QUEBEC CITY, June 2, 2014 /PRNewswire/ - Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZ) (the "Company") today announced that a poster was presented on the design of its current ZoptEC (Zoptarelin doxorubicin in Endometrial Cancer) Phase 3 trial in women with advanced, recurrent or metastatic endometrial cancer. The poster #TPS5630 titled, "ZoptEC: Phase 3 study of zoptarelin doxorubicin (AEZS-108)in platinum-taxane pretreated endometrial cancer (Study AEZS-108-050)", D. S. Miller, H. Gabra, G. Emons, D. S. McMeekin, A. M. Oza, S. M. Temkin, I. Vergote, was presented over the weekend by lead investigator, David S. Miller, MD, of the University of Texas Southwestern Medical Center, in Dallas, during the 50th Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago. Currently, more than 100 sites are in operation and some160 patients have been recruited for this ZoptEC Phase 3 trial.
Background: A platinum-taxane combination is commonly used both as adjuvant and first line therapy for advanced, recurrent, and metastatic endometrial cancer (EC). Zoptarelin doxorubicin (formerly AEZS-108) is a hybrid anticancer agent in which doxorubicin is chemically linked to zoptarelin, a D-Lys6-analogue of luteinizing hormone releasing hormone (LHRH). Zoptarelin doxorubicin was initially evaluated in tumor types reported to express receptors for LHRH. Depending on the method used to determine LHRH receptor expression, LHRH receptors have been found in 40% to 90% of ECs. A Phase 2 study of zoptarelin doxorubicin in EC patients showed activity, including those previously treated with platinum-taxane [Emons et al. 2014].
Methods: This open-label, randomized-controlled study compares the efficacy and safety of zoptarelin doxorubicin and doxorubicin. The study is expected to include 500 EC patients progressing after prior therapy with platinum-taxane-based chemotherapy. There are about 120 expected study sites in North America, Western and Central/Eastern Europe, and Israel. Patients are centrally randomized in a 1:1 ratio and receive either zoptarelin doxorubicin (267 mg/m2) or doxorubicin (60 mg/m2) intravenously, every 3 weeks and for up to 9 cycles. Response will be evaluated every 3 cycles during treatment, thereafter, every 12 weeks until progression.
Primary and secondary endpoints: All patients will be followed for survival as the primary efficacy endpoint (EP). Secondary EPs include progression-free survival, objective response-rate, and clinical benefit rate. The final analysis is planned after about 384 events have occurred, with interim analyses after about 128 and 192 events.
The poster is available at this link.
For more information on this trial, please consult (ClinicalTrials.gov Identifier: NCT01767155; EudraCT No: 2012-005546-38; ZoptEC: Zoptarelin doxorubicin in endometrial cancer).
About Zoptarelin Doxorubicin
Zoptarelin doxorubicin represents a new targeting concept in oncology using a hybrid molecule composed of a synthetic peptide carrier and a well-known chemotherapy agent, doxorubicin. Zoptarelin doxorubicin is the first intravenous drug in advanced clinical development that directs the chemotherapy agent specifically to LHRH-receptor expressing tumors, resulting in a more targeted treatment with less damage to healthy tissue. The Company is currently conducting a ZoptEC (Zoptarelin doxorubicin in Endometrial Cancer) Phase 3 trial in women with advanced, recurrent or metastatic endometrial cancer, while zoptarelin doxorubicin is also in an investigator-initiated Phase 2 trial in prostate cancer. Aeterna Zentaris owns the worldwide rights to this compound.
About Endometrial Cancer
Endometrial cancer is the most common gynecologic malignancy in developed countries and develops when abnormal cells amass to form a tumor in the lining of the uterus. It largely affects women over the age of 50 with a higher prevalence in Caucasians and a higher mortality rate among African Americans. According to the American Cancer Society, an estimated 49,560 new cases of endometrial cancer in the U.S., and 35,600 in Europe were expected during 2013, with about 20% of recurring disease.
About Aeterna Zentaris Inc.
Aeterna Zentaris is a specialty biopharmaceutical company engaged in developing novel treatments in oncology and endocrinology. The Company's pipeline encompasses compounds at various stages of development. For more information, visit www.aezsinc.com.
This press release contains forward-looking statements made pursuant to the safe harbour provisions of the US 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 efficiently commercialize one or more of its products or product candidates, 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 US 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.