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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.

The majority of people living with multiple sclerosis who use wheelchairs or scooters for mobility reported falling at least once over a six-month period, according to a new study. While most studies have focused on ambulatory MS patients, this may be the first study to assess the prevalence and circumstances of falls among those who already experience significant mobility issues and require the use of wheelchairs or scooters to get around. In ambulatory MS patients who are able to move around on their own, about 50 percent reported falling during a six-month period. The current study recruited 44 MS patients from May 2014 to July 2015 who required wheelchairs or scooters to move about. These patients were from medical centers across the United States and Asia. They were asked to complete a survey focusing on the prevalence of falls, the frequency of injuries, the circumstances surrounding the falls, and quality-of-life indicators. Thirty-three of the 44 participants (75 percent) reported falling at least once in the previous six months. This number is higher than any of the other studies that assessed the prevalence of falls in MS patients. Many of these people experienced more than one fall within those six months. Of these falls, 87.5 percent occurred inside the home. The top four activities reported by participants that led to these falls included using the toilet, transferring, walking short distances, and reaching for an object. Some of the people said the falls were serious, and 8 percent of participants reported an injury because of their fall. Perhaps for this reason, many reported concerns about falling (76.7 percent). And, more telling, 65.9 percent of these MS patients reported altering their activities because they feared falling. The use of mobility devices may affect the prevalence of falls. Participants were asked if they had fallen using a specific mobility device. Here is how they responded: 66.7% reported falling while using power wheelchairs; 37.5% fell while using manual wheelchairs; 66.7% fell when using scooters; 71.4% reported falling while using a walker; 100% fell while using a cane. Because of the high prevalence of falls while using a mobility device, researchers said, clinicians should provide better education regarding the use and function of these mobility devices. There were no significant correlations between people who experienced falls and quality-of-life indicators in this study. Results from the study highlight the need for interventions specifically targeted for MS patients who use mobility devices such as wheelchairs and scooters. The body of research regarding predictors of falls suggest that some of the risk factors can be modified; therefore, more effort should be made to prevent falls using targeted rehabilitation interventions.

Opioid growth factor (OGF) can serve as a new biomarker to determine diagnosis and progression of multiple sclerosis (MS), say researchers at Pennsylvania State University. Their study, “Serum [Met5]-enkephalin levels are reduced in multiple sclerosis and restored by low-dose naltrexone,” appeared in the journal Experimental Biology and…

Active brain inflammation appears to be one of the causes driving anxiety and depression in patients with relapsing-remitting multiple sclerosis (RRMS), finds an Italian study published in the journal Neurology. RRMS is the most common form of the disease when patients are initially diagnosed. Multiple sclerosis patients…

April and Bernie Hester are busy planning their second 500-mile thru-hike of South Carolina's Palmetto Trail, which they will begin on Oct. 1 to raise awareness for multiple sclerosis and funds for the National MS Society. Thousands of people hike parts of the trail every year, but few do the entire 500-mile hike, said Suzette Anderson, of the Palmetto Conservation Foundation (PCF), an organization dedicated to conserving South Carolina's natural and cultural resources. The couple's "Finish MS Hike" is the second time they'll be hiking the full trail this year. In April they started hiking from the sea and 66 days later completed the trail in the mountains. This time they'll start in the mountains and end at the sea. The couple will traverse over mountains, on trails, through cities, and on roadways. April, who has MS, is hoping that her efforts will bring much-needed awareness to the condition and that the pair can reach their goal of raising $100,000 for MS research toward a cure. Their effort, combined with the debilitating effects of MS, are among the reasons why April and Bernie Hester were recognized as trail ambassadors by the PCF. The couple will post regular updates on their “Finish MS Hike” blog and Instagram account, to allow people to follow their adventures, read about their journey, and gain insight as they face and conquer challenges along the way. The couple has already written a few entries to keep their audience informed. The Palmetto is the longest trail and largest trail construction project in South Carolina. Today, the trail crosses the state from Walhalla in the mountains of Oconee County to Awendaw on the coast in Charleston County. Another 150 miles in the Midlands and Upstate remain to be acquired and constructed. To help raise money to "Finish the Trail," the PCF and RJ Rockers Brewing Company have combined their passions for trekking and craft beer to create Palmetto Trail Pale Ale. A portion of sales goes to support and finish the Palmetto Trail. You can buy Palmetto Trail Pale Ale at any of the following locations: RJ Rockers Brewery, Craft and Draft, Texas Roadhouse, Thirsty Fellow, Flying Saucer, Capital City Club, Triangle Char+Bar, Bohemian Bull, Publico Kitchen & Tap.

Relapsing-remitting multiple sclerosis (RRMS) patients accurately report the use of the RebiSmart autoinjector to their neurologists, a questionnaire-based study has found. The Phase 4 noninterventional CORE study also suggests that being knowledgeable about RebiSmart is a key factor in improving usage in younger patients and those with lower disability levels.

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…

Behavioral therapy focusing on goal attainment might reduce cognitive fatigue in multiple sclerosis patients, finds a study that used brain imaging to examine goal-oriented tasks involving rewards. Since fatigue is one of the most common MS symptoms, affecting up to 90 percent of patients, researchers at the Kessler Foundation in East Hanover, New Jersey, say their findings could open the door to new non-medication approaches to treating MS-related fatigue. Scientists believe that a part of the brain, called the fronto-striatal network, causes fatigue. But studies also show that the network is active during goal attainment tasks, and that such tasks can reduce fatigue in healthy people. Equipped with this knowledge, Kessler researchers recruited 19 MS patients and 14 healthy controls, and exposed them to one of two conditions. In the first, they had the chance to win money while gambling. Researchers called this the outcome condition. The second condition did not include the prospect of a reward, or outcome. The tasks were performed in a brain scanner. Using functional magnetic resonance imaging of the brain — a method that tracks brain activity by monitoring blood flow — researchers could study how different tasks activated the fronto-striatal network. It turned out that the prospect of a reward activated parts of the network in deep brain structures, while parts of the prefrontal cortex were more active during the task without a potential reward. Importantly, the activation seen during the reward condition was linked to significantly lower levels of fatigue, which researchers measured outside the scanner. While researchers used a gambling task to study the process, similar exercises like achieving a good score on a test, might work equally well, researchers said. In fact, goal attainment is already incorporated in many neuropsychological rehabilitation efforts, including in MS.

Today is Falls Prevention Awareness Day, an annual campaign that occurs every Sept. 22 to encourage multiple sclerosis patients and others prone to falls to give a little extra thought on how to identify factors for falls. The event, coordinated by the National Council on Aging, will be the 10th in an annual series that has taken place since 2007. The National Multiple Sclerosis Society is contributing to the event by presenting research into MS-related falls, as well as resources to identify risk factors of falling. Research shows that 50 to 70 percent of MS patients report falling at least once over a six-month period, with about 30 percent falling several times. Many people with MS also get injured when they fall, adding significantly to the burden of MS. Studies show that typical MS symptoms, such as poor gait and balance, or the loss of proprioception — the perception of where body parts are in a space — contribute to falls in MS, which typically occur while doing everyday activities at home. To better understand why people with MS fall, and how to best prevent it, current research focuses on better detection of falls. One approach is to use automatic fall detection devices, which patients can wear. A 2015 symposium on gait and balance in MS focused specifically on falls. The meeting concluded that although knowledge and prevention strategies have improved, much remains to be done. In that regard, the International MS Fall Prevention Research Network helps researchers collaborate on falls research. But neurological symptoms are not the only factors at play. Psychological issues make up another area in the risk spectrum, says the NMSS. Fear of falling or overconfidence both contribute, as does inactivity. Besides the guide, the NMSS has also developed the Free From Falls program, containing eight modules with webinars, downloadable educational material and video-guided exercises. These materials teach patients about biological, behavioral and environmental risk factors for falling, while also offering tips and strategies that may reduce the risk of falls.

Two molecules known to regulate cellular signaling contribute to the underlying mechanism of progressive multiple sclerosis, found a recent study conducted by investigators at Oregon Health & Science University and Yale University School of Medicine. These two proteins are related to each other, as they participate in the same cellular signaling process that regulate the immune system's response. Previous studies have blamed them for the worsening of several autoimmune and inflammatory disorders including rheumatoid arthritis, systemic sclerosis and systemic lupus erythematosus. The research team found that patients with progressive MS had higher levels of MIF and D-DT proteins than those with the relapsing-remitting form of the disease. In addition, these proteins inflamed the central nervous system, making patients sicker. An analysis of the genes that encode the proteins revealed that higher levels of MIF were linked to the presence of two genetic variants that are more frequent in patients — particularly males — with progressive disease. Researchers confirmed their findings with animal models of MS-like disease that were genetically engineered to lack MIF and D-DT proteins. Taken together, this finding suggests that a simple genetic test could identify patients carrying the MIF genetic susceptibility — and therefore more likely to develop a severe form of MS. This study was partially funded by the National Institutes of Health, the National Multiple Sclerosis Society, the Rocky Mountain MS Center Tissue Bank and the U.S Department of Veterans Affairs.

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…

The life science tech company IQuity has begun taking orders from physicians for an RNA-based blood test that can provide reliable yes or no results for multiple sclerosis in seven days – dramatically faster than previous options, which took months or years. The test, IsolateMS, can be a game-changer in…

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…

Women with low levels of vitamin D in their blood are more likely to develop multiple sclerosis (MS) later in life, finds a large-scale study on women in Finland. The study, “25-Hydroxyvitamin D deficiency and risk of MS among women in the Finnish Maternity Cohort,” appeared in the journal…

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…

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…

Specific gut bacteria may drive the progression of multiple sclerosis, according to a study showing that two bacterial species made the disease worse in a mouse model of MS. Researchers at the University of California, San Francisco also pinpointed a species — found in lower numbers in MS patients —…

Patients with primary progressive multiple sclerosis have more severe cognitive impairment than those with relapsing-remitting multiple sclerosis, according to a German study that analyzed published data on the topic. PPMS patients did especially poorly on verbal learning and verbal memory tests, said the study, which suggested that PPMS patients need disease management that specifically focuses on their cognitive difficulties, which do not necessarily correlate with the degree of overall disability. The study gathered data from 47 previously published studies in an attempt to analyze potential differences in cognitive performance between patients with RRMS and PPMS. These studies included 4,460 patients — 3,456 with RRMS and 1,004 with PPMS — and plenty of information about patient and disease features. This allowed researchers to perform a meta-analysis of pooled data from various studies, that is considered the highest level of scientific evidence. Researchers noted that PPMS patients performed worse on cognitive tests, both when considering global scores and tests of specific cognitive domains. Yet both groups scored similarly in levels of anxiety, depression and fatigue. Using statistical analyses, the research team found that differences in sex, education, disease duration, manual dexterity and fatigue could not explain the poorer test results among PPMS patients. On the other hand, PPMS patients were, on average, older than those with relapsing disease, and the team found that this difference accounted for poorer test results in cognitive tests of processing speed and working memory. Yet differences in other cognitive aspects also remained when researchers took age into account. Differences in disability, measured by the Expanded Disability Status Scale, could also not explain why PPMS patients performed worse on the cognitive tests. A detailed look revealed that the largest differences between RRMS and PPMS patients were in verbal learning and verbal memory, along with the age-associated difference in processing speed. Depression and anxiety also brought down processing speed, researchers said, even though the two groups did not differ in their levels of anxiety and depression. The data shows that cognitive impairment in MS is not directly related to the course of the disease. Research may explain differences in other factors including genetics, the degree of brain tissue loss and medications.

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…

Having a concussion when you’re 11 to 20 years old could increase your risk of developing multiple sclerosis later, a Swedish study suggests. The collaboration between Örebro University and Karolinska Institutet showed that a concussion in adolescence raised the risk of developing MS by 22 percent. Two or more concussions…

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…