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
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
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.