SPMS

The types of brain and spinal cord inflammation patches that occur in a precursor condition to multiple sclerosis help determine whether a person develops MS in the next 15 years, a British neurologist reported today. Wallace J. Brownlee of the University College London Institute of Neurology made the observation in…

Five clinics in the Washington area that specialize in administering intravenous and injected treatments to people with chronic diseases are now offering the new multiple sclerosis therapy Ocrevus (ocrelizumab). Arise Infusion Therapy Services said its staff is helping patients manage the authorization process that many insurers require before agreeing to cover…

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.

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…

A high daily dose of simvastatin improves multiple sclerosis patients’ cognitive function, according to a new analysis of Phase 2 clinical trial results. The British team that did the research will start a study soon on whether simvastatin, which goes by the brand name Zocor and other labels, can also slow…

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…

The National Multiple Sclerosis Society (NMSS), together with its British partners, plans to launch a Phase 3 trial in the next few months to investigate whether simvastatin — a cheap drug that controls cholesterol levels — may be a suitable treatment for people with secondary progressive multiple sclerosis (SPMS). The trial,…

Siponimod slows the progression of multiple sclerosis patients’ disability, a Phase 3 clinical trial indicates. The therapy reduced the risk of disability progression in patients with secondary progressive multiple sclerosis (SPMS) by 21 percent over three months, researchers said. At six months, the reduction was 26 percent, they said. Researchers…

An investigational treatment called ATA188 that wipes out B-cells targeting the Epstein-Barr virus (EBV) has shown promise as a multiple sclerosis treatment, a Phase 1 clinical trial involving a small patient group indicates. The trial, conducted in Australia, covered six people with primary or secondary progressive MS. B-cells are a…

People with secondary progressive multiple sclerosis (SPMS) are more likely to feel exhausted and have limited leg function than those without progressive MS as they age, a preliminary study suggests. The findings will be presented at the American Academy of Neurology (AAN) 69th Annual Meeting, set for April 22-28 in Boston.

Australia’s Innate Immunotherapeutics confirmed that its Phase 2b clinical trial evaluating the drug MIS416 in patients with secondary progressive multiple sclerosis (SPMS) will wrap up by April 30, as scheduled, and data is expected to be release in the fall. MIS416 is a biologically derived new immune modulator that can…

Stem cell transplants are most effective if done in young multiple sclerosis (MS) patients in early disease stages, who have not gone through several rounds of other treatments, according to a large study that followed transplant patients for more than five years. Study results also found that people with relapsing MS are much…

Gilenya (fingolimod) a multiple sclerosis (MS) drug developed to target the immune system and control inflammation, can also reduce the negative action of astrocytes, further controlling inflammation, says a new study. The article, “Sphingosine 1-Phosphate Receptor Modulation Suppresses Pathogenic Astrocyte Activation and Chronic Progressive CNS Inflammation,” appeared in the…

Cyclophosphamide (CPM) may delay the progression of disability in the first years of secondary progressive multiple sclerosis (SPMS), but patients must take it for two years — and many are unlikely to tolerate it for that long. The study, “Double-Blind Controlled Randomized Trial of Cyclophosphamide versus Methylprednisolone in Secondary Progressive…

A presentation at the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) 2016 Congress gave patients with progressive multiple sclerosis (MS) a reason for optimism, as Novartis reported that siponimod (BAF312) reduced the risk of disability progression in a Phase 3 study of patients with secondary progressive (SP) MS.

A pilot study exploring the antioxidant lipoic acid in patients with secondary progressive multiple sclerosis (SPMS) demonstrated that treatment for two years reduced the speed of brain tissue loss and improved the patients’ walking speed. The surprising finding was presented during the “New directions in progressive MS research”…

The presence of certain brain and spinal cord lesions can be used to predict if an MS patient with clinically isolated syndrome will progress into relapsing or secondary progressive multiple sclerosis (SPMS) within 15 years. Researchers agree that knowing which patients who will rapidly deteriorate will help physicians tailor both…

Immune activity in brain membranes may be the key to determining inflammatory profiles in the brain. These profiles, in turn, are linked to levels of brain gray matter damage, and to disability, in both early and later stages of multiple sclerosis (MS). Researchers behind the study, which was presented during the Parallel…

Patients with secondary progressive multiple sclerosis (SPMS) who were treated with BAF312 (siponimod), a sphingosine-1-phosphate (S1P) inhibitor, in a Phase 3 clinical trial showed a  significantly reduced risk for disability progression compared to placebo, Novartis recently announced. BAF312 is a selective modulator of specific types of the S1P receptor. This receptor is…

RedHill Biopharma announced that the final patient has completed the last step of its Phase 2 clinical study (CEASE-MS) of RHB-104 as a potential treatment for people with relapsing-remitting multiple sclerosis (RRMS). RHB-104 is an antibiotic oral medication that blocks inflammation in addition to killing bacteria. RHB-104 was originally developed as a treatment for…

An immunologist at Victoria University of Wellington is leading a clinical trial that will use existing drugs in a new way to try to treat secondary progressive multiple sclerosis (SPMS), a disease form that affects more than one-third of all multiple sclerosis patients but has no effective treatment options. Anne La Flamme, a professor…

Innate Immunotherapeutics, Ltd., announced that it has completed patient enrollment in its ongoing Phase 2B, placebo-controlled clinical trial assessing the efficacy and safety of the drug MIS416 as a once-weekly treatment for secondary progressive multiple sclerosis (SPMS). MIS416 is a biologically derived immune modulator that targets myeloid cells, a subset of innate immune cells that can…

PJSC Pharmsynthez, a pharmaceutical company based in Russia, recently announced completed follow-up findings and data analysis from a Phase 2a proof-of-concept clinical trial of its novel therapeutic vaccine Xemys for the treatment of multiple sclerosis (MS). Xemys utilizes Xenetic Biosciences patented ImuXen technology. In the open-label, dose-escalating trial, 20 patients…

MediciNova, Inc., announced that MN-166 (ibudilast) has been approved for “fast track” development by the U.S. Food and Drug Administration (FDA) as a potential treatment for progressive multiple sclerosis (MS). Progressive MS includes both the primary progressive (PPMS) and secondary progressive (SPMS) forms of the disease. MediciNova’s MN-166 was licensed from Kyorin Pharmaceuticals for its potential…

Dr. Wayne Moore, from the University of British Columbia and the Vancouver General Hospital, will present an overview and analysis of the major histology and pathology aspects that characterize and differentiate relapsing-remitting multiple sclerosis (RRMS) and progressive forms of the disease, primary progressive MS (PPMS) and secondary progressive MS (SPMS).

At the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum 2016, being held from Feb. 18–20 in New Orleans, LA, researchers have gathered to discuss “Progressive MS: Bench to Bedside and Back,” the meeting’s theme. Secondary progressive multiple sclerosis (SPMS) is one of four types of MS, and is…

Scientists from the Neuroimmunological Diseases Unit at the National Institutes of Health (NIH) will present results of a study investigating several biomarkers that might lead to a more sensitive and accurate diagnostic test of central nervous system (CNS) inflammation, a key aspect of progressive multiple sclerosis (MS). The data is being reported today, Feb.18, at the…