- Current Research at the Multiple Sclerosis Center
- Groundbreaking clinical trial
- New MS Treatments: How Close Are We to a Cure?
The work, of course, is not done. This spring, Dr. Kraft will present research on new diagnostic approaches that will help doctors pinpoint which type of MS a patient has, suggesting which course of treatment to pursue. And, more rounds of trials will take place, each bringing the world one step closer to life-changing treatments.
One grace-note to the story came, not at the end, but shortly after Dr. Kraft presented the early results in He was invited to give a lecture at Fred Hutch. The lecture hall was bustling with scientists.
Yet, the first row of chairs were empty, except for one curious audience member: Dr. Donnall Thomas, the University of Washington researcher whose groundbreaking bone marrow transplant procedure became a model for new treatments of MS. It was a satisfying moment, capped by a pleasant conversation with Dr. Reflecting on his entire journey, however, Dr. Kraft goes all the way back to the beginning. The most consistent motivator has been curiosity and the pleasure of learning how the world works. As a child, I enjoyed taking things apart to understand them. As an adult, I am very intrigued by how disease works, and how understanding those mechanisms can help us diagnose a disease, treat it, and make a difference in the life of a patient.
Pioneering Progress. And yet, even Dr. Kraft looks up at the stars. In order for these research projects to have the greatest impact, we need to run quick and efficient clinical trials to test potential treatments. Recruitment has now been completed at our Cambridge and Edinburgh centres for a phase 2 trial to see if a drug called bexarotene can boost myelin repair. Although the trial only involves people with relapsing MS, a myelin repair treatment could help everyone with MS. Results telling us whether it has the potential to be the first myelin repair treatment for MS are due next year.
If it does, it could become one of the first disease modifying therapies for people with secondary progressive MS. Researchers at Queen Mary University of London are investigating whether ocrelizumab can help people with primary progressive MS retain the use of their hands.http://leondumoulin.nl/language/from/forfeit.php
Current Research at the Multiple Sclerosis Center
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Meanwhile, a December study published in The Lancet reported that the over-the-counter medication clemastine fumarate showed evidence of promoting remyelination, which is the restoring of the myelin sheath that covers central nervous system CNS cells and supports their function. This effect was seen in 50 patients with RMS who were experiencing chronic demyelinating optic neuropathy while on immuno-modulating therapy.
In other cases, medications with promising data may face delays as they navigate the regulatory process. Ozanimod belongs to a class of drugs called S1P receptor modulators, which essentially trap immune cells in the lymph nodes so that they cannot enter the CNS and create lesions. In response, Celgene expressed its confidence in ozanimod and said it would work with the FDA to address outstanding items. Exciting work is also being done in examining whether medications long used to treat other conditions — including antibiotics and the anti-epilepsy agent phenytoin — may have re-purposed roles in treating MS.
Stem cell and genetic research is advancing as well, and there is an increasing and intriguing focus on how diet and the gut microbiome bacteria — or immunologic milieu of the gastrointestinal tract — affect MS and its treatment. Finally, two growing areas of research are outgrowths of the progress made over the past two decades in offering people with MS a variety of therapies.
This is key to helping physicians and patients make the best possible decision about treatments. The second area examines the long-term safety of disease-modifying therapies.
Groundbreaking clinical trial
These provide critical information on medications that tens of thousands of patients may now be taking for 10 or even 20 years or longer. Keeping up with the vast array of medications, techniques, and new areas of inquiry in MS is challenging, and at times can be overwhelming to healthcare professionals, patients, and family members alike. Of all the challenges we face in MS, having too many advancements is perhaps the most-welcomed one! We hope this MS Research Update serves as a useful guide to many of the highlights as well as the hurdles facing our field, and provides insight into the many steps needed to investigate and prove that a new treatment strategy is both safe and effective.
In reporting on recent research, this publication describes clinical trials involving numerous participants. It is important to remember that those study populations are made up of individual men and women who each made the decision to participate in a trial. By making this decision, a person chooses to take an active role in furthering our understanding of MS and its treatment, to the potential benefit not only of herself or himself, but of all people with multiple sclerosis.
We encourage interested readers to ask their providers about possible opportunities to contribute to MS research. The more diverse populations that enroll in clinical trials, the more meaningful are the results. We open this MS Research Update with this note of gratitude to all the individuals with MS who made these trials possible. For more information about participating in clinical trials for the treatment of MS and its symptoms, readers may visit mymsaa. MSAA does not endorse or recommend any specific products or therapies.
Readers are advised to consult their physician before making any changes to their medication, diet, exercise, or other treatment regimen. This initial phase of testing in humans is done in a small number of healthy volunteers, and is designed to determine what happens to the drug in the human body — how it is absorbed, metabolized, and excreted. Once a drug has been shown to be safe, it must be tested for efficacy. This second phase of testing may last from several months to two years, and involve up to several hundred patients.
In a Phase III study, a drug is usually tested in several hundred to several thousand patients, usually in multiple medical facilities around the world. Phase III studies typically last two or more years. Phase IV clinical trials are conducted after a drug has been approved. Participants are enrolled to further monitor safety and side effects, while evaluating long-term efficacy. Please note that not all of the approved treatments for MS have been included in this section. For a full listing, please see this chart giving an overview of the approved DMTs.
Antibodies are proteins that are produced by the immune system in response to a foreign substance, to help protect the body from infection and disease. Monoclonal antibodies are derived from a single antibody cell and are identical to that single cell cloned and then replicated.
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They are produced from animal tissue, most commonly laboratory mice. Humanized monoclonal antibodies are antibodies from non-human species, again commonly a mouse, whose protein sequences have been modified to increase their similarity to antibodies produced naturally in humans. Monoclonal antibodies can be extremely powerful and effective, as they can be specifically directed toward a certain part of a system while leaving the other parts of the system untouched.
This can be very desirable when trying to impact a structure as complex as the immune system. Several other monoclonal antibodies have shown promise in MS, and three of these are reviewed in this section. Several investigational oral medications that are currently under study, work in a manner similar to Gilenya in that they also trap the immune cells in the lymph nodes so that they cannot get into the CNS to create lesions. It is hoped that these agents, which include siponimod BAF , ozanimod RPC , and ponesimod, will maintain or potentially improve on the efficacy and safety of Gilenya.
However, researchers continue to remain vigilant with regard to risks, including cardiovascular side effects such as bradycardia slowed heart rate and infections. The earlier listing of approved and experimental drugs is only a fraction of the many treatments currently being studied.
New MS Treatments: How Close Are We to a Cure?
Some of the following are among the most exciting potential therapies under investigation. These very brief snapshots of highly technical concepts will warrant more in-depth explanations in the future, if early clinical trials are encouraging. Although it may seem counterintuitive for the body to create a protein with this function, in a healthy individual it performs an important job. It has been shown to promote spinal cord remyelination and axonal integrity in the animal model of MS EAE.