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Photofrin PDT reduces esophageal cancer occurrence in patients with Barrett's High Grade Dysplasia - Results of a 5-year follow-up study
Photofrin PDT reduces esophageal cancer occurrence in patients with Barrett's High Grade Dysplasia - Results of a 5-year follow-up study.
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[{"type":"text","content":"\n\n\n\n\nTSX SYMBOL (Toronto Stock Exchange): AXP\nNASDAQ SYMBOL (NASDAQ National Market): AXCA\n\nMONT SAINT-HILAIRE, QC, Sept. 13 /CNW Telbec/ - Coinciding with the World\nCongress of Gastroenterology 2005 being held in Montreal, Canada, Axcan Pharma\nInc. (\"Axcan\" or the \"Company\") disclosed new data demonstrating that\nPhotofrin photodynamic therapy (\"PDT\") used in conjunction with omeprazole, a\nstandard acid suppression therapy, reduced occurrence of esophageal cancer.\nThis new clinical information is based on the analysis of the 5-year follow-up\nobservation of patients with High Grade Dysplasia (\"HGD\") associated with\nBarrett's esophagus (\"BE\") who were randomized in the original pivotal 2-year\nPhase III study conducted by Axcan which led to regulatory approval in 2003.\nSince HGD and the eventual possibility of developing cancer in BE are\ninextricably linked, the original 24-month follow-up study was continued over\n5 years to confirm the reduction in cancer occurrence.\n\"We are extremely pleased with these results since they confirm that\nPhotofrin PDT has the potential to be used for the prevention of esophageal\ncancer and that it is a clinically effective endoscopic therapy in reducing\nthe incidence of cancer in patients with Barrett's High Grade Dysplasia,\"\ncommented Dr. FranEcois Martin, Senior Vice-President, Scientific Affairs of\nAxcan. \"Results already noted in our initial study are now strengthened by the\n5-year follow-up. It has been demonstrated that Photofrin PDT is not only safe\nand effective but that its effects are prolonged,\" he concluded.\n\nSTUDY RESULTS\n\nThe study used multiple sites and involved 208 patients randomized (2:1)\nto Photofrin PDT used in conjunction with omeprazole 20mg twice-a-day, or to\nomeprazole alone at a dose of 20mg twice-a-day.\nAt the end of the 5-year follow-up, results of the study confirmed that\nPhotofrin PDT used in conjunction with omeprazole was superior to omeprazole\nalone in preventing the progression to cancer, with about twice the likelihood\nof cancer occurring in the omeprazole alone group (29%) compared to Photofrin\nPDT used in conjunction with omeprazole (15%). This reduction of the\nprogression to cancer is highly statistically significant\n(p (equal sign) 0.0272).\nThe original pivotal 2-year Phase III study had shown successful HGD...