www.fdanews.com/articles/102151-bioms-mbp8298-trial-receives-positive-safety-review
BioMS' MBP8298 Trial Receives Positive Safety Review
December 12, 2007
An independent data safety monitoring board has reviewed data from Canadian drugmaker BioMS Medical’s Phase III trial of MBP8298, a treatment of secondary progressive multiple sclerosis (MS), and recommended continuing the trial.
The randomized, double-blind MAESTRO-03 trial has enrolled approximately 510 patients who will receive either MBP8298 or placebo intravenously every six months for two years.
The primary endpoint is defined as a significant increase in the time to progression of the disease as measured by the Expanded Disability Status Scale in patients with HLA-DR2 or HLA-DR4 immune response, BioMS said.