In Preparation for Clinical Trials: Procyon BioPharma Signs Agreements With American Manufacturers
09:27 GMT-04:00 Thursday, July 26, 2001
MONTREAL, QUEBEC--Procyon BioPharma Inc. ("Procyon") announced today the signing of a manufacturing supply agreement with Goodwin Biotechnology Inc. (GBI) (Plantation, Florida) to produce the lead candidate of Procyon's ANA anti-cancer platform technology, chimeric monoclonal antibody c-2C5. Under this agreement, GBI will perform process development and cGMP manufacturing of this monoclonal antibody. Concurrently, as part of the development of the PSP94 platform, Procyon has also signed a supply agreement with Multiple Peptide System (MPS) (San Diego, California) for the production of cGMP PCK3145, the lead peptide candidate for prostate cancer therapy. These supply agreements will enable the Company to move ahead into Phase I/II human clinical trials with both its novel anti-cancer platform technologies in a timely fashion.
"The agreement for cGMP production of our lead candidates, for both ANA and PSP(94) anti-cancer platform technologies, is an important key element to achieve our corporate milestone of filing an IND application and subsequently beginning human clinical trials," said Hans J. Mader, President and CEO of Procyon BioPharma Inc.
GBI is a fully integrated biologics contract manufacturer based in Plantation, Florida, that specializes in cGMP-compliant manufacturing of recombinant products for Phase I/II human clinical trials. GBI is especially well known for its expertise in monoclonal antibody production (for both the therapeutic and diagnostic industries). Being fully integrated, GBI can also handle cell-line engineering, cell banking (MCB and WCB) and full qualification, upstream and downstream manufacturing process development, and final product fill.
MPS is a privately held company, based in San Diego, specializing in small to large scale manufacturing of custom peptides for research and therapeutic applications. MPS is part of ISOCHEM (Gennevilliers, France), a subsidiary of GROUPE SNPE (Paris, France) specializing in fine chemicals.
Procyon BioPharma Inc. is a publicly listed, biopharmaceutical Company focused principally on advancing two powerful platform technologies that have the potential to diagnose and treat cancer. Procyon's non-pathogenic Antinuclear Autoantibodies (ANAs) bind specifically to multiple cancer cell types strongly enhancing the immune response to cancer cells. Prostate Secretory Protein (PSP(94)) is a naturally occurring human protein that has the potential to treat prostate cancer by inhibiting abnormal prostate cell growth. In addition, the estimation of PSP(94) levels in prostate cancer patients may have prognostic and diagnostic applications. Procyon also has two late-stage products: FIBROSTAT(R), a topical cream for the management of newly formed scars following surgery or burns and COLOPATH(R), a rapid, non-invasive screening test for colorectal cancer.
Procyon's shares trade on the Toronto Stock Exchange under the ticker symbol, PBP.
This release contains forward-looking statements that reflect the company's current expectations regarding future events.
The forward-looking statements involve risks and uncertainties. Actual events could differ materially from those projected herein and depend on a number of factors including, but not limited to, changing market conditions, successful and timely completion of clinical studies, uncertainties related to the regulatory approval process, establishment of corporate alliances and other risks detailed from time to time in the company's filings.
FOR FURTHER INFORMATION PLEASE CONTACT: Procyon BioPharma Inc., Hans J. Mader, President and CEO, (514) 685-9283, ir@procyonbiopharma.com, www.procyonbiopharma.com, or, NATIONAL Public Relations Inc., Nathalie Bourque, Public Relations, (514) 843-2309, or, Renmark Financial Communications Inc., John Stella, Investor Relations, jstella@renmarkfinancial.com, or, Renmark Financial Communications Inc., John Boidman, Investor Relations, jboidman@renmarkfinancial.com |
