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Aeterna Zentaris Granted Special Protocol Assessment by the FDA for Phase 3 Registration Trial in Endometrial Cancer with AEZS-108
QUÉBEC CITY, Dec. 28, 2012 /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, Dec. 28, 2012 /CNW Telbec/ - Aeterna Zentaris Inc. (NASDAQ:\n AEZS) (TSX: AEZ) (the \"Company\") today announced that it has reached an\n agreement with the U.S. Food and Drug Administration (\"FDA\") on a\n Special Protocol Assessment (\"SPA\") for an upcoming Phase 3\n registration trial in endometrial cancer with its doxorubicin peptide\n conjugate, AEZS-108. The SPA agreement states that the proposed trial\n protocol design, clinical endpoints and planned analyses are acceptable\n to the FDA to support a regulatory submission.\n\n\n\"We are pleased with the agreement with the FDA which provides us with a\n clearly defined development and regulatory pathway for AEZS-108 in\n endometrial cancer\", stated Juergen Engel, PhD, President and CEO at\n Aeterna Zentaris. \"AEZS-108's innovative targeted approach could offer\n a new treatment option for women with endometrial cancer and provide\n the Company with a significant market opportunity.\"\n\n\nStudy Design \n\n\nThis will be an open-label, randomized, multicenter Phase 3 trial\n conducted in North America and Europe, comparing AEZS-108 with\n doxorubicin as second line therapy for locally-advanced, recurrent or\n metastatic endometrial cancer. The trial will involve approximately 500\n patients and the primary efficacy endpoint is improvement in median\n Overall Survival.\n\n\nAbout Special Protocol Assessments (\"SPA\") \n\n\nThe SPA process is a procedure by which the FDA provides official\n evaluation and written guidance on the design and size of proposed\n protocols that are intended to form the basis for a Biologics License\n Application (\"BLA\") or New Drug Application (\"NDA\"). Final marketing\n approval depends on the results of efficacy, the adverse event profile\n and an evaluation of the benefit/risk of treatment demonstrated in the\n Phase 3 trial.\n\n\nAbout AEZS-108\n\n\nAEZS-108 represents a new targeting concept in oncology using a hybrid\n molecule composed of a synthetic peptide carrier and a well-known\n chemotherapy agent, doxorubicin. AEZS-108 is the first intravenous drug\n in advanced clinical development that directs the chemotherapy agent\n specifically to Luteinizing Hormone Releasing Hormone (\"LHRH\")-receptor\n expressing tumors, resulting in more targeted treatment with less\n damage to healthy tissue. The p...