BioMS Medical expands pivotal multiple sclerosis trial into Spain and Germany
BioMS Medical Corp, a leading developer in the treatment of multiple sclerosis (MS), today announced it has received approval from the Spanish Agency for Medicines and Healthcare Products (SAMHP) in Spain and from the Federal Institute for Medicines and Medical Products in Germany to start patient enrolment for its pivotal phase II/III clinical trial of MBP8298, a proprietary synthetic peptide for the treatment of secondary progressive multiple sclerosis (SPMS).
Pivotal Phase II/III Multiple Sclerosis Trial
BioMS Medical is currently enrolling patients across Canada, the U.K., Sweden, Denmark and The Netherlands in its pivotal phase II/III clinical trial evaluating MBP8298 for the treatment of secondary progressive multiple sclerosis (SPMS). The trial is a randomised, 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 (EDSS), in patients with HLA-DR2 and/or HLA-DR4 immune response genes. Time to disease progression in patients with other HLA-DR types will be assessed separately as an exploratory arm of the same study. To date the trial has successfully passed five safety reviews by its independent Data Safety Monitoring Board.
Source: BioMS Medical Corp.