AEterna Zentaris to submit IND for cetrorelix in benign prostatic hyperplasia following FDA review

By Lisa Kerner

Charlotte, N.C., June 21 - AEterna Zentaris Inc. said it plans to submit an Investigational New Drug application within the next few months to begin a phase 3 program for cetrorelix, its lead luteinizing hormone-releasing hormone (LHRH) antagonist product candidate, in benign prostatic hyperplasia (BPH).

The decision followed a review by the Food and Drug Administration of the safety and efficacy data from the company's phase 2 program with cetrorelix.

"We continue to commit our resources as we aggressively advance our promising product candidates through our pipeline and pursue our strategy of becoming a late-stage biopharmaceutical company before year-end," president and chief executive officer Gilles Gagnon said in a company news release.

"Our successful meeting with the FDA regarding cetrorelix marks a major milestone for the company and is further proof of the significant potential of our LHRH antagonist therapeutic approach."

BPH, characterized by an abnormal benign growth of the prostatic tissues caused by testosterone, causes pain while urinating and frequent urges to urinate during the night. Left untreated, BPH may develop into prostate cancer.

Cetrorelix, marketed under the brand name Cetrotide, is also being studied in a phase 2 trial in Japan.

Based in Quebec City, Quebec, AEterna Zentaris discovers, develops and markets therapies for cancer and endocrine disorders.

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