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The Cutting Edge

Reprinted from PN March 2011

Cutting-edge research took place in almost every field of multiple sclerosis (MS) in 2010.

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Exciting advances were made in 2010 in virtually every field of multiple sclerosis (MS) research. Progress toward finding new therapies is illustrated by the availability of the first oral disease-modifying therapy. Progress was also made toward finding ways to restore function and improving quality of life and specific MS symptoms through exercise, meditation, rehabilitation, and medications, including the first therapy specifically approved to treat a symptom of MS (Ampyra). The understanding of factors that influence whether a person develops MS deepened this year, bringing us closer to finding ways to prevent the disease. 

The National MS Society (NMSS) continues to propel research forward with a comprehensive strategy and program. In 2010, the organization provided $36 million to support 325 new and ongoing projects, including everything from discovery research to the society’s commercial drug development efforts through Fast Forward. In addition, thanks to the efforts of MS activists, $4.5 million was specifically set aside for funding MS research out of the 2010 Department of Defense budget.

The society launched new projects focusing on discovering risk factors that lead to progressive disability, projects aimed at speeding diagnosis, research on protective mechanisms of vitamin D and estrogen, tests determining whether a new device can improve walking ability, and many more.

The society’s listing of clinical trials in MS 2010 includes 129 ongoing studies ranging from research of oral therapies for treating MS or its symptoms to novel agents such as green-tea extracts and a study of the antioxidant idebenone in people with primary-progressive MS.

Following are highlights from the many important, potentially high-impact research results that occurred last year, presented according to the society’s three key research approaches: stopping MS, restoring function, and ending MS forever. A more detailed report is at www.nationalmssociety.org/research/research-news/index.aspx. 

Toward Stopping MS

Exciting progress was made toward finding better therapies for MS, including the availability of the first disease-modifying therapy for MS taken by mouth.

- Gilenya™ (Novartis International AG) capsules were approved by the Food and Drug Administration (FDA) for reducing the frequency of clinical relapses and delaying the accumulation of physical disability in relapsing forms of MS, making it the first oral disease-modifying therapy for the treatment of MS. Cleveland Clinic doctors voted this among the top ten medical breakthroughs of the year (www.nationalmssociety.org/research/research-news/news-detail/index.aspx?nid=3871).

- Positive results from the phase III trial of oral Cladribine (EMD Serono), known as the CLARITY study, were published showing it reduced relapse rates compared to placebo by up to 57.6% in a study involving 1,326 people with relapsing-remitting MS, and also showed other benefits. Cladribine can interfere with the activity of lymphocytes, a subset of white blood cells. Additional studies are underway, and the company has applied to FDA for marketing approval (www.nationalms society.org/research/research-news/ news-detail/index.aspx?nid=2569).

- Teriflunomide (Sanofi-Aventis) is a novel oral compound that inhibits the function of specific immune cells. Results from a two-year, phase III trial in 1,088 people with relapsing MS (the TEMSO trial), comparing two doses against placebo, showed that both doses significantly reduced the rate of MS relapses by up to 31.5% relative to placebo, and the higher dose was found to reduce the risk of disability progression by 29.8% compared to placebo. MRI scanning showed reduced risk of new MS lesions and reduced disease activity.

The most common side effects were nausea, diarrhea, mildly elevated liver enzymes, and thinning hair. Additional trials of teriflunomide are underway.

- NMSS and the MS Society of Canada committed more than $2.4 million to support seven grants on chronic cerebrospinal venous insufficiency (CCSVI) to determine its role in the MS disease process. The applications underwent a rigorous expedited review process by an international review panel that included experts from all key relevant disciplines, including radiology, vascular surgery, and neurology. The studies, launched July 1, 2010, were deemed necessary because it is not known yet whether, or if so, how, CCSVI contributes to MS disease activity (www.nationalmssociety.org/ research/research-news/news-detail/ index .aspx?nid=2206).

- Results of the phase II CHOICE study, in which 230 people with relapsing MS taking interferon beta and having disease activity were administered one of two doses of daclizumab (Biogen Idec and Abbott) or placebo, were published, showing the higher dose reduced disease activity on MRI scans by 72%, and the lower dose by 25%. Phase III studies of this immune modulator are underway.

- At least two small clinical trials are currently underway—one at the University of Wisconsin, supported with funding from NMSS—testing the idea that infection with intestinal parasites may reduce immune attacks in MS. This relates to the “hygiene hypothesis,” that MS may be less common in underdeveloped regions be­cause early exposure to common infections stimulates immune responses that help offset the attack on the brain and spinal cord in MS (www.nationalmssociety.org/research/research-news/news-detail/index.aspx ?nid=3458).

- In a study of more than 5,000 people with MS, researchers identified characteristics that may help predict the rate of disease progression or worsening. Motor symptoms at onset (such as muscle stiffness, known as spasticity) and male gender were associated with a faster progression from relapsing-remitting MS to secondary-progressive MS. Investigators at the University Medical Centre in Groningen, the Netherlands; the University of British Columbia; and elsewhere were funded by NMSS, the MS Society of Canada, and others.

Toward Restoring Function

Progress was made toward finding ways to repair nervous-system damage and toward improving quality of life and specific MS symptoms through exercise, meditation, rehabilitation, and medications.

- FDA approved the marketing of Ampyra™ (dalfampridine, formerly known as fampridine SR; Acorda Therapeutics) for its ability to improve walking in people with any type of MS. This is the first therapy specifically approved to treat a symptom of MS, and it represents a big step forward for the many people who may benefit (www.nationalmssociety.org/research/research-news/news-detail/index.aspx?nid=3871).

- FDA approved the first drug specifically developed to treat uncontrollable laughing or crying, also called pseudobulbar effect, or PBA. Nuedexta™ (dextromethorphan hydrobromide and quinidine sulfate, formerly called AVP-923; Avanir Pharmaceuticals) is an oral therapy shown to significantly reduce episodes in people with MS, ALS, and other disorders (www.nationalmssociety.org/research/research-news/news-detail/index.aspx?nid=4050). 

- International consensus on the future of stem-cell transplantation research for people with MS was published, paving the way for coordinated global research efforts and potentially better and quicker patient access to stem-cell clinical trials. The guidelines, developed by an international panel of MS experts, with input from MS societies around the world, spell out hope for the future of MS stem-cell research and debunk myths about overseas stem-cell clinics claiming to cure the condition (www.nationalmssociety.org/research/research-news/news-detail/index.aspx ?nid=3161). 

- Researchers co-funded by the NMSS have identified a molecule that appears to stimulate the brain’s natural ability to repair myelin in rodents. (Myelin is the insulating coating on nerve fibers that is damaged in MS.) The finding, which needs further research to translate to human disease, resulted from a massive high-tech screening system to identify new strategies to repair nervous-system damage in MS. Collaborators at the University of Cambridge, University of Edinburgh, and others were funded by NMSS’s Promise: 2010 Nervous System Repair and Protection Initiative, the MS Society of the UK and Northern Ireland, the ARSEP Foundation, and others (www.nationalmssociety.org/news/news-detail/index.aspx?nid=4319).

- FDA cleared the way for the first human clinical trials of experimental stem-cell-based therapy aimed at healing spinal-cord injury, to be conducted by Geron Corporation. This may have future implications for MS because the cells to be tested in this small safety trial are progenitor cells from which oligodendrocytes arise. Oligodendrocytes make the insulating and nourishing myelin that wraps around nerve fibers, and these are among the cells that are damaged during the course of MS.

- A pilot clinical trial conducted by University of California- San Francisco researchers involving 60 people with all types of MS tested low-dose Naltrexone, a drug approved for treating addiction. Results suggested it may improve several measures of mental-health quality of life and pain, and that further testing in larger numbers of individuals may be warranted.

- A team at UCLA funded by NMSS found that depression is linked to brain-volume loss in specific subregions of the “hippocampus,” an area of the brain known to be important in memory. Tissue loss in this area was linked as well with abnormal secretion patterns of the stress-related hormone cortisol. The results warrant further study but are an important clue to a symptom that can interfere greatly with the quality of life of people with MS.

- The largest study of its kind showed that mindfulness-based meditation significantly improved health-related quality of life, depression, and fatigue in a study involving 150 people with relapsing-remitting and secondary-progressive MS. This controlled study by University Hospital (Basel, Switzerland) researchers shows the value of an alternative treatment and highlights the importance of focusing on quality-of-life issues to improve well-being.

Toward Ending MS Forever

Understanding factors that influence whether a person develops MS deepened last year, bringing us closer to finding ways to prevent the disease. 

- Two new studies added to evidence for a possible role for Epstein-Barr virus (EBV) in the development of MS. In one, Harvard School of Public Health investigators showed that an EBV-positive blood test preceded MS diagnosis in a large sample of MS cases identified through U.S. military databases. In another, an international team reported reactions to a specific protein associated with EBV were increased in people with MS compared with siblings who did not have MS. However, another study, from the University of Colorado Denver School of Medicine, found no evidence of EBV infection in the central nervous system of people with MS.

- Harvard School of Public Health researchers showed that two individual factors previously identified as increasing the likelihood of developing MS—exposure to Epstein-Barr virus and tobacco smoking—may interact and multiply to substantially increase the risk of developing MS in those with both risk factors. The results warrant confirmation in further studies (www.nationalmssociety.org/research/research-news/news-detail/index.aspx?nid=3100).

These and many other efforts by researchers around the world reflect the rapid pace of MS research today.

Further Steps

On January 11, 2011, the society hosted a live webcast on repairing the nervous system, in which a panel of international investigators provided the latest information concerning research on stopping MS progression, understanding the causes of damage in MS, imaging tools to track damage and repair, and treatment approaches on the horizon to repair the nervous system and restore function (www.nationalmssociety.org/news/news-detail/index.aspx?nid=4355).

Contact: www.nationalmssociety.org.

 

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