The US Food and Drug Administration (FDA) has granted approval of URRMA Biopharma Inc 's Investigational Device Exemption (IDE) application for the Anti-R7V Diagnostic Kit. This is equivalent to a Phase II in the more commonly used terminology pertaining to FDA pharmaceutical drug regulations, and will allow URRMA to proceed with Pre-Market Approval (PMA) clinical studies (Phase III equivalent).
URRMA, headed by its President and CEO, Dr. Michel Fallet, is a private biotech company based in Montreal with a P-3 level research lab located in Marseille, France. This research facility is under the direction of URRMA's Chief Scientific Officer and Director of Research, Prof. Jean-Claude Chermann, the co-discoverer of the HIV virus that causes AIDS.
URRMA's proprietary technology is based upon Professor Chermann's discovery of the anti-R7V antibody found to be present in individuals who are HIV positive, but who have not progressed to AIDS disease. The R7V epitope, to which the antibody combines, is acquired by the HIV upon its exit (budding) from an immune cell and is incorporated onto it's surface envelope. The anti-R7V antibody can adhere to the R7V epitope on the HIV's surface envelope, causing the structure of the HIV envelope to be changed in such a way so as to prevent the HIV from entering other healthy immune system cells and thus the HIV is in effect neutralized.
URRMA's diagnostic kit detects the presence or absence of the anti R7V antibody in HIV positive individuals. A strong correlation has been found whereby if the anti R7V antibody is present in HIV positive individuals; these individuals will not progress to AIDS within the foreseeable future. URRMA believes this information will help the attending physician in deciding whether or not to prescribe the current regiment of anti-AIDS drugs, as well as helping the patient in deciding whether or not to accept the high cost and health risks inherent with these drugs. Monitoring of the individual's CD4 counts and viral load measurements should be performed as well.
In addition to their diagnostic kit, the Company is also conducting research activities for the development of therapeutics based on their R7V technology with the first product being an Anti-R7V monoclonal antibody.
A large market is expected in North America and Europe as part of a potential overall worldwide AIDS diagnostic market of $1 billion. The kits could be commercially available in the United States by mid 2003, assuming the PMA application is submitted to the FDA before December 31, 2002, and full approval for commercialization is obtained within the normal period. Clinical trials for the PMA process have begun, and will continue through the end of this year.