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| |  Phase II Study on URSO for Colorectal Cancer to Begin MONTREAL -- Jan. 20, 1997--AXCAN (TSE; ME: AXP) -- Axcan Pharma announces the beginning of a phase II clinical study to evaluate the efficacy and safety of URSO(TM) in preventing the recurrence of adenomatous polyps, often an advance sign of colorectal cancer. Axcan has filed an Investigational New Drug submission related to the use of ursodiol for this purpose . The study will be carried out with 600 patients by the Mayo Clinic at three sites in the United States: Rochester, Minnesota, Scottsdate, Arizona and Jacksonville, Florida. It is estimated that a maximum of two years will be required to complete the work. "Colorectal cancer is one of the most common malignancies seen in developed nations and is responsible for over 60,000 deaths each year in the United States alone," said Leon Gosselin, President of Axcan. "Approximately 160,000 new cases of colorectal cancer are diagnosed each year in the United States," he added. Published data in animal models indicate that ursodiol could prevent recurrence of adenomatous polyps which are precursors of colorectal cancer. Bile acids appear to influence the development of these benign polyps in the colon and their transformation into malignancies. Ursodiol modifies the fecal bile acid milieu which has been linked to the development of colon cancer based on clinical, animal-model, and in-vitro studies. "The data from experimental studies is now significantly mature to suggest that the alteration of colonic bile acids by ursodiol may decrease the development of carcinomas," Mr. Gosselin stated. "This would justify the clinical development of URSO(TM) as a chemopreventive agent in colorectal cancer," he concluded. The use of URSO(TM) ursodiol 250 mg tablets for the treatment of all stages of primary biliary cirrhosis (P.B.C.) recently received unanimous recommendation for approval from the FDA Expert Advisory Panel for Gastrointestinal drugs. P.B.C. is a deadly debilitating liver disease affecting 50,000 North Americans and represents a potential U.S. $100M market. Axcan Pharma specializes in the field of gastroenterology and is also active in contraception, the prevention of sexually transmitted diseases and hemodialysis. Founded in 1983, its head office is located in Mont-St-Hilaire, (Quebec), and it has other offices and subsidiaries in Laval (Quebec), Calgary, (Alberta), and Plattsburgh, (New York).
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