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Sex, age, disability level, and current disease-modifying therapy use are linked to how multiple sclerosis (MS) patients weigh the potential benefits and safety risks of treatments, new research from two teams funded by the National Multiple Sclerosis Society shows. These studies shed light on how…

Sex and intimacy are good for people with multiple sclerosis (MS), just as they are for anyone without the disease. And while fear of talking with a partner about possible sexual challenges created by MS is perfectly normal, there is help available to deal with potential problems. That’s according…

The first patient has been enrolled in a Phase 2 multicenter clinical trial testing the use of NurOwn cellular therapy to treat progressive multiple sclerosis (MS), BrainStorm Cell Therapeutics announced. The open-label trial (NCT03799718), titled Safety and Efficacy of Repeated Administration of neuron (MSC-NTF Cells) nin Participants…

Two-year treatment with temelimab reduced brain atrophy, or shrinkage, preserved myelin, and reduced disease progression in patients with relapsing-remitting multiple sclerosis (RRMS), according to findings from an extension study of a Phase 2b clinical trial. Temelimab, previously known as GNbAC1, is a monoclonal antibody that neutralizes the MS-associated human…

The Cleveland Clinic Nevada is recruiting participants for DELIVER-MS, a clinical trial comparing two common treatment approaches for relapsing-remitting multiple sclerosis (RRMS). Results from the DELIVER-MS trial, titled “Determining the Effectiveness of Early Intensive Versus Escalation Approaches for the Treatment of Relapsing-Remitting Multiple Sclerosis” (…

Treatment with ublituximab continues to be safe and well-tolerated by patients with relapsing forms of multiple sclerosis, according to an extension study of a Phase 2 trial. According to a press release, Edward Fox, MD, PhD, from Central Texas Neurology Consultants, will give the presentation on May 7 at poster session P3: MS Clinical Trials and Therapeutic Research. Ublituximab is an investigational monoclonal antibody being developed by TG Therapeutics to target the immune B-cell marker protein CD20. This leads to the depletion of B-cells from the blood and central nervous system — B-cells are activated during MS relapses. According to the company, ublituximab may be superior to current anti-CD20 treatments in MS, enabling both lower doses and shorter infusion times. Final results of the main TG-Therapeutics-sponsored Phase 2 trial were recently presented at the 4th Annual Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum, held in Dallas, Texas. Data showed that 93% of the 48 patients enrolled (mean age 40 years) were relapse-free after a 48-week treatment with ublituximab. The annualized relapse rate — the number of relapses per year — was 0.07. In addition, median B-cell depletion was more than 99% throughout 48 weeks. Moreover, 87% of participants showed no evidence of clinical disease. Magnetic resonance imaging showed a complete elimination of T1 lesions at 24 and 48 weeks 24 in all 46 patients analyzed. Mean T2 lesion volume decreased by 10.6% at 48 weeks, compared with the beginning of the study. T1 lesions refer to areas of active inflammation and disease activity, while T2 lesions are a measure of the total amount of lesions, both old and new. Ublituximab was found to be well-tolerated, and did not induce an severe treatment-related adverse events. The most frequent adverse events were infusion-related reactions. No patient had to discontinue treatment due to an ublituximab-related side effect. At the upcoming AAN meeting, Fox will present data on both this Phase 2 trial and its open-label extension, in which 37 patients from the primary study continued receiving one-hour infusions of 450 mg of ublituximab every 24 weeks for an additional 96 weeks. Safety was monitored throughout the study, and disability assessments using the Expanded Disability Status Scale were conducted every 48 weeks. As of October 2018, nearly 30% of participants had completed 48 weeks of treatment in the extension study. Results showed that ublituximab continues to be well-tolerated, with no discontinuations due to adverse events. “The Phase 2 OLE supports that one-hour infusions of [ublituximab] continue to be safe and well tolerated,” the researchers wrote. Of note, five of the eight study authors are affiliated with TG Therapeutics. The team expects additional patient follow-up data from the study to be available by the time of the AAN presentation. According to the scientists, the results support the ongoing Phase 3 ULTIMATE program, which includes the ULTIMATE 1 and ULTIMATE 2 trials. These studies are comparing the efficacy and safety of 450 mg of ublituximab with Aubagio over 96 weeks of treatment in relapsing MS patients. Both trials are led by Lawrence Steinman, MD, at Stanford University. TG Therapeutics expects to have results from these trials as early as mid-2020.

The evaluation of disease progression in multiple sclerosis (MS) patients through magnetic resonance imaging (MRI) can be performed without the use of a contrast agent, new research has shown. These findings suggest that routine use of contrast-enhanced MRI is unnecessary for most follow-ups with MS patients, reducing both imaging…

Increased production of an anti-inflammatory molecule called interleukin (IL)-10, and suppression of a subtype of immune T-cells, may mean that a fatty acid called pentanoate is effective against inflammatory and autoimmune diseases such as multiple sclerosis (MS), according to new research in mice. The study, “The…

The National Multiple Sclerosis Society is funding a new Phase 2 clinical trial to test the effectiveness of stem cell therapy on individuals with progressive forms of multiple sclerosis (MS), using mesenchymal stem cells from their own bone marrow. The ability of stem cells to both self-renew and create…

Spurred on by a recent multiple sclerosis (MS) prevalence study, which revealed that the number of MS patients in the U.S. is double (nearly one million) what had been previously thought, the National Multiple Sclerosis Society is marking MS Awareness Week by sharing stories of those affected…

Women with multiple sclerosis (MS) do not experience more relapses right after giving birth, as previously believed, according to a preliminary study. The study also revealed that mothers with MS who breastfeed their babies have a lower relapse risk compared with those who do not breastfeed. The data, “…

An application has been submitted for the use of ozanimod to treat adult patients with relapsing-remitting multiple sclerosis (RRMS) within the European Union, according to Celgene, the developer of ozanimod. The marketing authorization application was submitted to the European Medicines Agency…

Immunic Therapeutics has enrolled the first patient in its Phase 2 clinical trial testing IMU-838, a potential oral therapy for relapsing-remitting multiple sclerosis (RRMS). IMU-838 (vidofludimus calcium) is a next-generation selective modulator of the immune system. It works by inhibiting an enzyme called dihydroorotate dehydrogenase (DHODH), which plays a role…

Treating multiple sclerosis with Tecfidera induces specific genetic alterations that may reduce the levels of immune T-cells targeting the central nervous system, researchers report. Environmental stimuli may induce epigenetic changes in cells — meaning not alterations in the genes themselves, but changes in gene expression (the process by which information in a gene is synthesized to create a working product, like a protein). Epigenetic changes may induce MS development, as these alterations can cause T-cells to attack the central nervous system. One type of epigenetic change is DNA demethylation, the removal of methyl chemical groups, in which molecules involved in metabolism (such as fumarate) interact with enzymes known as DNA demethylases. This process in key for T-cell activation, function and memory, suggesting that it could be an immunomodulatory target. Fumaric acid esters were shown to be effective in MS clinical trials, leading to the approval of Tecfidera (by Biogen) for people with relapsing-remitting forms of the disease. However, their complete mechanism of action remains unclear. Aiming to address this gap, scientists at the Advanced Science Research Center (ASRC) at The Graduate Center of The City University of New York and the Icahn School of Medicine at Mount Sinai, recruited 98 MS patients, either previously untreated (47 people, mean age of 38.4), treated with Tecfidera (35 people, mean age of 42.3), or treated with glatiramer acetate (16 patients, mean age of 43.4) — marketed as Copaxone by Teva Pharmaceuticals, with generic forms by Sandoz (as Glatopa) and by Mylan. All patients had stable disease for at least three months, but disease duration was shortest in untreated patients — 40.4 months vs. 130 months in those given Tecfidera, and 100 months in patients using glatiramer acetate. Blood samples were collected from each participant to assess epigenetic changes in T-cells expressing the cell surface marker CD4. MS patients typically have an activated form of these cells in their blood and cerebrospinal fluid, the liquid surrounding the brain and spinal cord. Results revealed that, compared to the other two groups, treatment with Tecfidera was associated with a lower percentage of T-cells containing the CD3, CD4, and CD8 markers, as well as lower levels of subsets of T-cells expressing the CCR4 and CCR6 receptors, which are critical to T-cell migration to the gut, brain, and skin. Treatment with glatiramer acetate resulted in significantly milder alterations in T-cell percentages compared to no treatment. Researchers then found that FAEs induce excessive methylation — the addition of methyl groups — in T-cells containing CD4, compared to glatiramer acetate. Specifically, this overmethylation was observed in a micro-RNA — tiny RNA molecules than control gene expression — known as miR-21, key for the differentiation of a subset of T-cells called T helper-17 (Th17) cells and for CCR6 expression in MS mouse models. These Th17 cells are critical in tissue inflammation and destruction, and have been implicated in MS. The epigenetic effects of FAEs were subsequently validated by comparing pre- to post-treatment with Tecfidera in seven patients. In turn, in vitro (lab dish) experiments showed that FAEs act specifically on the activation of naïve T-cells — those able to respond to new pathogens to the immune system — containing the CD4 or the CD8 markers. Of note, patients with MS have shown increased miR-21 levels, particularly during acute relapses. As such, the team hypothesized that its hypermethylation by FAEs could contribute to remission and the prevention of relapses in this patient population. These results "suggest that the metabolic-epigenetic interplay in T-cells could be harnessed for therapeutic purposes," the researchers wrote, and that the immunomodulatory effect of FAEs in MS is due at least in part to the epigenetic regulation of T-cells. The researchers believe that their findings have a broader implication, beyond MS. "Our findings about therapeutically active metabolites have implications for the treatment of not only multiple sclerosis but also other autoimmune diseases, such as psoriasis and inflammatory bowel disease, which involve the same type of T-cells," Achilles Ntranos, the study’s lead author, said in a press release. "Understanding the epigenetic effect of metabolites on the immune system will help us develop several novel strategies for the treatment of autoimmune diseases, which could help patients and physicians achieve better clinical outcomes," Ntranos added. Patrizia Casaccia, the study’s senior author, concluded: "It may one day be possible to target and suppress production of the specific brain-homing T-cells that play a role in the development of MS."

After months of preparation with storytelling experts, three ordinary Americans with multiple sclerosis (MS) took the stage in New York late last year to share their MS journeys. The three joined TV personality Montel Williams at an event inaugurating My MS: Second Act, a joint effort co-sponsored by…

A daily cup of flavonoid-rich cocoa may help ease fatigue in people with relapsing-remitting multiple sclerosis (RRMS), according to the results of a small clinical trial. The study “A randomised double-blind placebo-controlled feasibility trial of flavonoid-rich cocoa for fatigue in people with relapsing and remitting multiple sclerosis” was…

Drinking about 290 calories of sugar-sweetened beverages — the equivalent of about two cans of non-diet soda — per day may be associated with a higher level of disability in patients with multiple sclerosis (MS), compared to those who seldom consume such beverages, according to a preliminary study. The…

MSCopilot, a software device designed for the self-assessment of multiple sclerosis (MS), distinguishes between patients and healthy controls, and potentially could be used in clinical practice for the monitoring of MS disability progression and patients’ response to treatment. Matthieu Lamy, from Ad Scientiam, the…

It is a question that multiple sclerosis (MS) patients, loved ones, and the larger community have asked for some time: “Will there be a cure for multiple sclerosis?” MS News Today had the opportunity to ask that question of leaders at the Americas Committee for Treatment and Research in…

Researchers at Kent and Canterbury Hospital, U.K., are recruiting 20 patients with multiple sclerosis (MS) who can walk at least eight meters with a walking aid to test the effectiveness of a five-week exercise program using assistive robotic technology. A patient completes balance and strengthening exercises using the…

In recognition of March as Multiple Sclerosis (MS) Awareness Month, the Multiple Sclerosis Association of America (MSAA) is calling attention to the disease’s impact on families. More specifically, the nonprofit organization is focusing its awareness campaign on the topics “Relationships and MS” and “Spotlighting Care Partner Needs,” according…

In the time necessary to perform a standard multiple sclerosis (MS) functional exam, gamified tests on a smartphone app provide much richer and reliable measurements of several distinct neurological functions, according to new data. These findings suggest that creatively-constructed smartphone apps may one day recreate entire neurological exams.

Women diagnosed with multiple sclerosis (MS) say they lack guidance regarding family planning, pregnancy, and breastfeeding, according to a survey. Sixteen percent of those women also reported they didn’t become pregnant due to MS-related concerns. Casey E. Engel,  clinical researcher at Weill Cornell Medical College in New York,  presented the…

Patients with a range of diseases and disorders, including multiple sclerosis (MS), report high satisfaction with botulinum toxin — also known as Botox (onabotulinumtoxinA) — as a treatment for spasticity, results from the ASPIRE clinical trial show. The data were presented last week by Daniel S. Bandari,…

Academic neurologists are seeing many patients with neurological diseases interested in or receiving unapproved stem cell-based treatments, sometimes with negative health and/or financial consequences, according to a U.S. survey of neurologists. The data were reported by Wijdan Rai, MD, from Ohio State University in a poster titled “Complications of Stem Cell…

Full results of a Phase 2 clinical trial testing TG Therapeutics’ lead candidate ublituximab (TG-1101) for relapsing multiple sclerosis (MS) showed that treatment for 48 weeks resulted in a marked reduction of brain and spinal cord lesions, an almost complete depletion of relapse-associated immune B-cells, and significantly halted disability…

The levels of epsilon toxin are increased in multiple sclerosis (MS) patients, and its presence in laboratory rodents replicated some aspects of disease activity, according to data presented at the 4th Annual Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum. The researchers suggested that the epsilon…

A method based on cerebrospinal fluid measurements and magnetic resonance imaging (MRI) can aid in stratifying patients with multiple sclerosis (MS) at the time of diagnosis, which may help identify a tailored therapeutic approach for each patient from early disease stages. The data was presented by Roberta Magliozzi, from…

Evobrutinib, Merck KGaA’s oral candidate for relapsing multiple sclerosis (MS), is safe and can significantly reduce active brain lesions over 24 weeks of treatment, results of ongoing Phase 2 study show. Xavier Montalban, PhD, MD, with Vall d’Hebron University Hospital in Barcelona, presented the results in the talk “Primary…

Two new magnetic resonance imaging (MRI) biomarkers — called central vein sign and paramagnetic rim sign — could be useful for differentiating true radiologically isolated syndrome (RIS) patients from those with mimicking features, new research shows. The findings were presented at the Americas Committee for Treatment and Research in Multiple…