Aeterna Zentaris Announces Initiation Of Phase 2 Portion Of Phase 1/2 Trial With AEZS-108 In Prostate Cancer
QUÉBEC CITY, 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 US$1.6 million grant from the National Institutes of Health to Jacek Pinski, 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 February 2012 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 link. 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 Hospital, West Los Angeles and Pasadena clinics."
Juergen Engel, 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 2) in the Phase 1 portion. Six patients that were administered the 210 mg/m 2 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.
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