Active Biotech acknowledged in an update on laquinimod, the oral small molecule being developed by Teva Pharmaceutical Industries to treat multiple sclerosis (MS) and Huntington’s disease (HD), that the U.S. Food and Drug Administration (FDA) has rescinded the special protocol assessment given to a Phase 3 study of the treatment in…
News
StemGenex CSO Tells FDA at Hearing to Regulate Adult Stem Cell Therapies as ‘Blood Tissue Product’
In a presentation at a U.S. Food and Drug Administration (FDA) public hearing earlier this month, the chief scientific officer of StemGenex Medical Group, Steven A. Brody, MD, PhD, said succinctly: “Stem cells have arrived and have captivated the scientific and medical communities. With this excitement comes responsibility and with this…
Results from the ORATORIO trial, exploring Ocrevus (ocrelizumab) for the treatment of primary progressive forms of multiple sclerosis (MS), showed that the drug stopped disease progression for more than two years in more patients than a placebo. The findings, a highlight at the European Committee for Treatment and Research…
Progressive MS Alliance Awards $18M to 3 Research Projects into Disease Treatments, Expanded Testing
The International Progressive Multiple Sclerosis (MS) Alliance, a worldwide group of MS organizations that support research efforts, has awarded three, four-year grants — called Collaborative Network Awards, and worth $6 million each — to speed work into potential treatments for progressive MS. Found in about 15 percent of all initially diagnosed…
A newly discovered potential biomarker of multiple sclerosis (MS) may help to distinguish between people who will go on to have less severe disease and those in whom the disease will progress, researchers at Linköping University in Sweden report. The biomarker’s discovery came through an investigation into the immune system of MS…
Results from the extension period of a Phase 2 trial, assessing ozanimod as a potential treatment for relapsing-remitting multiple sclerosis, showed that the drug can effectively and safely improve clinical measures of RRMS after two years of treatment. The announcement was made by Celgene International Sàrl, a subsidiary of Celgene Corporation,…
Researchers showed that it could be possible to treat and cure inflammatory diseases such as multiple sclerosis (MS) by injecting a single dose of biodegradable polymer particles containing myelin self-antigen into the lymph nodes.
The U.S. Department of Health and Human Services (HHS) recently announced policy changes designed to make information about clinical trials of investigational drugs, biologics and products more widely available to the public, issuing amended rules that specify the requirements for registering clinical trials and for submitting summary results to its ClinicalTrials.gov website. The…
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.
Lemtrada (alemtuzumab) as a first treatment option for relapsing multiple sclerosis (MS) patients reduced relapse rates and disability progression throughout a study period of six years — although most patients received treatment only in the first two years. The study showed that Lemtrada has the potential to harness disease activity…
#ECTRIMS2016 – Few Serious Autoimmune Reactions to Lemtrada Treatment Seen in 3 MS Clinical Trials
Autoimmune side effects during five years of Lemtrada (alemtuzumab) treatment were generally not serious and mainly affected the thyroid, according to an analysis of patients in three large, Phase 3 clinical trials of the therapy. The data were presented at the Free Communications 1 session of the European Committee…
A recent study showed that after one year, the majority of multiple sclerosis (MS) patients taking oral Gilenya (fingolimod) therapy stuck with their treatment, while a large proportion of those using injectable disease-modifying drugs did not. The data, presented at the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) 2016…
Accelerated Cure Project is still recruiting for its iConquerMS project, REAL MS, an already 3,000-strong patient-powered research network for people with multiple sclerosis (MS). REAL MS (Research Engagement About Life with Multiple Sclerosis) is a longitudinal research study, designed partly by MS patients themselves, intending to answer critical questions about individual experiences of living with MS from among a large and heterogeneous group…
Novartis recently announced positive results from the ACROSS study, which is assessing the clinical effect of Gilenya (fingolimod) in 10-year disability outcomes in people with relapsing-remitting multiple sclerosis (RRMS). The results were presented at the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) Sept. 14-17 in London. The ACROSS study…
GeNeuro announced that it has reached — more quickly than expected — the halfway mark for patient enrollment in its Phase 2b study, CHANGE-MS, assessing GNbAC1 as a therapy for relapsing-remitting multiple sclerosis (RRMS). Patient recruitment is continuing at sites across Europe. The company also reported on the trial’s design in a poster presentation, “A placebo…
A recent study showed that the clinical benefits offered by Ampyra (fampridine) in improving mobility among multiple sclerosis (MS) patients has clinical significance. The results were shown in an oral presentation, “Sustained clinically meaningful improvements in walking ability with prolonged-release fampridine: results from the placebo-controlled ENHANCE study,” at the European Committee for…
A five-year study comparing the efficacy of different treatments for relapsing-remitting multiple sclerosis (RRMS) found that, in general, Lemtrada (alemtuzumab) and Tysabri (natalizumab) are more effective as therapies than Gilenya (fingolimod) and interferon β. Study results were presented in an oral presentation, “Comparison of 5-year treatment outcomes between alemtuzumab versus natalizumab, fingolimod and interferon β-1a,”…
In a large nationwide study in Finland, researchers found evidence supporting the link between vitamin D deficiency and an increased risk for multiple sclerosis (MS) in women. The results were given in an oral presentation, “Serum levels of 25-hydroxyvitamin D and risk of multiple sclerosis among women in the Finnish Maternity Cohort,”…
#ECTRIMS2016 – Sanofi Releases Patients’ Views of Aubagio as Effective Treatment for Relapsing MS
Sanofi Genzyme presented positive results from its Phase 4 study into patient-reported assessments of Aubagio (teriflunomide), an approved oral treatment for relapsing forms of multiple sclerosis (RMS). Real-world patient responses were reported at the 32nd Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), recently held in London. The clinical…
Preliminary results of a study in Danish patients with multiple sclerosis (MS) suggest that inverse comorbidity may exist in the MS population, lowering patients’ risk for other types of diseases. The results were given in an oral presentation, “Inverse comorbidity in multiple sclerosis. Findings in a complete nationwide cohort,” at the 32nd Congress of the European…
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”…
#ECTRIMS2016 – Data on Merck Treatment for Relapsing MS, Cladribine Tablets, Show Long-Term Benefit
Merck recently presented new efficacy data from its three Phase 3 clinical trials, showing that a relatively short course of treatment with Cladribine tablets led to long-term reductions in annualized relapse rate (ARR) in people with relapsing multiple sclerosis (RMS). The data were given in two oral presentation at the 32nd Congress of the…
There might be years-long lags in response to disease-modifying drugs in patients with progressive forms of multiple sclerosis (MS), according to a study that analyzed data from two large clinical trials of progressive MS patients. The study fuels the idea that clinical trials of disease-modifying drugs for progressive MS need…
Here’s my Pick of the Week’s News as published by Multiple Sclerosis News Today. #ECTRIMS2016 was undoubtedly the star of the week ECTRIMS, the European Committee for Treatment and Research in Multiple Sclerosis, dominated the news stories of the week when it held its 32nd congress in London. There…
#ECTRIMS2016 – Poor Medication Adherence in Pediatric MS Patients Linked to Fatigue, Lack of Routine
Children with multiple sclerosis (MS) in North America identified a number of challenges in adhering to disease-modifying therapies — a potential first step to devising therapeutic approaches that might improve adherence to MS medications among young patients and, subsequently, disease outcomes in these children. The results were presented in the talk, “Medication adherence in…
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…
Biogen and AbbVie presented positive new post-hoc analysis from the pivotal DECIDE clinical trial, which showed that a significantly larger number of relapsing multiple sclerosis (RMS) patients treated with Zinbryta (daclizumab) had no evidence of disease activity (NEDA) compared to those treated with Avonex (interferon beta-1a). The data were given at the recent 32nd Congress of the European…
Patients with relapsing-remitting multiple sclerosis (RRMS) might benefit from cholecalciferol (vitamin D3) oil as an add-on therapy in the early phases of the disease. This finding was presented in an oral presentation, “High dose cholecalciferol (vitamin D3) oil as add-on therapy in subjects with relapsing-remitting multiple sclerosis receiving subcutaneous interferon β-1a,” given at the 32nd…
Long-term observations together with mathematical modeling present a way of predicting the likely disability trajectory of multiple sclerosis (MS) patients. The approach was outlined in a presentation, titled “Long-term disability trajectories in primary progressive MS patients – a latent class growth analysis,” given at the 32nd Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), held in London…
A high fraction of patients with multiple sclerosis (MS) who underwent a transplant with their own bone marrow stem cells after immunosupression therapy, show no signs of disease activity after treatment, according to a new study. The results were presented in a talk, “Clinical experience in aggressive multiple sclerosis treatment with…