News

Merck Extension Study Confirms Mavencladā€™s Long-term Benefits in Relapsing MS Patients

Three-fourths of relapsing multiple sclerosis patients who took two short courses of Mavenclad over two years remained relapse-free for four years, according to newly published data from the medication's Phase 3 extension trial. Moreover, patients who took Mavenclad during the first two years and then a placebo for the next two years fared similarly to those who took Mavenclad for the entire four-year period. The European Commission on Aug. 25 approved Mavenclad ā€” developed by Merck KGaA (known as EMD in North America) ā€” to treat relapsing forms of MS in Europe. It based that approval on data from the Phase 3 CLARITY, CLARITY EXTENSION, and ORACLE-MS trials, as well as the Phase 2 ONWARD trial, and the ongoing long-term PREMIERE study. Besides showing the long-term impact of two short courses of Mavenclad ā€” patients took tablets for a maximum of 20 days over two years ā€” this latest study showed that continuing treatment into the third or fourth year offered no additional benefits. This finding supports Merckā€™s earlier studies, which suggested that Mavenclad resets the immune system. This is a stark contrast in treatment approach to most approved MS drugs which work by suppressing either T- or B- immune cells over the long term. Researchers also deemed safety to be similar in the two groups. Most adverse events were mild or moderate, and most patients who had their B-cells and T-cells depleted in the first part of the study had normal, or nearly normal, levels at the end of the extension. Shingles were most common in patients who received the highest cumulative dose of the drug, affecting 4.8 percent of participants. But in the remaining treatment groups, rates of the viral infection were similar at 1.1 to 2 percent, researchers said. Besides Merck's own studies, an independent study recently demonstrated that Mavenclad also improves patientsā€™ quality of life. As such, the company plans to file regulatory approval for Mavenclad in the United States and elsewhere.

#MSParis2017 – Gilenya Reduces Relapses in Children and Adolescents with MS, Novartis Trial Shows

Gilenya decreased relapses in children and adolescents with multiple sclerosis in the phase 3 PARADIGMS trial, according to the therapy's developer, Novartis. The Swiss company will present the trial's results at the 7th Joint ECTRIMS-ACTRIMS meeting, set for Oct. 25-28 in Paris. The study addressed the safety and efficacy of an oral, once-daily dose of Gilenya in 215 MS patients aged 10 to 17. Participants received 0.5 mg or 0.25 mg of Gilenya, according to their body weight, and results were compared with those of intramuscular Avonex (interferon beta-1a given once weekly). The trial ā€” conducted at 87 sites in 25 countries ā€” was designed in partnership with the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA) and the International Pediatric Multiple Sclerosis Study Group. Gilenya led to a "clinically meaningful decrease in the number of relapses" over a period of up to two years, compared to Avonex, according to the trial. The safety results of Gilenya matched those observed in previous trials, with adverse events more likely among the Avonex group. Importantly, the PARADIGMS trial is the first-ever randomized, controlled Phase 3 study of a disease-modifying therapy in pediatric MS. No treatment is currently available for children and adolescents with MS. Novartis will now complete a thorough evaluation of the results and later submit Gilenya for approval by regulatory agencies. It will also extend the study to a five-year period.

MS Society of Canada Creates ‘Wellness Toolbox’ to Help Patients Manage Their Disease

The Multiple Sclerosis Society of Canada ā€” with input from both experts and patients ā€” 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 HermĆØs 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.

#MSParis2017 – TG Therapeutics to Discuss Ublituximab’s Effectiveness at ECTRIMSā€“ACTRIMS Meeting in Paris

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 ECTRIMSā€“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 studyā€™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. Ublituximabā€™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.

Retroviral RRMS Treatment GNbAC1 Fails Phase 2 Trial, But Research Continues, Say Sponsors

A Phase 2b trial assessingĀ 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 ServierĀ ā€” the two European companies thatĀ jointly developed the drug…

RRMS Patients Needed for Phase 3 Trial to Assess Adverse GI Effects of ALKS 8700 Therapy vs. Tecfidera

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

Topas and Lily Are Partnering to Develop Therapies for Autoimmune Disorders

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 ā€” for instance, the bodyā€™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 ā€” 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 ā€” 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, Topasā€™ 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."

Horseback Riding Plus Standard Care Can Help MS Patients Improve Balance, Other Symptoms

Therapeutic horseback riding, also known as hippotherapy, when combined with standard care regimens significantly reduces fatigue and spasticity in multiple sclerosis. It also improves balance and quality of life, according to a German study. Hippotherapy takes advantage of a horse's natural movements to develop a patient's muscle tone and improve breathing, while strengthening the torso muscles. Horseback riding also improves balance control, coordination and gait, while boosting a patient's social communication skills, which can benefit self-esteem. ā€œHippotherapy as a complementary treatment can be defined as one-patient-one-horse physiotherapy treatment with and on the horse,ā€ researchers wrote. Team leaders Vanessa Vermƶhlen and Petra Schiller of the University of Cologne evaluated the benefits of half-hour weekly sessions of hippotherapy in combination with standard care. They randomly assigned 70 MS patients with lower limb spasticity to either an intervention group that did 12 weeks of hippotherapy, or a control group that received only standard therapy. The team evaluated the impact therapeutic horseback riding had on balance, measured by the Berg Balance Scale (BBS). They also measured its effect on other multiple sclerosis symptoms and signs, including fatigue, quality of life, pain, and spasticity. Overall, the team found that those who received hippotherapy plus standard care improved their BBS scores by 4.8 points after six weeks of therapy, and 6.4 by the trial's end. These increases were significantly higher than those achieved by the control group (2.9 points at six weeks and 3.1 points at 12 weeks). Although this represents a difference of only 3.3 points after 12 weeks, it still reflects a relevant change in patients' balance control capabilities, the authors said. In addition, the researchers also recognized significant improvements in fatigue, spasticity and quality of life of those undergoing hippotherapy plus standard care compared to those on the control group. The observed beneficial effects of hippotherapy validate previous reports that showing that activities with horses could help adults and children improve their balance, gait and psychomotor abilities.

MS Patients Can Use Smartphone to Take Part in Novartis Study of Movement Performance and Symptoms

A multiple sclerosis study will collect information about patients' movement performance and symptoms from their smartphones, Novartis has reported. The study is aimed at evaluating in real time the daily challenges of people living with MS. The results may help researchers develop new ways to measure treatments' effectiveness, the company said. Novartis is partnering on what it has dubbed the elevateMS study with Sage Bionetworks. The non-profit research organization is developing new predictors of disease to accelerate health research. A cellphone application will allow MS patients to send information about their situation from anywhere. The app will use sensors to gather information on patients' movements. It will also assess functional performance tasks that participants engage in. Patients can also fill out questionnaires with the app. A division of Apple called the Apple ResearchKit platform developed the app. Those interested in participating in the study can download it here. The elevateMS app allows a smartphone user to register important features of their disease. It includes a symptom tracker tool that allows users to record their overall wellness. They can also get an overview of what's been happening to them on an activity dashboard. Patients, neurologists and disease advocates gave Apple's app team input that helped with the design. "As physicians, we always want to know how our patients with MS are doing on the treatments we prescribe," Dr. Stanley Cohan, medical director of the Providence Multiple Sclerosis Center in Portland, Oregon, said in a press release. "With the elevateMS app, study participants can frequently document their symptoms in a personal health story," said Cohan, one of the scientific advisors to the study. "In turn, this data may provide researchers with new ways to look at disease progression and treatment effectiveness." The elevateMS study is open to MS patients 18 years old or older in the United States who own a smartphone. Additional information about it is available at www.elevatems.org.

Nortis Awarded $688K Grant from NIH to Develop ‘Living’ Model of Blood-Brain Barrier for Research

Nortis, a Seattle-based biotech company, has received a $688,000 grant by the National Institutes of Health to create a living, 3-D model of the human blood-brain barrier that will be used for laboratory testing to accelerate drug development and lessen the likelihood of failure in clinical trials. This grant provides funding for a third year of a Small Business Innovation Research (SBIR) award given to Nortis by the National Institute of Neurological Disorders and Stroke (NINDS), a branch of the NIH. SBIR provides grants to U.S.-based small businesses to do federal research and enable the commercialization of technology. The blood-brain barrier is a tissue barrier that only allows certain molecules to pass from blood vessels into the brain. It is a protective mechanism to prevent the entry of foreign bodies and infection-causing organisms in the brain. Researchers are trying to find ways of delivering medications across this barrier, to reach brain tissues to treat diseases that include multiple sclerosis. "Understanding how drugs are transported across the blood-brain barrier and interact with the brain presents a significant scientific challenge," Thomas Neumann, CEO of Nortis and principal investigator on the project, said in a press release. "More predictive preclinical models based on human tissue are urgently needed to reduce costs and minimize clinical trial failures," he added. "This grant will help us develop new in-vitro alternatives to traditional pharmaceutical drug development testing on laboratory animals."

Researchers Identify Nerve Pathway Linking Brain Inflammation, Gut Dysfunction in MS

Chronic stress and inflammation in the brain can cause multi-organ dysfunction including severe gut failure, mediated by a newly identified nerve pathway in animal models of multiple sclerosis, a Japanese study shows. MS is an autoimmune disease caused by CD4+ T-cells that cross the blood-brain barrier protecting the central nervous system. This inflames and stresses the brain and spinal cord. In previous studies, a team led by professor Masaaki Murakami of Japan's Hokkaido University showed that these cells could cross the blood-brain barrier in specific sites. These entrance sites depend on brain regional activation, which was found to be triggered by specific nerve interactions ā€” a mechanism the team called gateway reflexes. In collaboration with other Japanese researchers and a team from Germany, the project aimed to address the potential correlation among chronic stress, brain inflammation and organ failures in MS. Using mice with MS-like disease ā€” the experimental autoimmune encephalomyelitis model ā€” researchers found that animals that had autoreactive CD4+ T-cells and which were exposed to stressful conditions developed severe symptoms such as gastrointestinal failure, or even death. Detailed analysis of the animals' brains showed that in stressed mice, CD4+ T-cells accumulated in two specific sites in the center of the brain around blood vessels. This event would cause inflammation around those vessels, and activation of a nerve pathway that is commonly turned off. This switch led to gut dysfunction, bleeding and failure. "These results demonstrate a direct link between brain micro-inflammation and fatal gastrointestinal diseases via the establishment of a new neural pathway under stress," Murakami, the study's senior author, said in a news release. Researchers were able to prevent gut symptoms by inhibiting inflammation in the brain or blocking the nerve pathway responsible for driving the signals from the brain to the gastrointestinal tract. "Micro-inflammation in the brain is also seen in Alzheimer's disease and Parkinson's disease," Murakamai concluded. "So it's of particular interest to investigate possible connections between brain micro-inflammations and organ dysfunctions, including those within the brain itself, in those patients."

Mavenclad Improves Relapsing MS Patientsā€™ Quality of Life, Independent U.K. Study Finds

Merckā€™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. ā€œCladribine 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,ā€ study leader Klaus Schmierer, a neurologist at both QMUL and Barts Health NHS Trust, said in a press release. ā€œIn 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 patientsā€™ 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 ā€” a maximum 20 days ā€” triggered effects that were upheld for two years. Studies of Mavencladā€™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.

Autoimmunity Traced to Failure of B-cell Protein, Caveolin-1, to Work as Intended in Study

A newĀ and potentially important mechanism in the development ofĀ autoimmune diseases likeĀ multiple sclerosis was discovered by scientists at the University of Freiburg, Germany. They identify aĀ protein, called Caveolin-1, that is essential to immune cells called B-cells working as intended to protect a person from pathogens or ā€” in its absence…

MS-related Death Rate in British Military Is Much Higher Than in Other Professions, Study Finds

British military personnel are at significantly higher risk of dying from multiple sclerosis than people in other occupations, a study reports. University of Southampton researchers had done a previous study of mortality rates by occupation by checking records of residents of England and Wales. They noticed that the death rate among MS patients in the armed forces was much higher than that of people in other professions over three successive decades. MS has a genetic component but is also influenced by environmental factors, including vitamin D deficiency, smoking and certain viruses. Researchers wanted to learn why so many military people die of MS, and the causes. The team looked at the death records of men aged 20-74 between 1979 and 2010. They compared military people's MS-related mortality rates and death rates from all motor neuron diseases with those of other occupations. They also compared rates across social classes, which in the military presumably means lower-ranking enlisted people, higher-ranking enlisted people, and officers. They discovered that the MS-related mortality rate among military people was significantly higher than in other professions. The death rate from MS was also significantly higher than the rate from all motor neuron diseases in the armed forces. Interestingly, military people did not have a higher MS-related death rate when the team divided those in the study into three social classes or when they compared the armed forces mortality rate to those of similar occupations, such as police and fire services. The consistency of the findings, together with the high statistical significance observed, indicated that the results were not due to simple chance or a problem with the study method, the team said. They speculated that the higher military death rate could stem from the close proximity in which military personnel live and work, which could facilitate the transmission of infections that have the potential to cause MS. The results conflicted with those of a study that analyzed hospital admissions due to MS in a population of former military personnel. It reported no increased incidence of MS-related admissions in former military people, compared with non-military controls. Since such cohort studies are less prone to bias, the Southampton team called for more research on the topic.

Twin Cities MuckFest MS, Mud- and Obstacle-filled Run for MS Society, Set for Saturday

The Twin Cities MuckFest MS is set for Saturday at the Scott County Fair in Jordan, Minnesota. All money raised in the event will go to the National Multiple Sclerosis Society to support its work in helping people living with multiple sclerosis and in advancing research toward better treatments and a cure. The MuckFest MS is a fun mud run that has raised millions for the Society, and requires no special training or equipment ā€” the only things needed, organizers says, are sneakers, a sense of humor and a willingness to get a little mucky. Participants run on a designed 5K course that features super-sized obstacles and lots of mud. A first wave of runners in the Aug. 19 event will take to the course at 9 a.m., followed by successive groups every 20 minutes throughout the day. "We muck it because ā€¦ We want to end MS," MuckFest MS proclaims on its webpage. "Even though the event is built for laughs from start to finish, weā€™re on a serious mission to advance cutting-edge research and support the life-changing work of the National MS Society." Runners are advised to wear closed-toe sneakers, and cleats of any kind are not permitted. An older of soiled choice of clothing is welcome, but should be clothes that won't restrict movement and will provide protection as runners move through the obstacles. Pants or shorts are acceptable. Many muckers, organizers say, choose to wear thin work or athletic gloves to better grip obstacles and ropes. All MuckFest MS events are held in wet muddy fields, so there is little flat terrain. They are not ADA-standard accessible, wheelchair runners will have to move through grass and dirt. The organizers, however, promise to do their best to make portions of the event accessible to people with disabilities. Participation is $105 on the day of event, plus processing fee, and those planning to register Saturday are asked to arrive by 10 a.m. Online registration is now closed. Spectators are welcome without charge. According to the MS Society, "the MuckFest MS runners and volunteers have raised over $27 million to support the life-changing work of the National MS Society" to date. "That means more cutting-edge research and continued support for people living with MS in your community." Multiple Sclerosis News Today plans to interview an event participant ā€” Beth Kantor, a retired nurse from Plymouth, Minnesota, who has relapsing MS ā€” after the event. Kantor is also volunteering at this year's MuckFest MS, helping others as they too take to the course. The first wave/start time is at 9:00 a.m Saturday, August 19, and then every 20 minutes throughout the day. More information, including a look at the obstacles, is available here. A blog by past Muckfesters, offering ideas and suggestions, is also available. MuckFest MS runs take place in a dozen U.S. cities each year. AbbVie is the national sponsor, and local sponsors for MuckFest MS 2017 include Acorda and Genentech. A national event sponsor is The Traveler Beer Co.

Ocrevus Approved in Canada to Treat Relapsing-Remitting MS

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 ā€” or mention ā€” 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.

Enzyme Regulates Development of Specific T-cells That Contribute to Autoimmune Disease, Study Suggests

A new study highlights a crucial role for the enzyme protein tyrosine phosphatase N2 in the development of early immune T-cells, and suggests that decreased levels of this enzyme can lead to the production of subsets of T-cells that contribute to the development of autoimmune diseases such as multiple sclerosis. T-cells, which are a type of immune cells that fight infection, are composed of multiple subsets that have different roles in immunity. Researchers at Monash University set out to characterize the role of PTPN2 in early T-cell development and in the development of T-cell subsets Ī±Ī² TCR and Ī³Ī“ TCR. To do this, researchers deleted the gene coding for PTPN2 and looked at the resulting T-cell population. Results demonstrated that the deletion of PTPN2 led to the production of Ī³Ī“ T-cells with pro-inflammatory properties that have been associated with many autoimmune diseases by inhibiting certain pathways that regulate proper T-cell development. ā€œThis is an important advance in our understanding of critical checkpoints in T-cell development,ā€ Tony Tiganis, principal research fellow in the Department of Biochemistry and Molecular Biology at Monash University in Australia, said in a press release. ā€œIt helps decide whether the progenitors go on to become T-cells or something else; if they become one type of T-cell or another type.ā€ Interestingly, there are already drugs that target some of the pathways that PTPN2 regulates, which could lead to the use of existing drugs to treat some of these autoimmune diseases, including MS. ā€œUnderstanding the mechanisms that govern early T-cell development and how these are altered in human disease may ultimately afford opportunities for novel treatments. This is very exciting,ā€ said Florian Wiede, a post-doctoral candidate at Monash and first author of the study.