BIOMS MEDICAL MOVES FORWARD WITH MULTIPLE SCLEROSIS TRIAL
BioMS Medical has announced that more than 200 patients have been enrolled in its pivotal Phase II/III clinical trial for the treatment of secondary progressive multiple sclerosis (SPMS). An interim safety and efficacy analysis will be performed on data from the first 200 patients enrolled when they have completed 24 months of the clinical trial.
The trial is a randomized, double-blind study enrolling approximately 553 patients who will be administered either MBP8298 or placebo intravenously every six months for a period of two years. The primary clinical endpoint for the trial is defined as a statistically and clinically significant increase in the time to progression of the disease as measured by the Expanded Disability Status Scale, in patients with HLA-DR2 and/or HLA-DR4 immune response genes.