treatment

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.

Falls Common Among Wheelchair, Scooter Users in People with MS, Study Reports It’s happened to me. I’ve gone over backward when I tried to “gun” the throttle of my lightweight scooter when its rear wheels were up against a door threshold. And my heavier scooter can have a…

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.

Do you ever stop and ponder the value of MS drugs? I’m not talking about if they work and the ways they improve our lives. I’m thinking of the COST of them and what their pricing means to investors. I get several market analysis reports on the pharmaceutical industry,…

Researchers at the University of Nottingham and neurologists at Nottingham University Hospitals NHS Trust in England will be working with a team from the Cleveland Clinic in Ohio to better understand the best therapeutic strategy for multiple sclerosis (MS) patients. The $10.6 million international clinical trial was one of five…

The Patient-Centered Outcomes Research Institute (PCORI) has awarded $13.4 million to two scientists at Baltimore’s Johns Hopkins University (JHU) to study how best to treat newly diagnosed patients with relapsing-remitting multiple sclerosis (RRMS). The study will be led by Dr. Ellen Mowry, an associate professor of neurology and epidemiology at…

Researchers have taken the first steps towards the development of a gene therapy for multiple sclerosis — a treatment that boosted anti-inflammatory immune processes and reversed severe paralysis in mouse models of the disease. The University of Florida Health research team said it was optimistic that the therapy can work…

Disarm Therapeutics has completed the first round of financing to develop a compound that prevents axonal degeneration in patients with multiple sclerosis (MS) and other neurodegenerative conditions. The treatment approach is based on an earlier discovery at Washington University in St. Louis, showing that the enzyme SARM1…

People with multiple sclerosis (MS) often face geographic barriers that end up limiting their treatment options. That has led a Case Western Reserve University researcher to test online- and teleconference-based methods of reducing fatigue and improving patients’ quality of life. Matthew Plow, assistant professor at the university’s Frances Payne Bolton…

The U.S. Patent and Trademark Office has issued a patent for human embryonic stem cells derived mesenchymal stem cells, called hES-T-MSC or T-MSC, and for their method of production. This newly patented technology was developed by ImStem Biotechnology in collaboration with the University of Connecticut (UConn) to advance new…

TG Therapeutics is recruiting participants for two Phase 3 clinical trials that will evaluate the safety and effectiveness of TG-1101 (ublituximab) as a treatment for relapsing forms of multiple sclerosis. ULTIMATE 1 (NCT03277261) and ULTIMATE 2 (NCT03277248) will compare TG-1101, a glycoengineered monoclonal antibody, with Genzyme’s Aubagio…

As patients, we deserve the best care for our MS and we should accept nothing less. I have had many years of difficulty trying to find adequate MS care since my diagnosis in 2010. I have gone from neurologist to neurologist, even before I knew my symptoms pointed to MS. My…

Probiotics Consumption May Improve Certain Disease Parameters in MS Patients, Study Suggests Probiotics (bacteria that help move food through your gut) have been used for years to help treat stomach disorders such as irritable bowel syndrome, inflammatory bowel disease, and some types of diarrhea. More recently, researchers have…

A European Patent Office decision has opened the door to Synthon providing cheaper generic versions of Teva Pharmaceutical’s Copaxone to people with relapsing multiple sclerosis. What looks like the final hurdle to the generics was cleared when the patent office’s Technical Board of Appeal revoked the last of the patents that Teva…

Back in May, when I updated everyone about my Lemtrada treatment at six months post-infusion, I began with a question my wife asked: “Do you think you’re walking better?” And, I thought I was. Maybe. Just a little. I was walking a bit more smoothly, my left foot…

Probiotics may improve the health of people with multiple sclerosis (MS) by reducing disability and improving inflammatory and metabolic parameters, an Iranian study shows. Live microorganisms linked to health benefits, known as probiotics, have long been known to help chronic disease patients. In a previous study of people with major depressive disorder, probiotics treatment for eight weeks improved patients’ depression and metabolic parameters. More recently, authors investigated the impact of probiotics on a group of MS patients, looking not only at mental health and metabolic indicators, but also disability scores. Researchers at Tehran's Shahid Beheshti Hospital recruited 60 MS patients, divided them in half, and assigned 30 to take a probiotic capsule and 30 a placebo once a day for 12 weeks. The probiotic contained the healthy bacteria Lactobacillus acidophilus, Lactobacillus casei, Bifidobacterium bifidum and Lactobacillus fermentum. Researchers measured patients’ health parameters and disability scores at baseline and after treatment. The results showed that probiotic intake after 12 weeks improved MS patients' disability scores (assessed by the expanded disability status scale, EDSS) when compared to placebo controls. Although this improvement was statistically significant, it was not clinically significant — which is defined as a change of 1.0 point or more at EDSS levels less than 5.5, or 0.5 point or more at EDSS levels greater than 5.5). Moreover, benefits were also detected in several mental health parameters – Beck Depression Inventory, general health questionnaire-28 (GHQ-28), depression anxiety and stress scale. Consuming probiotic capsules also significantly decreased insulin levels and high-density lipoprotein (HDL) cholesterol in circulation, researchers also found. It also lowered certain markers of inflammation and oxidative stress, such as serum high-sensitivity C-reactive protein (hs-CRP) and malondialdehyde (MDA).

The Patient-Centered Outcomes Research Institute has awarded $38 million in grants for five projects that compare the effectiveness of different multiple sclerosis treatment strategies. A key aim of the research is to improve knowledge about the therapies to help doctors and patients choose the healthcare option that best meets patients’ needs. The…

Ocrevus (ocrelizumab) is a less expensive treatment option for relapsing multiple sclerosis (MS) than subcutaneous interferon beta-1a (Rebif) in the long-run, according to a cost-effectiveness analysis published in the Journal of Medical Economics. In addition to lower total costs over a 20-year period, the analysis suggested that Ocrevus…

GT Biopharma has acquired licensing and development rights for PainBrake —  Accu-Break Pharmaceuticals’ non-opioid pain medication to treat dysesthesia and pain caused by nerve damage in multiple sclerosis (MS). “I am looking forward to initiating the development of PainBrake as we anticipate that many patients with difficult-to-treat neuropathic pain could…

Autologous hematopoietic stem cell transplants for relapsing-remitting multiple sclerosis (RRMS) are superior to currently approved disease-modifying drugs, according to a Swedish study published in the Journal of Neurology, Neurosurgery & Psychiatry. In addition, says the review, the procedure’s safety profile has improved in the last decade, and is now just…

Two researchers at the University of Tasmania’s Menzies Institute for Medical Research have received an innovative multiple sclerosis research fellowship that was created to drive basic scientific research into treatment development and the doctor's office. MS Research Australia and The Macquarie Group Foundation founded the three-year, $750,000 program. It is unique in that it will bring together basic science researchers and therapy-development researchers to try to convert laboratory research into disease solutions. The grant was awarded to Professor Bruce Taylor, a Menzies researcher who is also a neurologist at the Royal Hobart Hospital, and to Dr. Kaylene Young, a neuroscientist whose long career in laboratory research has focused on mechanisms that the brain uses to repair itself. Taylor’s achievements include identifying genetic mutations that may increase the risk of a person developing MS. The award will help him move these discoveries to the lab to determine how the mutations harm cells. Young discovered that a type of non-invasive brain stimulation can increase brain stem cells' ability to produce new cells that repair the nervous system. She plans to move the technology, known as transcranial magnetic stimulation, from the lab to therapy-development-related research.

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 — developed by Merck KGaA (known as EMD in North America) — 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 — patients took tablets for a maximum of 20 days over two years — this latest study showed that continuing treatment into the third or fourth year offered no additional benefits. This finding supports Merck’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 patients’ quality of life. As such, the company plans to file regulatory approval for Mavenclad in the United States and elsewhere.

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…