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Wednesday

 
Inactivation of Protein Reduces Damage from MS
GEN News Highlights

Scientists found that deactivating a protein, cyclophilin D, protects nerve fibers from damage in a mouse model of multiple sclerosis.

"While we can't genetically inactivate cyclophilin D in people, there are drugs out there that can block the protein,” notes Michael Forte, Ph.D., senior scientist at the Vollum Institute at Oregon Health & Science University (OHSU). “Our research predicts that drugs that block cyclophilin D should protect nerve fibers from damage in MS."

Cyclophin D is a key regulator of molecular processes in the nerve cell's mitochondrion and can participate in nerve fiber death. Inactivating this protein strengthens the mitochondrion, helping to protect nerve fibers from injury.

The researchers believe that cyclophilin D is responsible for causing the unregulated opening of a pore in the mitochondrion's membrane that allows the calcium overload seen in MS patients. The OHSU team showed that mice lacking cyclophilin D still developed an MS-like disease, but unlike their counterparts possessing the protein, they partially recovered. Scientists found their nerve fibers remained intact and they resisted the free radicals and calcium overload.

The research was done by investigators at OHSU, Portland Veterans Affairs Medical Center, and the University of Padova in Italy. The findings are published in the April 24 issue of Proceedings of the National Academy of Sciences.

 

Medscape Today: Multiple Sclerosis Prevalence Increasing Faster Among Women Than Men

April 24, 2007 — Over time, more women than men are developing multiple sclerosis (MS), new research has shown.

In a study that will be presented May 2 at the American Academy of Neurology's 59th Annual Meeting, investigators at the University of Alabama at Birmingham School of Public Health, Cleveland Clinic, in Ohio, and Barrow Neurological Institute, in Phoenix, Arizona, found that between 1940 and 2000, the ratio of MS in women compared with men increased by approximately 50% per decade.

In 1940, the ratio of women to men with MS was 2 to 1. In 2000 it was 4 to 1, a finding that principal investigator Gary Cutter, PhD, from the Cleveland Clinic, confirms with similar results from a recent Canadian study.

Published in 2006 in Lancet Neurology (Orton SM et al. Lancet Neurol. 2006;5: 932 – 936), the study found that among individuals born during the 1930s, the ratio of women to men who developed MS in Canada was 2 to 1. However, the study showed that among those born during the 1980s, this ratio increased to over 3 to 1.

Similar findings, he said, were reported by Norwegian researchers in the European Journal of Neurology in 2001 (Celius EG, Vandvik B. Eur J Neurol. 2001;8:463 – 469).

"If this were the first time this [finding] had been observed, I would be very, very cautious about suggesting it is real. But given the fact that other investigators have made the same observation, I am pretty comfortable that this is a valid phenomenon. Having said that, we have no insight [from this study] as to why it is occurring," Dr. Cutter told Medscape.

Enormous Increase
Investigators examined data from the North American Research Committee on Multiple Sclerosis (NARCOMS) database. This online MS patient registry is one of the largest of its kind and includes 32,414 individuals with MS from across the United States and Canada.

Individuals enrolled in the registry self-report demographic and clinical information regarding their disease at enrollment and semiannually thereafter.

Age, sex, age at diagnosis, and age at onset were used to assess the female-to-male ratio. Investigators then adjusted for age at disease onset and year of diagnosis. Of the total number of registry participants, 30,336 were included in the final analysis.

Of the total study group, 72.5% were females and 93% were white. The mean year of diagnosis was 1973 for males and 1975 for females. Investigators found that the ratio of females to males increased from 2 to 1 for subjects diagnosed in the earlier time periods to more than 4 to 1 in recent years, an enormous increase in women over a 60-year period.

In addition, he said, the changes in prevalence appear to be more pronounced among those diagnosed at younger ages and in young women.

Avenues of Investigation
This research, along with the previous studies conducted in Canada and Europe, may help direct future studies.

"These studies show there are changes in the occurrence of MS among females relative to males, which should provide us with potential clues and possible avenues of investigation. We need to consider the changes that have occurred over time among women that may give rise to the disease. This could provide us with an important area of research that, to date, either has not been considered or has been understudied, leading ultimately to ways of preventing the disease," said Dr. Cutter.

Possible candidates include the increased use of hair dye and cosmetics, which may block vitamin D absorption, a factor some are considering associated with MS, the use of oral contraceptives, changes in obesity and smoking rates, earlier menstruation, and later age of first births.

American Academy of Neurology 59th Annual Meeting: Abstract P04.068. April 28 – May 5, 2007.


 

Acorda Therapeutics to Host Analyst and Investor Reception
Business Wire

Acorda Therapeutics, Inc.(R) (Nasdaq: ACOR) today announced that Dr. Lauren Krupp, Professor of Neurology at Stony Brook University, will present data from Acorda's Phase 3 clinical trial of Fampridine-SR in multiple sclerosis at their analyst and investor reception on May 2, 2007. This reception will follow a presentation of this data at the American Academy of Neurology (AAN) annual meeting.

Dr. Krupp's presentation will begin at 7:00 pm Eastern Time (ET) and will be able via a live webcast at http://phx.corporate-ir.net/phoenix.zhtml?p=irol-eventDetails&c= 194451&eventID=1529938

Archived versions of the webcast will be available for 90 days on our website at http://phx.corporate-ir.net/phoenix.zhtml?c= 194451&p=irol-irhome. (Due to their length, these URLs may need to be copied/pasted into your Internet browser's address field. Remove extra spaces if they exist.)

The platform presentation of the Phase 3 clinical trial of Fampridine-SR data at the AAN meeting will take place on May 2, 2007 at 4:15 pm ET. This abstract was selected to be part of the Scientific Highlights program, which spotlights the top five percent of the more than 1600 abstracts accepted for presentation at this meeting. This presentation was also selected for a second highlights session, Multiple Sclerosis Scientific Topic Highlights, to be presented on May 3, 2007 at 7:00 pm ET. The AAN meeting will take place at the Hynes Convention Center in Boston, MA.

Forward Looking Statements
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, regarding management's expectations, beliefs, goals, plans or prospects should be considered forward-looking. These statements are subject to risks and uncertainties that could cause actual results to differ materially, including Acorda Therapeutics' ability to successfully market and sell Zanaflex Capsules, the risk of unfavorable results from future studies of Fampridine-SR, delays in obtaining or failure to obtain FDA approval of Fampridine-SR, competition, the ability to obtain additional financing to support Acorda Therapeutics' operations, unfavorable results from its preclinical programs, and failure to protect its intellectual property or to defend against the intellectual property claims of others. These and other risks are described in greater detail in Acorda Therapeutics' filings with the Securities and Exchange Commission. Acorda Therapeutics may not actually achieve the goals or plans described in its forward-looking statements, and investors should not place undue reliance on these statements. Acorda Therapeutics disclaims any intent or obligation to update any forward-looking statements as a result of developments occurring after the date of this press release.

About Acorda Therapeutics
Acorda Therapeutics is a biotechnology company developing therapies for SCI, MS and related nervous system disorders. The Company's marketed products include Zanaflex Capsules(TM) (tizanidine hydrochloride), a short-acting drug for the management of spasticity. For full prescribing information, please go to www.zanaflexcapsules.com. Acorda's lead clinical stage product, Fampridine-SR, recently completed a Phase 3 study in people with MS. The Company's pipeline includes a number of products in development for the treatment, regeneration and repair of the spinal cord and brain.


Monday

 

Research and Markets: Oxford Handbook of Rehabilitation Medicine Summarizes the Management of Common Symptoms and Disorders for the Whole Rehabilitation Team

Business Wire
Research and Markets (http://www.researchandmarkets.com/reports/c54736) has announced the addition of Oxford Handbook of Rehabilitation Medicine, First Edition to their offering.

- A practical handbook that summarizes the management of common symptoms and disorders for the whole rehabilitation team
- Outlines the principles of rehabilitation medicine to improve understanding of the benefits that can follow an interdisciplinary rehabilitation programme
- Includes evidence-based guidelines for rehabilitation to help the reader assess the efficacy of rehabilitation medicine

Rehabilitation medicine is a new and growing specialty. Rehabilitation services are now available in most UK hospitals and rehabilitation has an increasing presence in the community. There is a strong evidence base for the efficacy of rehabilitation and there is no doubt that an active interdisciplinary rehabilitation programme produces real functional benefits for the person with disabilities and their family.

The Handbook of Rehabilitation Medicine outlines the basic principles of rehabilitation and the key factors that are required for a high quality rehabilitation service. There are specific chapters on the management of particular problems, including spasticity, continence, swallowing disorders and communication as well as problems with sexual function. The increasingly important area of technical aids and assistive technology is also covered. As well as physical problems, the book also outlines the management of cognitive, behavioural and emotional problems. The rehabilitation needs of people with specific disorders are also explained including multiple sclerosis, stroke, head injury, spinal injury and Parkinsons disease as well as musculo-skeletal problems, arthritis and amputation.

The Handbook of Rehabilitation Medicine is a comprehensive text that not only summarises the management of common symptoms and disorders but also outlines the increasing evidence base for the efficacy of these techniques. It will appeal to the entire rehabilitation team, as well as students, doctors and nurses interested in rehabilitation.

Readership: The book should appeal to medical students, junior doctors, nurses and the wide range of therapists involved in rehabilitation.

Authors, editors, and contributors
- Michael P. Barnes, Professor of Neurological Rehabilitation, University of Newcastle upon Tyne, Hunters Moor Regional Rehabilitation Centre and
- Anthony B. Ward, Consultant in Rehabilitation Medicine, North Staffordshire Regional Rehabilitation Unit, Stoke on Trent

1. Concepts of rehabilitation
2. Epidemiology
3. The rehabiliation team
4. Organization of services
5. Assessment of disability
6. Spasticity
7. Continence
8. Sex and sexuality
9. Eating and swallowing disorders
10. Communication
11. Other physical problems
12. Technical aids and assistive technology
13. Behavioural disorders
14. Psychiatry problems and rehabilitation
15. Cognitive and intellectual function
16. Broader issues in rehabiliation - handicap and participation
17. Multiple sclerosis
18. Stroke
19. Traumatic brain injury
20. Spinal cord injury
21. Parkinsons disease and movement disorders
22. Motor neurone disease
23. Disorders of peripheral nerves
24. Epilepsy
25. Dementia
26. Arthritis
27. Spinal pain and soft tissue rheumatism
28. Amputation
29. Ageing and disability

For more information visit http://www.researchandmarkets.com/reports/c54736


 
NIH Awards $7.39 million to Burnham Neurobiologists

Newswise - A team of researchers at the Burnham Institute for Medical Research ("Burnham") has been awarded $7.39 million from the National Institute of Child Health and Human Development of the National Institutes of Health. The funding will support a five-year, multi-project study entitled "Neuron-Glia Communication in Development."

Glial cells are at the center of most functions of the nervous system. They outnumber neurons (nerve cells) in the brain and spinal cord by a factor of 10:1 and provide physical and nutritional support for neurons. They are also believed to guide the migration of neurons during development and to regulate the chemical environment surrounding synapses in the adult brain. And yet, little is known about the molecular mechanisms by which glial cells communicate with neurons and how the failure of such communication leads to neurological diseases. New studies underway at Burnham are addressing this information gap.

"The study of neuron-glia communication is a rapidly emerging field in basic neurobiology. It also has strong relevance to demyelinating diseases, such as multiple sclerosis and neuropathies," said project director Yu Yamaguchi, M.D., Ph.D. Myelin is the protective sheath coating nerve fibers, and the damage or loss of myelin (demyelination) severely impairs the ability of nerve fibers to conduct electrical signals. Multiple sclerosis is the most well known of the so-called demyelinating diseases. "With this funding, we expect to resolve how glial cells function in the normal brain. But also, we hope to provide new insights into the mechanisms of demyelinating diseases," said Yamaguchi.

In this NIH-funded project, Dr. Yamaguchi, who is a Professor in Burnham's Glycobiology Program, leads a team including four other faculty members at the Institute: Professor William Stallcup, Ph.D., Professor Elena Pasquale, Ph.D., Professor Barbara Ranscht, Ph.D., and Assistant Professor Dongxian Zhang, Ph.D. This is a mature collaboration: the members of this team have worked together for more than 10 years as a highly interactive group at Burnham. Their work has contributed key findings about the formation of nerve cell circuitry, synaptic functions, proliferation and migration of nerve cells, helping to advance medical researchers' understanding of normal brain development as well as cancer and degenerative diseases of the brain.

About Burnham Institute for Medical Research. Burnham Institute for Medical Research conducts world-class collaborative research dedicated to finding cures for human disease, improving quality of life, and thus creating a legacy for its employees, partners, donors, and community. The La Jolla, California campus was established as a nonprofit, public benefit corporation in 1976 and is now home to three major centers: a National Cancer Institute-designated Cancer Center, the Del E. Webb Center for Neurosciences and Aging, and the Infectious and Inflammatory Disease Center. Burnham today employs over 750 people and ranks consistently among the world's top 20 research institutes. In 2006, Burnham established a presence at the University of California, Santa Barbara, led by Dr. Erkki Ruoslahti, Distinguished Professor. Burnham is also establishing a campus at Lake Nona in Orlando, Florida that will focus on diabetes and obesity research and will expand the Institute's drug discovery capabilities. For additional information about Burnham and to learn about ways to support its research, visit http://www.burnham.org.

Saturday

 
BioMS Medical announces lead investigator in United States phase III multiple sclerosis trial

EDMONTON, April 20 /PRNewswire-FirstCall/ - BioMS Medical Corp , a leading developer in the treatment of multiple sclerosis (MS), is pleased to announce Dr. Clyde E. Markowitz as the lead investigator in the United States for the Company's pivotal phase III clinical trial of its lead drug, MBP8298, for the treatment of secondary progressive multiple sclerosis.

Dr. Markowitz is Director of the Multiple Sclerosis Center at the Hospital of the University of Pennsylvania in Philadelphia. He is an Assistant Professor of Neurology at the University of Pennsylvania School of Medicine and an attending neurologist at the Hospital of the University of Pennsylvania.

"With few approved therapies for secondary progressive MS, this trial is important for the MS community and patients," said Dr. Markowitz. "I am pleased to play a key role in assessing the impact that MBP8298 may have on delaying disease progression of secondary progressive MS."
Dr. Markowitz is a member of the American Academy of Neurology and the International MS Forum. Dr. Markowitz is also Chairman of the clinical advisory committee for the Delaware Valley chapter of the National Multiple Sclerosis Society and a member of the Penn Neuro Care, MS section of the National Multiple Sclerosis Society. Dr. Markowitz is the author and co-author of a number of publications in the field of MS, and he serves as an ad hoc reviewer for Multiple Sclerosis, Journal of Clinical Immunology, Neuro-Rehabilitation and Neural Repair, and The Consultant.

BioMS Medical recently received clearance from the United States Food and Drug Administration (FDA) for the initiation of a pivotal phase III clinical trial to investigate the use of MBP8298 as a treatment for patients with secondary progressive MS.

The pivotal phase III clinical trial in the US, named MAESTRO-03, will be a randomized, double-blind study enrolling approximately 510 patients who will be administered either MBP8298 or placebo intravenously every six months for a period of two years. The primary clinical endpoint for the trial is defined as a statistically and clinically significant increase in the time to progression of the disease as measured by the Expanded Disability Status Scale (EDSS), in patients with HLA-DR2 and/or HLA-DR4 immune response genes (up to 75% of all MS patients are HLA-DR2 and/or HLA-DR4 positive).

About BioMS Medical Corp.
-------------------------
BioMS Medical is a biotechnology company engaged in the development and commercialization of novel therapeutic technologies. BioMS Medical's lead technology, MBP8298, is for the treatment of multiple sclerosis and is being evaluated in two pivotal phase III clinical trials for secondary progressive MS patients, MAESTRO-01 in Canada and Europe and MAESTRO-03 in the United States. It additionally is being evaluated for relapsing remitting MS patients in a Phase II trial in Europe entitled MINDSET-01. For further information please visit our website at www.biomsmedical.com.

This news release may contain certain forward-looking statements that reflect the current views and/or expectations of BioMS Medical with respect to its performance, business and future events. Such statements are subject to a number of risks, uncertainties and assumptions. Actual results and events may vary significantly.

 
Clay Walker sounds stronger than ever on his new album
By Matt Curry The Associated Press

DALLAS - More than a decade after he was diagnosed with multiple sclerosis, Clay Walker's voice sounds stronger than ever on his first new studio album in four years.

The country singer's ''Fall,'' filled with twangy honky-tonk songs and ballads that test his range, was released this week. The CD's disturbingly funny '' 'Fore She Was Mama,'' in which a 10-year-old discovers old photos of his mother's bikini-clad partying days, is already a hit.


The album also includes a duet with the late Freddy Fender on his classic ''Before the Next Teardrop Falls,'' in which Walker croons in Spanish. He began learning the language four years ago.


''That will always be his song, but there was total magic in the studio,'' he said during a recent phone interview. ''He put his hand on my shoulder and said he had been asked to do it hundreds of times but had never done it, but that he felt that this was the right moment. . . . It was the last song he ever recorded, so I'm proud to be part of his legacy.''


The duet - Walker's first - was recorded last year. Fender, who was diagnosed with lung cancer in early 2006, died in October.


Walker, whose long string of hits includes ''If I Could Make a Living'' and ''Rumor Has It,'' acknowledged an uncomfortable lapse of time between releases. ''A Few Questions'' came out on RCA in 2003. His six earlier albums were all on Giant Records, but ''Fall'' marks his Curb debut.


''Yeah, I think it was too long. There was a lot of red tape leaving one record label and going to another one. It was a process that was excruciating,'' he said.


The black-hatted singer, who stays active by riding cutting horses and playing basketball, said his illness has not affected his work. He boasts never missing a show due to MS (or any other reason).


''It used to be a death sentence,'' Walker, 37, said. ''I'm living proof you can manage the disease.''


The divorced father of two young daughters was diagnosed with MS in 1996 and takes a daily injection to keep the disease in check. MS occurs when patients' immune systems go awry and attack the fatty layer of insulation, called myelin, that protects nerve fibers in the brain and spine, thus damaging or even destroying nerves.


Some patients, including Walker, have ''relapsing-remitting MS,'' periods of severe symptoms after which patients almost totally recover until the next attack.


''I would say, if anything else, it has inspired me to want to do more,'' said Walker, who started the nonprofit Band Against MS Foundation in 2002 to raise money for research.


Walker, who grew up in southeast Texas and lives in Houston, got his start on the honky-tonk circuit before his first single, ''What's It to You,'' hit No. 1 in 1993. Since then, he's sold 8 million albums and has had 11 No. 1 country hits.


He likes the sound of his latest release. It seemingly includes something for everyone, including the heart-tugging ''It Ain't Pretty (But It's Beautiful)'' and Walker's playful ''She Likes It in the Morning.'' He said '' 'Fore She Was Mama'' - in which the family matriarch won't admit to having smoked marijuana - elicits a strong response on the road.


''It's great when a song can be humorous without being hokey, and the writers made a good country song without it being a novelty,'' he said. ''Any time we do it, it gets a huge reaction. I think a lot of moms are looking in the rearview mirror saying, 'I hope the kids aren't looking at my face right now, because I'm blushing.' ''


Thursday

 

Live Show Next Week: Why Is My Head in a Haze? on April 26

LIVE SHOW ONE WEEK AWAY: Thursday, April 26, 2007
Why Is My Head in a Haze?
If you've ever lost a word from the tip of your tongue or struggled to calculate the tip at dinner, you have some idea of what it’s like to live with cognitive symptoms of MS.

Tune in on April 26 to find out what causes symptoms of memory loss and poor concentration. Learn all about exercises and treatments that might help and get expert strategies for overcoming obstacles like these in day-to-day life.

And, as always, our expert guests answer questions from the audience.

Time is running out - register now

Date:
Thursday, April 26, 2007

Time:
5:30 p.m. PDT / 6:30 p.m. MDT / 7:30 p.m. CDT / 8:30 p.m. EDT

Location:
On the phoneOn the Internet

Day of Event Link:
http://www.healthtalk.com/multiplesclerosis/programs/10_715/index.cfm

How to participate: It’s okay if you haven’t registered prior to the show – we’d still love for you to attend. There are two ways you can tune in:

On the phone: On Thursday, April 26 approximately 10 minutes prior to show time, call 1-800-601-8584 on a touch-tone telephone. An operator will greet you and transfer you into the show.

On the Internet: On Thursday, April 26 approximately 10 minutes prior to show time, access the following Web address from any computer: http://www.healthtalk.com/multiplesclerosis/programs/10_715/index.cfm

Be sure to install Media Player for Mac or Windows and test it before the show. Find easy download instructions at http://www.healthtalk.com/wmpdownload.cfm.

Thank you for tuning in!

We wish you and your family the best of health,
The HealthTalk Multiple Sclerosis Team


 
WEBCAST from MS Learn Online - MS Treatment Options: Making it Work for You

MS Treatment Options
Making it Work for You



Our presenter is neurologist James D. Bowen, MD, Medical Director of the Evergreen HealthCare MS Center in Kirkland, Washington. Prior to joining the MS Center in June 2006, Dr. Bowen served as director of neurology services for the Western Multiple Sclerosis Clinical Center at the University of Washington Medical Center. Dr. Bowen received his bachelor of science degree in chemistry from Eastern New Mexico University and his medical degree from The Johns Hopkins University School of Medicine. He completed residencies in internal medicine and neurology at the University of Washington. He is board certified in neurology, and has taught in the departments of both Neurology and Rehabilitation Medicine. Dr. Bowen is involved in several organizations, including the American Academy of Neurology. He has served on the Clinical Advisory Committee of the Greater Washington Chapter of the National Multiple Sclerosis Society for many years, and has chaired the committee since 1999. He was inducted into the National MS Society 2005 Volunteer Hall of Fame in the Health Professional and Researchers category for his contributions as a volunteer.

This webcast will focus on:
Side Effects of the Disease Modifying Agents
Using MRI's as an Early Warning System
Up and Coming...Oral Treatments?

Click here to go to this webcast. If the webcast does not appear please type (or cut and paste) the following URL into your browser: http://skins.broadbandvideo.com/nmss/event.asp? showid=29355&clipid=29350

This webcast is pre-recorded and may be played at any time.

Please note if you have a pop-up blocker on your computer, you will need to disable it prior to participating in an MS Learn Online webcast.

Tuesday

 
CONGRATS TO DR VOLLMER: NEW ORAL MS DRUG FAMPRIDINE-SR IS CLOSER DUE TO DR VOLLMER & HIS TEAM


Timothy Vollmer, M.D.
Chairman, Division of Neurology
Barrow Neurological Institute


Give Dr. Vollmer & his Team of docs congrats on the completion and publication of their study on the oral MS drug Fampridine-SR

The team includes docs from:
Yale University
Barrow Neurological Institute
University of Rochester
Mellen Center, Cleveland Clinic Foundation
Washington University

This is their study on Fampridine-SR:
Fampridine-SR in multiple sclerosis: a randomized, double-blind, placebo-controlled, dose-ranging study

ABSTRACT

Objective:

To determine the safety of sustained-release 4-aminopyridine in subjects with mutiple sclerosis (MS) and to examine dose-related efficacy up to 40 mg twice daily.


Methods:
Multicenter, randomized, double-blind, placebo-controlled, study. Following a 4-week baseline peroid, subjects were randomly assigned to receive Fampridine-SR (n=25, doses from 10 to 40 mg twice daily, increasing in 5 mg increments weekly) or placebo (n=11). A battery of assessments was performed weekly, including the MS Functional Composite (MSFC), fatigue questionnaires, and lower extremity manual muscle testing.


Results:

Improvement were seen in lower extremity muscle strength (prospective analysis) and walking speed (post-hoc analysis) in the Fampridine-SR group compared to placebo (unadjusted p-values of 0.01 and 0.03, respectively).


There were no significant differences in other MSFC measure or fatigue scores.The most common adverse events were dizziness, insomnia, paresthesia, asthenia, nausea, headache, and tremor. Five subjects were discontinued from Fampridine-SR because of adverse events at doses greater than 25 mg, and these included convulsions in two subjects at doses of 30 and 35 mg twice daily.


Conclusions:
Future studies should employ doses up to 20 mg twice daily with lower extremity strength and walking speed as potential outcome measures.


Monday

 

TYSABRI: Penn Researchers Find Treatment for MS also Reduces Vision Loss in MS Patients




.

Penn Researchers Find Treatment for MS also Reduces Vision Loss in MS Patients
First MS Study to Include a Test of Visual Function
> Researchers at the University of Pennsylvania School of Medicine have found that natalizumab (TYSABRI®) – a drug that slows disability and reduces relapse rates in patients with multiple sclerosis (MS) – also reduces vision loss in patients with relapsing MS. 
> Researchers found vision loss – a worsening of vision defined as a two-line (10-letter) reduction in letter chart scores – was reduced by as much as 47% among people taking natalizumab, compared to those taking placebo
> The study appears in the April 17 issue of Neurology.
(PHILADELPHIA) – According to a study that appears in the April 17 issue of Neurology, researchers at the University of Pennsylvania School of Medicine have found that natalizumab (TYSABRI®) – a drug that slows disability and reduces relapse rates in patients with multiple sclerosis (MS) – also reduces vision loss in patients with relapsing MS.  Vision loss is one of the most common and disabling symptoms of MS.
"Not only does natalizumab prevent the worsening of vision loss in people with relapsing MS, but it is also associated with significant reductions in the likelihood of sustained vision loss due to inflammatory demyelination of nerve fibers that connect to the eye, a common cause of visual loss in MS," says Laura J. Balcer, MD, MSCE, Associate Professor of Neurology and Ophthalmology at Penn, and lead author of the paper.

Low-Contrast Letter Chart
Using low-contrast letter acuity charts, researchers found vision loss – a worsening of vision defined as a two-line (10-letter) reduction in letter chart scores – was reduced by as much as 47% among people with MS taking natalizumab, compared to those taking placebo.
Image Courtesy: Precision Vision, LaSalle IL
The researchers analyzed data from two randomized, double-blind, placebo-controlled, parallel group, phase 3 clinical trials involving 2,138 men and women with relapsing MS from clinical centers in Europe, North America, Australia, and New Zealand.  More than half of the participants received natalizumab every four weeks for two years, while the remaining participants received placebo.  Visits were conducted every 12 weeks and visual function testing was performed at each study visit.  Low-contrast letter acuity was measured using low-contrast letter charts (eye charts with gray letters on a white background).
Researchers found vision loss – a worsening of vision defined as a two-line (10-letter) reduction in letter chart scores – was reduced by as much as 47% among people taking natalizumab, compared to those taking placebo.
"Not only do the findings of the study add to our understanding of the effects of natalizumab, but the results provide strong validation for a simple, sensitive, cost-effective, and clinically meaningful measure of visual function in MS," advises Dr. Nicholas LaRocca, Associate Vice President, Health Care Delivery and Policy Research at the National MS Society.
The researchers caution that, as with any therapy, the benefits of natalizumab must be considered in the context of potential risks or complications.  In the case of natalizumab, three confirmed cases of progressive multifocal leukoencephalopathy (PML) – a rare, often lethal brain disease – have been reported.
Despite the fact that vision loss is a common and important cause of disability in MS, the natalizumab clinical trials were the first to include a test of visual function.  These trials showed that low-contrast letter acuity eye chart testing is an effective measure for assessing visual outcomes, and may be useful in future clinical trials.
This study was supported by Biogen Idec and Elan, makers of natalizumab.  Dr. Balcer has received support for consulting from Biogen Idec as well as from other companies for work on developing visual outcome measures for MS clinical trials.

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