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AEterna Zentaris Announces Results from Two Phase 3 Studies with Cetrorelix in Benign Prostatic Hyperplasia
Date:8/17/2009

Cetrorelix pamoate is currently in three Phase 3 trials involving more than 1,600 patients with symptomatic BPH in Canada, the United States and Europe.

The first Phase 3 efficacy trial Z-033, titled, "Cetrorelix pamoate intermittent IM dosage regimens in patients with symptomatic BPH: a 1-year placebo-controlled efficacy study and long-term safety assessment", involved 667 patients mostly in North America and assessed an intermittent dosage regimen of cetrorelix as treatment for BPH-related signs and symptoms.

As announced recently, patients completing the 52 week double-blind study are then allowed to continue into an open-label extension of this study, sponsored by sanofi-aventis, where patients receive the same dosing regimen of cetrorelix by IM injection at Week 52, 54, 78 and 80, and are followed up to Week 90. Patients entering this extension study will be followed-up for safety, IPSS and quality of life, thus providing follow-up data on cetrorelix for up to 5 years.

The second multi-center Phase 3 efficacy study Z-036 for which patient recruitment was completed in October 2008, involves 420 patients, mainly in Europe. Patients in this randomized placebo-controlled study with open-label extension conducted under the supervision of lead investigator, Prof. Frans M.J. Debruyne, M.D., of the Andros Mannenkliniek, Arnhem, The Netherlands, receive cetrorelix according to similar dosing regimens used in the first efficacy study Z-033.

The primary endpoint for both North American and European efficacy studies is absolute change in IPSS 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 third trial of the program is the safety study Z-041 titled, "Cet
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SOURCE AETERNA ZENTARIS INC.
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