Photofrin PDT reduces esophageal cancer occurrence in patients with Barrett's High Grade Dysplasia

09-14-2005: Axcan Pharma Inc. disclosed new data demonstrating that Photofrin photodynamic therapy ("PDT") used in conjunction with omeprazole, a standard acid suppression therapy, reduced occurrence of esophageal cancer.

This new clinical information is based on the analysis of the 5-year follow-up observation of patients with High Grade Dysplasia ("HGD") associated with Barrett's esophagus ("BE") who were randomized in the original pivotal 2-year Phase III study conducted by Axcan which led to regulatory approval in 2003. Since HGD and the eventual possibility of developing cancer in BE are inextricably linked, the original 24-month follow-up study was continued over 5 years to confirm the reduction in cancer occurrence.

The study used multiple sites and involved 208 patients randomized (2:1) to Photofrin PDT used in conjunction with omeprazole 20mg twice-a-day, or to omeprazole alone at a dose of 20mg twice-a-day. At the end of the 5-year follow-up, results of the study confirmed that Photofrin PDT used in conjunction with omeprazole was superior to omeprazole alone in preventing the progression to cancer, with about twice the likelihood of cancer occurring in the omeprazole alone group (29%) compared to Photofrin PDT used in conjunction with omeprazole (15%). This reduction of the progression to cancer is highly statistically significant (p = 0.0272).