BioMS Medical Reports Positive Final Phase II Results In Multiple Sclerosis Trial
May 23, 2003
Source: BioMS Medical Corp.
BioMS Medical Corp today 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 Mr. 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=10) and placebo (n=10).
Statistically Significant Results in Patients with HLA-DR2 or HLA-DR4 Genes Clinical progression was measured by changes in score on the Expanded Disability Status Scale (“EDSS”), as the primary clinical indicator. EDSS is used to assess patients’ ability to function on a scale of 0 to 10. Patients were considered to have progressed if they had a confirmed change in EDSS of greater than or equal to 1.0 when their baseline score was less than or equal to 5.0, or a change of greater than or equal to 0.5 when their baseline score was greater than or equal 5.5.
At the end of the double-blinded phase, 0 out of 10 (0%) of the DR2/4 patients on MBP8298 progressed on EDSS as compared to 6 out of 10 (60%) of the patients on placebo (Fisher’s Exact test p=0.0108).
“Potentially delaying the debilitating progression of MS represents a major step forward in the treatment of MS,” said Mr. Kevin Giese. “A 100% stabilization rate over a two year period in the DR2/4 group exceeded our expectations.”
At the end of the open label phase, only three of the DR2/4 patients on MBP8298 (30%) had progressed at 42 months, meaning that the median time to confirmed progression for the MBP8298 patients is at least four years as compared to that of the placebo patients which was 2 years (Log Rank test p=0.004). The results were equally valid for both Primary and Secondary Progressive MS patients.
Patients’ anti-MBP antibody levels were also measured in relation to injections of MBP8298. In the double blinded phase, DR2/4 patients that were injected with MBP8298 showed a significant and sustained reduction in anti-MBP antibodies. This sustained reduction was significantly related to absence of clinical progression as measured by EDSS (Fisher’s Exact test p=0.0108).
In terms of safety, patients on MBP8298 showed no statistically significant difference from the placebo group in terms of adverse events, use of steroids or in the results from eight different MRI tests. No treatment-related serious adverse events were recorded in the patients receiving MBP8298, providing further confirmation of the drug’s safety and tolerability.
Results in the Total Population The 32 patients in the double blinded phase were made up of 16 patients that received MBP8298 and 16 that received placebo. In terms of EDSS, only 5 out of 16 patients on MBP8298 progressed as compared to 9 out 16 patients on placebo, which constitutes a 44% reduction in progression (Fisher’s Exact test p=0.29). Similarly, in terms of the two secondary clinical outcomes, the 22 meter Timed Walk and Foot Taps, both the overall and DR2/4 sub-group results showed patients on MBP8298 scoring better than placebo, although not with statistical significance. There were no statistically significant results on any safety parameter, nor was there any serious MBP8298-related adverse event.
Further information from the Phase II MBP8298 trial can be heard on an audio webcast at the Company’s website at www.biomsmedical.comSubmitted 8/27/2003 8:17:29 PM