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Aeterna Zentaris: FDA Approves Investigational New Drug (IND) Application for Doxorubicin Targeted Conjugate Compound, AEZS-108, in Bladder Cancer
Date:5/12/2010

QUEBEC CITY, May 12 /PRNewswire-FirstCall/ - Aeterna Zentaris Inc. ( AEZS, TSX: AEZ) (the "Company"), a late-stage drug development company specialized in oncology and endocrine therapy, today announced that the U.S. Food and Drug Administration (FDA) has approved the Company's Investigational New Drug (IND) application for its doxorubicin targeted conjugate compound, AEZS-108, in luteinizing hormone releasing hormone (LHRH) receptor positive urothelial (bladder) cancer. Following this approval from the FDA, the Company expects to initiate a Phase 2 clinical trial in this indication in the second half of this year.

The study will be conducted at the Sylvester Comprehensive Cancer Center at the University of Miami Miller School of Medicine with Gustavo Fernandez, M.D., Assistant Professor of Medicine, as the Principal Investigator, and will include up to 64 patients, male and female, with advanced LHRH-receptor positive urothelial (bladder) cancer. The study will be conducted in two parts; the first one will be a dose-finding part in up to 12 patients and then, the chosen dose will be studied for its effect on progression-free survival.

Juergen Engel, Ph.D., President and CEO of Aeterna Zentaris stated, "We are very pleased with the FDA's approval and excited about this Phase 2 trial in bladder cancer, since it will be our first with AEZS-108 in the United States, and the first one to include male patients. With this upcoming Phase 2 trial, as well as the current Phase 2 trial in advanced ovarian and endometrial cancer conducted in Europe, for which final results are expected before year-end, AEZS-108 has become a major component of our oncology portfolio."


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1. Aeterna Zentaris Receives Orphan-Drug Designation from the FDA for AEZS-108 in Ovarian Cancer
2. AEterna Zentaris Announces Termination of Agreement with sanofi-aventis U.S. for the Development, Commercialization and Licensing of Cetrorelix in Benign Prostatic Hyperplasia
3. AEterna Zentaris Partner, Keryx, Initiates Phase 3 Registration Trial with Perifosine (KRX-0401) for the Treatment of Patients with Advanced Multiple Myeloma
4. AEterna Zentaris Announces Appointment of New Board Member
5. AEterna Zentaris Partner, Keryx, Reports Updated Phase 1/2 Data, Including New Survival Data, on Perifosine (KRX-0401) in the Treatment of Advanced Multiple Myeloma at the 51st Annual Meeting of the American Society of Hematology
6. AEterna Zentaris Announces Results from its European Phase 3 Study with Cetrorelix in Benign Prostatic Hyperplasia
7. AEterna Zentaris Anti-Cancer Compound, Perifosine (KRX-0401), Receives FDA Fast Track Designation for the Treatment of Relapsed/Refractory Multiple Myeloma
8. AEterna Zentaris Announces Positive Results for Phase 2 Study with LHRH-Receptor Targeted Cytotoxic Conjugate AEZS-108 in Endometrial Cancer
9. AEterna Zentaris Receives US$5.5 Million from Institutional Investors
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11. AEterna Zentaris to Complete Phase 3 Clinical Trial of Macimorelin (AEZS-130) as First Oral Diagnostic Test for Growth Hormone Deficiency
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