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Aeterna Zentaris: FDA Grants IND to Investigator at University of Miami School of Medicine for Phase 2 Trial with AEZS-108 in Triple-Negative Breast Cancer
QUÉBEC CITY, Oct. 25, 2011 /CNW Telbec/ - Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX:&#...
About this update from Cosciens Biopharma Inc.
[{"type":"text","content":"\n\n\n\n\n\nQUÉBEC CITY, Oct. 25, 2011 /CNW Telbec/ - Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZ) (the \"Company\") today\n announced that the U.S. Food and Drug Administration (FDA) has granted\n Alberto J. Montero, M.D., Assistant Professor, Department of Medicine,\n Division of Hematology/Oncology, Sylvester Comprehensive Cancer Center\n at the University of Miami Miller School of Medicine, an\n Investigational New Drug (IND) approval for the initiation of a\n randomized Phase 2 trial in chemotherapy refractory triple-negative\n (ER/PR/HER2-negative) luteinizing hormone-releasing hormone receptor\n (LHRH-R)-positive metastatic breast cancer with the Company's targeted\n cytotoxic LHRH analog, AEZS-108.\n\n\nJuergen Engel, Ph.D., President and CEO of Aeterna Zentaris stated,\n \"Patients with triple-negative breast cancer have poorer outcomes\n compared to other breast cancer subtypes and are in need of a safe and\n effective therapeutic regimen. Because LHRH receptors are expressed in\n a majority of triple negative-breast cancer, we believe AEZS-108 could\n represent a novel targeted treatment for these patients. Expansion into\n the breast cancer indication with AEZS-108 after recent positive Phase\n 2 results in endometrial and ovarian cancer, as well as positive Phase\n 1/2 results in prostate cancer, is further proof of the potential of\n this innovative compound in a variety of cancer indications for both\n women and men.\"\n\n\nThe Study\n\n\nThis will be an open-label, randomized, two-arm, multicenter Phase 2\n study involving up to 74 patients. Eligibility criteria include\n histologically documented breast cancer (either primary or metastatic\n site) that is ER-negative, PR-negative, HER2 non-overexpressing by\n immunohistochemistry (0, 1) or fluorescence in situ hybridization (FISH); expression of LHRH-R receptor confirmed by IHC on\n archival (or current biopsy of breast tumor or metastatic site) breast\n cancer tissue; prior treatment that includes having received 1 to 3\n prior chemotherapy regimens in the metastatic setting; and metastatic\n breast cancer (Stage IV) with measurable disease by RECIST 1.1\n criteria. Patients will be randomized in a 1:1 ratio into one of the\n two treatment arms: AEZS-108 (267 mg/m2 every 21 days) [Arm A] or SSC (standard single agent cytotoxic\n chemotherapy [Arm B...