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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

o placebo-controlled trials investigated two formulations of cetrorelix to determine the extent and duration of symptomatic improvement and to select the interval between courses for an intermittent treatment scheme.

Trial Design

Trial-A compared 3 regimens of subcutaneous cetrorelix acetate with placebo (35 patients/group): 5mg x 4, 7 days apart; 10mg x 4, 7 days apart; and 10mg x 2, 14 days apart.

Trial-B compared 4 regimens of intramuscular cetrorelix pamoate with placebo (30 patients/group, 14 days between doses): 30mg x 2; 30mg x 3; 60mg and 30mg; 60mg x 2. Patients were followed up for 20 and 28 weeks after the first dose in Trial-A and B, respectively. International Prostate Symptom Score (I-PSS) primary endpoint was assessed in 4-weekly intervals; other endpoints included uroflow, prostate size, and testosterone levels.

Results

In both trials, 4 weeks after first dose, all regimens showed a statistically significant reduction in I-PSS from baseline; at week 12, the difference from placebo was statistically significant for all dosage regimens except the 30mg x 2 in Trial-B (Trial-A: p<0.05; Trial-B: p <0.001). Generally, the improvement in I-PSS, which tended to be better in the higher dosage groups of Trial-B (reduction of 5-7 points, i.e. 30%-40%), was maintained throughout the follow-up period and was paralleled by an improvement in uroflow. A slight, dose-dependent reduction in prostate size was noticed in both trials. All dosage regimens tested were well tolerated, and none were associated with sexual side effects.

Conclusions

In both studies, a prolonged duration of effect extending far beyond the end of the short-term treatment course was observed. For the long-term management of BPH patients, the results from both studies support a 6-month interval between subsequent treatment courses.

About Cetrorelix

Cetrorelix is part of AEterna Zentaris' LHRH antagonist therapeutic approach that has de
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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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