Nov. 12, 2012
/PRNewswire/ - Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZ) (the "Company") today announced the start of the Phase 2 portion of its ongoing Phase 1/2 study in castration- and taxane-resistant
prostate cancer (CRPC) with AEZS-108. The trial on the Company's targeted cytotoxic luteinizing hormone-releasing hormone (LHRH) analog, AEZS-108, is being supported by a three-year
grant from the National Institutes of Health to
, MD, PhD, Associate Professor of Medicine at the Norris Comprehensive Cancer Center of the
University of Southern California
Preliminary data for the Phase 1 portion of this trial, presented in
at the American Society of Clinical Oncology Genitourinary Cancers Symposium, demonstrated that AEZS-108 was well tolerated and demonstrated early evidence of antitumor activity in men with CRPC. The poster on these preliminary data can be viewed on line through the following
. Final Phase 1 data are expected to be presented at an upcoming conference in 2013.
Dr. Pinski stated, "AEZS-108 has been very well tolerated in this heavily pre-treated population, and its efficacy, so far, is impressive. We are fully committed to the Phase 2 portion of the study as shown with the opening of additional sites at the
Los Angeles County
West Los Angeles
, PhD, President and CEO of Aeterna Zentaris said, "We would like to congratulate Dr. Pinski and his colleagues on the progress made with this study. AEZS-108 is a key element of our personalized medicine approach in oncology, and we look forward to results for the Phase 2 portion of this trial, as AEZS-108 could offer a novel targeted treatment for men suffering from prostate cancer."
Phase 2 Portion of the Phase 1/2 Study
This is a single-arm Simon Optimum design Phase 2 study involving up to 37 patients with pre-treated CRPC, using the dose selected (210 mg/m
) in the Phase 1 portion. Six patients that were administered the 210 mg/m
dose in the Phase 1 portion of the trial, have already been included in the Phase 2 portion.
For the Phase 2 portion, patients receive AEZS-108 intravenously over 2 hours in repeating 21 day cycles, until progression of the disease, unacceptable toxicity or patient withdrawal. If clinical benefit is observed, up to 6 cycles will be administered. Patient's continuation beyond 6 cycles is left at the discretion of the Principal Investigator. Premedication includes dexamethasone 8 mg. Maximal Prostate Specific Antigen (PSA) response is calculated using PSA Working Group 2 guidelines. Response Evaluation Criteria in Solid Tumors (RECIST, v. 1.1) is used to assess response for patients with measurable disease.