treatment

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…

I’ve had a cold for two weeks. So, I’ve been more tired than usual. Too tired, in fact, to write the column that was supposed to post last Tuesday. (I apologize to all of you who wait, with bated breath, for the appearance of the MS Wire each…

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.

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.

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.