QUEBEC CITY, June 15 /PRNewswire-FirstCall/ - AEterna Zentaris Inc. (NASDAQ: AEZS; TSX: AEZ), a global biopharmaceutical company focused on endocrine therapy and oncology, today reported that patient follow-up in the open-label safety study (study 041) of its Phase 3 program in benign prostatic hyperplasia (BPH) with its lead endocrinology compound, cetrorelix pamoate, is scheduled to be completed at the end of this week. Therefore, data analysis and reporting will be brought forward from the scheduled fourth quarter into the third quarter of 2009, and will follow the disclosure of results from the first double-blind placebo controlled efficacy study (study 033). BPH is a benign enlargement of the prostate, affecting more than 20 million men in the U.S. alone.
"We are very pleased to have reached this stage of the Phase 3 development of cetrorelix in BPH and look forward to the data emerging in the next quarter. We are also pleased that the ongoing reviews of safety data from our Data and Safety Monitoring Committee have not shown any need for protocol or study procedure amendments to the studies," said Paul Blake M.D., Senior Vice President and Chief Medical Officer of AEterna Zentaris.
The safety study (041) titled, "Cetrorelix pamoate in patients with symptomatic BPH: an open-labeled safety and efficacy assessment study", will assess an intermittent dosage regimen of cetrorelix pamoate as a potential safe and tolerable treatment providing prolonged improvement in BPH-related signs and symptoms. Patients receive cetrorelix pamoate by intra-muscular (IM) injection at Weeks 0 and 2, and are followed up to Week 26. The main endpoint is the incidence of possibly drug-related adverse events. More information on this trial may be obtained at www.clinicaltrials.gov under the reference number NCT00
|SOURCE AETERNA ZENTARIS INC.|
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