European Journal of Neurology Publishes MBP8298 Phase ll and Long-Term Follow-up Data
Long-term efficacy and safety shown in multiple sclerosis patients-.
Edmonton, Alberta, June 13, 2006 – BioMS Medical Corp (TSX: MS), a leading developer in the treatment of multiple sclerosis (MS), today announced that results of the phase II and long-term follow-up treatment of MS patients with MBP8298 have been published in the European Journal of Neurology (EJN). The publication highlights long-term efficacy, safety and mechanism of action data in respect of MBP8298. The journal also features an editorial entitled “The coming of age for antigen-specific therapy of multiple sclerosis.” The data was published in the EJN online early issue and is expected to appear in the August 2006 printed issue.
The results show that MBP8298 safely delayed disease progression for five years in progressive MS patients with HLA-DR2 or HLA-DR4 immune response genes. Treatment and follow-up of patients demonstrated that patients in this DR2 and DR4 responder group, who comprise up to 75% of MS patients, had a median time to disease progression of 78 months as compared to 18 months for patients who received placebo.
“Our data suggest that we can safely delay progression of MS in an identified responder group of patients for extended periods of time,” said Ingrid Catz, co-inventor of MBP8298 and co-author of the phase II study. “Recognizing the high variability of the disease in MS patients, the clinical and mechanistic evidence gathered to date supports the rationale of targeting patients with the HLA-DR2 or HLA-DR4 immune response gene. The identification of this responder group will improve efficiency toward the achievement of objectives in future clinical trials with MBP8298, while the potential for clinical responses in patients with other HLA haplotypes is further explored.”
“While this is phase II data and needs to be confirmed in the on-going phase III trial, it is very hopeful information for MS patients,” said Dr. Mark Freedman, Professor of Neurology at the University of Ottawa and Director of the Multiple Sclerosis Research Clinic at the Ottawa Hospital. “To delay disease progression for five years in progressive MS patients is a big step – there are currently very limited options available to treat this form of multiple sclerosis.”
“The MS Society is pleased to hear about the positive results from this clinical trial and will watch closely the Phase III clinical trials,” adds Dr. William J. McIlroy, national medical advisor for the MS Society of Canada. “Having a drug that treats progressive MS would be very well received.”
Phase II and Long Term Study Results
The Phase II study followed 32 patients with clinically diagnosed, MRI-confirmed progressive MS for 24 months, comparing safety and efficacy between MBP8298 and placebo administered intravenously every six months. Patients with the HLA-DR2 and/or HLA-DR4 immune response genes were identified as the key responder group, with no HLA-DR2 and/or DR4 patients on MBP8298 demonstrating progression during the initial 24 months, as compared to over 50% of the patients on placebo (p=0.01). After 5 years of open label follow-up treatment, comparison of disease progression in the HLA-DR2 or DR4 patients receiving MBP8298 with those in the original placebo group showed that the median time to first confirmed progression on EDSS was 78 months compared to 18 months for patients who had received placebo (Kaplan-Meier analysis, p = 0.004, relative rate of progression = 0.23). Patients were entered into the trial as matched pairs, had comparable baseline characteristics, and were randomized on a 1:1 basis between drug and placebo. Measurements of progression on EDSS followed the standard scoring method of one full point change for those patients with a starting EDSS score of 5.0 or less, and one half point change for those patients with a starting score of 5.5 or higher.
No serious adverse events were reported during the trial and follow up period, with MBP8298 appearing to be well tolerated. The most common side effect reported was occasional injection site redness and burning that was not seen to be evident of increased hypersensitivity or allergic reaction, and with as many placebo patients in the double blind trial reporting this side effect as patients receiving drug. To date, there are more than 300 patient years of treatment experience with the longest individual patient treatment period now at more than 12 years.
Novel Mechanism of Action
In MS patients the body’s immune system inappropriately attacks the myelin coating around the nerves in the brain and spinal column, whereas healthy people are otherwise “tolerant” of such common body components. The proposed mechanism of action of MBP8298 is, by design, to re-introduce such a state of “tolerance” to a critical portion of the nerve’s Myelin Basic Protein that is an immunological site of attack in many MS patients. This is accomplished by the IV injection of a large dose of a soluble antigen, as represented by MBP8298, into MS patients. The phase II results published in the EJN demonstrated significant evidence of this “tolerance” effect, as HLA-DR2 and HLA-DR4 patients not only responded clinically to MBP8298, but they also had their antibodies to Myelin Basic Protein suppressed during the course of their treatment. This effect was achieved through the treatment regimen of one intravenous injection two times per year.
Pivotal Phase II/III Multiple Sclerosis Trial
BioMS Medical is currently enrolling patients across Canada, the U.K., Sweden and Denmark in its pivotal phase II/III clinical trial evaluating MBP8298 for the treatment of secondary progressive multiple sclerosis (SPMS). The trial is a randomized, double-blind study enrolling approximately 553 patients who will be administered either MBP8298 or placebo intravenously every six months for a period of two years. The primary clinical endpoint for the trial is defined as a statistically and clinically significant increase in the time to progression of the disease as measured by the Expanded Disability Status Scale (EDSS), 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. To date the trial has successfully passed four safety reviews by its independent Data Safety Monitoring Board.
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