2009 saw exciting research progress, unprecedented opportunities on the horizon, and more scientists than ever working on resolving important questions. Despite the year's economic and financial challenges, the National Multiple Sclerosis Society continues to propel research forward to end MS. In 2009 the Society provided over $33.5 million to support 345 new and ongoing projects in its research portfolio, plus $1.5 million for Fast Forward, the Society's drug development subsidiary which continues to attract new funding streams. In addition, thanks to the efforts of our MS activists, $5 million was specifically allocated for funding MS research out of the 2009 Department of Defense budget.
As 2009 comes to a close, the Society maintains its nimble pursuit of promising research opportunities to end MS and has issued an international call for grant applications to expeditiously examine the potential impact of the chronic cerebrospinal venous insufficiency (CCSVI) hypothesis on disease process in MS. Working with MS Societies around the world, an international panel will be convened to conduct a joint expedited review of the grant applications submitted in order to ensure a coordinated, strategic approach to funding the best research examining the CCSVI hypothesis in 2010.
The following is just a small sample of the many important, potentially high-impact research results that occurred during 2009, which support the Society's three research goals: stopping MS, reversing the damage and restoring function, and ending MS forever.
STOPPING MS
- Several papers published this year provided more evidence that starting on MS therapies early after disease onset, or even before a definite diagnosis, can pay off later by delaying disease progression. In addition, results of clinical trials of oral therapies and therapies with infrequent dosing regimens were presented at medical meetings and in journal articles, a number of which appear to have benefit against MS attacks, and safety profiles that look acceptable.
- Novartis International AG announced that oral FTY720 (fingolimod) significantly reduced relapse rates and slowed disability progression over two years in a large-scale, phase 3 trial in relapsing-remitting MS. According to the company, safety data confirmed a positive benefit-risk profile, and the company plans to seek marketing approval at the end of calendar year 2009.
- An oral drug was submitted to the FDA for marketing approval in September 2009. In a large-scale clinical trial, cladribine tablets significantly reduced relapse rates and other disease activity in people with relapsing-remitting MS. If the FDA application is successful, it would be the first approved oral disease-modifying therapy for MS.
- Positive results were announced by sponsors of a clinical trial of the experimental IV monoclonal antibody ocrelizumab, which significantly reduced disease activity on MRI scans in a study of 220 people with relapsing-remitting MS. Since this was a phase 2 study, additional research will be needed to further determine this drug's safety and benefits.
- An international task force convened by the Society published a landmark paper in the journal Multiple Sclerosis to guide neurologists through the complex process of distinguishing MS from look-alike disorders ("differential diagnosis"). This paper was the most frequently downloaded paper from the journal's Website this year.
- Fast Forward made its first investments in promising agents. This effort to speed the delivery of new treatments to people with MS has already attracted over $20 million in new funding.
- A small NIH-supported study by Stanford University researchers found that women who breastfed their babies exclusively (without giving supplemental bottles) for at least the first two months post-partum were less likely to have an MS relapse than those who did not breastfeed or who did not breastfeed exclusively during the first two months.
- Multiple previous studies have documented that smoking cigarettes increases the risk of developing MS. Harvard researchers have now tracked hundreds of smokers, ex-smokers and never-smokers, all of whom had MS, for an average of over three years. They reported that disability progressed more quickly in smokers. In several measures, ex-smokers did not differ substantially from never-smokers, suggesting that quitting may delay MS progression. In two other separate studies, State University of New York, Buffalo researchers reported links between smoking and brain tissue damage observed on MRI scans of people with MS, and Karolinska Institute investigators in Sweden confirmed negative effects of smoking, but found no association between the use of snuff and the risk of developing MS. The latter study suggests a component of cigarettes other than nicotine is responsible for the increased risk of developing MS
- Early, small-scale trials are underway or getting started to test the potential of a special type of adult stem cell found in the bone marrow, called mesenchymal stem cells. Although these cells have the potential for both turning down MS immune attacks and stimulating nervous system repair, it's still too early to know whether this approach will prove safe and beneficial.
- To help ensure that stem cell trials are conducted in a scientifically sound way that will move the field forward, the Society convened an international meeting with our counterparts in the U.K., Italy, and France to develop guidelines for stem cell trials, which are expected to be published in 2010.
- A European collective of imaging experts known as "MAGNIMS" published new information on imaging and clinical findings that might help explain why some people experience a mild course of MS, also known as "benign" MS. They recommended that cognitive functions, not just physical functions, be taken into account when labeling a person's MS as benign.
- The first large-scale clinical ("phase II") trial of the sex hormone estriol in MS, funded by the National MS Society and especially its Southern California chapter, along with the NIH, continued to recruit women with MS to participate, expanding the number of centers to 16 across the US. The two-year trial could lay the groundwork for a larger, definitive trial that could lead to a new treatment option for women with MS.
REVERSING MS DAMAGE/RESTORING FUNCTION