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BioMS Gets Approval for Phase II MS Trial

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By: Tim Wright

Editor-in-Chief, Contract Pharma

BioMS Medical Corp. has received regulatory approval to initiate a Phase II trial to investigate the efficacy and safety of MBP8298 in patients with relapsing-remitting multiple sclerosis (RRMS) in the first of several European countries. Patient enrollment is expected to begin in the third quarter of this year and BioMS anticipates as many as 30 sites will participate.

The 12-month, double blind, placebo-controlled trial will enroll as many as 215 RRMS patients. The trial will be followed by a 15-month active treatment open label extension period. The primary objective of the study is to demonstrate efficacy and safety of MBP8298 versus placebo in patients who are positive with immune response genes HLA-DR2 or HLA-DR4. Patients with the immune response genes, HLA-DR2 or HLA-DR4, account for as much as 75% of the MS patient population.

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