Progress in 2015 Toward Stopping MS, Restoring What’s Been Lost, and Ending MS Forever
December 10, 2015
Important research progress occurred in 2015, offering new leads toward our vision of a world free of MS. The Society mobilizes people and resources so that everyone affected by MS can live their best lives as we stop MS in its tracks, restore what has been lost and end MS forever. We continue to pursue all promising paths to uncover solutions, wherever those opportunities exist, with special focus on progressive MS, nervous system repair, lifestyle/wellness and genes/environment.
The results of previous Society investments continue to mount, and we are committed to growing our research funding even further. In 2015 the Society invested over $53 million in 380 new and ongoing research projects and initiatives. Here is a brief summary of significant 2015 research progress and initiatives, including links to details.
Focus Area - Progressive MS:
- Positive results were reported from three phase 3 trials of an experimental therapy called ocrelizumab (Genentech, a member of the Roche Group), showing positive impacts in relapsing MS and, for the first time in a large-scale trial, a modest impact in primary progressive MS.
- The Society collaborated to convene a scientific workshop to set research priorities for understanding how co-morbidities (other medical conditions) impact MS severity and clinical trial outcomes, and to explore implications for program development. Finding solutions to address co-morbidities may slow down progression, increase lifespan and quality of life of people with MS.
- A new study uncovered a gene variation linked to response to MS therapy, which may open new treatment approaches with further research toward the important goal of personalized medicine in MS.
- The first generic version of daily Copaxone® (glatiramer acetate), branded “Glatopa” (by Sandoz, a Novartis company, developed in collaboration with Momenta Pharmaceuticals), was approved by the FDA and distribution began by Sandoz in June. Additional generics of this therapy are expected soon.
- Scientists at the University of Virginia uncovered evidence of a previously unrecognized network of vessels that facilitate immune system activity in the brain. The team showed evidence of this network of “lymphatic vessels,” in both mice and people. Further research is needed to understand how and whether lymphatic vessels play a role in MS, and whether they present new opportunities for stopping MS disease activity.
- Results were published from a Phase 3 Trial of daclizumab high-yield process (Zinbryta™) in relapsing MS, showing it could significantly reduce relapse rates and disease activity observed on MRI scans over the course of 2 to 3 years. (Biogen and AbbVie have applied to regulatory agencies in the U.S. and Europe to obtain marketing approval to treat people with MS.)
- The 2015 John Dystel Prize for MS Research went to Prof. Alastair Compston (University of Cambridge) for driving breakthroughs in therapeutic immunology and genetics.
RESTORE AND REPAIR
- A clinical trial co-funded by the Society of a repurposed oral epilepsy therapy called phenytoin showed promise for protecting the nervous system. Neuroprotection is a leading strategy for slowing down or stopping progression.
- While disappointing results were announced from major trials of Tysabri (natalizumab) in secondary progressive MS and Gilenya (fingolimod) in primary progressive MS, learnings from these trials have advanced our understanding of the processes that lead to progression and will inform future clinical trial designs.
- A study found that MS progressed faster in those who continue to smoke cigarettes compared to those who quit after an MS diagnosis. This may be explained in part by a Society-funded study showing that mice exposed to smoke showed increased inflammation and oxidative stress.
- The MS Outcome Assessments Consortium had its 3rd annual meeting with the FDA, and added new clinical trials data and partners in this global effort to develop a tool that will provide a sensitive way to detect the benefit of potential treatments that slow or reverse MS progression.
- The International Progressive MS Alliance held a scientific meeting on MS pathophysiology, funded 11 new collaborative network planning grants, and has grown to 14 member societies and pharmaceutical participation through the Industry Forum.
Focus Area - Lifestyle/Wellness:
- Promising results were reported from a phase 2 clinical trial of the leading myelin repair strategy called anti-LINGO (Biogen). The agent was given by monthly IV infusion for 20 weeks to 82 people who had a first episode of optic neuritis (which often precedes a confirmed diagnosis of MS). Those given anti-LINGO had faster nerve signals – thought to be an indicator of myelin repair – along the optic nerve compared to those on placebo.
- The Society collaborated to convene the International Conference on Cell-Based Therapies for Multiple Sclerosis in Lisbon in November 2015, gathering more than 70 experts to discuss the state of cell therapy and possible next steps to drive comprehensive research and collaborations, and to develop clinical trial designs to provide timely answers to the question of which cells and approaches show most promise for treating people with MS.
- Researchers funded by the Society discovered novel stem cells residing in the brain, and found a way to stimulate the cells to repair myelin in mice with an MS-like disease. The Society, through Fast Forward, has partnered with the team to develop a potential therapy for MS based on these findings.
- Results were reported from a series of individuals with MS treated experimentally with immune-suppressing therapy followed by transplantation of blood stem cells (also known as HSCT), aiming to “reboot” the immune system. Improvements were reported in disability scores and reduced disease activity in some with relapsing MS with disease durations of 10 or fewer years, but not in those with secondary progressive MS or people with greater disease duration. Controlled trials are needed to understand the full benefits and risks, and at least one is underway. Read more about stem cells and MS
- Canbex Therapeutics leveraged Society seed funds (through Fast Forward) to attract financing for a phase 2 clinical trial of a potential therapy for MS-associated spasticity.
- Drs. Laura Balcer, Peter Calabresi and Elliot Frohman won the 2015 Barancik Prize for Innovation in MS Research for producing ground-breaking research focused on the anatomy and biology of the retina and other structures of the eye in people with MS, and applying optical coherence tomography (OCT), a common and easy-to-use eye scanning technique, to study MS and to potentially speed clinical trials.
ENDING MS FOREVER
Focus Area - Genes/Environment:
- Two telephone-delivered interventions succeeded in reducing fatigue, pain, and depression in a study of 163 people with MS, yielding new information on success that can be achieved through the use of telecommunication and information technologies to provide health care at a distance. These types of innovative strategies are being explored by the Society to ensure that people with MS have access to comprehensive, high quality health care.
- A collaborative team performed a small study exploring the potential benefits of exercise on cognition and to find the best design for a larger clinical trial; this study is now ongoing with Society support, testing whether aerobic exercise, or stretching and toning, can improve thinking speed in people with MS with mild cognitive changes.
- The Society convened experts in October to help establish priorities in wellness research related to diet, physical activity and emotional health, as part of the larger Wellness Initiative.
Focus Area - Lifestyle/Wellness:
- Researchers at McGill University reported that people with gene variations linked to low vitamin D had double the chance of getting MS, confirming previous links between vitamin D and the risk of MS. Trials are underway to determine whether taking vitamin D supplements can help treat MS in people who already have the disease.
- The Society-funded expansion of the Pediatric MS Network to 12 centers with the addition of 3 new sites to enhance research capacity. Leveraging Society support, the Network is engaged in research to better understand the cause(s) of MS, how best to treat children with MS, and clues for preventing the disease for everyone at risk.
- Australian researchers reported that previous infection with Helicobacter pylori (which has been linked to stomach ulcers) was associated with a lower risk of developing MS in women, and less severe disability among those women who developed the disease. More research is needed to determine if this association means that H. pylori itself can trigger MS.
- Researchers co-funded by the Society reported that higher levels of the internal-clock hormone melatonin were linked with lower relapse rates in people living with MS. While there is still not enough evidence to recommend supplementation with melatonin, this observation helps to explain some of the seasonal variation in MS symptoms and could lead to new strategies for treatment.
- The MS Microbiome Consortium reported early findings from an analysis of blood and stool samples from people with MS treated with glatiramer acetate, untreated individuals, and people without MS. Results showed differences in gut bacteria between these groups. The team has a new Society Collaborative MS Research Center Award to pursue this and other promising research.
- A team from Germany reported that short-chain fatty acids in the diet promote the development of immune cells that can regulate the attack on the brain and spinal cord in an MS-like disease in mice, but only in the presence of gut bacteria. These findings lend evidence to the potential importance of diet in MS and opens new possibilities for developing diet-based treatments to help manage MS.
- Society-supported researchers found that MS-like disease in mice responded differently to a high salt diet, depending on their genetic makeup and gender, offering a clue to understanding whether reducing salt can inhibit MS immune attacks.
- Results from two lab studies in the U.S. and Europe suggested that high levels of salt shift the balance of the immune system toward inflammation, and that salt alters the function of several types of immune cells pertinent to MS. The U.S. team is conducting a pilot clinical trial to explore the impact of high- and low-salt diets on MS disease activity.
Together, we are changing the pace of MS research progress and accelerating life-changing impact for everyone living with MS.
Copaxone is a registered trademark of Teva Pharmaceutical Industries Ltd.
Zinbryta is a trademark of Biogen