clinical trials

We wait in anticipation for multiple sclerosis (MS) drugs to clear Phase 3 clinical trials and get to the Food and Drug Administration (FDA) for approval, but I honesty knew little of the process that takes place before the large-scale testing of drugs in Phase 3. I was selected to…

This chewing gum handout in the exhibit area of the recent Drug Information Association (DIA) 2016 meeting says it all from the pharmaceutical company perspective – recruiting patients for their studies is often a distasteful and difficult process. While I appreciated the gum in this package, this image left a…

A pilot study in patients with progressive multiple sclerosis (MS) found a steroid treatment of benefit by decreasing oxidative stress in the cerebrospinal fluid. The study, “One-time intrathecal triamcinolone acetonide application alters the redox potential in cerebrospinal fluid of progressive multiple sclerosis patients: a pilot study,” was published in the journal …

Developments of treatments for MS dominate my pick of the week’s news in MS News Today. Included is a vaccine and a new oral drug. Vaccine to Treat Multiple Sclerosis Showing Promise and Soon to Enter Phase 3 Clinical Testing This is something a bit different because, usually vaccines are designed to…

Coherus BioSciences recently reported that its candidate therapy for multiple sclerosis (MS), CHS-131, reduced the development rate of new brain lesions by nearly 50% in previously untreated relapsing-remitting MS patients. The Phase 2b trial (NCT02638038), randomizing patients to receive either CHS-131 or placebo in a double-blind manner, also showed the…

A therapeutic vaccine for patients with multiple sclerosis (MS), called Xemys, is showing positive results in pre-clinical and clinical trials, and is soon to enter Phase 3 clinical testing. Xemys was developed by researchers at the Institute of Bioorganic Chemistry of the Russian Academy of Sciences and their colleagues. While traditional vaccines are…

Flex Pharma, Inc., announced the start of a Phase 2 clinical trial assessing the safety and efficacy of FLX-787 in multiple sclerosis (MS) patients who suffer from cramps, spasms, and/or spasticity as a result of the disease. The trial is being run in conjunction with Neuroscience Trials Australia. Flex Pharma’s FLX-787 is a single molecule,…

Adamas Pharmaceuticals recently reported positive results from its Phase 2 proof-of-concept clinical trial evaluating ADS-5102 (amantadine HCl), an extended-release version of amantadine, in multiple sclerosis (MS) patients with difficulties in walking. The trial (NCT02471222), a double-blind, placebo-controlled and two-arm parallel group study, evaluated ADS-5102 given once daily at 340 mg, at bedtime, for four…

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…

People with MS who were involved in a long-term clinical trial are out and about enjoying a full and normal life with no signs of the disease. This follows their recovery from the stem cell transplants involving aggressive chemotherapy, or aHSCT as the procedure is known. Results of the clinical…

Genmab announced plans to soon begin a Phase 3 clinical trial program assessing the subcutaneous formulation of ofatumumab as a potential treatment for relapsing multiple sclerosis (MS). The company, working in collaboration with its partner Novartis, will begin enrolling patients in September in trials that will evaluate the efficacy and safety of ofatumumab compared…

Stem cell treatment has been proven to both halt MS clinical relapses and the development of new brain lesions over a prolonged period, according to the results of a new study. The results, achieved in 23 out of 24 patients in a Phase 2 clinical trial, were published in…

GeNeuro, a biopharmaceutical company that focuses on novel treatments for autoimmune diseases such as multiple sclerosis (MS), announced that the first patients with relapsing-remitting multiple sclerosis (RRMS) are under treatment with the company’s leading drug, GNbAC1, in a Phase 2b clinical trial. GNbAC1 is a monoclonal antibody designed to neutralize MSRV-En, a protein…

Arrien Pharmaceuticals has initiated Phase 1 clinical trials of their first agent, ARN-6039, a molecule that targets a specific subset of immune cells called T helper 17 (Th17), for the potential treatment of patients with relapsing, remitting, and progressive multiple sclerosis (MS). A growing body of evidence has suggested a…

Two case reports from the Sheltering Arms Physical Rehabilitation Centers presented at the Consortium of Multiple Sclerosis Centers (CMSC) 2016 Annual Meeting demonstrated how a multiple sclerosis (MS) clinical practice guideline for rehabilitation was implemented through the rehab path, highlighting the importance of consistency of practice and continuity of care for…

Results from a Phase 2 clinical trial showed that five-year clinical outcomes of patients with highly active relapsing-remitting multiple sclerosis (RRMS) are significantly improved when patients are treated with high-dose immunosuppressive therapy combined with autologous hematopoietic cell transplantation. The study, “Five-Year Outcomes of Halt-MS: High-
Dose Immunosuppressive Therapy and Autologous Hematopoietic Cell…

Data from an extension phase of a Phase 3 clinical trial, given in an oral presentation by MedDay, reported that the biotin  MD1003 showed effectiveness over time as a possible treatment of non-active, progressive multiple sclerosis (MS). The data were presented at the recent 2nd Congress of the European Academy of Neurology (EAN) in Denmark by Professor Ayman Tourbah,…

Mitochon Pharmaceuticals announced the completion of a second year of financing, raising a total $1.6 million to advance its lead compound, MP101, a mitochondrial targeted neuro-protective agent, into clinical testing. The company is developing mitochondrial modulators for patients with neurodegenerative diseases ranging from Alzheimer’s and Parkinson’s to multiple sclerosis (MS). A number of studies have…

The first U.K. clinical trials of robotic legs that might allow people with mobility impairment to move — hands-free — are underway at the University of Kent. Clinicians and engineers at Kent are carrying out the study in a partnership with the East Kent Hospital’s University Foundation Trust…

With an interest multiple sclerosis (MS) before even starting college, Dr. Ellen Mowry has spent her entire research career investigating the disease. Her epidemiological studies led her to indications that vitamin D might be particularly important for people with MS, and she now dedicates her research to the topic — knowledge she will share at the…

TG Therapeutics recently announced the opening of a new clinical trial evaluating TG-1101, its glycoengineered anti-CD20 monoclonal antibody, in patients with relapsing-remitting multiple sclerosis (RRMS). The Phase 2 clinical trial, titled “A Placebo-Controlled Multi-Center Phase 2 Dose Finding Study of Ublituximab, a Third-Generation Anti-CD20 Monoclonal Antibody, in Patients…

The Multiple Sclerosis Outcome Assessments Consortium (MSOAC) is making available to qualified researchers a new database containing almost 2,500 records of patients who were part of the placebo groups of nine multiple sclerosis (MS) studies. The MSOAC is a large-scale partnership, launched by the National MS Society and Critical…

MedDay recently disclosed full study results from the MS-SPI and MS-ON Phase 2b/3 trials of its therapeutic candidate MD1003 in patients with multiple sclerosis (MS). Specifically, the trials included people with “not active” progressive MS and those with either relapsing or progressive MS and visual loss, respectively. Data, presented at the recent American…

Potentially groundbreaking research by the Tisch Multiple Sclerosis Research Center of New York (MSRCNY) will be presented on April 19 at the 68th American Academy of Neurology (AAN) Annual Meeting taking place in Vancouver, Canada. Dr. Saud A. Sadiq, director and chief research scientist at the Tisch center, will present results of a…

A Phase 2 clinical trial testing the efficacy of a common antihistamine, clemastine fumarate, to treat optic nerve damage in people with multiple sclerosis (MS) found the drug able to slightly reverse damage to their visual system. The  study, conducted by researchers at the Multiple Sclerosis Center at the University of California San…

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…

Genentech announced that it will present new data from three Phase 3 clinical trials of its experimental multiple sclerosis (MS) therapy Ocrevus (ocrelizumab) at the 68th annual meeting of the American Academy of Neurology (AAN) being held in Vancouver, Canada, from April 15–21, 2016. Additionally, results of a new endpoint for…

MedDay SAS recently announced that it has raised €34 million, about $38.5 million, in a Series B financing round. The money will enable the company to lead a confirmatory Phase 3 clinical trial, called SPI2, in the United States to assess its lead candidate, MD1003, as a treatment for progressive multiple sclerosis (MS). MedDay concluded…

PathMaker Neurosystems, Inc., recently announced the launch of an Institutional Review Board (IRB)-approved clinical trial, in partnership with Northwell Health (formerly North Shore-LIJ Health System) and The Feinstein Institute for Medical Research, to evaluate the safety and efficacy of MyoRegulator for the treatment of spasticity, one of the most common symptoms in multiple sclerosis…

The National Multiple Sclerosis Society announced that it has invested $25.3 million to support nearly 60 new research projects aiming to better understand and treat multiple sclerosis (MS), and seven clinical training awards as part of its strategic approach to eventually curing MS. This investment is part of the Society’s plan to commit a…