AEZS Aeterna Zentaris Inc

QUEBEC CITY, April 30 /PRNewswire-FirstCall/ -- AEterna Zentaris Inc. (NASDAQ:AEZSNASDAQ:TSX:NASDAQ:AEZ), a global biopharmaceutical company focused on endocrine therapy and oncology, today announced that Prof. Frans M.J. Debruyne, M.D., Ph.D., Chairman and CEO of Andros Men's Health Institutes in The Netherlands, won the award for Best Poster Presentation in a Poster Session at the 23rd Annual European Association of Urology Meeting, which was held March 26-28, 2008 in Milan, Italy. Titled "LHRH antagonist cetrorelix for symptomatic BPH: Prolonged improvement beyond end of treatment in placebo-controlled trials." FMJ Debruyne, A.A. Gres, A. Bantschev, M. Tzvetkov, K. Grdovic, the poster referred to previously disclosed results from two Phase 2 trials with cetrorelix in benign prostatic hyperplasia (BPH), which showed a prolonged duration of effect extending far beyond the end of the short-term treatment course. Prof. Jurgen Engel, Ph. D., Executive Vice President, Scientific Affairs at AEterna Zentaris commented, "We would like to congratulate Professor Debruyne for this prestigious award which acknowledges his significant contribution to the quality and achievements of our drug development program with cetrorelix in BPH. The data observed in these Phase 2 trials warranted our current extensive Phase 3 program with cetrorelix in this same indication and we look forward to presenting the results in Q3 2009, as stated previously. We believe cetrorelix could provide a novel, efficient, convenient and safe treatment for the millions of men with BPH." THE POSTER Introduction and Objectives Preliminary studies indicated prolonged, unmaintained improvement in signs and symptoms of BPH after short courses of cetrorelix. Two placebo-controlled trials investigated two formulations of cetrorelix to determine the extent and duration of symptomatic improvement and to select the interval between courses for an intermittent treatment scheme. Trial Design Trial-A compared 3 regimens of subcutaneous cetrorelix acetate with placebo (35 patients/group): 5mg x 4, 7 days apart; 10mg x 4, 7 days apart; and 10mg x 2, 14 days apart. Trial-B compared 4 regimens of intramuscular cetrorelix pamoate with placebo (30 patients/group, 14 days between doses): 30mg x 2; 30mg x 3; 60mg and 30mg; 60mg x 2. Patients were followed up for 20 and 28 weeks after the first dose in Trial-A and B, respectively. International Prostate Symptom Score (I-PSS) primary endpoint was assessed in 4-weekly intervals; other endpoints included uroflow, prostate size, and testosterone levels. Results In both trials, 4 weeks after first dose, all regimens showed a statistically significant reduction in I-PSS from baseline; at week 12, the difference from placebo was statistically significant for all dosage regimens except the 30mg x 2 in Trial-B (Trial-A: p