BioMS Medical Corp announced positive final results from its Phase II clinical trial for the treatment of multiple sclerosis (MS) with its synthetic peptide MBP8298. The MBP8298 peptide is designed to reduce the disease-associated production of a group of anti-MBP antibodies that are reactive with the central nervous system.
"The strength of these results confirms our confidence that MBP8298 has the real potential to achieve our ultimate objective, to commercialize a best-in-class compound for the treatment of MS," said Kevin Giese, President of BioMS Medical. "In anticipation of these positive results, we have been preparing the regulatory submissions for a pivotal confirmatory clinical trial, targeted to commence in 2003."
The 4 year Phase II trial enrolled 32 patients with either Primary or Secondary Progressive MS. The study had two phases, a two-year randomized double-blinded, placebo-controlled phase, followed by a two-year open label phase. During the double-blinded phase patients were given 500 mg of the MBP8298 peptide intravenously every 6 months. Data from the trial was analyzed both in terms of overall results, and in terms of a genetic sub-group of patients who carried either HLA-DR2 or HLA-DR4 immune response genes ("DR2/4"). These genes are associated with T-helper cells involved in the production of anti-MBP antibodies targeted by the MBP8298 peptide.
Whereas the incidence of DR2/4 genes in the normal population is relatively low, in the MS population patients that have either the DR2 or DR4 genes account for approximately 75% of the estimated 2 million MS patients worldwide. Of 32 patients enrolled in the double-blinded phase of the trial, there was a representative sample of 20 patients that carried either the DR2 or the DR4 genes, and these were evenly divided between patients dosed with MBP8298 (n(equal sign)10) and placebo (n(equal sign)10).