by at least 3 points. Notably, the 46% of patients who had received previous treatment for BPH showed an important mean improvement of 5 points, which is only slightly less than the 6 point improvement seen in treatment-naive patients. Maximum uroflow improved by 25%, from 10.3 to 12.5 ml/sec, and also the mean uroflow showed similar improvement.
Juergen Engel, Ph.D., AEterna Zentaris President and CEO stated, "Although the data received for the open-label safety study Z-041 with a nearly 6 point reduction in IPSS are in line with what we had observed in our Phase 2 program, we are disappointed by the failure to achieve the primary endpoint in the efficacy study Z-033. We remain committed to the ongoing Phase 3 program with cetrorelix in BPH and are working towards receiving the results of the second pivotal efficacy study Z-036 in November."
Herbert Lepor, M.D., Professor and Chairman, Department of Urology, at NYU School of Medicine, New York and Lead Investigator of the Z-033 trial added, "These findings are unexpected in light of the previous Phase 2 experience. Those data and the strength of the safety data available to date had given us confidence in this potential new treatment for BPH. It is now important to await results of the other placebo-controlled efficacy study Z-036."
Conference Call
The Company will host a conference call and webcast to discuss these results later today, Monday, August 17, 2009 at 10:00 a.m., Eastern Time.
Participants may access the live webcast via the Company's website at www.aezsinc.com in the "Investors" section, or by telephone using the following numbers: (outside Canada): 800-588-4942. (Canada): 416-644-3426 or 514-807-8791. A replay of the webcast will also be available on the Company's website for a period of 30 days.
About the Phase 3 Program with Cetrorelix in BPH
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AEterna Zentaris Reports Second Quarter 2009 Financial and Operating Results2.
AEterna Zentaris to Present at Upcoming Canaccord Adams 29th Annual Global Growth Conference3.
AEterna Zentaris to Announce Second Quarter 2009 Financial and Operating Results on August 11, 20094.
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AEterna Zentaris Opens Extended Study for Cetrorelix in Benign Prostatic Hyperplasia9.
AEterna Zentaris Discloses Preliminary Phase 2 Trial Results for Perifosine in Combination with Radiotherapy for Non-Small Cell Lung Cancer10.
AEterna Zentaris Acquires All Assets from Ardana for Growth Hormone Secretagogue Compound, AEZS-13011.
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