Æterna Zentaris reports Phase 3 results of its cetrorelix pamoate Z-036 trial for BPH

Dec 7 2009

Æterna Zentaris Inc. (NASDAQ: AEZS; TSX: AEZ) (the "Company"), a global biopharmaceutical company focused on endocrine therapy and oncology, today reported Phase 3 results for its European efficacy trial Z-036 in benign prostatic hyperplasia (BPH), with cetrorelix pamoate.

Study Z-036 did not reach its primary endpoint. There were no clear differences in overall efficacy, with all 3 groups (including placebo) showing an improvement in International Prostate Symptom Score (IPSS) of approximately 6 points that was maintained throughout the 52 weeks. There was observation of an improvement in uroflow, both maximum and mean, and in residual volume in all treatment groups. These favorable changes are reflected in an overall improvement in Quality of Life measures. Cetrorelix was well tolerated, there were no relevant differences to placebo with regard to both clinical adverse events or changes in laboratory parameters with the exception of the anticipated hormonal changes.

Juergen Engel, Ph.D., Æterna Zentaris President and CEO stated, "We are obviously disappointed by the failure of study Z-036 to reach its efficacy endpoint. Despite the disappointment, we would like to thank the investigators and all those involved in this project for their dedicated work. We will now focus our development efforts on our late-stage oncology compounds perifosine, our oral PI3K/AKT inhibitor and AEZS-108, our targeted doxorubicin conjugate, as well as our oral ghrelin agonist AEZS-130 in endocrinology."