AEterna Zentaris Reaches 2nd Stage of Patient Recruitment for Phase 2 Trial in Ovarian Cancer with the Innovative LHRH Receptor Targeted Conjugate...(w months as they will be pivotalin formu...),Health

Juergen Engel, Ph.D., President and CEO of AEterna Zentaris stated, "These results confirm the early signals of anticancer activity we have seen in our phase 1 study with this new targeting concept we developed in collaboration with the Nobel Prize laureate Dr. Andrew V. Schally."

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
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