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AEterna Zentaris Reports First Patients Treated with Anti-Cancer Compound AEZS-108 in Phase 2 Trial in Ovarian and Endometrial Cancers
Date:2/12/2008

an open-label, non-comparative multi-center Phase 2 trial will have as its primary endpoint the partial or complete tumor response rate according to RECIST and/or GCIG guidelines. Secondary endpoints will include time to progression, survival, toxicity as well as adverse effects. The trial 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 will be 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. The planned study period is approximately 24 months. Further information on the trial 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 pretreated with various chemotherapies.

The study showed that AEZS-108 was well tolerated by patients with gynaecological tumors. Furthermore, AEZS-108 is the first drug in a clinical study that targets the cytotoxic activity of doxorubicin specifically to LHRH-receptor expressing tumors. Finally, signs of anti-tumor activity were observed in three out of 13 patients treated with 160 or 267 mg/m2 of AEZS-108, including three patients with complete or partial response.

About AEZS-108

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SOURCE AETERNA ZENTARIS INC.
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