SPMS

Novartis’ investigational oral treatment siponimod (BAF312) reduces the risk of disability progression in patients with secondary progressive multiple sclerosis (SPMS), a new analysis of Phase 3 trial results show. Using what the company describes as more accurate methods to assess siponimod effect’s on progression risk, necessary because the…

Investigational therapy ibudilast leads to a significant reduction of brain atrophy, supporting its potential to effectively treat progressive multiple sclerosis (MS), new data from a Phase 2 clinical trial show. These results will be shared at the upcoming 2018 Annual Meeting of the American…

Novartis‘ siponimod (BAF312) can reduce blood levels of a biomarker of nerve cell damage in patients with secondary progressive multiple sclerosis (SPMS), a Phase 3 clinical trial shows. Researchers will present the latest results of the ongoing trial at the 2018 annual meeting of the American Academy…

People with secondary progressive multiple sclerosis (SPMS) have more cognitive decline than those with relapsing-remitting MS (RRMS), according to a Greek study. The finding confirmed a long-held assumption that the more progressive form of the disease — SPMS — also involves more cognition problems. Some previous research has confirmed that…

Siponimod (BAF312) reduces the risk of disability progression in patients with secondary progressive multiple sclerosis (SPMS), a Phase 3 clinical trial shows. An article about the Novartis therapy’s trial results appeared in the journal The Lancet. The title is “Siponimod versus placebo in secondary progressive multiple sclerosis…

People with multiple sclerosis (MS) can indeed have a poorer-than-usual sense of smell, with problems possibly starting at early diseases stages, a small Turkish study reports. This work supports previous research noting olfactory problems in MS patients. It also argues that longer disease duration and more relapses are associated…

Non-Hispanic whites, especially females, are more likely to die from multiple sclerosis (MS) than any other racial group, though blacks tend to die earlier, concludes a study by researchers at the University of Southern California’s Keck School of Medicine. Their survey, “Multiple Sclerosis Mortality by Race/ Ethnicity, Age, Sex,…

Atara Biotherapeutics has received a green light to enroll U.S. patients into a Phase 1 trial of ATA188 for progressive or relapsing-remitting multiple sclerosis (MS). The study was initially launched in Australia, but with the U.S. Food and Drug Administration (FDA) having cleared the company’s application, the trial…

A Phase 3 clinical trial evaluating AB Science’s masitinib as a treatment for progressive multiple sclerosis can continue without having to add patients, an independent review board has decided. The decision indicates that the therapy has been effective enough that its population base does not need to be expanded, the…

Like a lot of people with MS, I took part in the “Great Ocrevus Rush of 2017,” with the fanfare surrounding the release of the first therapy in the United States known to have some ability to stem the advancement of primary and secondary progressive MS.

Blood levels of the nerve damage marker neurofilament light provide a reliable picture of multiple sclerosis activity in both the relapsing-remitting and progressive forms of the disease, a Swedish study reports. The University of Gothenburg researchers also discovered a close link between its levels in blood and spinal fluid. This means the…

Gilenya (fingolimod) lowered relapse rates in children and adolescents with relapsing multiple sclerosis at a “magnitude” — almost 82 percent — never before seen in a scientific study and could be “life changing” for these hard-to-treat patients, a top researcher with Novartis, the treatment’s developer, said in an…

A clinical study now enrolling people with progressive or relapsing multiple sclerosis (MS) will examine the feasibility of older patients stopping use of disease-modifying therapies if they have had no relapses for a number of years. John Corboy, with the University of Colorado School of Medicine, presented the study at…

Older patients with secondary progressive multiple sclerosis (SPMS) have reduced risk of experiencing disease relapse, according to a study presented at the 7th Joint ECTRIMS-ACTRIMS Meeting, being held Oct. 25-28, in Paris, France. The study, “Relapses in patients with secondary progressive MS: a matter of disease duration…

While Tysabri (natalizumab) failed to slow worsening disability in people with secondary progressive multiple sclerosis (SPMS) in a Phase 3 trial, researchers now suggest that the treatment did improve walking and arm function in people with advanced disability. Researchers presented new analyses of data from the ASCEND trial (…

MD1003, a high-dose biotin developed by MedDay, slowed or prevented further disease progression among progressive multiple sclerosis (MS) patients in a Phase 3 clinical trial, researchers announced at the Oct. 25–28 7th Joint ECTRIMS-ACTRIMS Meeting in Paris, France. The effects of the treatment were seen to be upheld over…

Sanofi Genzyme‘s Lemtrada (alemtuzumab) and Biogen’s Tysabri (natalizumab) are more effective in preventing conversion to secondary progressive multiple sclerosis (SPMS) compared to older injectable drugs, researchers from the University of Cambridge in the U.K. reported at the 7th Joint ECTRIMS-ACTRIMS Meeting Oct. 25-28 in Paris. The…

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…

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 —…

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.

Secondary progressive multiple sclerosis (SPMS) patients have larger quantities of certain antibodies to the stomach ulcer bacterium Helicobacter pylori than those with relapsing-remitting multiple sclerosis (RMSS), finds a Greek study which also showed that MS patients in general differ from healthy people in this aspect. Although researchers at the University of Thessaly think…

Children with multiple sclerosis consume less iron, which may affect their immune and nervous systems, according to a study. Most MS cases occur between the ages of 20 and 40, but sometimes children under 18 develop it. Pediatric-onset MS, as it is called, is believed to account for 3 to 5 percent of cases that adults have now. Despite their low frequency, they are important because "the study of factors early in life which could affect their disease may provide important insight into the disease more generally," the researchers from the Network of Pediatric MS Centers wrote. One of the factors that could be important in the onset of MS is diet. But little has been known about how diet influences the risk and progression of the disease, particularly in pediatric MS. In a study funded by the National MS Society, researchers decided to investigate the association between diet and MS in children, according to a press release. The team recruited 312 MS patients 18 and younger from 16 children's hospitals in the United States, and 456 controls without MS. The participants, or their parents, answered a questionnaire dealing with the participants' medical history, their physical development, and whether they were exposed to potentially harmful environmental factors. The questionnaire also covered demographic information and race. Researchers used the Block Kids Food Screener questionnaire to obtain information about the participants' diets, including their intake of fiber, fat, carbohydrates, proteins, fruits, vegetables, dairy products, and iron. The analysis showed no meaningful link between the consumption of fiber, fat, carbohydrates, proteins, fruits, vegetables, and dairy products and children's development of MS. Children with the disease did have lower iron intake than the controls, however. Although in this exploratory study researchers didn’t look at whether there was a cause-and-effect relationship between iron and MS, the results suggested that children with the disease may be less likely to consume iron, a fact that warrants further investigation. Iron is a vital mineral for our body to function properly, and low iron intake may affect the immune and nervous systems. Future studies on the risk of children developing MS should "investigate the role of specific vitamins and minerals," the team said. They should also "investigate the influence of dietary factors on disease outcomes in already established" cases of MS.

A new analysis of Phase 2 clinical data on Innate Immunotherapeutics’ investigational drug MIS416 to treat secondary progressive multiple sclerosis has confirmed that the drug failed to improve neuromuscular function or patient reported outcomes. The initial evaluation of data obtained from the one-year trial, announced in June, showed disappointing results. These results, gleaned from 70 patients who were randomly designated to receive either weekly injections of MIS416 or a placebo control, failed to demonstrate significant differences or clinically meaningful improvements in patients treated with MIS416 compared to those in the control group. After this initial setback, the Australian company sponsored an additional analysis of the trial results to identify any potential subgroup of clinical responders that could benefit from MIS416 and who might have been masked in the first population-based analysis. However, this post-hoc analysis also failed to show any positive effects of MIS416. Although the detailed report of this second analysis has not yet been released, the Sydney-based company conceded that the final outcome will not change. "All previous reports of MIS416 making a meaningful difference in the lives of many patients must either be dismissed as a very robust placebo effect or the trial failure is attributable to some other reason. It is my view that there may be other reasons," Innate CEO Simon Wilkinson said in a press release. "Patients with SPMS have a complex mix of symptoms and their disease can't be monitored by a simple blood test or MRI scan," he added. "We used the best assessment tools available as recommended by expert practitioners in MS, but we suspect they weren't sensitive enough to pick up the small but potentially significant changes that can lead to a substantial impact on patients' activities of daily living and quality of life." The lack of efficacy of MIS416 shown by the trial results is inconsistent with previous clinical experience, and the benefits reported by those receiving MIS416 for the past eight years.

Genentech shared new insights into the workings of Ocrevus (ocrelizumab) and its effectiveness in reducing disease activity and slowing progression in relapsing and primary progressive multiple sclerosis (MS) at the recent 3rd Congress of the European Academy of Neurology (EAN). The new findings, previously reported here, built on analyses of information gathered during the three Phase 3 clinical trials assessing Ocrevus' safety and efficacy, as well as through monitoring patients in extension studies. The studies showed that nearly 40 percent of Ocrevus-treated relapsing patients and nearly 30 percent of primary progressive patients achieved NEPAD during the Phase 3 trials. In contrast, only 21.5 percent of those treated with Rebif and 9.4 percent receiving placebo achieved NEPAD — figures that demonstrate Ocrevus’ impact on patients’ lives, as well as Ocrevus’ ability to slow the decline in walking ability and other types of disabilities are comparable between patients with relapsing and primary progressive disease — data that demonstrate that the treatment acts on disease mechanisms that drive disability in both disease forms. How these effects play out in the long-term is the subject of ongoing research, as Genentech continues to follow these patients in an extension study. In addition, Ocrevus' prescription label strongly advises against pregnancy while on the treatment. Despite precautions, some women became pregnant during the trials. One of the meeting presentations narrated outcomes of these pregnancies; one healthy baby born at term and two ongoing pregnancies in women exposed to the drug. But while Genentech monitors women who become pregnant while on Ocrevus, the number of reported pregnancies is too small to draw conclusions about the treatment’s safety in pregnancy, and researchers do not know if Ocrevus also depletes B-cells in the fetus or in the baby born to a treated woman.

The over-the-counter antioxidant lipoic acid slowed brain deterioration in patients with secondary progressive multiple sclerosis (SPMS), according to a pilot study. An Oregon Health & Science University research team conducted the study, “Lipoic acid in secondary progressive MS.” It was published in the journal Neuroimmunology and Neuroinflammation. A hallmark…

Innate Immunotherapeutics' MIS416 has failed to help secondary progressive multiple sclerosis (SPMS) patients in a Phase 2 clinical trial. The company said it will continue testing the therapy, made up of natural compounds, to see if it can benefit any MS subgroups. Trial participants who received MIS416 had no meaningful improvements in neuromuscular function or the outcome of their disease, compared with those who took received a placebo. “It is disappointing that these results don’t show benefit for people with secondary progressive MS, for whom there are few treatment options,” Dr. Bruce Bebo, executive vice president of research at the National MS Society, said in a news release. Scientists hoped the injected therapy would modulate the activity of immune cells that affect the protective myelin coating around nerve cells, decreasing the inflammation and brain tissue damage associated with MS. Deterioration of the coating is a hallmark of the disease. The one-year trial (NCT02228213) tested the safety and effectiveness of MIS416 on 93 patients with SPMS in Australia and New Zealand. The patients randomly received MIS416 or a placebo once a week. There were no differences in the groups' scores on a disability index — the expanded disability status scale — or in brain volume changes detected by magnetic resonance imaging. In addition, there were no differences between in disease outcomes that patients reported. The self-reported barometers included the Multiple Sclerosis Impact Scale, the Neurological Fatigue Index, and the Brief Pain Inventory. "I am extremely disappointed by this outcome," Professor Pam McCombe, a principal trial investigator, said in a company press release. "Looking for measurable changes in patients with progressive MS using the assessment tools currently at our disposal is frustrating and complicated. We were hopeful that MIS416 would be an option to treat this group of patients who currently do not have effective treatment options." In addition to MIS416 failing to be effective, the group who received it had more treatment-related adverse events than the placebo group. The events were mainly related to the first dose, Innate said. The main problems were fever, chills, and muscle weakness. The company has been providing MIS416 to Australian MS patients under a compassionate use program. It said it will continue evaluating the safety and tolerability of the drug to see if it helps any subgroups of patients. Those findings will determine the future of the compassionate use program, it said. “These results are a shock, and definitely not what we were expecting based on our previous clinical experience with MIS416 and the reporting of treatment benefits we have received from many compassionate use patients over an extensive eight-year period," said Simon Wilkinson, Innate Immunotherapeutics' chief executive officer. "These data will be as distressing to them as they will be for all the stakeholders who were relying on the outcome of this study."

Fatigue and limited leg function are more common among older people with progressive multiple sclerosis than in those with relapsing forms of the disease, according to a study. In fact, they are a sign that the disease of a person with relapsing MS is becoming worse by reaching the progressive MS…

Patients with secondary progressive multiple sclerosis (SPMS) have a higher burden of illness than patients with relapsing-remitting multiple sclerosis, a new study showed. The study, “Characteristics, burden of illness, and physical functioning of patients with relapsing-remitting and secondary progressive multiple sclerosis: a cross-sectional US survey,” appeared  in…

Older patients with secondary progressive multiple sclerosis (SPMS) as well as older relapsing patients whose MS has been inactive after five years may safely discontinue their treatments, Canadian researchers at Vancouver’s University of British Columbia argue. Their Sanofi Genzyme-sponsored study, “When Should Disease-Modifying Treatments Be Discontinued in Patients with Multiple Sclerosis: An…

Long-term therapy with Tysabri (natalizumab) significantly improved the mental state of people with secondary progressive multiple sclerosis (SPMS), according to results of a Biogen-supported study with patients taking the drug for almost two years. Biogen presented the study, “The Impact of Natalizumab on Health-Related Quality of Life in Patients with Secondary Progressive…