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AEterna Zentaris Reaches 2nd Stage of Patient Recruitment for Phase 2 Trial in Endometrial Cancer with the Innovative LHRH Receptor Targeted Conjugate, AEZS-108
Date:11/3/2008

ead oncology compound, AEZS-108 in both endometrial and ovarian cancer. The data also strengthens our belief that increased clinical benefit for patients could be achieved by specifically targeting LHRH-receptor expressing tumors using doxorubicin. Finally, this program remains on track and we expect to disclose full results over the next few months."

About the Phase 2 Program

Entitled, "The antitumoral activity and safety of AEZS-108 (AN-152), a LHRH agonist linked doxorubicin in women with LHRH-receptor positive gynaecological tumors", this European open-label, non-comparative multi-center Phase 2 program has as its primary endpoint, the partial or complete tumor response rate according to RECIST and/or GCIG guidelines. Secondary endpoints include time to progression, survival, toxicity as well as adverse effects. The program will include up to 82 patients (up to 41 with a diagnosis of platinum-resistant ovarian cancer and up to 41 with disseminated endometrial cancer). Patients are administered an intravenous infusion of 267 mg/m2 of AEZS-108 over a period of 2 hours at a constant rate, every Day 1 of a 21-day (3-week) cycle. The proposed duration of the study treatment is six, three-week cycles. Further information on the program is available at http://www.clinicaltrials.gov.

Prior Phase 1 trial results

On June 3, 2007 positive results of an open, multi-center, sequential group, dose-escalation Phase 1 study in various gynaecological cancers were presented at the American Society of Clinical Oncology's (ASCO) Annual Meeting in Chicago, Illinois. 17 patients with LHRH-receptor positive gynaecological cancers were recruited. AEZS-108 was administered by intravenous infusion over two hours at dosages of 10, 20, 40, 80,160 and 267 mg/m2. At 160 mg/m2, six patients had a total of 32 cycles and at 267 mg/m2, seven patients had a total of 27 cycles. Most of the patients had been pretr
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SOURCE AETERNA ZENTARIS INC.
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