Positive results from Aeterna Zentaris' AEZS-108 Phase 2 study in ovarian cancer patients

Nov 2 2009

Preliminary evaluation after completion of treatment phase shows that primary efficacy endpoint has been met for patients with advanced-stage platinum-resistant, taxane-pretreated ovarian cancer.

AEterna Zentaris Inc. (TSX: AEZ; Nasdaq: AEZS) (the "Company"), a global biopharmaceutical company focused on endocrine therapy and oncology, today announced positive efficacy data from a Phase 2 study with its targeted cytotoxic peptide conjugate, AEZS-108 (formerly AN-152), in patients with platinum-resistant and taxane-pretreated ovarian cancer. In a personalized healthcare approach, the study selected patients with tumors expressing LHRH receptors, the key element in the targeting mechanism of AEZS-108. Under coordination by Prof. Gunter Emons, MD, Chairman of the Department of Obstetrics & Gynaecology at the University of Gottingen, Germany, this open-label, multi-center and multi-national Phase 2 study 'AGO-GYN-5' is being conducted by the German AGO Study Group (Arbeitsgemeinschaft Gynakologische Onkologie / Gynaecological Oncology Working Group; www.ago-ovar.de), in cooperation with clinical sites in Europe.

Preliminary Results

All 43 patients with LHRH-receptor positive ovarian cancer who entered study AGO-GYN-5 have completed their study treatment. A preliminary evaluation shows that the study met its primary efficacy endpoint of 5 or more responders in 41 evaluable patients.

Responders, as well as patients with stable disease after completion of treatment with AEZS-108, will now be followed to assess the duration of progression-free survival and, ultimately, overall survival. More detailed analyses, which will also include efficacy data from post-treatment follow-up of the ovarian cancer patients, are currently in preparation and will be presented at forthcoming scientific conferences.

Juergen Engel, Ph.D., AEterna Zentaris President and Chief Executive Officer stated, "We are pleased with the progress of this project. The successful completion of the recruitment and treatment phase and the apparent activity in this difficult group of cancer patients is encouraging. This is the basis we were looking for, in order to take the next steps in the further development of AEZS-108 in gynaecological cancers and possibly also in prostate cancer."