Positive efficacy data from Phase 2 study of AEZS-108 announced

Nov 25 2009

Primary efficacy endpoint has been met for patients with advanced-stage or recurrent endometrial cancer

AEterna Zentaris Inc. (NASDAQ: AEZS; TSX: AEZ) (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 advanced or recurrent endometrial cancer. In a personalized health care approach, the study selected patients with tumors expressing luteinizing hormone-releasing hormone (LHRH) receptors, the key element in the targeting mechanism of AEZS-108. Under the coordination of 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

A preliminary evaluation has shown that the study AGO-GYN 5 met its predefined primary efficacy endpoint of 5 or more responder patients with endometrial cancer. The study is currently ongoing, and responders, as well as patients with stable disease after completion of treatment with AEZS-108, will be followed to assess the duration of progression-free survival and, ultimately, overall survival. Detailed analyses of the study results will be presented at forthcoming scientific conferences.

Juergen Engel, Ph.D., President and Chief Executive Officer at AEterna Zentaris stated, "We are pleased with the progress of this Phase 2 program. Along with the recently disclosed positive results for the ovarian cancer indication, the good news for the endometrial cancer indication provides us with an even stronger basis to take the next steps in the development of AEZS-108 in gynaecological cancers."