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.