Strong Ph II data for AEterna Zentaris' ozarelix

Canada's AEterna Zentaris reported positive Phase II results in hormone-dependent, inoperable prostate cancer patients on ozarelix, its luteinizing hormone-releasing hormone antagonist. The findings, which were presented at the Societe Internationale d'Urologie meeting, held in Cape Town, South Africa, showed that the first primary efficacy endpoint of finding a tolerable dosage regimen ensuring continuous suppression of testosterone at castration level (<0.5ng/ml) was achieved at a 130mg intramuscular dose every four weeks during a three-month test period.

According to the firm, the second primary endpoint of the open-label, randomized-controlled, 64-patient, multicenter dose-finding trial, relating to time to onset-of-action was also well achieved as all patients had testosterone in castration range within two days after dosing. Furthermore, a secondary efficacy endpoint, related to a decrease in prostate-specigic antigen level of at least 50%, was achieved with all patients. "These Phase II data provide further evidence that ozarelix, most importantly, is well tolerated and effective while demonstrating a unique very fast onset of action," said Jurgen Engel, executive vice president of AEterna Zentaris' global R&D and its chief operating officer.