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QUEBEC CITY, April 15 /PRNewswire-FirstCall/ - AEterna Zentaris Inc. (NASDAQ: AEZS; TSX: AEZ), a global biopharmaceutical company focused on endocrine therapy and oncology, today reported the completion of patient recruitment for the Company's first efficacy trial of its Phase 3 program in benign prostatic hyperplasia (BPH), a non-cancerous enlargement of the prostate, with its flagship product candidate, cetrorelix. The study involves approximately 600 patients primarily in the United States and Canada, with additional sites in Europe.
"We are very proud to have reached this important milestone. The Phase 3 program in BPH with cetrorelix is on track and we expect to provide results in the third quarter of 2009 as stated previously," commented Paul Blake, M.D., Senior Vice President and Chief Medical Officer of AEterna Zentaris.
This first efficacy study, titled "Cetrorelix pamoate intermittent IM dosage regimens in patients with symptomatic BPH: a 1-year placebo-controlled efficacy study and long-term safety assessment", will assess an intermittent dosage regimen of cetrorelix as a safe and tolerable treatment providing prolonged improvement in BPH-related signs and symptoms.
About the Phase 3 Program with Cetrorelix in BPH
The first multi-center efficacy study commenced first patient
randomization in April 2007 and completion of patient recruitment was
announced today. It is currently being conducted primarily in the United
States and Canada, with additional sites in Europe and involves
approximately 600 patients under the supervision of lead investigator,
Herbert Lepor, MD, Professor at NY University School of Medicine, New York.
Patients enter a 4-week run-in no-treatment observation period to confirm
sever
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