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Aeterna Zentaris: First Patient Treated For Phase 2 Trial With AEZS-108 In Triple-Negative Breast Cancer

QUÉBEC CITY, Feb. 20, 2013 /PRNewswire/ - Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZ) (the "Company") today announced that a first patient has been treated for the randomized Phase 2 trial in chemotherapy refractory triple-negative ("ER/PR/HER2-negative") luteinizing hormone-releasing hormone receptor ("LHRH-R")-positive metastatic breast cancer, with the Company's targeted doxorubicin peptide conjugate, AEZS-108. Alberto J. Montero, MD, Assistant Professor, Department of Medicine, Division of Hematology/Oncology, Sylvester Comprehensive Cancer Center at the University of Miami Miller School of Medicine, is the lead investigator of this trial which also include sites at the Universities of Regensburg and Goettingen, in Germany.

Juergen Engel, Ph.D., President and CEO of Aeterna Zentaris stated, "Patients with triple-negative breast cancer have poorer outcomes compared to other breast cancer subtypes and are in need of a safe and effective therapeutic regimen. Because LHRH receptors are expressed in a majority of triple-negative breast cancers, we believe AEZS-108 could represent a novel targeted treatment for these patients. Expansion into the breast cancer indication with AEZS-108 after positive Phase 2 results in endometrial and ovarian cancer, as well as positive interim Phase 1/2 results in prostate cancer, is further proof of the potential of this innovative compound in a variety of cancer indications for both women and men."

The Study

This is an open-label, randomized, two-arm, multicenter Phase 2 study which will involve up to 74 patients. Patients will be randomized in a 1:1 ratio into one of the two treatment arms: AEZS-108 (267 mg/m 2 every 21 days) [Arm A] or SSC (standard single agent cytotoxic chemotherapy [Arm B]) at the discretion of the treating oncologist.

The primary study endpoint is median time of progression-free survival. Secondary endpoints include overall response-rate, and overall survival. The study will also evaluate AEZS-108's toxicity profile and patients' quality of life relative to conventional cytotoxic chemotherapy.

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