AEterna Zentaris has initiated an extended study in the Phase-III program with cetrorelix pamoate, for the treatment of benign prostatic hyperplasia (BPH).
Cetrorelix pamoate is currently in three Phase-III trials involving more than 1600 patients with symptomatic BPH in Canada, US and Europe.
Earlier, Sanofi-Aventis had entered into an agreement with AEterna Zentaris for the development, registration and marketing of cetrorelix in BPH for the US market.
According to the agreement, patients completing two years of therapy in the North American trial of cetrorelix, NCT00449150, will be eligible to continue with cetrorelix treatment, according to treatment regimen of the ongoing Phase-III study, till the end of 2011.
Patients in the extension study will be followed-up for safety, International Prostate Symptom Score (IPSS) and quality of life during the extended treatment, providing follow-up data on cetrorelix for up to 5 years.
Juergen Engel, President and CEO, AEterna Zentaris, said: We have been pleased with the decision of patients and their physicians to continue into this extended period of open-label treatment follow-up, sponsored by our partner Sanofi-Aventis US. We look forward to presenting the data from the double-blind portion of the study in the next quarter.