AEterna Zentaris (AEZS) to Initiate Phase 3 Program in Benign Prostatic Hyperplasia

November 29, 2006 7:42 AM EST

AEterna Zentaris Inc. (Nasdaq: AEZS) plans to initiate its Phase 3 program in benign prostatic hyperplasia (BPH) before year-end with its luteinizing hormone-releasing hormone (LHRH) antagonist compound, cetrorelix, after the Company's Investigational New Drug Application (IND) was accepted by the U.S. Food and Drug Administration (FDA).

In the first multi-center study, patients will enter a 4-week run-in no-treatment observation period to confirm severity and stability of voiding symptoms based on the International Prostate Symptom Score (IPSS). Patients will then be allocated to cetrorelix in a double-blind, randomized, double-dummy, placebo-controlled fashion.

The primary efficacy endpoint of this first study is absolute change in IPSS between baseline before beginning treatment and Week 52, while safety endpoints include changes in sexual function as well as BPH symptom progression equal to or more than 4 points and/or acute urinary retention and/or need for BPH related surgery. Other important endpoints consist of plasma levels of testosterone and changes in bone mineral density.

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