treatment

The Multiple Sclerosis Society of Canada — with input from both experts and patients — has developed a "wellness toolbox" with strategies to help multiple sclerosis (MS) patients cope with their disease. Wellness is becoming a big area of research, particularly in patients with chronic diseases such as MS. With an estimated 291 cases per 100,000 inhabitants in 2013, according to the Multiple Sclerosis International Foundation, Canada has the world's highest incidence of MS. While pharmaceutical and scientific research are advancing in the therapeutic area, studies are also underway to determine the contribution of wellness factors such as nutrition, physical activity and emotional well-being -- to quality of life for MS patients. With that in mind, the Toronto-based MS Society of Canada conducted a Wellness Survey, which led to the launch of the Hermès Canada | MS Society Wellness Research Innovation Grant. These grants are awarded to scientists conducting research on MS and wellness factors. The University of Saskatchewan, which received one such grant in 2016, investigated the effect of Pilates in people with MS. The study recruited 30 MS patients. Half took Pilates classes twice a week and massage therapy once a week, while the other half only did once-a-week massage therapy. Results showed that patients who took Pilates classes saw an improvement in their overall condition, compared to patients in the control group. To create its wellness toolbox, the MS Society of Canada received input from MS patients about strategies that have helped them manage the disease and live a full life.

TG Therapeutics will discuss ublituximab's ability to deplete B-cells linked to multiple sclerosis and to reduce inflammatory brain lesions at the 7th Joint ECTRIMS–ACTRIMS Meeting in Paris next month. The three presentations will cover preliminary results of a Phase 2 clinical trial of ublituximab's safety and effectiveness as a treatment for relapsing forms of MS, the company said in a press release. The conference will be Oct. 25-28. Dr. Amy E. Lovett-Racke of Ohio State University will discuss ublituximab's ability to decrease B-cells associated with MS after six months of treatment. Ublituximab is an antibody that targets B-cells carrying the CD20 protein on their cell surfaces. These cells are thought to play a role in MS development. Dr. Matilde Inglese of the Icahn School of Medicine at Mount Sinai in New York will discuss ublituximab's ability to decrease study participants' inflammatory brain lesions. And Dr. Edward Fox of Central Texas Neurology Consultants, the trial's principal investigator, will do a poster-session presentation on the study's patient characteristics and preliminary results as a whole, including safety. The ongoing Phase 2 trial is still recruiting patients with relapsing forms of MS. Researchers are randomly assigning participants to receive intravenous infusions of either ublituximab or a placebo. One of the study’s primary goals is to see how well ublituximab depletes B-cells 28 days after the start of treatment. Another primary goal is to see how safe the therapy is, with the measurement being treatment-related adverse events that patients experience over six months. Ublituximab’s ability to reduce relapses will be a secondary measure of the trial. Researchers will assess it after 48 weeks of treatment. Fox, who is the director of the Multiple Sclerosis Clinic of Central Texas, and a clinical assistant professor at the University of Texas Medical Branch in Round Rock, made a ublituximab presentation at the 3rd Congress of the European Academy of Neurology in June. It revealed that the therapy nearly depleted B-cells only four weeks after treatment started. Earlier data suggests that ublituximab can be administered in only one hour. Ocrevus, the only approved MS therapy that targets B-cells with CD20, requires 3 1/2 hours. Although the Phase 2 trial is continuing, the data generated so far supports plans for two Phase 3 trials, TG Therapeutics said. They will randomize patients to receive either ublituximab or Aubagio. The trials, which the company hopes to start by the end of September, will be conducted under a Special Protocol Assessment agreement with the U.S. Food and Drug Administration. It allows the FDA to evaluate the design and population size of a trial a company intends to use to seek a drug's regulatory approval. The FDA has refused to approve therapies whose trial design it believed to be flawed. Obtaining a design sign-off before a trial improves the chance of a treatment being approved if it meets the study's objectives.

Many of you are considering making the switch to Ocrevus (ocrelizumab) as your disease-modifying therapy for multiple sclerosis. This is a switch I made recently. There are so many questions and unknowns about how this treatment might help me, and I’m trying to…

A Phase 2b trial assessing the experimental retroviral-targeting treatment GNbAC1 in patients with relapsing-remitting multiple sclerosis (RRMS) failed to meet its primary goal of reducing brain lesions and other signs of brain inflammation within six months. But researchers at GeNeuro and Servier — the two European companies that jointly developed the drug…

A substance that the pancreas secretes can promote the regeneration of the protective nerve-cell coating that is damaged in multiple sclerosis, a mouse study shows. The substance is fibroblast growth factor 21, or FGF21. It promotes remyelination, the renewal of the myelin sheath protecting the central nervous system, according to the…

The European Commission has approved Merck KGaA’s Mavenclad (cladribine tablets) to treat highly active relapsing forms of multiple sclerosis (MS). The Aug. 25 decision in Brussels marks the first approval of a highly efficient oral short course therapy for MS in Europe. Mavenclad has been shown to harness disease activity for…

Alkermes is funding a Phase 3 clinical trial evaluating the effects of its ALKS 8700 therapy on the gastrointestinal tracts of relapsing-remitting multiple sclerosis (RRMS) patients, compared to Tecfidera (dimethyl fumarate), according to a news release by the National Multiple Sclerosis Society. ALKS 8700, an orally administrated form of monomethyl fumarate, is still…

Topas Therapeutics and Eli Lilly and Company are teaming up to develop compounds that could be used to treat inflammatory and autoimmune diseases, such as multiple sclerosis and diabetes. The compounds, based on a Topas technology platform, will be aimed at restoring immune tolerance. Immune tolerance refers to the immune system being unresponsive to certain antigens — for instance, the body’s own proteins. Without immune tolerance, the body can generate an excessive immune response that prompts the immune system to attack healthy organs or tissue — a process called autoimmunity Under the multiyear agreement, Topas will receive research and development funding. It will also receive financial rewards from the success of any drug developed under the collaboration. The agreement will give Lilly the option to license all therapies created under the collaboration, and to develop them further. "We are excited to be working with Lilly to generate drug candidates using our proprietary technology," Timm Jessen, the CEO of Topas Therapeutics, said in a press release. "We expect this work to support the value of our approach" of triggering immune tolerance against antigens, he said. The fact that an important pharmaceutical company like Lilly is interested "in our technology, we believe, supports the strong commercial potential of our work." Topas develops compounds against autoimmune reactions — that is, situations in which the immune system attacks healthy parts of the body. It is already developing treatments for multiple sclerosis, type 1 diabetes, celiac disease, and other autoimmune disorders. While the majority of such therapies try to shut down the immune system, Topas’ approach is to trigger antigen-specific immune tolerance. This allows the body to regain control over an excessive immune response, while sparing the body's normal immunity. Topas links its compounds to tiny nanoparticles that liver sinusoidal endothelial cells can absorb. The liver cells are the first place where immune T-cells can learn what the body should not fight against. In studies of mice with multiple sclerosis, a single injection of nanoparticles containing peptides found in neurons triggered a potent protective effect, improving the disease's symptoms and blocking its progression. Peptides are components of proteins. "Lilly is committed to be an innovation leader in immunology," said Dr. Thomas F. Bumol, senior vice president of biotechnology and immunology research at Lilly. "Topas has a very novel approach to immune tolerance induction, which we would like to see successfully applied to certain disease-relevant antigens. We look forward to working together with Topas on their unique platform."

Merck’s Mavenclad tablets significantly improve quality of life among relapsing multiple sclerosis patients while reducing the number of relapses, according to new analyses of previously unpublished data from clinical trials assessing the drug. This new data, published in the Multiple Sclerosis Journal, come just as the European Commission ponders whether to approve the once- rejected therapy to treat relapsing forms of MS. Its decision is expected later this month, seven years after a perceived increased of cancer risk led the European Medicines Agency (EMA) to block Mavenclad. In 2011, the U.S. Food and Drug Administration (FDA) rejected the medication, forcing its eventual withdrawal from the Australian and Russian markets, where it had already been licensed. For the study, researchers at Queen Mary University of London used data obtained from the EMA through a Freedom of Information request. They analyzed data from the Phase 3 CLARITY trial, which compared Mavenclad to placebo. The trial's 1,326 participants completed a quality-of-life questionnaire that focused on disease aspects such as mobility, self-care, usual activities, pain or discomfort, and anxiety. After two years, those on Mavenclad had significantly improved their quality of life compared to the control group, particularly in terms of self-care. Mavenclad also helped mobility, which might be related to its ability to prevent relapses and delay progression, researchers said. While researchers assessed quality of life using two different questionnaires, patients had only completed one in sufficient numbers to allow for a solid analysis. The other quality-of-life tool provided researchers with numerically positive results, but the low number of responses made the result difficult to interpret. This wasn't the first time QMUL researchers have contributed in this way to knowledge of Mavenclad in MS. In 2015, they used a Freedom of Information request to obtain data showing that Mavenclad was not related to increased cancer risk. “Cladribine seemed to have such excellent potential as a treatment for MS that we thought it was tragic the development program was shelved, and significant parts of the clinical trial data remained unpublished,” study leader Klaus Schmierer, a neurologist at both QMUL and Barts Health NHS Trust, said in a press release. “In addition to the drug being highly effective, well tolerated and safe as far as short-term studies can show, we now know it also improves patients’ quality of life. The new results seemed so clear, we felt it was extremely important to publish and share these data." Mavenclad has now been studied in some 2,700 patients with relapsing MS in the Phase 3 trials CLARITY, CLARITY EXTENSION, and ORACLE-MS, as well as the Phase 2 ONWARD trial, and the ongoing long-term study PREMIERE. The treatment differs from most other oral MS therapies in that a short treatment course — a maximum 20 days — triggered effects that were upheld for two years. Studies of Mavenclad’s mechanisms suggest the drug gets such results by resetting the immune system. In June 2017, the EMA's Committee for Medicinal Products for Human Use urged the European Commission to approve Mavenclad. Merck also plans to seek U.S. approval for its therapy and is now in talks with the FDA about Mavenclad's future.

Older Immunosuppressants May Increase MS Patients’ Cancer Risk, Study Reports We’re talking about some pretty harsh immunosuppressant drugs here: azathioprine, mitoxantrone, and possibly cyclophosphamide. Unlike newer drugs, targeted to specific cells, these knocked out an entire spectrum of immune cells when they were administered. If you’ve used…

of the neurons.

The state where I live has legalized medical marijuana (MMJ) and it’s getting ready to open state-licensed marijuana dispensaries. So, I’ve been thinking about using MMJ to treat some of my MS symptoms. How can MMJ help MS patients? A 2012 study by researchers at the University…

I stood at the front door of my house and could only shake my head as I watched the backhoe digging a deep trench in my yard. A sewer line malfunction created a mess in my basement and it turned out to be a broken clay pipe in…

Health Canada has approved Ocrevus for the treatment of adults with relapsing-remitting multiple sclerosis (RRMS) with active disease, Roche Canada announced. The approval followed the positive results from the Phase 3 OPERA studies, which evaluated the safety and efficacy of Ocrevus in 825 patients with RRMS. The OPERA 1 and OPERA 2 trials showed that Ocrevus significantly reduced disease activity and disability progression of RRMS patients, with annual relapse rates falling by almost half. Moreover, Ocrevus outperformed Rebif, the standard of care in MS, in slowing worsening of disability and significantly reducing lesions seen on MRI scans over a two-year treatment period. "Ocrevus is a major addition to the treatment options available for MS. The RRMS Ocrevus clinical trial data show a significant reduction in relapses and disease progression, as well as a good safety profile," Daniel Selchen, a neurologist and head of the Division of Neurology at St. Michael's Hospital in Toronto, said in a press release. "For appropriate patients, Ocrevus will be of great value in reducing the burden of MS." The treatment's approval, however, did not extend to — or mention — people with primary progressive MS, in contrast to the U.S. Food and Drug Administration's action in March, which approved Ocrevus for both MS forms. Health Canada did not give address PPMS in its announcement. Estimates are that 100,000 Canadians are currently living with MS, and most have the relapsing form. A number welcomed Ocrevus' arrival for what it offers in their fight against this disease.

The risk of people with multiple sclerosis developing cancer is higher if they have used immunosuppressants than if they haven’t, according to a study that followed more than 1,000 patients for a decade. The findings indicate that the often discussed association between MS and cancer may stem from older types of…

I was surprised to see that a study of a potential MS drug labeled MD1003 is still accepting participants. It’s a study that I’d love to take part in, if only I was a few years younger. MD1003 is a high dose of biotin, a form of…

A patient satisfaction evaluation of three autoinjector devices for delivering multiple sclerosis treatments found that Bayer’s electronic autoinjector Betaconnect was the choice of 57 percent of the 85 people who took part in the study. Higher satisfaction with an autoinjector can lead to better adherence, or patients sticking with treatment,…

Atara Biotherapeutics recently published an update of the company’s quarterly financial results and operational highlights, including the advancement of its T-cell based immunotherapy strategies for multiple sclerosis (MS) and cancer. One of the investigational therapies featured in the report is ATA188, a potential treatment for MS.

A bacteria present in the gut, called Prevotella histicola, prevented multiple sclerosis from developing in a preclinical mouse model, found researchers at the Mayo Clinic in Rochester, Minnesota, along with colleagues at the University of Iowa. Current research suggests that alterations to the gut microbiome residing in human intestines may potentially trigger inflammatory diseases such as MS. In an attempt to identify which gut resident bacteria are capable of modulating immune responses, researchers studied cultured small pieces of intestine tissue extracted from biopsies of patients with celiac disease. The team then isolated three bacteria strains and found that one of species — P. histicola — had the capacity to suppress MS in a preclinical animal model of the disease. “This is an early discovery but an avenue that bears further study," Dr. Joseph Murray, a Mayo Clinic gastroenterologist and the study's lead author, said in a press release. "If we can use the microbes already in the human body to treat human disease beyond the gut itself, we may be onto a new era of medicine. We are talking about bugs as drugs." By investigating how P. histicola modulated immune responses to suppress MS, researchers found that bacteria decreased the expression of two pro-inflammatory cytokines – interferon-gamma and interleukin (IL)-17. Overall results show that P. histicola has immune modulatory activity and can suppress abnormal immune responses, which ultimately prevent autoimmunity. This supports the idea that maintaining a healthy microbial community within our intestines is a potential therapeutic strategy for MS. "Our work is a classic example of a bedside-to-bench and potentially back to bedside study. Recent MS microbiome studies have shown the lack of Prevotella genus in patients with the disease and an increase when patients were treated with disease-modifying drugs," said Ashutosh Mangalam, the study's first author and an assistant professor of pathology at University of Iowa's Carver College of Medicine. "And it's not just for MS, because this may have a similar modulating effect on other nervous system and autoimmune diseases."

Insurance companies want people to use generics, rather than the more expensive brand-name drugs, right? Maybe not. Because, at least in some cases, they’re doing just the opposite. Some patients are being forced to use brand-name drugs even when those drugs have generic equivalents. Not surprisingly, that means…

Spasticity in multiple sclerosis patients can be eased through a combination of botulinum toxin type A (BoNT-A) injections and rehabilitation. However, caregiver support is required to keep patients on this treatment, according to results of a retrospective analysis. Spasticity, a muscle control disorder characterized by tight or stiff muscles, is a major MS symptom. The condition is significantly detrimental to patients’ quality of life, affecting their general mobility and balance. Several oral anti-spasticity drugs are available. However, “treatment of spasticity in MS is frequently challenging because of the complex clinical picture and the undesired effects associated with oral therapy, such as fatigue, dizziness, and hypotension,” the researchers wrote. Previous studies show that BoNT-A, a toxin that blocks nerve activity in muscles, is an effective therapy for the management of MS-related spasticity. The long-term effectiveness and persistence of BoNT-A use in patients with MS-related spasticity, however, remains poorly investigated. The research team in Italy proposed “to investigate the long-term persistence to treatment with BoNT-A for MS-related spasticity and the determinants of BoNT-A discontinuation in daily clinical setting.” In total, the researchers reviewed data from 185 patients, out of which 121 were considered in their final analysis. They observed that, at the end of the follow-up period, 44% of the patients in the analysis were still being treated with BoNT-A, but 56% had discontinued treatment. Overall, these results “confirm the beneficial effect of combining BoNT-A injections with rehabilitation and highlights the crucial role of caregivers for achieving better long-term outcomes in people with MS suffering from spasticity,” the team concluded.

Advancells says its stem cell-based therapy completely reversed multiple sclerosis (MS) in an Indian pilot trial with only one MS patient. The patient, Rahul Gupta, was diagnosed with MS seven years ago and has since suffered multiple relapses. His disease was progressing fast and he was quickly losing his ability…

TG Therapeutics and the U.S. Food and Drug Administration (FDA) have agreed on a special protocol assessment for a Phase 3 trial program evaluating TG-1101 (ublituximab) to potentially treat relapsing forms of multiple sclerosis (MS). A special protocol assessment (SPA) is a procedure by which the agency officially evaluates the…

I regularly see comments on various social media sites from MS patients who have traveled, or who plan to travel, outside the U.S. to be treated with stem cells. Some of these patients have reported excellent results and a reversal of symptoms. Others have died. Many MS patients…

Two compounds found in sunscreens suppressed multiple sclerosis symptoms in mice, a study shows. The substances, known as salate derivatives, belong to a class of compounds called nonsteroidal anti-inflammatory drugs. Evidence from the 1970s suggested that higher vitamin D levels from getting more sunlight could reduce the rate of MS. Subsequent studies indicated this was unlikely, however. Researchers who noticed that ultraviolet light suppresses MS in mice hypothesized that this could be the reason for the reduced prevalence of the disease in tropical areas. University of Wisconsin researchers wondered if sunscreen would prevent ultraviolet light from suppressing MS in mice. The team, led by Dr. Hector F. DeLuca, an emeritus professor in the university's Department of Biochemistry, chose six commercially available sunscreens, then exposed the mice to UV radiation. Confirming previous findings, they observed that UV radiation decreased the severity of MS. But, unexpectedly, they discovered that when mice were not receiving ultraviolet light, some of the sunblocks suppressed their MS for up to 30 days anyway. An analysis revealed that the salate derivatives homosalate and octisalate were the sunscreen components responsible for suppressing MS. The two are esters of salicylic acid, a common medication for acne, psoriasis, warts, and dandruff. Further analysis showed that homosalate was able to suppress MS by itself, but octisalate needed to be combined with homosalate to achieve significant results. The team also discovered that the salates' effectiveness depended on the dose. The more that homosalate was applied, the better the result, they said. The only adverse effect of homosalate and octisalate was temporary skin irritation. The study indicated that salate esters' ability to suppress MS is not due to their sunblocking ability per se, because some of the sunscreen brands that did a good job of blocking sunlight did not suppress the disease. Salate derivatives are well-known inhibitors of the enzyme cyclooxygenase, or COX. Because COX-2 has been found in MS lesions, salate derivatives might improve MS by suppressing COX, the researchers said. Overall, “salates may be useful in stopping the progression of MS, and may provide new insight into mechanisms of controlling autoimmune disease,” the researchers concluded.

Resistance training like weight lifting can protect or even regenerate the nerve cells of relapsing-remitting multiple sclerosis patients, slowing the progression of the disease, according to a clinical trial. A hallmark of MS is the brain shrinking faster than normal, and findings from this trial indicates that resistance training can slow the shrinking or even make some brain areas grow. Research has shown that physical training benefits MS patients, helping them alleviate many symptoms, including excessive fatigue and balance control problems. Recent studies suggest that exercise can have a disease-modifying role in MS. This means physical activity can be an important adjuvant, or add-on therapy, for standard-of-care regimens. Researchers followed 35 patients with relapsing-remitting MS for 24 weeks. Eighteen patients did resistance training twice a week, consisting of four lower- and two upper-body exercises. The other 17 patients struck with their normal routines. Before and after the 24 weeks, doctors took magnetic resonance imaging scans, or MRIs, to evaluate patients' brain structures. After the 24 weeks, the scans showed less brain shrinkage in those who had resistance training. Some of their cortical brain regions were also thicker — an indication they were growing. It is not clear why exercise benefits MS patients' brains, nor if exercise has the same effect on all patients. Additional studies are needed to clarify its therapeutic effect, the researchers said. That knowledge could help improve current MS therapies.

Twenty-four people have now received the multiple sclerosis and psoriasis therapy KY1005 in a Phase 1 clinical trial, according to its developer, Kymab. The Cambridge, England, company creates human antibody drugs for autoimmune diseases. The trial will focus on KY1005 as a psoriasis therapy, although its mechanism of action should work…

What does your neurologist consider when he or she is deciding how best to treat your multiple sclerosis? A recent report from Spherix Global Insights, a business intelligence and market research company that looks at drug trends every quarter, sheds some light on that. In my…

Long-term Tysabri (natalizumab) treatment of relapsing multiple sclerosis (RMS) improves physical and mental health and leads to greater satisfaction with therapy, new research shows. The study, ”Long-term natalizumab treatment is associated with sustained improvements in quality of life in patients with multiple sclerosis,” appeared in the journal…

Abarca Health has signed a value-based reimbursement contract with Biogen for select products in its multiple sclerosis (MS) portfolio. This is the first time such an agreement applies outcomes-based contracts to cover Medicaid patients in the United States. The deal offers a novel approach to connecting outcomes with the…