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AEterna Zentaris to Report Data from Safety Study of Phase 3 Program in Benign Prostatic Hyperplasia with Cetrorelix Ahead of Schedule
Date:6/15/2009

The third study in the Phase 3 program, a multi-center safety study, for which patient recruitment was completed in December 2008, is an ongoing open-label, single-armed study involving 528 patients in North America. The lead investigator is Joel Kaufman, M.D., Associate Clinical Professor in Urology at University of Colorado School of Medicine in Denver, Colorado and at Urology Research Options in Aurora, Colorado.

First efficacy results are expected during the third quarter of 2009 with an NDA filing targeted in 2010.

Recently, AEterna Zentaris also announced that patients completing two years of therapy with cetrorelix in the first efficacy study (study 033), will be eligible to continue with the cetrorelix treatment, according to treatment regimen of the ongoing Phase 3 study, until the end of 2011. Patients entering this extension study sponsored by the Company's partner sanofi-aventis, will be followed-up for safety, International Prostate Symptom Score (IPSS) and quality of life during the extended treatment, providing follow-up data on cetrorelix for up to 5 years.

About Cetrorelix

Cetrorelix pamoate is an investigational agent that has shown in Phase 2 studies to provide fast and long lasting relief of BPH symptoms and was well tolerated, with a low incidence of sexual side effects. Cetrorelix is part of AEterna Zentaris' luteinizing hormone-releasing hormone (LHRH) antagonist therapeutic approach. This peptide-based active substance was developed by the Company in cooperation with Nobel Prize winner Prof. Andrew Schally, currently of the U.S. Veterans Administration in Miami.

Cetrorelix acetate is marketed under the brand name Cetrotide(R), the first LHRH antagonist approved for therapeutic use as part of in vitro fertilization programs (controlled ovulation stimulation/assisted reproductive technologies) in Europe, the USA and Japan. It was launched on the market through Serono (now
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SOURCE AETERNA ZENTARIS INC.
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Related biology technology :

1. AEterna Zentaris Opens Extended Study for Cetrorelix in Benign Prostatic Hyperplasia
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3. AEterna Zentaris Acquires All Assets from Ardana for Growth Hormone Secretagogue Compound, AEZS-130
4. AEterna Zentaris Presents Data Supporting Evaluation of AEZS-108 in Prostate Cancer at ASCO Meeting
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6. AEterna Zentaris to Announce First Quarter 2009 Financial and Operating Results and Hold Annual Shareholder Meeting on May 6, 2009
7. AEterna Zentaris Regains Compliance with Nasdaq Minimum Bid Price Listing Requirement
8. AEterna Zentaris Presents Phase 1 Results for AEZS-112 in Patients with Advanced Cancer and Lymphoma at AACR Annual Meeting in Denver
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10. AEterna Zentaris To Present Data on Anticancer Compounds AEZS-112 and AEZS-126 at AACR Annual Meeting
11. AEterna Zentaris Reports Fourth Quarter and Full-Year 2008 Financial and Operating Results
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