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AEterna Zentaris: Lead Investigator for Cetrorelix Trials in BPH Wins Best Poster Presentation Award at European Association of Urology Meeting in Milan
Date:4/30/2008

eek 52, 54, 78 and 80 will be followed up to Week 90.

A second, similarly designed multi-center Phase 3 efficacy study, being led by Prof. Frans M.J. Debruyne, M.D., Ph.D., from The Netherlands, will enroll approximately 400 patients in Europe. The third Phase 3 trial scheduled to start shortly, is an open-label, single-armed multi-center safety study involving approximately 500 patients in both North America and Europe, and is being led by Joel Kaufman, M.D., Associate Clinical Professor of Urology, University of Colorado School of Medicine, Denver, Colorado, and Urology Research Options, Aurora, Colorado.

The primary endpoint for both North American and European efficacy studies is the change in I-PSS between baseline and Week 52. Other efficacy endpoints include additional measures of BPH-symptom progression and the need for BPH-related surgery. Safety endpoints include changes in sexual function. Other important endpoints include plasma changes in levels of testosterone, and assessment of other adverse events.

The cetrorelix Phase 3 program is based on comprehensive clinical practice guidelines to ensure quality control, including input from expert advisors on study design, publishing results in peer-reviewed journals and discussion of the studies with regulatory agencies.

Benign Prostatic Hyperplasia

Benign prostatic hyperplasia (BPH) is one of the most common diseases of aging men - affecting more than 20 million men in the United States - but its etiology is far from being completely understood. Data from ongoing research suggest BPH and its associated lower urinary tract symptoms (LUTS) are more complex conditions than once thought. While previous research on BPH etiology tended to focus on testosterone and other hormones, more recent research suggests other factors may play a greater role in the development of BPH and LUTS - including inflammation, various growth factors, and adrenoreceptors.

BPH-associated LUTS inc
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SOURCE AETERNA ZENTARIS INC.
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Related biology technology :

1. AEterna Zentaris Partner, Spectrum, Provides Update on Ozarelix in Benign Prostatic Hyperplasia
2. AEterna Zentaris Completes Patient Recruitment for First Phase 3 Efficacy Trial with Cetrorelix in Benign Prostatic Hyperplasia
3. AEterna Zentaris Announces Changes to its Management Team
4. AEterna Zentaris and Paladin Labs Complete Sale and Purchase of Miltefosine Rights
5. Aeterna Zentaris Begins Second Phase 3 Trial of Cetrorelix for Benign Prostatic Hyperplasia
6. Aeterna Zentaris Reports Fourth Quarter and Full-Year 2007 Financial and Operating Results
7. AEterna Zentaris and Paladin Labs Announce Sale and Purchase of Miltefosine Rights
8. AEterna Zentaris Announces the Departure of SVP, Administrative and Legal Affairs
9. Aeterna Zentaris to Announce Fourth Quarter and Full-Year 2007 Financial and Operating Results on March 5, 2008
10. AEterna Zentaris to Present at the Upcoming Roth Capital Partners 20th Annual OC Growth Stock Conference in Dana Point, California
11. AEterna Zentaris Reports First Patients Treated with Anti-Cancer Compound AEZS-108 in Phase 2 Trial in Ovarian and Endometrial Cancers
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