QUEBEC CITY, June 2, 2014 /CNW Telbec/ - 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.
Forward-Looking Statements
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.