Aeterna Zentaris announces $1.5M NIH award for AEZS-108 Phase 1/2 study in refractory prostate cancer

Aug 5 2010

Grant awarded to Dr. Jacek Pinski to conduct the study at the Norris Comprehensive Cancer Center of the University of Southern California

Aeterna Zentaris Inc. (TSX: AEZ; Nasdaq: AEZS), (the "Company"), a late-stage drug development company specialized in oncology and endocrine therapy, today announced that the National Institutes of Health ("NIH") has awarded Dr. Jacek Pinski, Associate Professor of Medicine at the Norris Comprehensive Cancer Center of the University of Southern California, a grant of about US$1.5 million over three years to conduct a Phase 1/2 study in refractory prostate cancer with the Company's doxorubicin LHRH receptor targeted conjugate compound, AEZS-108. The study, entitled "A Phase I/II Trial of AN-152 (AEZS-108) in Castration- and Taxane-Resistant Prostate Cancer", will enroll up to 55 patients and will be conducted in two portions: the first portion will be an abbreviated dose-escalation followed by a single arm, Simon Optimum two-stage design Phase 2 study using the dose selected in the Phase 1 portion. The primary objective of the Phase 2 portion is to evaluate the clinical benefit of AEZS-108 in men with castration- and taxane-resistant metastatic prostate cancer, for which the presence of LHRH receptors has been confirmed.

Juergen Engel, Ph.D., President and CEO of Aeterna Zentaris commented, "We congratulate Dr. Pinski for the grant awarded by the NIH and we are very pleased to initiate this collaboration for AEZS-108. We are excited about this study since we believe AEZS-108, with its targeting approach, could represent an achievement in treating men with castration- and taxane-resistant prostate cancer, especially for those having LHRH-receptor-positive cells."

Jacek Pinski, MD, Associate Professor of Medicine at the Norris Comprehensive Cancer Center of the University of Southern California stated, "We are looking forward to working with Aeterna Zentaris which developed AEZS-108 in collaboration with the Nobel Laureate Dr. Andrew V. Schally, from the University of Miami and VA Medical Center in Miami. Given the positive results presented for LHRH-receptor-positive cells in prostate cancer at ASCO 2009, the positive results demonstrated for ovarian cancer at ASCO 2010 and the targeting action of AEZS-108 to be delivered specifically to the cancer cells, we hope to avoid damage to healthy tissue and to reduce side effects, since prostate cancer patients often have other medical conditions."

In previous research, Dr. Pinski found that cancerous cells in human prostate tissue contain the luteinizing hormone-releasing hormone (LHRH) receptor (ASCO 2009, abstract #5163), the cellular receptor specifically targeted by AEZS-108.

In addition to performing this Phase 1/2 trial, Dr. Pinski will also lead a team that uses new methods for collecting circulating tumor cells and analyzing data about AEZS-108's effectiveness in advanced prostate cancer.

SOURCE AETERNA ZENTARIS INC.