Æterna Zentaris Inc., of Quebec City, Canada, has announced the opening of an extended phase 3 study of cetrorelix, a treatment for benign prostatic hyperplasia (BPH). Earlier this year, Æterna Zentaris and sanofi-aventis U.S., of Bridgewater, N.J., entered into an agreement to develop, register, and market cetrorelix in the United States.
Cetrorelix, a luteinizing hormone-releasing hormone antagonist, is administered by IM injection. The drug is currently in three phase 3 trials involving more than 1,600 patients with symptomatic BPH in the United States, Canada, and Europe.
Under the agreement, Æterna Zentaris will be responsible for completing the phase 3 program and regulatory submission in the United States. Sanofi-aventis will be responsible for all commercial activities.
In phase 2 trials, the drug was well-tolerated, provided fast and long-lasting relief of BPH symptoms, and had a low incidence of sexual adverse effects.
North American patients completing two years of treatment will be eligible to participate in the extension study. They will be followed up for safety, International Prostate Symptom Score, and quality of life.
The first reports on efficacy are expected during the third quarter of 2009, and the companies anticipate filing a New Drug Application in 2010.