November 12, 2012 at 07:30 AM EST
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/m2) in the Phase 1 portion. Six patients that were administered the 210 mg/m2 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.

The primary endpoint of the Phase 2 portion is to evaluate the clinical benefit of AEZS-108 for these patients. Clinical benefit will be defined as non-progression at 12 weeks with no dose-limiting toxicity or other toxicity requiring termination of treatment.

Secondary endpoints include toxicity, time to RECIST and PSA progression, RECIST response rate for patients with measurable disease, PSA response rate, pain palliation, and overall survival. In addition, there will be correlative studies to investigate potential predictors of response and outcomes.

About AEZS-108 (zoptarelin doxorubicin acetate)

AEZS-108 represents a new targeting concept in oncology using a hybrid molecule composed of a synthetic peptide carrier and a well-known chemotherapy agent, doxorubicin. AEZS-108 is the first intravenous drug in a clinical study that directs the chemotherapy agent specifically to LHRH-receptor expressing tumors, resulting in more targeted treatment with less damage to healthy tissue. The product has successfully completed Phase 2 studies for the treatment of endometrial and ovarian cancer, and is also in Phase 2 trials in prostate and bladder cancer. The Company is currently planning a Phase 3 trial in endometrial cancer. AEZS-108 has been granted orphan-drug designation by the U.S. Food and Drug Administration and orphan medicinal product designation from the European Medicines Agency for the treatment of ovarian cancer. An Investigational New Drug in the U.S. is in place for the treatment of prostate, bladder and triple-negative breast cancer. Aeterna Zentaris owns the worldwide rights to AEZS-108.

About Aeterna Zentaris

Aeterna Zentaris is an oncology and endocrinology drug development company currently investigating treatments for various unmet medical needs. The Company's pipeline encompasses compounds at all stages of development, from drug discovery through to marketed products. For more information please visit www.aezsinc.com.

Forward-Looking Statements

This press release contains forward-looking statements made pursuant to the safe harbour provisions of the U.S. Securities Litigation Reform Act of 1995. Forward-looking statements involve known and unknown risks and uncertainties that could cause the Company's actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue R&D projects, the successful and timely completion of clinical studies, the risk that safety and efficacy data from any of our Phase 3 trials may not coincide with the data analyses from previously reported Phase 1 and/or Phase 2 clinical trials, the ability of the Company to take advantage of business opportunities in the pharmaceutical industry, uncertainties related to the regulatory process and general changes in economic conditions. Investors should consult the Company's quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to forward-looking statements. Investors are cautioned not to rely on these forward-looking statements. The Company does not undertake to update these forward-looking statements. We disclaim any obligation to update any such factors or to publicly announce the result of any revisions to any of the forward-looking statements contained herein to reflect future results, events or developments, unless required to do so by a governmental authority or by applicable law.

SOURCE AETERNA ZENTARIS INC.

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