Ph II/III MBP8298 trial completes enrollment

BioMS Medical Corp, a USA-based developer of products for multiple sclerosis, has completed patient recruitment in a pivotal Phase II/III trial of MBP8298 for the treatment of secondary progressive MS. The company says it remains on track to receive interim data from the first 200 patients to be enrolled in the trial by mid-2008, when they have completed 24 months of treatment.

The multicenter, double-blind, placebo-controlled trial is designed to evaluate the safety and efficacy of MBP8298 in 550 patients being administered either the drug or placebo intravenously every six months for a period of two years. The primary clinical endpoint is defined as a statistically- and clinically-significant increase in the time-to-progression as measured by the Expanded Disability Status Scale, 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.