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Aeterna Zentaris: Poster Presented at ASCO Meeting on the Design of the Current ZoptEC Phase 3 Trial in Endometrial Cancer
QUEBEC CITY , June 2, 2014 /CNW Telbec/ - Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX:
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About this update from Cosciens Biopharma Inc.
[{"type":"text","content":"\n\n\nQUEBEC CITY, June 2, 2014 /CNW Telbec/ - Aeterna Zentaris Inc. (NASDAQ:\n AEZS) (TSX: AEZ) (the \"Company\") today announced that a poster was\n presented on the design of its current ZoptEC (Zoptarelin doxorubicin in Endometrial Cancer) Phase 3 trial in women with advanced, recurrent or metastatic\n endometrial cancer. The poster #TPS5630 titled, \"ZoptEC: Phase 3 study of zoptarelin doxorubicin (AEZS-108)in\n platinum-taxane pretreated endometrial cancer (Study AEZS-108-050)\", D. S. Miller, H. Gabra, G. Emons, D. S. McMeekin, A. M. Oza, S. M.\n Temkin, I. Vergote, was presented over the weekend by lead\n investigator, David S. Miller, MD, of the University of Texas\n Southwestern Medical Center, in Dallas, during the 50th Annual Meeting of the American Society of Clinical Oncology (ASCO) in\n Chicago. Currently, more than 100 sites are in operation and some160\n patients have been recruited for this ZoptEC Phase 3 trial.\n\n\nBackground: A platinum-taxane combination is commonly used both as adjuvant and\n first line therapy for advanced, recurrent, and metastatic endometrial\n cancer (EC). Zoptarelin doxorubicin (formerly AEZS-108) is a hybrid\n anticancer agent in which doxorubicin is chemically linked to\n zoptarelin, a D-Lys6-analogue of luteinizing hormone releasing hormone\n (LHRH). Zoptarelin doxorubicin was initially evaluated in tumor types\n reported to express receptors for LHRH. Depending on the method used to\n determine LHRH receptor expression, LHRH receptors have been found in\n 40% to 90% of ECs. A Phase 2 study of zoptarelin doxorubicin in EC\n patients showed activity, including those previously treated with\n platinum-taxane [Emons et al. 2014].\n\n\nMethods: This open-label, randomized-controlled study compares the efficacy and\n safety of zoptarelin doxorubicin and doxorubicin. The study is expected\n to include 500 EC patients progressing after prior therapy with\n platinum-taxane-based chemotherapy. There are about 120 expected study\n sites in North America, Western and Central/Eastern Europe, and Israel.\n Patients are centrally randomized in a 1:1 ratio and receive either\n zoptarelin doxorubicin (267 mg/m2) or doxorubicin (60 mg/m2) intravenously, every 3 weeks and for up to 9 cycles. Response will be\n evaluated every 3 cycles during treatment, thereafter, every 12 weeks\...