AEterna Zentaris: Lead Investigator for Cetrorelix Trials in BPH Wins Best Poster Presentation Award at European Association of
April 30 2008 - 8:30AM
PR Newswire (US)
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
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