|02-15-2002, 09:30 AM||#1|
Join Date: Jul 2001
Preliminary Results from Phase II Trial of anti-Myelin Basic Protein for MS
BIOMS MEDICAL CORP - Preliminary Results from Phase II Trial
Vancouver, BC, Feb 15, 2002 -- BioMS Medical Corp., a leading developer in the treatment of multiple sclerosis, is very pleased to announce that it has received preliminary results regarding the Phase II MBP8298 human clinical trial on chronic progressive multiple sclerosis patients.
The placebo-controlled double-blind human clinical trial was conducted over a 42-month period on 32 patients at the University of Alberta. The Phase II trial involved the intravenous injection of MBP8298, the proprietary peptide technology licensed to BioMS Medical from the University of Alberta. Patients had levels of their anti-Myelin Basic Protein ("anti-MBP") antibodies in the cerebrospinal fluid measured, and were assessed as to clinical progression (or "decline") by such standard measures as the Expanded Disability Status Score ("EDSS") and the 22 meter Timed Walk. The trial was designed to identify a group of MS patients who showed complete or partial suppression of anti-MBP antibodies following injections of MBP8298, and to determine if this was related with any clinical stabilization.
The preliminary results indicate:
- A high percentage of patients had complete or partial
anti-MBP suppression after receiving intravenous injections
of MBP8298, confirming the results of the Phase I study.
- Three times more patients who received MBP8298 and showed
complete or partial anti-MBP suppression also showed some
clinical stabilization as measured by the EDSS and the 22m
Timed Walk, when compared to the placebo group.
- No clinically relevant peptide-related side effects were
Mr. Kevin Giese, President of BioMS Medical, commented, "These positive preliminary results are supportive of our position that a group of patients may potentially benefit subsequent to intravenous injections of MBP8298. With these results, BioMS Medical is continuing to design its clinical plan for regulatory approval on an international basis. The company expects to announce details of its trial plans over the next several months."
Full details of the Phase II trial will be released to BioMS Medical in the future, and the company will publicly release those results in keeping with the terms of the original licensing agreement with the University of Alberta.
Further analysis from Kevin Giese regarding the Phase II preliminary results can be heard on an audio archive on the company's web site at www.biomsmedical.com.