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news.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.
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Canada-based AEterna has reported that patient follow-up in the safety study of its phase-III program in benign prostatic hyperplasia (BPH) with its endocrinology compound, cetrorelix pamoate, is scheduled to be completed at the end of this week.
The data analysis and reporting will be brought forward from the scheduled fourth quarter into third quarter of 2009, and will follow the disclosure of results for efficacy study.
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.
Paul Blake, Senior Vice President and CMO of AEterna, said: 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.