BioMS gets US clearance for Ph III MBP8298 trial

USA-based BioMS Medical Corp has received clearance from the Food and Drug Administration for its Investigational New Drug application for the initiation of a pivotal Phase III clinical trial to investigate the use of MBP8298 as a treatment for patients with secondary progressive multiple sclerosis.

The IND allows the commencement of a pivotal Phase III secondary progressive MS clinical trial in the USA and has been granted on the basis of satisfying FDA criteria regarding preclinical, chemistry, manufacturing and safety data from the completed and ongoing studies of MBP8298.

Kevin Giese, chief executive of BioMS Medical, noted that there are approximately 400,000 Americans with MS and close to 50% of patients have secondary progressive forms. "Between the US initiative and the ongoing pivotal Phase III trial in Canada and Europe, we are successfully executing our global development plan for MBP8298," he said.