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Alkermes will showcase its work in developing a treatment that harnesses the effect of Tecfidera (dimethyl fumarate) for relapsing multiple sclerosis (MS), while lowering the risk of stomach problems at the 7th Joint ECTRIMS-ACTRIMS Meeting this month in Paris. The investigational drug, ALKS 8700, uses the same mechanism of action as Tecfidera. By building the molecule in a different way, however, the company expects it will show better tolerability. Once in the body, dimethyl fumarate turns into monomethyl fumarate (MMF), the molecule that actually impacts MS disease processes. But before giving rise to MMF, dimethyl can cause side effects in users, particularly gastrointestinal. In fact, stomach problem were what caused people in Tecfidera Phase 3 trials to stop the treatment. Alkermes uses a so-called prodrug approach to try to overcome this problem. By attaching a different compound to MMF — which breaks away from the molecule once in the body —  it is possible to deliver MMF with lesser gastrointestinal side effects, Phase 1 study data indicate. At the meeting, the company will present two posters on two clinical trials exploring ALKS 8700 in patients with relapsing-remitting MS. The first presentation, will describe a Phase 3 trial that aims to compare ALKS 8700 to Tecfidera in about 420 patients. The trial is primarily concerned with the drug’s safety, and will measure the occurrence and impact of gastrointestinal side effects in the two treatment groups. The presentation will only include descriptions of patients characteristics and study design, as outcomes are yet to be analyzed. Patients who complete the Phase 3 trial will be eligible to continue in an ongoing open-label, long-term safety study, called EVOLVE-MS-1, covered in the company’s second presentation. By March 3, 2017, the study had enrolled 543 patients. In addition to describing patient characteristics, researchers will present the rates of discontinuation caused by gastrointestinal adverse events within one month of starting the treatment.

Inhibiting an enzyme prevented mice from developing a multiple sclerosis-like disease, a European study reports. The finding about HDAC1, a member of the histone deacetylases family of enzymes, could open up new therapy possibilities for MS. Researchers published their study, “A T cell-specific deletion of HDAC1 protects against experimental…

TG Therapeutics’ ublituximab nearly eradicated a type of immune B-cell believed to be involved in multiple sclerosis, according to a Phase 2 clinical trial. The result was that none of the patients had a relapse during the first six months of the trial, which is continuing, researchers said. In addition, ublituximab reduced the brain and spinal cord lesions of the relapsing MS patients involved in the trial and prevented new ones from forming. The company will present the interim trial results in three poster presentations at the 7th Joint ECTRIMS-ACTRIMS Meeting in Paris, Oct. 25-28. Meanwhile, researchers will continue to study the effectiveness of ublituximab, a B-cell-depleting antibody, versus a placebo, for another six months. The trial is being held at several U.S. medical facilities. Participants receive two initial infusions of ublituximab or a placebo on day 1 and 15 during the first 28 days. After this initial period, those in the placebo-group are also given ublituximab and followed for 52 weeks. A key trial finding was that over the initial 24 weeks of the trial, the treatment nearly wiped out a type of B-cell known as CD20 that scientists believe is involved in the development of MS. Only 1 percent of the B-cells remained after a month. While helpful immune T-cell numbers dropped slightly after the first ublituximab infusion, they bounced back quickly. Researchers also reported a reduction in patients' magnetic resonance imaging (MRI) lesions, with no new inflammatory lesions appearing during the six months. So far, none of the trial participants has had a serious adverse event. Most of the adverse events were mild or moderate and related to the infusions. The trial also demonstrated that speeding up infusions did not increase infusion-related reactions. The speed-up results indicated that — if proven effective and safe — ublituximab will be more convenient for patients than B-cell-depleting drugs that require infusions stretching over several hours.

The Consortium of Multiple Sclerosis Centers has updated guidelines for using magnetic resonance imaging to evaluate people suspected of having multiple sclerosis. Doctors use the MRI guidelines not only to diagnose MS but also to track treatment results. A task force is reviewing the new guidelines before they're published. The working document is called  "Revised Guidelines of the CMSC MRI Protocol for the Diagnosis and Follow-up of MS." The task force, composed of neurologists, radiologists and imaging scientists experienced in MS, met in January 2017 to revise the guidelines. They also updated information about the situations for which standardized brain and spinal cord MRI scans should be used. One change is a recommendation that gadolinium, a contrast agent in scans, be used cautiously. The previous update, published in 2015, included no constraints on the use of gadolinium-based contrast agents. But soon after publication, information emerged showing that gadolinium, although not toxic, accumulates in the brain. This prompted the U.S. Food and Drug Administration to recommend limiting the use of gadolinium to “appropriate clinical circumstances.” To mirror the increased awareness of gadolinium deposits, the new guidelines say: “While there is no known central nervous system toxicity, these agents should be used judiciously, recognizing that gadolinium continues to play an invaluable role in specific circumstances related to the diagnosis and follow-up of individuals with MS.” Since 2009, the Consortium of Multiple Sclerosis Centers has addressed a number of other issues. One is encouraging the use of three-dimensional MRI for brain scans. Another is developing protocols for monitoring severe optic nerve inflammation and progressive multifocal leukoencephalopathy, or PML, a brain disease caused by a virus. The guidelines have been revised to recommend the specific timing of scans for monitoring PML. The update also includes recommendations for the timing of scans on patients receiving disease-modifying drugs. Since 2009, the guidelines have included recommendations on scans of radiologic isolated syndrome, a condition where MS-like MRI lesions are present without symptoms. And they have included provisions on the value of using MRI changes to evaluate treatment effectiveness. The centers' goal "is to standardize the MRI protocol and make these recommendations a useful guideline for neurologists, neuroradiologists, and related healthcare professionals during initial evaluations and during follow-up of patients with MS, and ultimately provide optimum care for those individuals dealing with this unpredictable disease,” June Halper, the centers' chief executive officer, said in a press release.

The 7th Joint ECTRIMS-ACTRIMS Meeting, taking place in Paris this month, is one of the largest scientific conferences focused solely on multiple sclerosis (MS), and the National Multiple Sclerosis Society will be among the many interested parties attending. To get a feeling for meeting highlights and presentations the…

Genentech will present a host of new information on its multiple sclerosis treatment Ocrevus and lessons its scientists have learned about the disease at the 7th Joint ECTRIMS-ACTRIMS Meeting in Paris, Oct. 25–28. The presentations will offer new insights into the therapy's mechanisms, safety and effectiveness in people with the primary progressive and relapsing forms of MS. They will also look at new ways to track MS, including additional biomarker possibilities. MS experts say the joint meeting of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) and Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) is one of the largest global congregations of scientists working on the disease. The information Genentech plans to present will demonstrate "the commitment of our scientists and research partners to advance understanding of MS progression through ongoing analyses of the Ocrevus Phase 3 clinical trials,” Dr. Sandra Horning, the company's chief medical officer and head of its Global Product Development arm, said in a press release. Genentech, which is part of the Roche group, said the 18 presentations will represent the largest body of evidence ever presented on Ocrevus. The discussions will reinforce the therapy's favorable benefit-risk profile, Genentech added. Two presentations will cover new ways that doctors can look for signs of disease activity that can lead to disability. One yardstick is called progression independent of relapse activity, or PIRA. Another is tracking slowly evolving lesions. Genentech researchers came up with the approaches when they analyzed a subgroup of patients in the OPERA I and OPERA II Phase 3 clincal trials, whose aim was to evaluate Ocrevus as a treatment for relapsing MS. The patients' disease progressed even though they had no relapses, researchers said. The team will also discuss how Ocrevus affected these patients' disease. Another presentation will cover long-term follow-up data from an extension of the ORATORIO Phase 3 clinical trial (NCT01194570), which dealt with Ocrevus' ability to treat primary progressive MS. It will   look at how well Ocrevus slowed the progression of patients' disability. Updated information on Ocrevus’ safety —  based on open-label extension studies — will be another component of the presentations. So far, researchers have detected no new safety issues. Genentech will also discuss a new way of using conventional magnetic resonance imaging (MRI) to identify and track slowly evolving lesions. The company's scientists think that tracking the lesions may be a good way to measure chronic disease activity. This would contrast with tracking ordinary MS lesions, which are biomarkers of acute — as opposed to chronic — disease activity. In addition to "two new potential markers of underlying disease activity and their impact on disease progression, we hope to bring new tools to the MS community to better understand and manage the disease,” Horning said. One tool, which Genentech has begun testing in clinical trials, is gathering patient information with sensors connected to a smartphone. Researchers are comparing the information obtained in the FLOODLIGHT study with what physicians record during patient visits. The research team believes the FLOODLIGHT method may be be able to detect subtle changes better. This could make it a better predictor of disease activity and long-term patient outcomes. In addition to the presentations, Genentech will sponsor two symposia at the meeting that will discuss how MS progresses, features of the chronic version of the disease, and the link between inflammation and the progression of MS. The U.S. Food and Drug Administration approved Ocrevus in March 2017.  

BC Platforms announced that Biogen and the Accelerated Cure Project (ACP) will use its platform to advance research in multiple sclerosis (MS) by bringing data collected through clinical trials, biobanks and the like directly to researchers and other experts in the field. Microsoft is also a project partner,…

Researchers found a significant increase in some types of gut bacteria and lower levels of an anti-inflammatory factor in untreated multiple sclerosis twins. The study offered working evidence that components of gut microbiota contribute to autoimmune diseases like MS. Researchers published their article in the journal Proceedings of the National Academy of Sciences.It was titled "Gut microbiota from multiple sclerosis patients enables spontaneous autoimmune encephalomyelitis in mice." Our gut contains millions of good bacteria, fungi, bacteria-like archaea, and viruses that we can't live without. Although there are 300 to 1,000 species of bacteria in our gut, most of our intestines is populated with 30 or 40 species. Recent increases in knowledge and technical advancements have made it possible for scientists to measure the equilibrium between different species in the gut, and analyze their influence on our health. One discovery was a link between the balance of bacteria in the intestines and autoimmune diseases like MS. A team of researchers decided to see if differences in gut microbiota play a role in MS progression and perhaps its onset. They analyzed the feces of 34 identical twins, one of each who had MS and one of each who didn't. They used twins to try to reduce genetic and environmental differences' influence on the onset of the disease. All of those with MS were Caucasian and had grown up with their healthy twin to adulthood. Researchers analyzed the type and abundance of microorganisms in the feces of both the MS-affected and healthy twins. They found no differences in species or amount of bacteria between siblings. What they did find was a significant increase in some types of bacteria, such as Akkermansia, in untreated twins with MS. The team transplanted fecal samples from MS-affected and healthy twins into a mice model of MS called experimental autoimmune encephalomyelitis. These animals have an inflammatory myelin-destroying disease of the central nervous system that is comparable to human MS. Myelin is a protective coating around neurons whose loss is associated with MS. MS twin-derived gut microbiota caused a significantly higher amount of mice to develop a relapsing–remitting autoimmunity similar to MS than healthy twin-derived microbiota. When researchers measured the microbial profiles of the mice's feces, they found significant differences in amounts of bacteria. The most important difference was in Sutterella, an organism that helps protect against inflammation. Sutturella levels were significantly reduced in the feces of mice transplanted with MS twin-derived microbiota compared with feces from healthy twins. The team also measured the mice's immune cells and the proteins they release. They discovered that immune cells in mice with MS-twin feces transplants produced less of the anti-inflammatory factor IL-10 than immune cells from mice colonized with healthy-twin samples. IL-10, or interleukin 10, is an important immune protein. When researchers transplanted the feces of healthy twins into the mice, then gave them an antibody that blocks the function of IL-10, they also became sick. This indicated that IL-10 may temper autoimmunity in the central nervous system. The team then measured the twins' immune blood components. They found that the healthy twin had higher quantities of IL-10 than the MS-affected one. This is a complex issue in which very subtle differences of type and amount of bacteria in the gut can have considerable consequences, they added.  

Aubagio (teriflunomide) may lead to reversible nail loss, researchers at Italy's University of Bologna reported after reviewing the case of a 55-year-old woman with relapsing-remitting multiple sclerosis. They described what happened to a patient who was referred to an MS clinic after experiencing acute optic neuritis — or inflammation of the optic nerve — three months earlier. Their report, “Nail loss after teriflunomide treatment: A new potential adverse event,” was published in the journal Multiple Sclerosis and Related Disorders. Doctors had been treating the woman with intravenous methylprednisolone. Physicians had judged her slightly disabled, with an Expanded Disability Status Scale (EDSS) score of 3, but had not diagnosed her with MS. When she was diagnosed a few months later, she began receiving interferon beta-1a. It did not work, so doctors switched her to Sanofi Genzyme's Aubagio. At first, she tolerated the treatment well, having only slight nausea after taking the medication. Physicians did not detect signs of liver toxicity or high blood pressure, which are relatively common side effects of Aubagio. Roughly three months after starting the medication, however, the woman began having more trouble walking problems and had mild hair loss. Two and a half months later, she said her nails had started falling out in the past month. When doctors examined her, she had lost two nails, while others appeared to have stopped growing. They were thinner than normal and some had detached from the nail bed. In addition, her hair loss continued. She had not started using other drugs, new cosmetics, or changed her diet. A dermatologist excluded the possibility that the condition was the result of fungus, psoriasis, or other conditions that could cause nails to fall off. Because doctors suspected that Aubagio could be the cause of the nail loss, they recommended that she stopped taking it. The patient switched to Biogen's Tecfidera (dimethyl fumarate) after a couple of weeks, and her nails started to grow again. This supported doctors’ idea that Aubagio had caused the nail loss, and that it was reversible. Nail growth is similar to that of hair, researchers said. The patient’s reaction could be an unusual version of the same process that makes people lose their hair when taking Aubagio, they said. Since nail loss is not described as a side effect of Aubagio on the medication's label, researchers urged MS specialists to consider the possibility if they see patients with the problem.  

Magnetic resonance imaging (MRI) brain scans of children could reveal changes associated with multiple sclerosis (MS) before any symptoms are developed, according to a study by scientists at Yale University School of Medicine. The findings suggest that brain and spinal cord scans can identify children at high risk for developing MS.

Scientists have been trying to find a way to restore a protective covering around nerve cells whose loss leads to the neuron damage associated with multiple sclerosis. A team at the University of California, San Francisco may have found a way to do it. And perhaps surprisingly, the possible solution…

A higher intake of dietary sodium, most often in the form of salt, does not increase the risk of developing multiple sclerosis (MS), Norwegian researchers concluded after analyzing data from more than 175,000 women. Their findings counter earlier evidence from experimental studies in cells and MS mouse models that suggested…

Diet can play an important role in whether children with relapsing multiple sclerosis have a relapse, researchers at the University of California, San Francisco argue. Their study demonstrated that a diet with a lot of fat increases the risk of a youngster having a relapse by 56 percent, with saturated fat tripling the risk. Eating a lot of vegetables, on the other hand, cuts the risk in half, the team said. Since children with MS tend to have relapses more often than adults, the researchers figured they would be a suitable group to study diet's impact on relapse. They recruited 219 children with relapsing-remitting MS or clinically isolated syndrome from 11 centers across the U.S. Clinically isolated syndrome is a condition that can evolve in MS. The research team use a questionnaire known as the Block Kids Food Screener to analyze what the youngsters ate. They tracked the children an average of almost two years, which was plenty of time for relapses to occur. And, in fact, they did occur in 42.5 percent of the group. It turned out that fat had a particularly devastating effect on the youngsters' relapse rate. For every 10 percent increase in energy intake that came from fat, there was a 56 percent increase in the children's risk of having a relapse. Saturated fats were the biggest driver of risk. When researchers look only at these fats, they discovered that the risk more than tripled. Examples of saturated fats include processed meats such as sausages, ham, and burgers, butter, hard cheeses, and whole milk. Vegetables had the opposite effect on risk, the researchers observed. Using a cup equivalent as a standardized measure, they learned that for every additional cup of vegetables the children ate, the risk of a relapse dropped in half. To exclude the possibility that other factors influenced the results, the team included information about age, sex, ethnicity, duration of disease, body mass index, treatment, and D-vitamin levels in their analyses. This did not influence the results. The team also looked at whether other food components, such as sugar, iron, fruit and fiber, would affect the risk of relapse. They did not find any links. Although the risk associations were strong, the researchers cautioned that the study's observational design meant that it was not able to prove that fat causes relapses. But there are several ways that fat could play a role in disease processes, they argued. For instance, high fat intake triggers the release of inflammation-promoting molecules. It also affectsf gut bacteria that are linked to immune processes. Vegetables lower the risk of inflammation and immune problems, the team said. In an accompanying editorial, Dr. Kathryn Fitzgerald of the Johns Hopkins School of Medicine said the study had important limitations. Researchers gathered information on the children's diet only in the week before they enrolled in the study. This might not adequately capture more long-term dietary patterns, she said. And fat is not simply fat, she pointed out, arguing that fish oil is believed to help MS patients. Although the California research offers insight, she called for long-term studies to define diet's role in MS.

Spain’s Oryzon Genomics will offer new data on the preclinical efficacy of ORY-2001, an epigenetic modulator it is developing to treat  multiple sclerosis (MS). Its presentation is set for Oct. 26 at MSParis2017, the joint international meeting of the European and Americas Committees for Treatment and Research in Multiple Sclerosis…

Pain, walking problems and fatigue are factors that most strongly lower self-perceived health in multiple sclerosis (MS), researchers at the New York University Langone Medical Center have found. This challenges current treatment approaches focus mainly on physical disability. It suggests that “invisible disability” may be more important to how patients…

The discovery of an immune cell quality control mission may have put scientists a step closer to understanding how autoimmune conditions such as multiple sclerosis arise. University of Alabama at Birmingham researchers identified regulatory immune cells with the quality control mission of destroying antibody-producing B-cells that mistakenly target the body's own tissue after an infection. An autoimmune disease is one in which the immune system attacks healthy tissue or organs instead of invaders. Eventually, the insight could lead researchers to new approaches for treating MS and other conditions caused by aberrant immune reactions. The Alabama researchers were studying the processes involved in the body's defense against a real threat — the influenza virus — when they discovered a population of immune cells whose action is relevant to autoimmune diseases. The study noted that T follicular regulatory cells appeared in the late stages of influenza infection. Their objective was to prevent the immune system from generating self-reactive antibodies — that is, those that attack the body's own tissue. These cells are poorly understood, the researchers explained. Their experiments, published in the journal Nature Immunology, focused on the molecular events surrounding the cells’ actions.  The team discovered that about a week after the infection, levels of an immune regulator called the IL-2 protein increased. This triggered the multiplication of common regulatory T-cells, or Tregs. When this phase of the immune reaction was fading, TFR cells started multiplying, reaching peak numbers about a month after infection. The formation of the TFR cells was therefore tightly linked to the processes controlling Treg production, researchers said, with falling levels of IL-2 allowing the new phase of the immune response. The TFR cells migrated to the lymph nodes — the headquarters of antibody-producing B-cells. Here, B-cells proliferate and change their antibody-producing genes to create new, stronger antibodies. But sometimes the gene changes, or mutations, give rise to an antibody that attacks the body, instead of invaders. Researchers discovered that TFR cells prevented B-cells, which gave rise to autoantibodies, from accumulating in the lymph nodes. Importantly, the TFR cells had no impact on the immune processes targeting the influenza virus. When researchers prevented TFR cells from forming or removed them from mice, the animals started producing autoantibodies, they explained. While this suggested that people with autoimmune diseases may have flawed TFR processes, the study did not investigate this, making the topic a possibility for future studies.

Nimbus Therapeutics and Celgene have agreed to work together to identify potential therapeutic compounds that can specifically target Tyk2 and STING — two proteins involved in inflammation and innate immune response. This strategic collaboration can open new therapeutic avenues for the treatment of multiple sclerosis (MS) and several autoimmune disorders. Nimbus, headquartered in Cambridge, Massachusetts, applies chemical computational analysis to identify and develop new compounds with potential for therapeutic use in a range of diseases. Two Nimbus immunology programs are already covered under the newly established agreement: one developing inhibitors of Tyk2 and antagonists of STING protein. Tyk2, or tyrosine kinase 2, mediates the signaling of several pro-inflammatory proteins, including interleukin (IL)-23, IL-12 and type-I interferons. Inhibiting this enzyme can stop signals from passing through. This can potentially impair inflammatory response. STING, or stimulator of interferon genes, is an important activator of immune responses. As such, finding ways to block its activity can help prevent autoimmunity and reestablish immune response balance. Under their accord, Nimbus will control the program's research and development; Celgene will have the option to acquire each program covered by the alliance.

Synthon’s prefilled syringe with 40 mg/ml of glatiramer acetate — the generic version of Teva Pharmaceutical’s Copaxone 40 mg — has received regulatory clearance in all 28 member states of the European Union (EU) plus Iceland, Liechtenstein and Norway to treat relapsing-remitting multiple sclerosis (RRMS). The low-dose…

Most multiple sclerosis patients who try Bayer’s BETACONNECT auto-injector stick with their treatment, a study reports. The electronic product may overcome the problem of many patients failing to stick to a therapy  schedule because of what they consider hassles connected with injections. An auto-injector is one that patients can use…

Groundbreaking evidence of the existence of lymphatic vessels in the human brain could answer the question of how the brain gets rid of waste products, and holds clear implications for neuroinflammatory disorders such as multiple sclerosis. The lymphatic system is a network that helps the body to rid itself of toxins and waste products. Lymphatic vessels, which are similar to blood vessels, transport a clear fluid – lymph – which is filtered in lymph nodes. It has long been thought that the brain lacks lymphatic vessels. However, a team of researchers at the National Institutes of Health (NIH), building on previous research in rodent brains, recently found evidence that the brain may actually drain waste through lymphatic vessels. The researchers injected healthy volunteers with a magnetic dye called gadobutrol, which is usually used as a contrast agent to image blood vessels. They then scanned the brains of these individuals using magnetic resonance imaging (MRI) under specific settings. This allowed them to view the dye within the outer layer of the brain, known as the dura. The MRI revealed that the dye was visible both as dots and straight lines, which might indicate lymph vessels. This suggested that the dye leaked out of blood vessels into the dura and were later 'picked up' by lymphatic vessels. These vessels were not seen when the volunteers were injected with another dye that does not leak out of blood vessels. Evidence of lymphatic vessels in the brain was also found in autopsied human brain tissue. Although a pair of 2015 studies had shown evidence of lymphatic vessels in the brains of mice, this is the first study that demonstrates that a similar system exists in human brains. “For years we knew how fluid entered the brain. Now we may finally see that, like other organs in the body, brain fluid can drain out through the lymphatic system,” Reich said . In addition to changing the way we think about the lymphatic system and the brain, this study lays the foundations for future research to investigate whether the function of the lymphatic system is altered in the brains of patients with multiple sclerosis or other disorders affecting the nervous system.

Two short courses of Lemtrada prevented multiple sclerosis from becoming active and progressing for five years, a study reported. Lemtrada's maker, Sanofi-Genzyme, said the study covered the two-year CARE-MS II Phase 3 clinical trial (NCT00548405) and a long-term extension (NCT00930553) trial of people with relapsing-remitting MS. In addition to demonstrating Lemtrada's effectiveness, the study showed that it was safe, researchers said. The Phase 3 trial participants had had an active disease, with at least two relapses in the two years before the study and an inadequate response to earlier treatment. The trial compared Lemtrada's effectiveness with that of Rebif. The Lemtrada group received 12-mg doses for five consecutive days at the start of the study and three consecutive days a year later. Ninety-three percent of the 435 patients who completed the trial enrolled in the extension, which followed patients for another three years. Remarkably, 60 percent of patients required no additional treatment after the two years of the Phase 3 study. Among the 376 patients who required more treatment, 30 percent had one additional Lemtrada course, 10.4 percent had two, and 1.6 percent had three. A small proportion of patients also received other disease-modifying treatments. The most common reason for additional treatment was relapse. Nevertheless, Lemtrada reduced annualized relapse rates to only 0.18 of patients by the fifth year. In addition, during the five years, 75 percent of patients experienced no worsening of their disability over six-month cycles. And 49 percent of patients' disability improved. Researchers also tracked patients' scores on the NEDA — or No Evidence of Disease Activity — index. The composite measure takes into account relapses, disease activity detected in MRI scans, and disability progression. In year five, 58 percent of patients achieved NEDA, slightly more than the 53 percent in year three. Another important finding was that patients' loss of brain tissue slowed in the first two years, and dropped further during the extension. Researchers also noted that adverse events dropped during the extension trial. Ninety-six percent were mild or moderate, and no patient left the study because of side effects. The rate of infusion-associated reactions was lower in the extension study than in the Phase 3 study. Patients who did have a reaction most often experienced headache, fever, or rash. Infections did not become more common with accumulating Lemtrada doses and, again, were less common in the extension trial. Patients most often developed colds or urinary tract infections. Autoimmune reactions against the thyroid gland were relatively common, however. Thirty-eight percent of patients developed them over the five years. Most were moderate in severity. Four patients developed various types of cancers. Researchers also examined Lemtrada in the CARE-MS I clinical trial and its extension trial. They reported long-term outcomes and safety findings similar to those in the latest study. Overall, the newest results demonstrated that Lemtrada slowed disease progression over five years in relapsing-remitting MS patients who failed to respond to previous therapy.

Researchers at Duke University want to determine if data collected through an iPhone app can ably capture individual experiences in people with multiple sclerosis to improve doctor-patient communication and overall disease understanding. According to a National MS Society report, the researchers want to investigate the benefits combining mobile phone-based data with machine learning (the ability of a smartphone to mimic human behavior) and patient participation. The study is currently enrolling MS patients, 18 or older, live in the United States and be able to read and understand English. Participants must own or have daily access to an iPhone (iOS 9 or greater) to download a free, MS Mosaic app from the Apple Store. The app is not yet available for Android phones. The rationale behind the study is that MS can be an extremely complex condition, with symptoms ranging from numbness, walking difficulty, to vision impairment and fatigue. Each patient's experience is different and can be affected by medication, emotional health, and environmental factors. This complexity can complicate research. Study participants will receive daily, weekly and monthly questionnaires to fill about their symptoms. Daily surveys should take no longer than a minute to complete, and weekly surveys about ten minutes. Initial registration should take about 20 minutes, the NMSS report says. In some of the surveys, participants will be asked to perform specific tasks while holding or using the mobile phone, like walking 25 steps, turning around, then walking back 25 steps – while holding the phone. Other tests include tapping on the phone screen repeatedly to test motor speed, coordination and fatigue, or playing a pattern game to assess short-term memory. These tasks should take about five minutes each. Patients can choose not to answer some of the questions or to participate in certain tasks. All information is collected through the app, and will be sent to a secure data server. Participants can export data to share with a healthcare provider. Each person will be identified by a code, and data will be analyzed in a way that maintains confidentiality. Researchers, however, be able to identify a participant should they need to do so for "research integrity or legal purposes," the report states. Questions regarding this study can be answered by sending an email to [email protected].

The U.S. Food and Drug Administration has approved both lower and higher doses of Mylan’s generic versions of Copaxone (glatiramer acetate) for relapsing multiple sclerosis. It is the first time the agency has authorized a higher-dose generic. Generic versions of the lower dose of 20 mg/mL — intended for…

The 7th Joint ECTRIMS-ACTRIMS Meeting, the world’s largest annual international conference devoted to basic and clinical research in multiple sclerosis, will run from Oct. 25 to 28 in Paris — the city of Jean-Martin Charcot, the “Father of Neurology,” who provided the first detailed description of multiple sclerosis (MS)…

Antisense Therapeutics announced that it is proceeding with a Phase 2b clinical trial of ATL1102, its lead candidate to treat multiple sclerosis, after the U.S. Food and Drug Administration (FDA) lifted a clinical hold it had placed on the company’s request — in the form of a trial application or IND —…

Non-invasive brain stimulation reduces fatigue in multiple sclerosis patients, concludes a study by researchers at New York University. Fatigue is one the most disabling symptoms of MS, affecting roughly 75 percent of people with the disease. Doctors often prescribe drugs to treat narcolepsy, as well as behavior-based treatments and exercise programs, but their benefits have not been consistent. This led scientists to study a technique of brain stimulation called transcranial direct current stimulation (tDCS), which had shown positive results in earlier neurology studies, including improvements of cognitive symptoms in MS. In tDCS, doctors place electrodes on the scalp via a headset to apply a low-amplitude electrical current at the dorsolateral prefrontal cortex — a brain region believed to play a role in fatigue and cognitive symptoms. The technique has been proven safe and tolerable. The NYU study randomly assigned 27 MS patients to receive either tDCS or placebo. Patients got treatment while playing a cognitive game directed at the brain’s processing speed and working memory. Sessions lasted 20 minutes each and took place five days a week, at patients’ homes. Participants reported their level of fatigue after 20 sessions, using a scale known as the Patient-Reported Outcomes Measurement Information System (PROMIS) that grades fatigue on a score of up to 32. A higher score correlates with more fatigue. The results showed a significant 5.6-point drop with tDCS, compared to a 0.9 point increase in the placebo group. Furthermore, patients may benefit from more sessions, since those who underwent 20 sessions reduced fatigue more than those who did only 10. The study also showed that patients with the most fatigue at baseline saw the biggest improvements. Remarkably, many participants reduced their fatigue to near-normal levels, researchers observed. Further studies are needed to ascertain the precise mechanism behind tDCS. Scientists believe it changes the brain’s excitability, which improves connections and facilitates learning. Meanwhile, the study's authors strongly advise MS patients not to try over-the-counter stimulation technologies outside of a reliable research setting. The research team plans to test tDCS in larger clinical trials for MS-related fatigue, motor and cognitive symptoms. Currently, the Multiple Sclerosis Comprehensive Care Center at NYU Langone Health is the only one in the United States to offer tDCS to MS patients.

Fast Forward, a non-profit subsidiary of the National Multiple Sclerosis Society, will give financial support to TG Therapeutics to advance TGR-1202 (umbralisib) into preclinical testing as a potential oral therapy for progressive forms of multiple sclerosis. The support, whose value was not specified, is part of a Sponsored Research Agreement between Fast Forward and the company. Research work will be led by Lawrence Steinman, MD, a professor of pediatrics, neurology, and neurological sciences at Stanford University. TGR-1202 is an orally administrated inhibitor that blocks a signaling enzyme called PI3K delta. Immune cells such as B-cells have high levels of this enzyme, which is thought to be important for cell proliferation and survival. "We look forward to evaluating umbralisib [TGR-1202]'s effect on our preclinical progressive MS models in hopes to move umbralisib closer to clinical development in MS," Steinman said. The approval of Ocrevus (ocrelizumab), by Genentech, to treat primary progressive and relapsing multiple sclerosis underscored the potential of B-cell-targeted therapies for MS patients. As a result, investigative drugs that also aim to bolster B-cell survival or activity, such as those being developed by TG Therapeutics, are an attractive approach to potentially treating patients. Another potential treatment by the company — an engineered antibody, TG-1101 — targets a specific sequence on the CD20 protein found on immune B-cells. This infusion therapy is now in two Phase 3 clinical studies for relapsing multiple sclerosis, ULTIMATE I and ULTIMATE II. Both are currently enrolling patients at sites in Kentucky, Tennessee, and New York.

A clear association was seen between the substantial pain that multiple sclerosis (MS) patients experience and lifestyle choices that either augment or ease that pain, like smoking habits, exercise, and diet and weight, researchers in Australia report. Common co-morbidities associated with MS, such as depression, anxiety, and fatigue, were also…

A five-year study demonstrated that Sanofi-Genzyme’s Lemtrada (alemtuzumab) provides long-term benefits for relapsing-remitting multiple sclerosis patients, reducing relapse rates and preventing the progression of the disease. Importantly, most patients required only the standard two-phase treatment course. Few needed additional courses because of relapse or new brain lesions. The study,…

Swiss regulatory authorities approved Ocrevus as a treatment for primary progressive and relapsing forms of multiple sclerosis on Sept. 28, making it the first approval of the drug in a European country. Since Switzerland is not part of the European Union, the approval will not affect the drug's regulatory status in other European countries. So far, the Roche/Genentech drug Ocrevus has been approved in North America, South America, the Middle East, Ukraine, and Australia. Like other countries where Ocrevus has been approved, it's the first drug OK'd in Switzerland for primary progressive MS, a form of the disease where disability moves forward relentlessly. And, as in other countries, the treatment option is equally appreciated among patients with relapsing types of MS. Ocrevus — an antibody that targets B-cells with the surface factor CD20 — was studied in two large Phase 3 trials in patients with relapsing MS called OPERA I and OPERA II (NCT01247324 and NCT01412333). Another trial, called ORATORIO (NCT01194570), is focused on people with primary progressive disease. The trials showed that the treatment significantly reduced disease activity and prevented progression in both patient groups. Researchers compared Ocrevus to Rebif (high-dose interferon beta-1a) in relapsing MS and to a placebo in primary progressive MS. Scientists also consider the drug to have a good safety profile. The most common side effects during the trials were mild-to-moderate infusion reactions and upper respiratory tract infections. Since its approval, researchers also have concluded that the treatment is less expensive than interferon. Ocrevus was approved in the U.S. on March 28, 2017. In the months that followed, many patients were concerned about the trial findings of more cancer cases in the treated, compared to control, groups. Since then, an increased risk of cancer with Ocrevus has not been confirmed, and researchers underscore that it is instead the coincidental and unusual circumstance that there were no cancer cases in the control group that created the imbalance. The European Medicines Agency is still processing the marketing application for Ocrevus. Roche reports that the company has filed marketing applications in more than 50 countries worldwide.