this year’s National Multiple Sclerosis Society, Connecticut Chapter Women Against MS (WAMS) Luncheon Friday, June 5, at the Omni New Haven Hotel at Yale.

Osmond, who was diagnosed with MS several years ago, is the son of Alan Osmond, the founder of the famed troupe of singing brothers. Ironically, Alan Osmond has battled the baffling and potentially debilitating effects of multiple sclerosis for the past 20 years.

In 2005, after graduating from college, Osmond’s health began to deteriorate. He found himself unable to walk and consequently in a wheelchair for the better part of a year. He was initially diagnosed with West Nile Virus and a year later, also diagnosed with multiple sclerosis. As a result of his illness, his breathing became so labored he could no longer sing and playing a guitar was out of the question.

Osmond is partnered with the National Multiple Sclerosis Society and serves as an official ambassador and spokesperson, raising awareness and educating others on the effects of the disease. He travels the country performing and sharing his personal story of living life to the fullest in the face of the unpredictable effects of multiple sclerosis.

For more information or to reserve a seat, please contact Allison Cohen at 860-714-2300, ext. 246. For more information on MS, its effects and the many ways to help, please visit, www.ctfightsMS.org. ...full story in StamfordPlus.com

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Saturday, May 30

Health Watch: MS Computer Game

WAGA Fox 5 Atlanta GA. for video news report

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Medical marijuana bill clears Illinois Senate

SPRINGFIELD - With the help of key suburban votes, a plan to let those suffering from certain medical ailments and conditions use marijuana cleared the Illinois Senate Wednesday.

The plan was approved 30-28 in the 59-member chamber, garnering the bare minimum of votes needed.

"This is not recreational," said state Sen. Linda Holmes, an Aurora Democrat who has multiple sclerosis. She said the issue is helping people with debilitating conditions improve their quality of life.

"It is long overdue," said Holmes, one of five area Democrats to vote "yes."

The ailments or conditions spelled out in the proposed law for legal use of marijuana include cancer, glaucoma, HIV, hepatitis C, Crohn's disease, Alzheimer's, epileptic seizures and muscle spasms associated with multiple sclerosis. ...full story in the Daily Herald

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Increased Scrutiny of Opioids Could Alter Prescribing Practice

GAITHERSBURG, Md., May 28 -- If a formal risk reduction plan for opioid painkillers increases the regulatory burden on physicians, they may simply stop prescribing such drugs, to the detriment of patients in severe pain, the FDA was told Thursday.

The FDA's Center for Drug Evaluation and Research wrapped up a two-day public hearing here to get input from physicians, pain patients, pharmacists, hospice workers, addiction groups, and others to decide what factors it should consider in drafting a Risk Evaluation and Mitigation Strategy (REMS) aimed at reducing adverse events caused by opioids.

The REMS would be the largest to date and govern all extended-release opioid drugs, with the possibility of including regular-release opioids. ...full report in MedPage Today

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What's new for 'Multiple Sclerosis in Medical News Today

Link Between Vitamin D And Reduction In Multiple Sclerosis Risk - Could a holiday in the sun reduce the risk of developing multiple sclerosis? In a recent review for F1000 Medicine Reports, Bridget Bagert and Dennis Bourdette highlight recent advances in potential treatments. ...full report in Medical News Today

One Size Does Not Fit All: A New Look At Therapies - Statins, a commonly prescribed class of drugs used by millions worldwide to effectively lower blood cholesterol levels, may actually have a negative impact in Multiple Sclerosis (MS) patients treated with high daily dosages. ...full report in Medical News Today

Prescribing Sunshine For Multiple Sclerosis? - Could a holiday in the sun reduce the risk of developing multiple sclerosis? In a recent review for F1000 Medicine Reports, Bridget Bagert and Dennis Bourdette highlight recent advances in potential treatments. ....full report in Medical News Today

MS Patients Report Greater Treatment Satisfaction With TYSABRI - Biogen Idec (NASDAQ: BIIB) and Elan Corporation, plc (NYSE: ELN) have announced interim results from an ongoing, one-year longitudinal health-outcomes study in which patients reported significantly higher levels of treatment satisfaction after three infusions with TYSABRI® (natalizumab) when compared to multiple sclerosis (MS) therapies used previously. The findings from the study, which were reported by patients on therapy, further demonstrate the benefits of TYSABRI in treating MS and are helping to redefine successful treatment of the disease. The study, which was performed in conjunction with HealthCore Inc., a health-outcomes research company, is being presented in a poster today during the 23rd Annual Meeting of the Consortium of Multiple Sclerosis Centers. ....full report in Medical News Today

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What's new for 'Multiple Sclerosis' in PubMed

Factors perceived as being related to accidental falls by persons with multiple sclerosis. - This study explores and describes factors that persons with multiple sclerosis (MS) perceive as being related to accidental falls.....Investigating accidental falls using the perspective of the patient gave important information about variables not earlier targeted in MS research. - Disabil Rehabil. 2009 May 16:1-10. [Epub ahead of print] in PubMed

A longitudinal study of cognition in nursing home residents with multiple sclerosis. - Over the first 4 years of a nursing home stay, cognition deteriorates in individuals with MS. Though there are not different rates of decline, residents with MS-Neuro and MS-Comb perform worse than residents with MS or MS-Psyc. - Disabil Rehabil. 2009 May 19:1-8. [Epub ahead of print] in PubMed

Ambulatory rehabilitation in multiple sclerosis. - In this review, we summarise the primary factors affecting ambulation and highlight available treatment methods. We review studies that have attempted to characterise gait deficits within this patient population. Finally, as ambulatory rehabilitation requires multidisciplinary interventions, we examine approaches, which may serve to support and maintain ambulation within this patient group for as long as possible. - Disabil Rehabil. 2009 May 19:1-8. [Epub ahead of print] in Pubmed

Quality of life in MS: Does aging enhance perceptions of mental health? - Results suggest that perhaps the process of getting older, or factors related to being older, enhance perceptions of mental health in individuals with MS. Results are discussed within the context of social comparison theory, which might be an adaptive strategy that could underlie response shift in older individuals with MS. - Disabil Rehabil. 2009 May 18:1-8. [Epub ahead of print] in PubMed

The perceived benefits and barriers to exercise participation in persons with multiple sclerosis. - When compared with previous studies conducted in the general population, the participants in the present study reported different perceived barriers to exercise participation. Furthermore, awareness of the benefits of physical activity is not sufficient to promote exercise participation in persons with MS. Perceived exercise self-efficacy is shown to play an important role in promoting exercise participation in persons with MS. - Disabil Rehabil. 2009 May 21:1-7. [Epub ahead of print] in PubMed

A study analysing inconsistent responses from people with multiple sclerosis in a recent national audit. - This study has revealed that simple, single questions on satisfaction with services do not offer a valid measure of patient experience. It has shown that there is a place for qualitative research in the area of patient satisfaction. - Disabil Rehabil. 2009 May 21:1-9. [Epub ahead of print] in PubMed

Development, standardisation and pilot testing of an online fatigue self-management program. - Disabil Rehabil. 2009 May 19:1-11. [Epub ahead of print] in PubMed

Exploring physical activity behaviour of persons with multiple sclerosis: a qualitative pilot study. - Results from this pilot study suggest that PA interventions will need to implement multiple strategies that target self-efficacy, social environment and coping styles. We found SCT and TMSC useful in understanding PA behaviour among persons with MS; however, a limitation to these theories is that they are not explicit in the relationship between health and cognitions. Future research will need to explore how to incorporate models of health and function into existing behaviour change theories. - Disabil Rehabil. 2009 May 21:1-14. [Epub ahead of print] in PubMed

Increased plasma levels of brain derived neurotrophic factor (BDNF) after multiple sclerosis relapse. - Our results provide some evidence for the involvement of BDNF in the pathogenesis of MS and suggest a role for this neurotrophin during the recovery of acute demyelinating inflammatory lesion. - Neurosco Lett. 2009 May 25. [Epub ahead of print] in PubMed

[Multiple sclerosis and pregnancy] - Mulltiple sclerosis and pregnancy Multiple sclerosis (MS) is diagnosed between the second and fourth decade. More than 2/3 of patients are women and are often in childbearing age. We may ask two main questions: Which implication of pregnancy on the evolution of MS has to be considered ? Which influence of MS on the pregnancy is expected? In other words could the pregnancy worsen MS and could MS represent specific risks for the pregnancy? - Rev Med Suisse. 2009 Apr 29;5(201):936, 938-40. in PubMed

[Neurobehavioral changes occurring during multiple sclerosis] - Behavioral changes occurring in patients affected by multiple sclerosis (MSI are often neglected by physicians but are actually part of the clinical spectrum of the disease. In addition, they are known to be responsible for a decline in the quality of life of MS patients. Recently, there has been a growing interest to investigate changes in the emotional experience of MS patients and their decision making, showing that the ability to take advantageous decisions was altered in MS. This paper reviews existing data on this topic. - Rev Med Suisse. 2009 Apr 29;5(201):951-4. in PubMed

Endogenous remyelination is induced by transplant rejection in a viral model of multiple sclerosis. - These data suggest that remyelination was initiated by the local response to xenograft transplantation. These findings illustrate the complexities of OPC transplantation into areas of robust immune-mediated pathology. - J Neuroimmunol. 2009 May 22. [Epub ahead of print] in PubMed

Quality of life in 1000 patients with early relapsing-remitting multiple sclerosis. - Quality of life is considerably impaired in early stages of MS. Treatment initiation with IM IFNbeta attenuates MS disease activity and improves QoL. Inability to work early during the disease is a major challenge for the social security systems. -Eur J Neurol. 2009 Jun;16(6):713-20. in PubMed

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Wednesday, May 27

Multiple Sclerosis - What Are People With MS and Their Health Care Providers Really Thinking?

- New national survey reveals insights on treatment of disease, psychosocial burden, and delays in starting treatment

ROCKLAND, Mass. and NEW YORK, May 27 /PRNewswire/ -- The National Multiple Sclerosis (MS) Society, in collaboration with EMD Serono, today released findings from a nationwide GfK Roper survey, "MS Viewpoints: Understanding the Outlook on Emerging Therapies" in conjunction with the first-ever World MS Day. The MS Viewpoints survey compared the perspectives of neurologists, MS nurses and other healthcare professionals (HCPs)* and people living with MS on treatments, psychosocial burdens of the disease, and delays in starting treatment. Results from the survey uncovered that people newly diagnosed with MS often delay starting treatment, citing fear or anxiety about current treatment options as a key reason.

About the Survey
Independent research group, GfK Roper Public Affairs & Media, conducted the survey, interviewing 250 neurologists, 250 MS nurses and other HCPs, and 250 people living with relapsing MS. Interviews focused on understanding and comparing views of the current treatment landscape and the potential impact of emerging therapies, and also explored some of the psycho-social barriers that people living with MS face on a daily basis. ....read the full story and learn more about this survey at PR Newswire

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Diabetes Drug Shows Promise Against Multiple Sclerosis

Newswise — A drug currently FDA-approved for use in diabetes shows some protective effects in the brains of patients with relapsing remitting multiple sclerosis, researchers at the University of Illinois at Chicago College of Medicine report in a study currently available online in the Journal of Neuroimmunology.

Patients taking pioglitazone showed significantly less loss of gray matter over the course of the one-year trial than patients taking placebo. Of the 21 patients who finished the study, patients taking pioglitazone had no adverse reactions and, further, found taking pioglitazone, which is administered in an oral tablet, easy.

The researchers focused on pioglitazone because of its known anti-inflammatory effects, Feinstein said. They used primary cultures of brain cells to show that pioglitazone reduced the production of toxic chemicals called cytokines and reactive oxygen species. These molecules are believed to be important in the development of symptoms in MS.

Claudia C. Kaiser, who was a post-doctoral student at UIC, is first author on the paper. Other authors are Dinesh Shukla and Demetrios Shias of UIC; Glen Stebbins, Dusan Stefoski and George Katsamakis of Rush University Medical Center; and Douglas Jeffrey of Wake Forest University School of Medicine. Takeda Pharmaceuticals funded the study and provided the drug but had no other involvement in the study. ....full report in NewsWise

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Tuesday, May 26

What's new for 'Multiple Sclerosis' in PubMed

Adult stem cell transplantation in autoimmune disease. - Hematopoietic stem cell transplantation for severe autoimmune disease has been shown to be feasible, and definitive phase III randomized trials are now in progress. Durable remission after immune reconstitution and tissue remodeling suggests an effect beyond profound immunosuppression. Mesenchymal stem cells show promise as immunomodulatory agents in autoimmune disease with low acute toxicity and no requirement for ablation of the recipient immune system. - Curr Opin Hematol. 2009 May 21. [Epub ahead of print] in PubMed

Retinal nerve fiber thickness in inflammatory demyelinating diseases of childhood onset. - Mult Scler. 2009 May 22. [Epub ahead of print] in PubMed

Pulmonary arterial hypertension associated with interferon beta treatment for multiple sclerosis: a case report. - Mult Scler. 2009 May 22. [Epub ahead of print] in PubMed

MRI measures show significant cerebellar gray matter volume loss in multiple sclerosis and are associated with cerebellar dysfunction. - Clinically relevant GM atrophy occurs in the cerebellum of MS patients and is more prominent than WM atrophy. As such, it may provide complementary data to other regional atrophy and intrinsic tissue measures. - Mult Scler. 2009 May 22. [Epub ahead of print] in PubMed

Evaluating potential therapies for bladder dysfunction in a mouse model of multiple sclerosis with high-resolution ultrasonography. - This study demonstrates a novel outcome measure in experimental MS that allows; repeated, non-invasive, high resolution ultrasonic monitoring of bladder function. - Mult Scler. 2009 May 22. [Epub ahead of print] in PubMed

Clinical trials of multiple sclerosis therapies: improvements to demonstrate long-term patient benefit. - This article reviews the key data and provides recommendations for optimizing clinical studies in MS to demonstrate long-term patient benefit. - Mult Scler. 2009 May 22. [Epub ahead of print] in PubMed

Multiple sclerosis rehabilitation outcomes: analysis of a national casemix data set from Australia. - Mult Scler. 2009 May 22. [Epub ahead of print] in PubMed

Fatigued patients with multiple sclerosis have impaired central muscle activation. - We conclude that impaired central motor activation is involved in MS-fatigue. - Mult Scler. 2009 May 22. [Epub ahead of print] in PubMed

Pharmacotherapy of multiple sclerosis: the PROOF trial. - Ultimately, the question of long-term efficacy of high- versus low-frequency INFB therapies remains unanswered. - Expert Opin Pharmacother. 2009 Jun;10(8):1235-1237. in PubMed

Use of neuromuscular electrostimulation in the treatment of dysphagia in patients with multiple sclerosis. - Our study showed that the treatment of swallowing problems with neuromuscular electrostimulation in patients with multiple sclerosis in this sample was successful in the reduction of pooling of saliva and in the reduction of aspiration. - Ann Otol Rhinol Laryngol. 2009 Apr;118(4):241-6. in PubMed

Randomized study of interferon beta-1a, low-dose azathioprine, and low-dose corticosteroids in multiple sclerosis. - ConclusionIn IFNbeta-naïve patients with early active RRMS, combination treatment did not show superiority over IFNbeta-1a monotherapy. - Mult Scler. 2009 May 22. [Epub ahead of print] in PubMed

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Prescribing sunshine for multiple sclerosis?

Could a holiday in the sun reduce the risk of developing multiple sclerosis? In a recent review for F1000 Medicine Reports, Bridget Bagert and Dennis Bourdette highlight recent advances in potential treatments.

Multiple sclerosis (MS) results from a failure of the body to recognize itself. The immune system attacks and destroys the sheath that protects nerve fibres, as if it were a foreign body or infection. Vitamin D, which is produced in the skin in response to natural sunlight, is an immune system regulator. This might explain why MS is less common in sunnier countries.

Giving MS sufferers vitamin D pills - or encouraging them to spend more time in the sun - might be a cheap and easy treatment. Bagert and Bourdette point out that oral vitamin D therapy is now in phase II clinical trials, to see how well it works and how much would be needed.

They say "The arrival of effective oral agents will give MS patients more therapeutic options and will be a major advance in the global effort to alter the natural history of this chronic disease".
Story in Eurek Alert

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Launch of Highly Anticipated Oral Agents and Increasing Use of Current and Emerging Injectable Drugs Will Drive the Multiple Sclerosis Drug Market to

Emerging Novel Oral Therapies Will Garner 29 Percent of the Total Market in 2018, According to a New Report from Decision Resources

WALTHAM, Mass., May 26 /PRNewswire/ -- Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that the approval and launch of highly anticipated oral agents as well as the increasing use of current and emerging injectable drugs will drive the overall multiple sclerosis drug market to nearly $10 billion in 2018 in the United States, France, Germany, Italy, Spain, the United Kingdom and Japan.

The new Pharmacor report entitled Multiple Sclerosis finds that emerging novel oral therapies, most notably Merck Serono/EMD Serono's oral cladribine and Novartis/Mitsubishi Tanabe's FTY-720 (fingolimod), will garner 29 percent of the total multiple sclerosis market in 2018. Oral cladribine and FTY-720 will together capture more than $2 billion in major market sales in 2018, despite safety concerns associated with both drugs. The report also finds that three additional emerging agents - Biogen Idec's pegylated interferon-beta-1a, Genzyme/Bayer Schering/Bayer HealthCare's alemtuzumab (currently marketed as Campath/MabCampath) and BioMS Medical/Eli Lilly's dirucotide - will also contribute substantially to market growth by providing new therapeutic options to patients.

"Owing to the multitude of emerging therapies in late stage development, each of which offers particular attributes, and because combination treatment in multiple sclerosis is rare, the market will become increasingly fragmented as current and emerging therapies vie for niche patient populations," said Decision Resources Analyst Bethany Kiernan, Ph.D. "Nevertheless, the need for efficacious, safe and/or convenient therapies will permit all agents--including those that show robust efficacy but bear serious safety risks--to fulfill crucial needs among patients, depending on the individual course of their disease."

The report also finds that, despite the improvements offered by emerging drugs, neurologists indicate that substantial unmet need remains for neuroprotective agents and for therapies that halt or reverse disease progression. Additionally, because many of the advantages offered by current and emerging agents are offset by significant drawbacks, opportunity remains for the development of therapies that possess a better balance of efficacy, safety and convenience. ....full report in PR Newswire

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Japanese find success for MS with Vitamin A-like drug

A man-made drug that is like Vitamin A has shown progress in controlling MS and some of the disease's worst symptoms. The results of the tests are published in the June issue of the American Journal of Pathology.

A group of Japanese scientists tested the synthetic retinoid AM80 at the National Institute of Neuroscience in Tokyo. They found that it prevents early symptoms of the autoimmune disease by blocking the function of Th17 T-cells, a type of immune cell known to play a role in the onset of multiple sclerosis.

In the Science Daily this week, the research team of Dr. Takahashi Yamamura (right), Dr. Christian Klemann and Dr. Shinji Oki (far left) announced the finding that the synthetic retinoid AM80 is effective in treating early symptoms in a mouse model of Multiple Sclerosis.

Their findings "conclude that treatment with the synthetic retinoid AM80 is a considerable intervention strategy for the acute phase of Th17-mediated autoimmune diseases such as MS."...full story in Examiner.com

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Struck down by the curse of MS - at age FIVE: Little Lucy reveals childhood toll of incurable disease

Lucy Wood is much like any other little girl. She adores Disney princesses and looking at her pony story books. Everyone knows her for her love of cuddles, and she dreams of being a pop star when she grows up.

But last summer, just a few days after her fifth birthday, she became one of the youngest people in Britain to be diagnosed with Multiple Sclerosis, the progressively disabling neurological condition.

For an adult such a diagnosis would be a dreadful blow, for a child it is unbearably cruel. 'Hearing the diagnosis was like being in a head-on car crash,' says her mother Sharon, 39. 'We already had a pretty good idea of what was wrong with Lucy but having it confirmed was horrific.' ...full story in the Daily Mail On Line

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Monday, May 25

One size does not fit all: A new look at therapies

Statins, a commonly prescribed class of drugs used by millions worldwide to effectively lower blood cholesterol levels, may actually have a negative impact in Multiple Sclerosis (MS) patients treated with high daily dosages.

A new study by researchers at the Montreal Neurological Institute (MNI), McGill University, demonstrates that statin therapy in mice inhibits myelin repair or remyelination in the central nervous system. The findings, published in The American Journal of Pathology, highlight the crucial need to monitor the effects of central nervous system-accessible immune therapies on the myelin repair processes in patients with MS and other progressive demyelinating diseases. ...read the full report in McGill University Health Centre

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Vitamin D may offer hope to sufferers of MS

New Canadian research is shedding light on intriguing evidence that vitamin D may cut relapse for some multiple sclerosis patients.

According to research presented at the annual meeting of the American Academy of Neurology, high doses of the vitamin appear safe for patients with MS and may even lead to a reduction in disease relapses.

Dr. Jodie Burton, a neurologist at the University of Toronto, studied 25 people with relapsing-remitting multiple sclerosis, a form of the illness characterized by relapses during which new symptoms can appear or old ones resurface.

"I think the results showing that vitamin D reduces attacks... require confirmation in a properly designed study," he said.

The best results in the study were only observed in those who took the larger doses. People in the high-dose group were given escalating doses of the vitamin for six months, to a maximum of 40,000 IU daily. Doses were then gradually lowered over the next six months, averaging out to 14,000 IU daily for the year.

Burton advises MS patients to talk to their doctors before beginning vitamin D supplements, noting that too much of the vitamin can be harmful for people with certain medical conditions such as kidney disease.

O'Connor advises other MS patients not to take too much vitamin D, suggesting they not exceed 2,000 IU to 4,000 IU units a day until further research can prove that higher doses aren't dangerous.

Recent research has found that proteins activated by vitamin D attach to a certain type of DNA, called DRB1-1501, which is believed to cause the disease.

Burton's team speculates that vitamin D reduces inflammation and stops the immune system from attacking its own cells, thereby ensuring the gene functions properly in the body. ...full report in CTV.ca

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Friends rally to help woman dealing with MS

Diann Carmichael’s family faces rising expenses as the Markdale-area woman’s multiple sclerosis reduces her independence.

A group of friends is organizing a fundraiser to help out.

“Having to accept help from the public isn’t easy for proud people who value independence and privacy. Diann suffers from a progressive form of multiple sclerosis which has put her into a wheelchair in just seven years and having to rely on others for help in a lot of everyday activities,” said Diann’s husband Darin Carmichael.

“Personally I’m not a really big fan of asking other people for money, but when you’re in a situation like this you have no choice. There’s a lot of expenses that come about here that we can’t handle on our own. All of our friends and family have been really good to chip in and organize this thing.

“A lot of things we wouldn’t be able to do without this as far as the van and the lift. We have to put a new wheelchair ramp on the house shortly. It’s got to be done,” he added.

“There are huge adjustments to accept . . . It’s really hard to admit that there are things I can’t do. My sister-in-law always says you just need to call and ask, but it takes a lot to make the call and ask that I need someone to help. If you’re an independent person you want to hold on to that as long as possible.”

The Sun Times

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Saturday, May 23

Video - Health Watch: Yearly MS Medicine

About 400,000 Americans are living with Multiple Sclerosis. MS is a disease of the central nervous system that is chronic and unpredictable. One Florida man said he was determined not to let MS dictate his life.
See Video news report WAGA Fox 5 Atlanta GA

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When Managed By Specialty Pharmacy, MS Patients More Compliant With Medications

Multiple sclerosis patients managed by a specialty pharmacy program were more compliant with medication, and had a lower risk of being hospitalized for their disease than those who were not managed by a specialty pharmacy program, according to a study completed by HealthCore, Inc.

HealthCore researcher Jingbo Yu presented the study at the International Society of Pharmacoeconomic and Outcomes Research 14th Annual International Meeting in Orlando, Fla. The retrospective study analyzed medical and pharmacy claims data.

The HealthCore study compared 3,055 patients managed by PrecisionRx Specialty Solutions to 807 patients who were not part of a specialty pharmacy-managed group over a period of one year. PrecisionRx provided patient education materials, regularly scheduled nurse calls and refill reminders to its members.

The study showed that those in the managed group had a 47 percent lower risk of being hospitalized to treat conditions associated with MS compared to the non-managed group. ...full study report in Medical News Today

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MS Societies In UK And Australia Provide International Research Opportunity

Worldwide collaborative ties among researchers investigating the debilitating neurological condition multiple sclerosis (MS) have been strengthened thanks to the introduction of the first UK and Australian Fellowship Exchange programme.

Dr Julia Morahan is the first person to be awarded the Macquarie Group Foundation Australia and UK MS Society Fellowship and she makes the move from investigating Motor Neurone Disease to research into MS.

The initiative cements the relationship between the UK MS Society and international scientists researching MS and is supported by the Macquarie Group Foundation - the philanthropic arm of Macquarie Group. ...full report in Medical News Today

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What Is Yeast Infection Or Candidiasis? What Is Vaginal Thrush?

Vaginal thrush (thrush) is a yeast infection caused by a type of fungus of the candida species, usually Candida albicans. It can affect all women, but is more common among women who are pregnant, those who have weakened immune systems, and women aged 30 to 50. Thrush is generally recurring - it comes back. The fungus, candida albicans, exists naturally in the vagina. As long as it does not multiply too much a woman will not notice it is there. However, if can sometimes multiply to such an extent that it causes swelling of the vagina and vulva. ...full report in Medical News Today

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Nicotinic Acid-Mediated Activation of Both Membrane and Nuclear Receptors towards Therapeutic Glucocorticoid Mimetics for Treating Multiple Sclerosis.

Nicotinic acid penetrates the blood brain barrier, cures pellagric dementia, has been used for over 50 years clinically without toxicity, and raises HDL concentrations to a greater degree than any pharmaceutical, thus providing unparalleled benefits against lipodystrophy. Summary analysis reveals that the expected therapeutic benefits of high-dose nicotinic acid administration far outweigh any known adverse risks in consideration for the treatment of multiple sclerosis.
PPAR Res. 2009;2009:853707. Epub 2009 May 17. in PubMed

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Patients with multiple sclerosis to form human chain on May 27