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Aeterna Zentaris: First Patient Dosed for Phase 3 Registration Trial in Endometrial Cancer with Zoptarelin Doxorubicin (AEZS-108)
All amounts are in U.S. dollars (unless otherwise noted) QUÉBEC CITY, July 31, ...
About this update from Cosciens Biopharma Inc.
[{"type":"text","content":"\n\n\nAll amounts are in U.S. dollars (unless otherwise noted)\n\n\nQUÉBEC CITY, July 31, 2013 /CNW Telbec/ - Aeterna Zentaris Inc. (NASDAQ:\n AEZS) (TSX: AEZ) (the \"Company\") today announced that the first patient\n has been recruited and dosed for the Phase 3 ZoptEC (Zoptarelin doxorubicin in Endometrial Cancer) trial in women with endometrial cancer resistant to\n platinum/taxane-based chemotherapy.\n\n\n\"We have reached another important milestone in the final clinical\n development stage for zoptarelin doxorubicin (AEZS-108) in treating\n endometrial cancer. Efforts are now focused on pursuing patient\n recruitment as swiftly as possible\", stated David Dodd, President and\n CEO of Aeterna Zentaris. \"This compound's innovative targeted approach\n potentially offers a much needed novel treatment option for women with\n endometrial cancer and it provides the Company with a significant\n market opportunity.\"\n\n\nThe Study\n\n\nThis is an open-label, randomized, multicenter Phase 3 trial to be\n conducted in over 120 sites in North America, Europe, Israel and other\n countries under a Special Protocol Assessment, comparing zoptarelin\n doxorubicin (AEZS-108) with doxorubicin as second line therapy for\n locally-advanced, recurrent or metastatic endometrial cancer. Lead\n investigators are David Scott Miller, MD, from the University of Texas\n Southwestern Medical Center, in Dallas, Texas, and Hani Gabra, MD, from\n the Imperial College London Hammersmith Campus in London, England. The\n trial will involve approximately 500 patients and the primary efficacy\n endpoint is improvement in median Overall Survival.\n\n\nSelected as the contract clinical development organization, Ergomed will\n also assume 30% (up to $10 million) of the clinical and regulatory\n costs for this trial.\n\n\nDetails for this trial are available at www.clinicaltrials.gov (NCT01767155).\n\n\nAbout Zoptarelin Doxorubicin (AEZS-108)\n\n\nZoptarelin doxorubicin (AEZS-108) represents a new targeting concept in\n oncology using a hybrid molecule composed of a synthetic peptide\n carrier and a well-known chemotherapy agent, doxorubicin. Zoptarelin\n doxorubicin (AEZS-108) is the first intravenous drug in advanced clinical development that\n directs the chemotherapy agent specifically to LHRH-receptor expressing\n tumors, resulting ...