20 March 2001
What is MBP8298?
MBP8298 is a synthetic Myelin Basic Protein peptide ("MBP") of comprised of 17 amino acids. It is injected intravenously into the body. In recent clinical studies, the time interval between injections has involved a period of months.
What is the science behind MBP8298?
MS is believed to
be an autoimmune disease whereby the myelin basic protein (MBP) in the
nerve's myelin sheath is attacked. University researchers have discovered
that in chronic progressive MS patients, disease attack results in increased
antibodies to the MBP in the cerebrospinal fluid. In a significant number
of people with chronic progressive MS, the immune system attacks a specific
amino acid sequence within MBP. Clinical studies have demonstrated that
synthetically replicating a key peptide, MBP8298, and injecting it into
patients - in certain circumstances - inhibits the antibody production
by inducing a postitive
What clinical trials have been conducted?
In the development of a pharmaceutical product, the regulatory government agencies in Canada, the U.S. and most of the rest of the world require formal pre-clinical and human clinical trial studies to be conducted. Phase III human clinical trials are normally the last and final phase of trials that are conducted prior to seeking regulatory approval to market a new pharmaceutical product. To date, the researchers have completed numerous pre-clinical studies on MBP8298, Phase I human clinical trials, and three out of four years of a Phase II human clinical trial in Canada. The Company is presently planning the next phase of advanced human clinical trials.
What are the clinical trial results?
A Phase I clinical trial involving 41 Chronic Progressive MS patients demonstrated that 61% of patients were put into remission, as measured by antibody levels in the spinal fluid. Phase II trial results have not been published as yet. There have been no clinically relevant untoward side effects demonstrated in the over 100 patients that have taken the peptide since 1992.
What is the target therapeutic market for MBP8298?
There are approximately 2.5 million MS sufferers worldwide, with an estimated 400,000 to 460,000 sufferers in North America. There are two basic types of MS, each of which represent approximately 50% of the MS patient population: relapsing remitting; and chronic progressive. MBP8298 targets the chronic progressive market segment. There have been few treatments for Chronic Progressive MS approved to date, and many of these treatments face limitations in terms of demonstrating a strong effectiveness and a lack of side effects. This represents a very large and unique market opportunity for the University's technology.