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AEterna Zentaris: First Patient Dosing for Safety Trial of Phase 3 Program with Cetrorelix in Benign Prostatic Hyperplasia

16 May 2008 - AEterna Zentaris Inc. reported dosing has commenced in the safety study of the Company's Phase 3 program with cetrorelix in benign prostatic hyperplasia (BPH).
 
Cetrorelix, a novel investigational luteinizing hormone-releasing hormone (LHRH) antagonist, is the Company's flagship product candidate. This 500-patient safety trial is the third of three Phase 3 studies - planned to enroll a total of 1,500 patients - to define the role of cetrorelix in the treatment of BPH, a non-cancerous enlargement of the prostate affecting millions of men.
 
"With this additional study, all three trials of our Phase 3 program are now in full gear. This milestone brings us one step closer to our goal of providing a novel, safe and efficient therapeutic approach to the millions of men suffering from BPH," said Paul Blake, M.D., Senior Vice President and Chief Medical Officer at AEterna Zentaris.
 
The safety study titled, "Cetrorelix pamoate in patients with symptomatic BPH: an open labeled safety and efficacy assessment study", will involve approximately 500 patients in North America and Europe, and 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 will receive cetrorelix pamoate by intra-muscular (IM) injection at weeks 0 and 2, and will be followed up to week 26. The main endpoint is the incidence of possibly drug-related adverse events.
 
Cetrorelix is part of AEterna Zentaris' LHRH antagonist therapeutic approach that has demonstrated in Phase 2 studies to provide fast and long-lasting relief of BPH symptoms while being well tolerated, with a low incidence of sexual side effects.