RedHill Biopharma, Ltd. recently announced promising interim results from its ongoing CEASE-MS Phase 2a clinical trial evaluating the safety and efficacy of a fixed dose of RHB-104 as an add-on therapy for the treatment of relapsing-remitting multiple sclerosis (RRMS). RHB-104 consists of an oral capsule formulation of an antibiotic combination therapy —…
clinical trials
Several clinical trials have shown that alemtuzumab (Lemtrada) effectively reduces relapse rates in patients with multiple sclerosis (MS), and improves disability in the early stages of the disease. A new study adds to evidence of the drug’s efficiency by finding that it affects different aspects of disability to varying degrees, a finding…
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…
The United Spinal Association, a nonprofit focused on improving the quality of life of people with spinal cord injuries and disorders (SCI/D), a group of conditions that include multiple sclerosis (MS), is collaborating with MedStar National Rehabilitation Hospital and Children’s National Medical Center to study the potential benefits of the bacteria…
Clinical trials have shown that ocrelizumab — an antibody targeting B-cells — is effective in multiple sclerosis (MS). As a result, some researchers and clinicians claim that B-cell depletion is a sufficient therapy in MS, and that drugs targeting other immune cells are obsolete. Not everyone agrees. A debate at…
Researchers at the National Institutes of Health (NIH) announced that a small clinical trial of a progressive multiple sclerosis (MS) treatment was stopped early due to poor results. The trial was evaluating the drug rituximab for its efficacy in depleting harmful immune cells and decreasing nerve damage in these MS…
Relapsing MS Treatment Showing Efficacy in Phase 2 Extension Study, Celgene Reports at ACTRIMS 2016
Celgene Corporation announced the results from an extension study of the RADIANCE Phase 2 clinical trial evaluating ozanimod in patients with relapsing multiple sclerosis (MS). The results were also presented at the recent Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum 2016 in New Orleans, Louisiana. Ozanimod is a small…
Genentech recently announced that the U.S. Food and Drug Administration (FDA) granted its investigational medicine ocrelizumab, a potential treatment for primary progressive multiple sclerosis (PPMS), Breakthrough Therapy Designation based on positive Phase 3 clinical trial results showing that ocrelizumab significantly reduced disability progression and other disease activity markers compared to placebo. The FDA designation is…
A new multiple sclerosis (MS) clinical trial being led by Case Western Reserve University investigators is now recruiting 215 individuals, across 10 U.S. states to assess whether the fatigue management and physical activity interventions often provided by rehabilitation centers can effectively be offered by telehealth, through a series of teleconferences and phone interviews. An National MS…
Synthetic Biologics, Inc., a clinical stage company focused on the development of therapeutics to protect the microbiome and to target disease-causing pathogens, recently announced disappointing results from an independent third-party analysis of a Phase 2 clinical trial evaluating Trimesta as a treatment for relapsing-remitting multiple sclerosis (RRMS) in women.
In a new study, researchers at the Scripps Research Institute (TSRI) uncovered the molecular mechanisms behind the perceived clinical efficacy of a specific drug type, sphingosine 1-phosphate receptor 1 (S1PR1) agonists, to diminish the harmful immune response that leads to autoimmunity in multiple sclerosis (MS) and other diseases, while still preserving the immune system’s…
Clinical trials suggest that hematopoietic stem cell transplantation (HSCT), a common treatment for bone marrow and blood cancers, could also help people with multiple sclerosis (MS). The technique involves harvesting new, undeveloped blood or bone marrow (hematopoietic) cells, typically from the person affected with the disease (autologous). The goal is to…
The U.S. Food and Drug Administration (FDA) will hold a one-day public hearing on four recent draft guidelines regarding the regulation of human cells, tissues, or cellular or tissue-based products (HCT/Ps). Critics of the proposed regulations warn that they curtail the medical use of autologous cell therapy and biologics, and their future potential…
The Tisch MS Research Center of New York (Tisch MSRCNY) recently announced that its stem cell-based therapy as a potential treatment for multiple sclerosis (MS) will move into Phase 2 clinical testing after encouraging results in a Phase 1 trial, and on the advice of the U.S. Food and Drug…
Recently, Biogen released results from its Phase 2 acute optic neuritis (AON) RENEW trial which tested Anti-LINGO-1. Learn more about this results here. So what is Anti-LINGO-1? According to the MS Society, Anti-LINGO-1 (also known as BIIB033) is a treatment in development by the pharmaceutical company Biogen which is currently…
Tiziana Life Sciences, plc, a biotechnology company specializing in drugs to treat immunological and oncological diseases, recently announced its intent to further develop foralumab, a fully human monoclonal antibody targeting the CD3 receptor. This approach, aiming to modulate the immune T cell response and achieve immunosuppression, is well-validated and has the potential to…
New research evaluating fingolimod’s clinical efficacy, safety, and tolerability in patients with relapsing-remitting multiple sclerosis (RRMS) largely supported its use, finding that the oral drug’s efficacy in a real-world setting was comparable to results observed in Phase 3 clinical studies. The research article, “Efficacy and Safety of Fingolimod in an Unselected…
MedChew Rx, by AXIM Biotechnology, the world’s first patented cannabinoid release chewing gum for pain and spasticity in multiple sclerosis (MS), is moving into clinical testing. If all goes well, the company plans for a global release date of 2017. Medical cannabis is believed to have considerable promise as a therapy for…
Teva Pharmaceutical Industries Ltd. and Active Biotech have discontinued the use of higher doses of the drug laquinimod in two ongoing multiple sclerosis (MS) studies. The decision was based on a recommendation by the Data Monitoring Committee (DMC) that is supervising the clinical trials after cardiovascular events, none of which were fatal,…
GeNeuro, a company developing therapies for neurological and autoimmune disorders, recently announced the initiation of a Phase 2b clinical trial to assess its lead investigational antibody GNbAC1 in patients with relapsing-remitting multiple sclerosis (RRMS). The trial, called “CHANGE-MS,” plans to enroll 260 patients across 68 centers across the European Union and…
RedHill Biopharma, Ltd., recently announced the conclusion of the last dosing and patient follow-up visit for its Phase 2a proof-of-concept study to assess the efficacy and safety of the experimental drug RHB-104 as an add-on therapy to interferon beta-1a in patients with relapsing-remitting multiple sclerosis (RRMS).
Synthetic Biologics, which specializes in the development of therapies for pathogen-specific diseases, recently announced the publication of new and positive data on results from a Phase 2 clinical trial evaluating the company’s product Trimesta™ as a treatment for relapsing-remitting multiple sclerosis (RRMS) in women. Professor Rhonda Voskuhl, director of the Multiple Sclerosis Program…
The National Multiple Sclerosis Society recently announced that a research team is recruiting 132 patients with a diagnosis of neuromyelitis optica spectrum disorders (NMOSD) for a Phase 3 clinical study comparing an experimental medicine with an inactive placebo. NMOSD is a rare disorder caused by immune system cells attacking…
MyTomorrows, a company that provides information and facilitates requests regarding clinical trials, diagnostic tests and medicines through its internet-based platform, and Hemispherx Biopharma, Inc, a pharmaceutical company specialized in the development of new therapies for life-threatening disorders, have partnered in an effort to make Hemispherx’s natural alpha interferon therapy…
The National Multiple Sclerosis Society has dedicated over $21 million to fund 78 new multiple sclerosis (MS) research studies as part of a broad research plan designed to address MS, re-establish lost functioning caused by the disease in patients, and ultimately end the disease forever. This recent round of investment into MS research is…
Alkermes plc, a fully integrated global biopharmaceutical company, recently provided a regulatory update and positive clinical trial data for ALKS 8700, an oral, innovative and proprietary monomethyl fumarate (MMF) compound that is being developed to treat multiple sclerosis (MS). ALKS 8700 is being developed to quickly and efficiently convert…
Helius Medical Technologies, Inc., a company dedicated to neurological wellness, recently announced that the multiple sclerosis (MS) pilot study assessing the company’s investigational Portable Neuromodulation Stimulator (PoNS™) device has met all of the study’s goals. PoNS is a non-invasive device that allows the delivery of neurostimulation through the…
Biogen Inc. recently reported that the Phase 3 ASCEND clinical trial study testing TYSABRI efficacy in patients with secondary progressive multiple sclerosis (SPMS) did not achieve its primary and secondary goals. According to the company, the comprehensive results of the study will be revealed at a future medical conference.
The Glatiramer Acetate Clinical Trial to Assess Equivalence With Copaxone (GATE) seems to be the first phase 3 clinical trial to test a generic disease-modifying medication for multiple sclerosis (MS) treatment. The data showed that glatiramer acetate, the generic drug, was equivalent to the trademark drug Copaxone for the…
Among the different therapeutic approaches being explored for treating MS, adult stem cell therapy continues to be one of the most discussed and anticipated in the MS community. “Stem cells” — the common term for undifferentiated, self-renewing proliferating cells — are currently being investigated for their ability to treat patients in a wide range of disease…