.MS Neighborhood

Julie Mock served in the Gulf War in 1991.

Julie Mock says she has multiple sclerosis, and there is simple explanation. She believes her exposure to a chemical agent during the Gulf War triggered the attack on her central nervous system.....Julie Mock remembers the day well.

"The plume was over us...we were in the area," she said.

The former army corporal and dental hygenist was with the 87th Medical Detachment in the Gulf in 1991 when U.S. forces blew up two Iraqi ammunition dumps and accidentally sent the nerve agents sarin and cyclosarin into the sky above her.
"Our chemical alarms went off from time to time and we thought they were malfunctioning," she said. Mock only had a short sleeve shirt on.....A lot of us noticed we were developing rashes that were hot and very itchy, after we were home, a lot of people…had achy joints, headaches," she said. "August of 2003 I was originally diagnosed with multiple sclerosis.”She believes she got the disease, which affects the central nervous system, from the chemical exposure....“Three people that served within 100 yards of me have been diagnosed with MS also," she said.

Yale School of Medicine researchers report in Science this week genetic evidence for the hypothesis that myelination, or formation of a protective sheath around a nerve fiber, consolidates neural circuitry by suppressing plasticity in the mature brain.

This finding has implications for research on restoring mobility to people who have lost motor functions due to spinal cord injury, multiple sclerosis, and other central nervous system disorders. The failure of surviving neurons to reestablish functional connection is most obvious after spinal cord injury, but limited nerve cell regeneration and plasticity is central to a range of neurological disorders, including stroke, head trauma, multiple sclerosis, and neurodegenerative disease, said senior author Stephen Strittmatter, professor in the Departments of Neurology and Neurobiology. Recovery of motor function after serious damage to the mature brain is facilitated by structural and synaptic plasticity.

Blocking vision in one eye normally alters ocular dominance in the cortex of the brain only during a critical developmental period, or 20 to 32 days postnatal in mice. Strittmatter's lab, working in collaboration with Nigel Daw, M.D., professor of ophthalmology and neuroscience, and his group, found that mutations in the Nogo-66 receptor (NgR) affect plasticity of ocular dominance. In mice with altered NgR, plasticity during the critical period is normal, but it continues abnormally so that ocular dominance later in development is similar to the plasticity of juvenile stages.MORE

Interferon beta-1b 250 mcg(1) treatment delayed the onset of clinically definite multiple sclerosis (CDMS) by one year (363 days) in patients with first clinical signs of multiple sclerosis (MS) compared to placebo, according to new findings from the BENEFIT (Betaferon/Betaseron in Newly Emerging MS For Initial Treatment) study presented at today's joint 21st Congress of the European Committee for the Treatment and Research in Multiple Sclerosis/10th Annual Meeting of the Americas Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS/ACTRIMS), Thessaloniki, Greece, by Professor Ludwig Kappos, Professor of Neurology and Clinical Neuroimmunology at the University of Basel, Switzerland.

Results from the study showed that treatment may significantly delay the development of CDMS. Patients in the treatment group experienced an additional 363 days delay in development of CDMS compared to the placebo group. At day 255 of the study, one-quarter of patients in the placebo group had developed CDMS, while it took 618 days for a comparable number of patients to develop CDMS in the treatment group. At the end of the two-year period, 45 percent of the placebo group compared with 28 percent in the interferon beta-1b group (p< 0.0001) had developed CDMS, a relative risk reduction of 50 percent in the group treated with interferon beta-1b. {CLICK FOR MORE}

"According to a new pan-European survey released today to coincide with the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) meeting, people living with multiple sclerosis (MS) are continuing to be rejected by a large section of society. Results from this survey, the largest general public survey in MS to date, have caused leading practitioners to call for increased awareness and understanding of the disease.

Over 5,000 respondents revealed that while most people would happily befriend a person with MS, nearly one in three1 would be disinclined to enter a relationship or marry someone with the condition, with men less likely to do so than women. This is despite the vast majority of people knowing that the condition, which affects people mostly in their 20s and 30s, is neither contagious nor likely to cause people to be unable to have children.

The same survey revealed that 56% Europeans still incorrectly believe that people with MS will die early... and as many as 75% think that people with the condition will need to use a wheelchair.

These statistics may help to explain why people with MS continue to feel misunderstood and isolated from the rest of society. "MS is the most common neurological disease in young adults {CLICK FOR MORE}

Fifty percent of people with MS suffer from depression. If you've been diagnosed with depression, a new resource is available to help you monitor your treatment to get well. Families for Depression Awareness is inviting families (people with depression and their family members or friends) to participate in a pilot evaluation of our Depression Monitoring Kit. The kit is designed to help you:
Get well faster and stay well....Understand what helps and what doesn't...Know if you're having adverse reactions to medication...Avoid hospitalizations and suicidal behavior.{CLICK}

This is Swedish survey found that pain is more common in multiple sclerosis than has previously been recognized. As many as 30% of people with MS reported central pain (pain associated with damage to the CNS) and mostly reported that pain as constantScienceDirect - European Journal of Pain ...Click to read study...

....The good news is that certain types of exercise can help people with MS. In addition to easing fatigue, exercise makes day-to-day living easier. It's also a mood booster, which can make quality of life a little better.....But exercise can be challenging for people with MS. That's because MS damages the nervous system, interrupting the messages sent between the brain and the rest of the body (see illustration). As a result, people with MS sometimes have problems with feeling, moving, seeing and even thinking. So, not all types of exercise are possible -- or beneficial.

Yoga has been shown to reduce fatigue in MS. And certain strength-training exercises can help boost mobility and muscle strength. The National Multiple Sclerosis Society also recommends tai chi (a gentle exercise consisting of slow, rhythmic body movements) and aquatic exercises. People with MS have a wide range of physical limitations, from mild to severe. That's why it's a good idea to work with a physical therapist or exercise specialist to develop a personal exercise regimen.

In addition to exercise, relaxation and stress reduction may also be helpful. A 2004 analysis that pooled results from 14 studies found a link between stressful life events and higher risk for MS relapses.

Other research has shown a higher risk of developing MS after a life-threatening event or a tragedy like the death of a child. The mechanism isn't fully understood. But one study found that reducing stress in people with MS lowered levels of gamma-interferon, a molecule that may contribute to relapses.

Many people wonder if diet can affect MS symptoms. Interestingly, MS is more common in people who live farther from the equator. The reason may be lack of sunlight. In the northern United States and other areas far from the equator, people get less ultraviolet radiation, which the body needs to make vitamin D. The Nurses' Health Study at Harvard found a link between MS and a lack of vitamin D. Women with the highest vitamin D intake from supplements (400 IU or more daily) were 40 percent less likely to develop MS than women who took no supplements. Although some doctors now recommend vitamin D supplements for people prone to MS, there's no proof that this will prevent the illness or influence its course.

Finally, researchers have found another habit that affects MS: smoking. Research from the Harvard School of Public Health suggests that quitting smoking may help limit or delay the progression of MS. In a study of 179 patients initially diagnosed with an early form of MS, investigators found that those who were current or past smokers were almost four times as likely as those who had never smoked to develop a more serious form of the disease.

In essence, the advice for people with MS is similar to that for many chronic diseases: exercise regularly, manage stress, eat a healthy diet and don't smoke.

...according to a study published in the journal 'Neurology'...."This randomised, controlled trial in 66 patients showed the drug was significantly superior to placebo. Sixty-five per cent of those taking part needed support to walk or were wheelchair users. They suffered from moderate to severe central neuropathic pain which had not been alleviated by currently available medications. Patients continued to take their existing medication throughout the trial. Sativex was administered as an oral spray, allowing flexible dosing suited to the variable nature of MS.

Dr Carolyn Young, the principal investigator and consultant neurologist at the Walton Centre for Neurology and Neurosurgery in Liverpool, said, "Central neuropathic pain occurs frequently in people with MS. It can be tremendously debilitating and unresponsive to existing therapies. Our findings demonstrate that Sativex was effective in reducing both central pain in MS and pain-related sleep disturbance in a population with moderate to severe central pain inadequately relieved by existing medication."Multiple Sclerosis Society Website

"his past weekend, while thousands of cyclists participated stateside in MS Bike Tours®, a group of 15 U.S. military personnel concerned about the plight of those struggling with the effects of multiple sclerosis participated in a 100-mile ride in the desert terrains of Iraq. Like those living with MS, a disease whose hallmark is unpredictability, these soldiers too are living lives filled with unpredictability.

The cyclists are stationed at Forward Operating Base (FOB) Danger, in Tikrit. Major Fred Evans, 42nd Aviation Brigade Liaison Officer, organized "Team Danger," the group of cyclists. Major Evans has participated in MS Bike Tours through his local Society chapter (Greater North Jersey). He says finding riders was easy and that supporting the National Multiple Sclerosis Society is just a continuation of the values the military is based upon.

"Over here we're fighting for our country, fighting the global war on terrorism," said Evans. "With this bike tour we're trying to help people, not only in the United States, but all over the world, in fighting this disease and in trying to find a cure for multiple sU.S. Soldiers in Iraq Cycle 100 Miles in the Desert to Raise Awareness for Multiple Sclerosis: Financial News - Yahoo!
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Twenty-Four Countries in Europe, Latin America and Asia Included in Study to Help Identify Optimal Long-Term Treatment Practice

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"The FDA now finds itself in an unenviable position, after receiving an application to clear Tysabri (natalizumab) again, seven months after the multiple sclerosis product was pulled from the market following its links to two fatalities, despite showing clinical efficacy.

And many industry observers expect the agency's risk-benefit analysis to come under scrutiny as the review process moves forward.

"I think they're bound to hold an advisory panel meeting, because these are the exact types of issues you'd want in a public forum," said Elise Wang, an analyst with Citigroup. "And I think there will be a tug of war, with us hearing from patients about how much they need this new therapy and that they're still willing to take the risk."

Still, with the agency's risk-averse nature these days and Tysabri's mysterious connection to progressive multifocal leukoencephalopathy (PML), a rare and potentially fatal demyelinating disease of the central nervous system, the bar is set high for approval.

The supplemental biologics license application from Biogen Idec Inc. and Elan Corp. plc includes final two-year data from the Phase III AFFIRM monotherapy trial and the combination SENTINEL study that evaluated Tysabri with Avonex (interferon beta-1a, also from Biogen Idec), as well as an integrated safety assessment of Tysabri-treated patients completed after the market withdrawal, a revised label and a risk management plan.

Officials could not be reached at either company, but both issued public statements that highlighted the product's "therapeutic benefit" and their "extensive safety evaluation." That was a message often heard from the companies in the months after voluntarily pulling Tysabri from the market and suspending all ongoing clinical trials earlier this year on reports of PML, a side effect that Wang called "very severe." (See BioWorld Today, March 1, 2005.)

Patricia O'Looney, the National Multiple Sclerosis Society's director of biomedical research, called that event a "disappointment." While no test exists to determine one's propensity to the condition, Tysabri patients have been advised to watch for symptoms such as motor weakness on one side of the body, rapidly developing changes in mental function, language disturbance, visual disturbance or changes in behavior or personality.

To date in the partners' subsequent safety analysis, three cases were confirmed, two of which were fatal, but the partners' review uncovered no more. More than 8,000 people have taken the drug.

That positive safety evaluation, in which Cambridge, Mass.-based Biogen Idec and Dublin, Ireland-based Elan consulted with PML and multiple sclerosis experts, has prompted support for Tysabri and its resubmission. But Wang told BioWorld Today that it's still a struggle to discern the "appropriate steps that can be taken to be able to monitor for the risk of this happening." Should the FDA sign off on the resubmission, the risk-benefit equation will fall on the shoulders of patients and prescribers, O'Looney noted. The companies requested a priority review that would result in FDA action in about six months, rather than in 10 months for a standard review.

"We're pleased that no more PML cases were diagnosed," O'Looney told BioWorld Today, "and we're pleased that it's now at the point that the companies are submitting it to the FDA for a hopefully expedited review."

The alpha-4 antagonist first received FDA approval late last year following an accelerated review. The clearance was based on single-year results from AFFIRM and the SENTINEL study; in the former, Tysabri reduced relapse rates by 66 percent compared to placebo, and top-line results from the latter showed a 54 percent reduction in relapse rate for Tysabri combined with Avonex vs. Avonex alone. (See BioWorld Today, Nov. 29, 2005.)

"The efficacy data was exceptionally strong for this drug," Wang said, "so I have a tendency to believe that in the end that it has a chance to come back, but there are going to be some very strict criteria under which it's going to be used."

She noted that it won't be suitable for immunocompromised patients, and likely won't be indicated for combination use with Avonex, as that pairing resulted in two of the PML cases. Wang also pointed to uncertainty about Tysabri's duration of use, as well as a cloudy future for its use in Crohn's disease and rheumatoid arthritis, two other settings in which it was studied.

She added that the drug is not likely to ever hit blockbuster status, as was once touted. Her New York firm, which makes a market in Biogen Idec's securities, has no sales projections for Tysabri in its current forecast model.

O'Looney, who conceded that though Tysabri does not cure multiple sclerosis, called it "an additional option for a physician and patient to talk about in trying to control the progressive aspects" of the disease. She added that should it again receive FDA approval, use of the drug would be determined on a "case-by-case basis" depending on a patient's varying needs. Biogen Idec and Elan will submit a similar data package update to European regulatory authorities as part of an ongoing review process that began last summer. "BioWorld Today

The 21st Conference on Multiple Sclerosis opened in Thessaloniki today with the participation of 3,500 delegates organized jointly by the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) and the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS).

In this year's conference have been invited to participate among others 70 distinguished neurologists and neuroscientists from Europe, the United States and Canada.

According to conference president and neurology professor in Thessaloniki's Aristotle University Ioannis Milonas, an estimated 2.5 million people around the world suffer from multiple sclerosis an illness that afflicts more often people 20-30 years old.

Multiple sclerosis is an inflammatory disease of the central nervous system and one of the most common neurological diseases observed in young adults. It rarely appears in children and after the age of 50. It is an autoimmune disease meaning that the body's natural defenses are actually attacking its own myelin (=the nerve insulating material).

New drugs and new treatment methods will be presented in the conference.

Each year around 2.5 million people world-wide, including 400,000 Americans, are affected by multiple sclerosis, a crippling disease that targets the brain and spinal cord. While the exact causes for this disease remain unknown, recent research by the Yale School of Medicine and the University of Connecticut Health Center brings scientists one step closer to finding a cure.

The study, co-authored by Nancy Ruddle, director of graduate studies for epidemiology and public health at Yale, and University of Connecticut professor Stephen Pfeiffer, was published in last week's "Proceedings of the National Academies of Science." The team was successful in distinguishing between antibodies that do and do not contribute to the disease, but the two researchers said there is a long way to go before multiple sclerosis can be fully understood and prevented.

"Research like this is a little piece to a larger puzzle," Pfeiffer said. "[Finding a treatment] will not happen in one big flash. A treatment will be the development of a gradual accretion of many people's work."

Both Pfeiffer and Ruddle said the collaboration and information exchange between the two labs was crucial to their success.

Pfeiffer and Ruddle are two of many scientists across the world working on multiple sclerosis, a chronic autoimmune disease in which the body attacks the insulating material surrounding nerve cells. Without this insulation, called myelin, information cannot travel as fast, resulting in ascending paralysis and impaired physical mobility.

Because the disease is chronic, Ruddle said such symptoms usually develop later in life, at which point little can be done to prevent future degeneration. Thus, researchers must identify the causes of multiple sclerosis and treat the disease in its early stages to prevent it from seriously damaging the body.

"MS is the most common neurological crippler of young adults in our society," said Stephen Waxman, chair of Yale's Neurology Department. "We need to learn more about it so we can cure it. Nancy and Pfeiffer have taken an important step forward."

Pfeiffer, who has been studying multiple sclerosis since 1970, and his team observed the biology of myelin-producing cells and the changes antibodies associated with multiple sclerosis induce in these cells. They then injected two types of antibodies -- those known to contribute to multiple sclerosis and those known not to contribute -- to better understand the workings of the disease.

This process, which began a few years ago, did not always procure sufficient results, Pfeiffer said.

"[In research like this] your heart can be broken for months," he said, "and then suddenly you see something that works. Then in a flash [your work] becomes the most exciting thing in the world."

For Pfeiffer's lab, the excitement came with discovery that the antibodies reacted with a specific molecule, known as MOG, on the surface of myelin cells, he said. After this discovery Ruddle's lab took a more clinical approach, using mice models to learn more about how antibodies cause multiple sclerosis.

Ruddle's team studied the animal version of multiple sclerosis, known as EAE -- both diseases target myelin and affect extremities. While the human disease is chronic, mice experience an acute form that lasts less than two weeks.

Ruddle injected the animals with components of both human and rat MOG. They discovered the antibodies that cause multiple sclerosis recognize MOG on the cell surface and can change the MOG-making cells, while benign antibodies only recognize MOG inside the cell and cannot alter the MOG-making cell, Ruddle said.

Ruddle and Pfeiffer said their findings show promise but are not a clinical end in themselves. Pfeiffer said there is no definite timeline or course for the development of a multiple sclerosis cure, but further teamwork and collaborations will be needed to beat the disease.
yaledailynews.com

THESSALONIKI, Greece--(BUSINESS WIRE)--Sept. 28, 2005--Prof. Mark Freedman of the University of Ottawa will present at the conference the initial results of a landmark study that successfully predicted impending disease activity in multiple sclerosis (MS) patients using technology developed by Glycominds Ltd.

For the first time researchers have shown that it is possible to predict, using a blood test, whether or not a patient will imminently develop an active form of MS, after the first neurological event.

"Neurologists have been struggling with a decision to initiate or not disease modifying therapy after only a single attack of what might be MS," said Prof. Mark Freedman, the principal investigator of the study known as PRACTIMS (Prognosis and Response of Anti-Carbohydrate Titer In MS). "Knowing at this earliest timepoint that a patient is destined to develop active disease would greatly assist this decision," he added.

The MS predictor test is a simple blood test based on novel biomarkers to indicate the likely course of a patient's condition.

The study results show that the Glycominds technology was able to correctly predict the future course of the disease in patients, on the basis of retrospective blood samples taken from 90 patients after their first neurological event.

The Glycominds test correctly identified in advance the 36 percent of patients who later on suffered additional clinical events in the two year period following their first symptoms.

Currently, doctors are unable to tell if a patient who has suffered a single neurological event will develop a mild or active form of the devastating disease. Consequently many people who do not require treatment, find themselves on life-long therapy regimens which may be expensive, cause adverse side effects and leave them in a perpetual state of anxiety. At the same time, many MS patients do not receive the more aggressive therapeutic intervention they may require because doctors are uncertain of whether they will continue to have an active disease.

"Glycominds next plans to validate externally these results on thousands of retroactive patient samples and to bring this product to market during 2006," said Avinoam Dukler, CEO of Glycominds.

The dramatic results of the current study have been judged important enough to be included as part of the "late-breaking news" section on Oct. 1 of a major scientific conference, the 21st Congress of the European Committee for the Treatment and Research in Multiple Sclerosis and the 10th Annual Meeting of the American Committee for Treatment and Research in Multiple Sclerosis taking place in Thessaloniki, 28 September - 1 October 2005

The most complete genetic study to date of multiple sclerosis singles out a cluster of genes on chromosome 6 as the only group to play a significant role in MS.


These findings, presented today at the annual meeting of the American Neurological Association, may constitute a turning point in the quest for an MS gene, according to principal investigator Jonathan Haines, Ph.D.


"No other region of the genome harbors a gene with a similar overall influence on MS genetics," said Dr. Haines in an oral presentation of the study. Dr. Haines is director of the Human Genetics Program at Vanderbilt University in Nashville, Tenn.


The genes that show so much promise are the major histocompatibility complex (MHC) genes, a cluster that enables the body to distinguish autologous cells from bacteria or other pathogens. When the MHC system is impaired, the body can develop antibodies against autologous cells, as in MS. An interaction between a variation in the MHC system and environmental challenges are the likely cause of MS, he said.{CLICK FOR MORE} CME Teaching Brief - MedPage Today

"Lhermitte’s sign (LS) is highly prevalent in patients with multiple sclerosis (MS), has a variable natural course and is significantly associated with the presence of cervical magnetic resonance imaging (MRI) abnormalities, researchers reported in August in Multiple Sclerosis journal.

The symptom is commonly stereotyped in individual patients. About 38% of patients with MS experience the sign at some time.

The aim of the study was to investigate LS frequency, natural history, characteristics and its radiological equivalents in MS population. The authors compared 300 patients with clinically definite MS (CD MS) with 100 healthy control subjects. All participants were interviewed using a structured questionnaire.

It was found that 41% of MS patients experienced LS during disease course. In 53% of those who reported LS, the symptom appeared within the first three years of the onset of the disease. LS began as an isolated symptom in 64% of the patients. The sign was polysymptomatic in 36% of them. Most of the participants described LS as a short-lasting sensation.

Cervical MRIs were performed in 43 MS patients. MRI revealed abnormalities in 17out of 18participants who reported LS. By contrast, only 13 out of the 25 who never experienced LS, demonstrated pathological changes on cervical MRIs.

Lhermitte’s sign represents brief sensations, variouslydescribed as tingling, vibrating pain or electric shock-like feelings travelling down the spine, often into one or both legs, and less commonly, into the arm(s), which occur suddenly on neck flexion. Movement or coughing may also provoke the symptom.

The sensations are often transient, resolving after a few weeks, but recurrences are frequent. The sign is not specific for MS and may be secondary to a variety of different pathologies (tumours or spondylosis) that may require exclusion.

Lhermitte’s signis named after Jacques Jean Lhermitte, who first described it, and is also rarely referred to as ”barber’s chair syndrome”."http://www.ingentaconnect.com/content/arn/ms

"Abstract:
We investigated the risks of twins for multiple sclerosis (MS). Our data are linked registers of all Danish twins and of all Danes born between 1920 and 1970 in whom MS was diagnosed before 1997. We compared differences in the risks for MS by Cox regression and standardized incidence ratios. Our analyses suggest that dizygotic twins have an approximately 60% lower risk for MS than monozygotic twins and a 20% lower risk than singletons. Monozygotic twins appear to have a somewhat higher risk for MS than singletons albeit not statistically significant. We offer no biological explanation for our findings, but suggest that either sharing fetal life with a genotypically different individual is beneficial for the immune system or that there is a linkage between the genes that influence dizygotic twinning and other genes that protect against MS"{CLICK FOR MORE}

Patients with multiple sclerosis (MS) are less physically active than healthy individuals. But there is not a significant difference in the physical activity between people with MS and diseased populations, according to a meta-analysis of 13 studies involving 2360 MS patients published in August in Multiple sclerosis journal.

The authors investigated the difference in physical activity among individuals with MS compared with nondiseased and diseased populations and examined factors (moderators) that explain variation in the overall difference in physical activity.

Larger effects with objective versus self-report measures of physical activity, nondiseased versus diseased populations and primary progressive versus relapsing–remitting MS (PPMS vs RRMS) were found.

Maintenance of general good health and positive attitude is very important for persons with MS or any chronic disorder. It is known that exercise may help in managing many MS symptoms.

According to a study published by researchers at the University of Utah in 1996, patients who took part in an aerobic exercise program showed improved strength, better bladder and bowel function, less fatigue and depression and increased their participation in social activities.

A good exercise program can help patients to develop the maximum potential of muscle, bone, and respiration, and to avoid secondary complications of MS.http://www.ingentaconnect.com/content/arn/ms

{CLICK FOR MORE}

The safety data from Active Biotech's (Stockholm:ACTI.ST) recently concluded clinical phase II safety study shows that laquinimod, a novel oral medication for the treatment of multiple sclerosis (MS), was well tolerated also at a higher dose. The results will be presented at the 21st Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) meeting in Thessaloniki, Greece, on September 30 by the Principal Investigator, Professor Magnhild Sandberg-Wollheim.

The aim of the study was to investigate the safety of orally administered laquinimod at a higher dose (0.9 mg/day) than the dose previously shown to be effective in reducing the number of active brain lesions (0.3 mg/day) (Polman et al. Neurology 2005;64:987-991).......{CLICK FOR MORE}

"Biogen Idec Inc. said it has submitted an application to the US Food and Drug Administration seeking a revised license so it can put its multiple sclerosis drug Tysabri back on the market.

The Cambridge company said the application contained the results of its extensive safety review of Tysabri use by multiple sclerosis patients and trial participants, and ''nearly complete" results of its safety review of participants in trials for Crohn's disease and rheumatoid arthritis.
''We are grateful to the MS community for their patience and support over the last several months while we've conducted an extensive safety evaluation of Tysabri in collaboration with leading experts," said Burt Adelman, Biogen Idec's executive vice president of development, in a statement. ''We look forward to working with regulatory authorities during the review process, and ultimately, we hope to provide Tysabri to people living with MS."
A Biogen Idec spokeswoman said the company asked the FDA for accelerated review of the application. If granted, the FDA could respond to the application within six months, rather than 10. A decision on the accelerated review request is expected within 30 days.
Biogen Idec and its partner Elan Pharmaceuticals of Ireland in February voluntarily pulled Tysabri off the market and discontinued clinical trials. One patient taking the drug had died of a rare brain disease and a second was suspected of having contracted it. That patient recovered. A third case of the disease was discovered among patients who had taken the drug for Crohn's disease, an intestinal ailment.
Since then, Biogen Idec has been scouring the records of patients who took Tysabri in clinical trials and during its time on the market. It said it hasn't found any other cases of the brain disease.
Analysts believe Biogen Idec will seek to restart Tysabri sales with a new warning label. Amy Brockelman, a company spokeswoman, declined to comment on the proposed labeling language. ''It's premature to comment on the specifics of the label while we're in discussions with regulatory authorities," she said.
Biogen Idec also filed similar safety review data with the European Medicines Agency. Tysabri hasn't been approved for sale in Europe and the new information will be added to the company's pending application"The Boston Globe

Researchers at The Hospital for Sick Children
(SickKids) have determined that women being treated for multiple sclerosis
(MS) with beta interferon therapy have increased risks of miscarriage or low
infant-birth weight. This research was reported in the September issue of the
journal Neurology.
Beta interferon therapy is the most commonly used therapy for treating
relapsing-remitting MS. Based on a protein found naturally in the body that
helps to regulate the immune system, it is known to help decrease the
formation of lesions, reduce the frequency of relapses and help affect the
course of the disease.{CLICK FOR MORE}

Biogen and Elan on monday said they have submitted new safety data to U.S. regulators on their drug Tysabri, in hopes of getting the withdrawn multiple sclerosis treatment back on the market.more... Reuters.com

"Elan and Biogen on Tuesday said they expected within weeks to submit additional safety information to U.S. regulators in hopes of returning their drug Tysabri to market as a treatment for multiple sclerosis. Irish drugmaker Elan and Biogen Idec, which is based in Cambridge, Massachusetts, in August said no new cases of PML were seen in an updated safety evaluation of Tysabri.

Biogen Idec spokeswoman Amy Brockelman on Tuesday said the drug "never lost" its original approval from the U.S. Food and Drug Administration, although it was withdrawn from the market.

She said her company and Elan now plan to submit the updated safety information on Tysabri to the FDA, as a possible prelude to re-launching the drug for treating multiple sclerosis. The data involves more than 3,000 patients with multiple sclerosis, Crohn's disease and rheumatoid arthritis that have taken Tysabri in past trials.

Some patients in the two late-stage multiple sclerosis trials took Tysabri by itself, while others took it in combination with Avonex, Brockelman said.

"At this point, we do not expect we will need to conduct additional multiple sclerosis trials to return Tysabri to market," Brockelman said.

Elan and Biogen Idec said in a release that they plan in coming weeks to complete a safety evaluation of Tysabri as a possible treatment for Crohn's disease -- an inflammatory bowel ailment -- and rheumatoid arthritis. Both diseases are caused by overactive immune systems that harm tissue." Reuters.com

Some people launch public campaigns to raise awareness of multiple sclerosis (MS) and its treatment - Wendy Booker has been doing it by scaling some of the highest peaks in the world. Last year, Wendy reached the top of Mount McKinley in Alaska, the highest point in North America at 20,320 feet.

She's been doing it by scaling some of the highest peaks in the world. Last year, Wendy reached the top of Mount McKinley in Alaska, the highest point in North America at 20,320 feet.

But that was nothing. This past summer, Wendy successfully scaled Mount Kilimanjaro the highest point in Africa, at 19,340 feet. Wendy and her team reached the summit around sunrise in mid-June. "We reached the top of Africa today, and it was awesome," she wrote in describing the feat on her website.

"For me, climbing gives me an opportunity to inspire others and to challenge myself," said Wendy. "Almost half of the people living with MS are not on one of the approved treatments, and I want to show them what I am able to accomplish with the help of a good diet, exercise....{CLICK TO READ MORE}

href="http://www.thestreet.com/_yahoo/stocks/robertsteyer/10243572.html?cm_ven=YAHOO&cm_cat=FREE&cm_ite=NA">Biogen, Elan Near Tysabri Filing"The companies said late Tuesday they expect to complete their safety review of Tysabri "in the coming weeks." Then they expect to seek approval to reinstate the drug as a treatment for multiple sclerosis.

Managing MS: Treatments for Acute Attacks

"SUMMARY: Ocular findings may be initial manifestations of multiple sclerosis and may predict additional demyelinating events. Recognizing these syndromes and signs will help clinicians to properly evaluate the patient, formulate an appropriate differential diagnosis, be able to discuss the prognosis with the patient, and help develop an effective therapeutic planThis paper reviews recent findings regarding the ocular manifestations in multiple sclerosis.

RECENT FINDINGS: Manifestations of multiple sclerosis in the eye include both the afferent and efferent visual pathways. Optic neuritis, the most common ocular manifestation of multiple sclerosis, may be the initial clinical disease manifestation. Recent long-term follow-up data show that most patients with demyelinating optic neuritis have an excellent prognosis for recovery of central visual acuity. Evidence is emerging, however, for significant and broad reduction in both contrast sensitivity and color perception in multiple sclerosis patients despite near-normal visual acuities. Ocular motor deficits in multiple sclerosis include internuclear ophthalmoplegia and nystagmus, resulting in diplopia, oscillopsia, blurred visual, loss of stereopsis, and reading fatigue. Multiple sclerosis also may be associated with ocular inflammatory diseases, in particular pars planitis and retinal periphlebitis. ."

STUDY...KEY PROTEIN LINKED TO TRANSVERSE MYELITIS AND MULTIPLE SCLEROSIS...Johns Hopkins researchers have discovered a single molecule that is a cause of an autoimmune disease in the central nervous system, called transverse myelitis (TM), that is related to multiple sclerosis.

Study: Predictors of long-term clinical response to interferon beta therapy

Early MS Scientists

Israeli therapy may slow onslaught of multiple sclerosis

"Researchers have identified a molecular suspect in a disorder similar to multiple sclerosis (MS) that attacks the optic nerve and spinal cord, according to a report presented at the 130th annual meeting of the American Neurological Association in San Diego. The protein, called aquaporin-4, is a channel protein that allows water to move in and out of cells.

"Aquaporin-4 is the first specific molecule to be defined as a target for the autoimmune response in any form of MS," said author Vanda A. Lennon, MD, PhD, of the Mayo Clinic in Rochester, Minnesota. "It is also the first example of a water channel being the target of any autoimmune disorder."

Because there are many other variants of aquaporins throughout the body, Lennon suggests that these proteins might play a role in poorly understood autoimmune disorders in other organ systems.

For some time, scientists have understood that multiple sclerosis is not so much a single disease, but a category of disorders with similar damage to different parts of the nervous system. Recently, progress has been made in teasing out a particular syndrome called neuromyelitis optica (NMO), in which the body mistakenly mounts an immune attack against the optic nerve and spinal cord.

Last year, Lennon and her colleagues at Mayo, along with collaborators in Japan, were able to detect a particular antibody that occurrs in most people with NMO, but not in patients with "classical" MS.

This is particularly important for clinicians because specific treatment recommendations to help prevent blindness and other later symptoms, including paralysis, differ for NMO and MS.

In the present study, Lennon and colleagues have identified an aquaporin as the target molecule of the NMO antibody. "This finding is a departure from mainstream thinking about MS and related disorders, where the major focus of research in the past century has been the myelin that insulates nerve fibers, and the cell that manufactures myelin, known as the oligodendrocyte," said Lennon.

The Mayo Clinic group's work reveals that the protein targeted by the NMO antibody is not a component of myelin, or of oligodendrocytes. Aquaporin-4, which is the most abundant water channel in the brain, is instead located in a different type of cell called astrocytes.

"Aquaporin-4 is concentrated in membranes in the precise site where spinal cord inflammation is found in NMO patients," said Lennon.

The next step in this research is to use this knowledge to create an animal model that can be used to confirm the relationhip between aquaporin-4 and NMO, as well as to develop new and improved therapies."medicalnewstoday.com

"New clinical trial results show that a leukemia drug offers a promising prospect for treating multiple sclerosis, but the drug's side effects prompted its sponsors to suspend dosing in the clinical trial while they discuss the next step with the Food and Drug Administration.

The drug is called Campath, and it is now approved in the U.S. for treating B-cell chronic lymphocytic leukemia. Campath is being developed for multiple uses by Genzyme. The companies said they will "work closely" with regulators and clinical investigators "to ensure that a comprehensive approach is in place to manage patient safety."

Friday's announcement offers a complicated good news/bad news scenario for the treatment of multiple sclerosis.

The companies preferred to focus on the positive news. "Based on these results, we will be moving this program forward with a tremendous sense of urgency," said Henri A. Termeer, chairman and CEO of Genzyme.

The latest test results come from a phase II (midstage) clinical trial. In order to secure FDA approval, the companies must conduct a bigger, more extensive phase III trial, and they must design a study that takes into account the safety issues that have been identified.

The red flag was the comparison of "serious adverse events" between MS drug Rebif, which had two, and Campath, which had nine. Among the Campath patients, three suffered from a disease, nicknamed ITP, that can cause abnormal bleeding due to low blood-platelet counts. Two of these patients received high doses of Campath, and one received a low dose. One patient died.

The companies said most patients had received a second year's worth of doses in a planned three-year study. The companies said they would evaluate "the necessity and timing of the third planned dose," adding that they are talking to the FDA "about what additional steps might be needed to protect patient safety."

The companies said they will continue to collect efficacy and safety date from the trial while they plan for a phase III trial.

The encouraging news from the phase II interim results shows that Campath patients had significantly fewer relapses of MS "after at least one year of follow-up" vs. Rebif patients. Schering and Genzyme said the comparison was statistically significant for both high doses and low doses of Campath, whose patients experienced at least a 75% reduction in relapse risk vs. Rebif patients.

However, the companies said there was no difference in effectiveness between the high dose and the low dose, so they will no longer test the high dose. In addition, Campath patients failed to achieve a statistically significant improvement vs. Rebif patients in another indicator of efficacy called "risk for progression of clinically significant disability."


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"Late Monday, StemCells said that a study conducted by researchers at the University of California at Irvine showed that transplanted human neural stem cells helped restore function in the limbs of mice whose spinal cords had been crushed.

The transplanted cells transformed themselves into specialized neural cells that conduct the electrical impulses used by the nervous system for motor function, the researchers said.

The study also indicated that stem-cell therapy might have a future in treating multiple sclerosis. According to researchers, some of the cells transformed into cells make up neural tissue called myelin. Multiple sclerosis is caused when the body's immune system attacks and destroys myelin cells.

Results of the study will appear today in the on-line edition of the Proceedings of the National Academy of Sciences, the company said."Biotechnology

"Yale School of Medicine researchers have identified three rapid diagnostic methods that can target antibodies commonly found in multiple sclerosis (MS) patients, greatly improving potential diagnosis and treatment....Although anti-myelin antibodies are often found in MS patients, the diagnostic value of these molecules that respond to infection are limited because they are also found in patients without MS, making it difficult to determine their role in the development of the disease. In addition, MS patients might generate anti-myelin antibody responses that reflect, rather than cause, the disease.

To address this diagnostic challenge, Nancy H. Ruddle and her team developed mouse models to find ways to distinguish between antibodies that cause MS from those that are present in MS patients but do not cause disease symptoms....The team, including researchers from the University of Connecticut, developed two ways to induce MS symptoms in mice. They found that though both treatment procedures yield antibodies to myelin, only one method made antibodies that could cause disease in other mice. These antibodies were shown to recognize and interact with a form of modified myelin found in MS. This myelin was not recognized with the antibodies that did not cause disease.MORE

Striking women between ages 20 and 40, Multiple Sclerosis hits women at the prime of their lives.

As careers and families are developing, MS begins to work against a body, creating difficulties with walking and vision and extreme fatigue.

While there is no cure, artist Jo Ann Rothschild says there is no reason to stop living life to fullest.

Her paintings sell for thousands of dollars, but in her early 20s MS threatened her artistic vision.

The disease began as a blind spot in Rothschild’s left eye and progressed to her being unable to hold the paintbrush. "I wanted to prove I could paint whether I could see with both eyes or not," she says.

Striking women between ages 20 and 40, Multiple Sclerosis hits women at the prime of their lives.
Connie Easterling, ARNP, a multiple sclerosis nurse in Orlando, Fla., says, "[A woman with MS] has to reevaluate her ability to care for children, care for her home, and whether or not she can continue working in her occupation depending on her level of disability."

Because MS starts in the brain, damage to crucial nerves eventually puts many patients in a wheel chair. Even so, most women, like Rothschild continue to work, taking medications to help with more serious symptoms.

Another treatment is to stay cool, raising the body’s temperature by one degree makes the symptoms flare up.

Rothschild is lucky, intensive treatment has meant no debilitating attacks for eight years. She attributes part of this to her passion for art. "I also think when you're in difficulty, it's important to have something that doesn't concentrate on the difficulty," Rothschild says.News 14

Telephone-administered psychotherapy may help relieve the depression of patients battling multiple sclerosis, according to a new study.

Researchers at the University of California, San Francisco, found that 16 weeks of therapy by phone helped ease feelings of depression.

Although two-thirds of depressed MS patients prefer therapy to antidepressants, just 10 percent to 45 percent make a first appointment, and half drop out by the end of treatment, experts say. Reasons include physical impairments, transportation woes and lack of time or money.

Phone-based therapy gets around many of those problems, but the researchers say research is needed to determine whether it is equivalent to face-to-face interventions.News-Leader.com

Women who take oral contraceptives or are pregnant have a lower risk of developing multiple sclerosis, a new study finds.

Earlier research with animals had shown that the female hormone estrogen delayed the onset and eased the course of MS. This suggested that oral contraceptives, which contain estrogen, and conditions associated with hormonal changes, such as pregnancy and the postpartum period afterward, may affect the risk of developing the disease, the researchers said.

"MS is more frequent in women than men," said study author Dr. Alvaro Alonso, a research fellow at the Harvard School of Public Health. "Some people have thought that perhaps estrogen can be modifying the risk of MS."

To explore the possible link between estrogen and multiple sclerosis, Alonso's team compared oral contraceptive use among 106 women who had been diagnosed with MS between Jan. 1, 1993, and Dec. 31, 2000, with 1,001 women without the disease.

The researchers found the incidence of multiple sclerosis among women using oral contraceptives was 40 percent lower. In addition, women had a higher risk of developing MS during the six months following a pregnancy and a slightly lower risk during pregnancy, the researchers noted.


Estrogen has an effect on the immune system, and MS is caused by an alteration in the immune system, Alonso explained. "We have seen that oral contraceptives can reduce the risk of MS in the short term," he said. "If you are taking oral contraceptives and you are [destined] to have MS, the onset of MS can be delayed one to two years."

In addition, when women are pregnant they have a lower risk of developing MS, Alonso said. "But this risk increases in the postpartum period, in just the six months after the delivery," he said.

The findings appear in the September issue of the Archives of Neurology.

Multiple sclerosis is believed to be an autoimmune disease that affects the central nervous system, which includes the brain, spinal cord, and optic nerves. Nerve fibers of the central nervous system are protected by a fatty tissue called myelin, which helps fibers conduct electrical impulses.

In MS, myelin is lost, leaving scar tissue called sclerosis. This disrupts the nerves' ability to conduct electrical impulses, resulting in symptoms that can include vision problems, loss of balance, lack of muscle coordination, slurred speech, and tremors, according to the National Multiple Sclerosis Society.

Alonso doesn't see the findings having any immediate implications for treating or preventing MS. "The decision to take oral contraceptives or the decision to become pregnant must not be influenced by the idea that this can increase or decrease the risk of MS," he said.

One expert noted that the findings may add to the understanding of why MS is more prevalent among women.

"There is a strong relationship between gender and immune-mediated disorders, such as MS, lupus, rheumatoid arthritis and others," said Nicholas LaRocca, director of health-care delivery and policy research at the National Multiple Sclerosis Society.

Moreover, several studies have found a relationship between pregnancy and reduced risk of MS attacks, he said. "So, this study adds one more bit of evidence to suggest that there may be significant hormone-mediated factors at work in MS."

Exactly what these factors are, how they work, and what their implications may be for future treatments remain to be determined, LaRocca added. "The society has for several years mounted an ambitious program of research directed at understanding the significance of gender in the pathogenesis of MS. As we continue to learn more about this aspect of MS, it will add to our understanding of the disease and, it is hoped, how best to treat it," he said.

Another study published in the same issue of the journal uncovers some new facts about a common MS treatment.

While treatment with the protein interferon seems to reduce new areas of damage in the brains of MS patients, it doesn't appear to affect the duration of these damaged regions, researchers reported.

Dr. Francesca Bagnato, of the National Institute of Neurological Disorders and Stroke, and colleagues analyzed MRIs for both the formation and duration of these damaged areas, called black holes, in six patients with relapsing-remitting type MS.

Bagnato's team found that the creation of new black holes increased during both interferon treatment and no treatment. But fewer were created during treatment.

"One can postulate that although interferon may reduce the frequency of black holes, after the lesion occurs, the drug is not changing the pathological process," Bagnato's group concluded.HealthDay

Lymphocytes found in MS lesions are thought to damage central nervous system tissues by secreting inflammatory molecules harmful to myelin and nerve cells. However, these cells also secrete neurotrophic factors, proteins that promote neural development and help protect injured or degenerating nerve cells. So far little is known about the potentially important role these proteins play in counteracting the effects of inflammation, but one recent study has contributed a bit more knowledge about the subject.
This study examined the production of several neurotrophic factors (such as brain-derived neurotrophic factor (BDNF), nerve growth factor (NGF), and glial cell line-derived neurotrophic factor (GDNF)) by blood cells from 21 subjects with relapsing-remitting MS. Blood samples were taken during stable periods, during relapses, and during recovery from relapse. Levels of BDNF as well as pro-inflammatory cytokines were found to be higher during relapse, while production of other neurotrophins was increased post-relapse. Higher levels of neurotrophin production were associated with complete recovery from relapses, whereas higher levels of inflammatory cytokine production were associated with incomplete recovery. The authors note that immune cells appears to lose their neuroprotective potential in conjunction with age and disease duration ...Click to read entire study...Entrez PubMed

Inflammatory bowel disease (IBD)is an autoimmune disease consisting of Crohn's disease and ulcerative colitis. Unlike the poorly understood but more common condition known as irritable bowel syndrome (IBS), IBD is frequently associated with symptoms occurring outside the bowel. These can include inflammation of the eyes, mouth ulcers, joint pain or swelling, and other inflammatory-related conditions.
Researchers have now shown that people with IBD have a higher than normal risk for developing multiple sclerosis and other autoimmune disorders. The full article is here (click on View print version (PDF)).

This risk is independent of treatment, but note that the medications used for IBD treatment, which block TNF-alpha (like Remicade and Humira), are also suspected of causing MS.Gastroenterology Online

OBJECTIVES: The aim of this study was to identify clinical, magnetic resonance imaging (MRI) and biological markers predictive of long-term clinical response to interferon beta (IFN beta) therapy in patients with relapsing-remitting multiple sclerosis (RRMS).METHODS: Sixty-eight patients treated with IFN beta were followed over a 6-year period. Relapse rate and disability progression were evaluated throughout the study. We considered suboptimal clinical response to be either the presence of sustained disability progression, or more than two relapses. Baseline and 12-month demographic, clinical and MRI findings, as well as the development of neutralizing antibodies (NAbs) against IFN beta during the first year of therapy were analyzed as predictors of long-term clinical outcome..CONCLUSIONS: Variables assessable within the first year of treatment significantly influence relapse rate and disability progression in patients with RRMS treated with IFN beta. These findings may help clinicians to make decisions regarding therapy regimen over time, and highlight the need for a prognostic algorithm.Entrez PubMed

This article discusses the benefit of providing good information and support networks for patients with multiple sclerosis. It reports the results of an audit examining the effectiveness of information programmes provided by MS specialist nurses and identifies patients' views on services promoting self-management. It demonstrates the advantages of such initiatives, emphasising their role in empowering patients, and could be used by nurses working with patients with other chronic conditions.Entrez PubMed

Objective - To examine neurological and magnetic resonance imaging (MRI) changes following discontinuation of interferon (IFN)-beta-1a treatment in secondary progressive multiple sclerosis (SPMS). Methods - The study involved 21 SPMS patients who received subcutaneous (s.c.) IFN-beta-1a 44 mug three times weekly (t.i.w.) for 12 months and were thereafter followed up without treatment for a further 12 months. The number of relapses, disability on the Expanded Disability Status Scale (EDSS) and MRI were recorded at baseline, at 12 months of IFN-beta-1a 44 mug t.i.w. and 1 year after discontinuation of treatment. Results - During the 12-month treatment EDSS score and volumes of brain T2- and T1-weighted lesions remained without significant progression, but at 12 months after treatment discontinuation both EDSS score and the volumes of cerebral lesions increased significantly. Cerebrospinal fluid fraction increased significantly both during the treatment and during follow-up. Conclusions - Discontinuation of IFN-beta-1a 44 mug t.i.w. in SPMS may be associated with an increase in neurological disability and brain lesions on MRI.
Entrez PubMed

Multiple sclerosis (MS) is known to accumulate within families. The magnitude of the familial risk, however, remains uncertain. Using a nationwide MS register and other national registers, the authors estimated relative and absolute risks of MS in a population-based cohort that included 19,615 first-degree relatives of 8,205 Danish MS patients followed from 1968 to 1997. The ratio of observed to expected numbers of MS cases served as the measure of the relative risk of MS. Lifetime risks of MS in first-degree relatives were estimated as the product of the relative risk and the national lifetime risk of MS. Overall, first-degree relatives had a sevenfold increased risk of MS (relative risk = 7.1, 95% confidence interval: 5.8, 8.8) (n = 90) compared with the background population. By modeling the individual incidence rate of MS as the sum of a familial component and a sporadic risk component, the familial excess lifetime risk was found to be 2.5% (95% confidence interval: 2.0, 3.2) among first-degree relatives of MS patients, irrespective of the gender of the proband and the relative. This percentage should be added to a sporadic absolute risk in the general population of 0.5% in women and 0.3% for men. Spouses of MS patients did not experience an increased risk of MS, suggesting no major role for environmental factors acting in adulthood.
Entrez PubMed

Georgetown artist Judi Bartnicki was diagnosed with MS in 2001, following removal of a benign brain tumor. The most severe impact from the disease has been on her left arm and hand. Judi is left-handed.
Bartnicki took up Pointillism in 1976, using the technique founded in the 1800s by French artist Seurat. Each of her original artworks takes from 200 to 600 hours to create. She uses crowquill pens dipped in India ink, and painstakingly places each individual dot in just the right place.

Determined to fight off this disease and continue creating her art, Bartnicki has been donating 10 percent of the sale of each painting to the MS Society, to fund research for a cure. She believes they are close to a breakthrough

Bartnicki is becoming increasingly well-known in the art world in America and in Europe. She is the first artist ever to be permitted to display the Multiple Sclerosis Society logo on her artworks, and many people are collecting her work.

David Landers, the actor who played Squiggy on the "Laverne and Shirley" show, has her artwork and is helping with the fundraising for MS.
Bartnicki wants to show other MS patients how to continue living with the condition.

"A lot of people with MS are deterred by the pain," says Bartnicki. "My [Pointillism] technique is really tedious, but I can do it. Too many people with MS just give up when they just need to push through it."
People interested in viewing Bartnicki's work online can see it on the Web site at www.nationalmssociety.org/mam/home. People interested in buying her work can do so online at www.picklepot.com.

Drug maker Biogen Idec Inc. on Thursday said it will lay off 650 workers, or about 17 percent of its work force, as part of a plan to reduce annual expenses by $200 million to $300 million.

The Cambridge-based biotechnology firm, seeking to regain its footing after withdrawing a multiple sclerosis drug over safety concerns, said it also plans to sell a San Diego manufacturing plant as well as the rights to Amevive, a psoriasis drug that generated $43 million in sales last year.

James C. Mullen, Biogen Idec's chief executive and president, said the company is "well-poised for near-term success'' but believes for the long term that it must cut programs "unlikely to create significant value.''

Biogen Idec announced the restructuring after its shares closed down 3 cents at $42.44 on the Nasdaq Stock Market, where the stock has traded in a 52-week range of $33.18 to $70.

Biogen Idec said the cuts to 650 positions worldwide will mostly occur by the end of the year, spread across various departments and locations. Of the total jobs to be cut, 250 will come from the company's Cambridge headquarters, which now has 1,700 employees.

Biogen Idec expects to take a pretax charge against its earnings of $30 million to $40 million to cover severance and restructuring costs resulting from the cuts.

The company has recently remained profitable despite its decision in February to withdraw the multiple sclerosis drug Tysabri. Biogen Idec developed the drug with its Irish partners, Elan Inc.,

The drug may heighten the risk of contracting a rare and often fatal disease of the central nervous system. The companies are completing a review of the drug's safety, and hope to report back to federal regulators by month's end in hopes that it will be found safe to return to the market, likely with a more restrictive warning label.

The drug was withdrawn after it was linked to two cases of a brain disease called progressive multifocal leukoencephalopathy, or PML. One of those patients died. On March 30, Elan and Biogen announced that a Crohn's sufferer who had been taking Tysabri also had died of PML

www.sanluisobispo.com

Clic to buy tickets at Brown Paper TicketsPresented by United Mesa Fire Fighter Charities (501c3) and Wake Up To Love, the 4th Annual UMFF Charity Concert will raise money for the Arizona Chapter of the National Multiple Sclerosis Society and United Mesa Fire Fighter Charities Foundation supporting a variety of legitimate Arizona Charities dedicated to improving quality of life for those in need. The event features performances from Frank Hannon (lead guitarist for the multi-platinum rock group "TESLA"), Las Vegas roots-rocker Franky Perez, State and Main (featuring TESLA drummer Troy Luccketta and percussionist Dom Moio), and 14-year old guitar phenomenon Nick Sterling. There will also be a silent auction with great rock and sports memorabilia, (including an electric guitar autographed by all 5 members of the legendary metal group Judas Priest), and raffles at the show. Visit www.umffcharityconcert.com for additional info.

Lifting weights can improve muscle strength and quality of life for people afflicted with the degenerative disease multiple sclerosis, a new University of Florida study finds. "This is the first published report using a conventional weight-training program for patients with MS," said Lesley White, a professor in UF's department of applied physiology and kinesiology and the study's lead author. "We designed an exercise program to develop muscle strength because MS causes muscle weakness and fatigue, which contribute to a declining cycle of fitness, loss of mobility and decreased quality of life."
The study, published in the December issue of the journal Multiple Sclerosis, showed that after eight weeks of supervised resistance training on conventional gym equipment, eight MS patients had stronger muscles, could walk better, and reported less overall fatigue and disability.
The results of this preliminary study have led the National MS Society to fund an ongoing follow-up study that tracks 10 MS patients undergoing more intensive strength training for 16 weeks. The new study includes more total repetitions, thereby increasing the overall training load on the subjects, and compares the results with a control group of 10 subjects of similar age and body type. Future work will probe for mechanisms at the cellular level associated with changes in muscle strength, White said.
MS currently affects 250,000 to 350,000 people in the United States and is twice as common in women as in men, according to the National Institutes of Health. Though the cause of MS is unclear, it is thought to be an autoimmune disorder, where white blood cells attack the fatty tissue, or myelin, surrounding the nerve fibers of the central nervous system. Myelin is responsible for the transmission of nerve impulses from the brain to the muscles. MS also can lead to the destruction of the underlying nerve cells, or neurons, and their axons, or nerve endings.
The disease causes debilitating fatigue and muscle weakness, often greatly limiting physical activity and resulting in secondary effects such as obesity and depression.
MS patients also can have painfully heightened sensitivity to heat. Previous studies of the effects of aerobic exercise on MS patients showed promise, but a concurrent increase in body temperature could also exacerbate their pain. Consequently, many doctors have been hesitant to prescribe exercise regimens as treatment, thinking it could do more harm than good, White said.
Strength training, however, does not increase body temperature like aerobic exercise does, and it focuses on one of the primary targets of MS -- muscle mass. The regimen of the study included no more than 30 minutes of supervised weight training twice a week for eight weeks, focusing on the legs, abdomen and lower back. Each subject's initial weight load was determined from a pre-study strength test. Once subjects could do 15 repetitions consistently, they progressed to higher weight resistance.
"Fatigue is a huge factor for people afflicted with MS," White said. "Because no previous data on MS patients doing strength training with conventional gym equipment have been reported, we wanted to be a little conservative in our approach and therefore designed a relatively low-intensity program. But the results of this preliminary study suggest that MS patients are capable of adapting to resistance training favorably, and may be able to tolerate more intensive training."
"We're very excited," said Jennifer Lee, president of the North Florida Chapter of the National MS Society. "MS is such a complicated disease, which is why papers like this are so important. I feel like it will be our responsibility that this goes out to the doctors that we work with."
There is no cure for MS, though patients suffering an attack can take anti-inflammatory corticosteroid drugs to alleviate the duration and severity of those attacks, as well as immunosuppressants to counteract the disease. MS has been around for many years, but treatments that can effectively stop its progression have been around only since 1994, Lee said. "The course and the treatment of MS have come so far in just a short period of time."
Perhaps because of improvements in doctors' ability to recognize the symptoms, the disease is being diagnosed at an ever-younger age; often patients are in their 20s or 30s when it is identified.
"The ability to gain control over part of your disease is very important for people with MS," Lee said, "especially because it's diagnosed at such a young age. They're just starting to gain control over their lives in their 20s and 30s."
Stella Sarkees, a participant in White's pilot study, received a diagnosis of MS at age 25, when an attack left her temporarily paralyzed. "I was very scared -- immobilized and depressed. It was a depression that you cannot imagine," she said. Sarkees had been living with MS for seven years and walked with a limp when she entered the program. She currently is the organizer of Living Well with MS, a support group for MS patients in Gainesville.
The weight training was beneficial both physically and emotionally, she said. After eight weeks in the program, she noticed an improvement in her walking and was able to stop taking medication for muscle spasms.
"The benefits of exercise are so obvious, and nobody's really studied it till now," she said. "Doctors tell you, 'Don't get tired, don't work out so much, don't get fatigued.'"
Although improving muscle strength is its main benefit, Sarkees said weight training gives MS patients another advantage that's less obvious but perhaps equally important.
"You feel empowered," she said. "It keeps the focus on something instead of the depression, the illness, the situation."
From University of Florida

Some exciting news on the horizon for multiple sclerosis patients. Scientists are testing a vaccine that seems to halt the progression of the disease. I t's hoped that 1 day the vaccine could reverse the effects of MS. Losing strength and coordination is a big problem. Sue Carlson was diagnosed with multiple sclerosis 10 years ago.

Sue Carlson, multiple sclerosis patient: "It came on suddenly and I was deteriorating quickly."

Sue's eyesight was failing, she was falling down and was forced to cut her workload in half, b ut she found hope in a clinical trial for a new vaccine called Neurovax.

Sue Carlson: "I had been on Neurovax for about 3 months and I realized things were starting to come back."

In fact, sue says her symptoms have gone away.

Arthur VandenBark, PHD. Neuroimmunologist: "W e've had a few examples where we've had very, very good responses, and many other examples where we've been able to stabilize the disease so it doesn't progress any further."

Scientists discovered that MS patients lose the foxp3 gene. Simply put, Neurovax restores foxp3 levels by expanding healthy cells which in turn block the bad cells that have become active.

Arthur VandenBark: "When we activate the regulatory cells, we're helping them to produce these anti-inflammatory factors."

If after more trials Neurovax proves successful, for some, combating MS could 1 day be as simple as a shot in the arm.

Arthur VandenBark: "Probably give them maybe 3 at the beginning once a month and then follow every 3-6 months with a booster injection."

Early results suggest Neurovax might be able to treat MSs in both early and late stages, which may be why Sue Carlson never misses a day of work.

MS Vaccine Shows Promise

RESULTS: There was no significant difference between the percentages of patients who discontinued and did not restart treatment with the products (interferon beta-1b, 41%; intramuscular interferon beta-1a, 34%; and glatiramer acetate, 28%). Four main reasons for medication discontinuation emerged: adverse effects (52%), physician-documented disease progression (40%), patient perception of drug ineffectiveness (20%), and cost (4%). No statistical differences were identified among the three agents for any of the reasons for discontinuation." CONCLUSION: Patient education on adverse effects and realistic patient expectations may be potential areas of study to improve discontinuation percentages with these agents.
MORE...Entrez PubMed

OBJECTIVE: To evaluate the effect of a software-supported intervention based on the Transtheoretical Model of Change and motivational interviewing on decreasing discontinuation (or increasing persistency) of Avonex (interferon beta-1a--Biogen), a medication for treatment of multiple sclerosis (MS). DESIGN: Randomized controlled experimental design comparison of software-based telephone counseling (intervention group) and standard care (control group). SETTING: United States. PARTICIPANTS: 366 patients with MS. INTERVENTION: Software-based telephone counseling. MAIN OUTCOME MEASURE: Discontinuation of Avonex treatment and movement among stages of the Transtheoretical Model of Change. RESULTS: Patients in the software intervention group demonstrated a statistically significantly lower proportion of Avonex treatment (1.2%) discontinuation than the standard care group (8.7%). In addition, stage movement away from discontinuation of Avonex (i.e., toward continuation of therapy) was significantly higher in the treatment group. CONCLUSION: The Transtheoretical Model of Change constructs and motivational interviewing processes were effectively incorporated into a software-based intervention program, and this significantly decreased the proportion of patients who discontinued treatment of MS with Avonex. The integration of behavioral theory with information systems offers a promising approach for pharmacists and other providers to promote medication persistency.[J Am Pharm Assoc (Wash DC). 2005 Jul-Aug;45(4):466-72]

A medication currently available in Southeast Asia to treat asthma and vascular disorders in the brain is now undergoing clinical testing as a possible therapy for multiple sclerosis. The drug is known as Ketas® (ibudilast) in Japan and Korea. But it uses a code name, MN-166, in its current clinical scrutiny as a possible MS treatment.

A Promising MS Drug?
The trials—the latest is a Phase 2 study that just completed patient recruitment—are sponsored by the drug's manufacturer, San Diego-based MediciNova. "MN-166 may present a significant advance in the treatment of relapsing-remitting MS," said Richard Gammans, PhD, the company's Chief Development Officer. "It has a proven record of safety and tolerability, and has the major advantage of oral dosing."

The drug works by inhibiting
phosphodiesterase IV (PDE4), an enzyme that blocks the activity of a hormone in the body that mediates some cellular functions.1 In the case of MS, inhibiting PDE4 increases levels of this hormone, which results in decreased inflammation. Inflammation is a hallmark of multiple sclerosis. In the central nervous system where damage occurs as a result of the disease, inflammation is a common side effect.2


MediciNova has not stated when it expects the Phase 2 trial to conclude.MS Neighborhood

Scientists at New York University School of Medicine say they've identified the molecular switch that controls production of myelin.

Myelin is a fatty protective coating surrounding nerve cells that ensures swift and efficient communication in the nervous system. The researchers say their findings may provide a new avenue for treating nervous system diseases, such as multiple sclerosis, which are associated with myelin damage.

A team led by Dr. James Salzer, professor of cell biology and neurology, identified the factor determining whether cells will be wrapped in thick layers of myelin.

The research team said it identified a gene called neuregulin as the myelin signal that directs Schwann cells to build elaborate sheaths of myelin around the axons of nerve cells.

Myelin forms the so-called white matter in the nervous system and constitutes 50 percent of the weight of the brain, and is an important component of the spinal cord and nerves in other parts of the body.

The study, supported by grants from the National Institutes of Health and the National Multiple Sclerosis Society, appears in the Sept. 1 issue of the journal Neuron.

MedlinePlus

People with inflammatory bowel disease have a higher than normal risk for developing multiple sclerosis and other autoimmune disorders, new studies show.

Researchers are also reporting that people with inflammatory bowel disease are at increased risk for asthma, arthritis, chronic kidney disease, psoriasis, bronchitis, and other conditions believed to be linked to the immune system.

"These studies remind us that the effects of inflammatory bowel disorders extend to every corner of the body, including the lungs and central nervous system," says Edward Loftus Jr. of the Mayo Clinic, who wrote an editorial accompanying two studies.

"The findings lend credence to the concept that patients with one chronic inflammatory condition are more likely than the general population to develop another."

Millions Suffer
It is estimated that more than 3 million Americans suffer from either Crohn's disease or ulcerative colitis, the two conditions that make up inflammatory bowel disease (IBD).

Ulcerative colitis commonly affects young adults; symptoms can include chronic diarrhea, abdominal cramping, weight loss, and fever. The condition is limited to the lining of the large intestine, and because of this it is curable by surgery that removes the colon. Crohn's disease involves any part of the intestinal tract from the mouth to the anus.

Unlike the poorly understood but more common condition known as irritable bowel syndrome (IBS), IBD is frequently associated with symptoms occurring outside the bowel. These can include inflammation of the eyes, mouth ulcers, joint pain or swelling, and other inflammatory-related conditions.

Link With MS Long Suspected
A link between IBD and multiple sclerosis has been suspected for some time, but earlier studies have been conflicting. Powerful new drugs used to treat IBD, which block inflammation-causing tumor necrosis factor (TNF -- a part of the immune system), are also suspected of causing multiple sclerosis.

Medications that block TNF like Remicade and Humira are now required to contain labels warning of a possible link to multiple sclerosis and similar conditions. But all agree that their role in the disease is far from clear.

In one of the two new studies...."
...Click to read entire article...my.webmd.com

The head of Biogen Idec Inc. said in an interview Wednesday his company will recommend to regulators within a month that the warning label be strengthened on a multiple sclerosis drug the company hopes to return to the market despite safety concerns.

James Mullen said Biogen Idec will likely recommend that Tysabri include warnings about three cases of an often-fatal brain disease that were confirmed after clinical trials of the drug, which was withdrawn from the market Feb. 28 despite hopes that it would become an important new tool in treating MS.

Mullen said the revised label that the company will propose to the U.S. Food and Drug Administration also will warn about risks for patients who have weak immune systems and therefore could be more susceptible to contracting the disease, called progressive multifocal leukoencephalopathy, or PML.

However, Mullen said the label language his company will suggest to FDA when it seeks permission to resume marketing Tysabri will acknowledge that scientists don't yet understand precisely how the bioengineered drug put the three patients who contracted PML at risk of contracting the rare disease. Two of those patients died.

"I think it's important for us to not overstate what we know," Mullen, Biogen Idec's chief executive and president, said in an interview with The Associated Press at the company's Cambridge headquarters. "We want to be concrete about what we know and what we don't know."

Mullen said Biogen Idec and its Irish partner in Tysabri, Elan Corp., plan to submit findings from their review of the drug's safety to the FDA by the end of September.

The companies had previously said the report would be submitted sometime in the fall so the FDA could review whether Tysabri can safely return to the market. Some industry analysts have said strong warnings on Tysabri's label could ruin the drug's chances of becoming a commercial success.

Mullen said it is "highly unlikely" the FDA will complete its own review by the year's end, but he said the regulators are "interested in a thorough but expeditious review of determining whether this can brought back to the market in the near future or not."

FDA spokeswoman Lenore Gelb declined to comment Wednesday.

Biogen Idec and Elan said Aug. 9 that more than 2,000 patients with multiple sclerosis who took Tysabri in clinical trials had been screened for PML as part of the companies' safety review, but no new cases were found.
The companies are close to finishing a similar review of about 1,500 people who took Tysabri in clinical trials to test its effectiveness in treating Crohn's disease and rheumatoid arthritis.
After reviewing one year of data from planned two-year trials, federal regulators in November approved Tysabri for sale to the 350,000 American sufferers of MS, a debilitating and incurable disease in which the body's immune system turns rebellious, attacking, inflaming and damaging its own nerve tissue.
The drug was withdrawn about three months after its approval, causing Biogen shares to plunge more than 42 percent the day of the announcement while Elan's stock fell 70 percent.
"We hope there is a pathway back to the market," Mullen said. "We think that unless we see some new surprises, that the risk-benefit profile for this product certainly warrants it being used for MS.
"We've got probably hundreds of letters from patients saying, 'Tysabri changed my life. I've got no other options. I'll sign whatever waiver I need to get access to this product.'" Boston.com

John Kurtzke developed a scale for measuring the severity of disability. The 1-10 scale is the most widely used systems for clinically judging the status of people with MS. The Expanded Disability Status Scale is also useful in measuring the efficacy of treatments in clinical trials.

The Expanded Disability Status Scale (EDSS) is a 0-10 scale, which provides a measurement for disability in MS and is a widely used standard for the clinical assessment of MS. It is employed by neurologists to track individual disease progression and as a benchmark in clinical trials.

The EDSS allows neurologists to assign a Functional System Score (FSS) to eight Functional Systems (FS) of the body that are affected by MS: pyramidal, cerebellar, brainstem, sensory, bowel and bladder, visual, cerebral, and other.

0.0 Normal neurological exam

1.0 No disability but at least one abnormal sign

1.5 No disability but more than one abnormal sign

2.0 Mild disability in at least one system

2.5 Mild disability in at least one system and minimal disability in 2 systems

3.0 Moderate disability in at least one system and mild disability 3-4 other systems

3.5 Fully mobile but moderate disability in one system and mild disability in others

4.0 Fully mobile without aid (with rest after 500 meters) and independent despite severe disability

4.5 Fully mobile without aid (with rest after 300 meters) & independent despite severe disability. May require some
assistance on activities

5.0 Fully mobile without aid (with rest after 200 meters) & disability may affect daily activities, requiring assistance

5.5 Fully mobile without aid (with rest after 100 meters). Disability influences daily activity.

6.0 Need a single cane, crutch, or brace in order to walk

6.5 Needs two canes, two crutches, or two braces in order to walk. Able to move 100 meters without rest

7.0 May be able to take a few steps but needs a wheelchair for mobility. Able to wheel self & transfer from wheelchair
independently

7.5 Need wheelchair for mobility. May need aid to transfer and may need a motorized wheelchair

8.0 Restricted to bed or limited time in a motorized wheelchair. Retains use of arms & performs self-care functions

8.5 Restricted to bed but performs self-care functions with limited use of arms

9.0 Confined to bed but able to communicate and eat

9.5 Immobile and unable to communicate or swallow

[about.com]