BioMS Medical Corp, a leading developer in the treatment of multiple sclerosis (MS), has received a Notice of Acceptance from the UK Medicines and Healthcare products Regulatory Agency (MHRA) for its pivotal phase II/III clinical trial of MBP8298, a proprietary synthetic peptide for the treatment of secondary progressive multiple sclerosis (SPMS).
The trial is a double-blind, placebo-controlled study involving up to 553 patients in both countries combined. Patients will be administered either MBP8298 or placebo intravenously every six months for a period of two years. While SPMS patients with any genetic profile will be included, the primary clinical endpoint for the trial is defined as a statistically and clinically significant increase in the time to confirmed worsening of disability as measured by the Expanded Disability Status Scale (EDSS) in the previously identified responder group, patients with immune response genes HLA-DR2 or HLA-DR4. Patients with these immune response genes account for up to 75 per cent of the MS patient population, the release said.
"With this approval, we will now be able to expand our recently initiated pivotal SPMS trial beyond Canada into the United Kingdom, another jurisdiction with a significant MS population," Kevin Giese, president of BioMS Medical said adding, "This approval is an important milestone in our strategy for developing MBP8298 on an international basis, with the goal of incorporating additional territories moving forward."
BioMS Medical Corp. is a biotechnology company dedicated to the development and commercialization of innovative therapies. The Company is poised to initiate a phase I clinical trial for HYC750, a therapeutic designed to mobilize stem cells and neutrophils for the treatment of cancer therapy related side-effects.