QUEBEC CITY, June 30, 2015 /CNW Telbec/ - Aeterna Zentaris
Inc. (NASDAQ: AEZS) (TSX: AEZ) (the "Company") today
announced it has reached its goal of recruiting 500 patients for
its pivotal Phase 3 ZoptEC (Zoptarelin Doxorubicin in
Endometrial Cancer) clinical study with zoptarelin
doxorubicin in women with advanced, recurrent or metastatic
endometrial cancer. The trial is being conducted in over 120 sites
in North America, Europe and Israel. The primary efficacy endpoint is
improvement in overall survival.
Following its first pre‑specified interim analysis last April, a
Data and Safety Monitoring Board recommended that the ZoptEC Phase
3 study continue as planned. A second interim analysis is expected
during Q4, 2015 at approximately 192 events, with the final
analysis planned at an anticipated 384 events. The trial is
expected to be completed by the end of 2016.
David A. Dodd, Chairman and CEO
of Aeterna Zentaris, commented, "We are very excited to have
completed patient recruitment for our ZoptEC Phase 3 trial in
endometrial cancer earlier than expected, and I would like to thank
everyone involved in this project for their steadfast commitment.
We believe zoptarelin doxorubicin has the potential to become the
first FDA approved medical therapy for advanced, recurrent
endometrial cancer. This could result in its rapid adoption as a
novel core therapy for patient treatment and management, and
therefore, could represent a significant market opportunity for the
Company. Moving forward, we are continuing to develop our
commercialization plans regarding zoptarelin doxorubicin in this
indication, including establishing additional partnerships in
territories that we do not intend to pursue ourselves. Furthermore,
contingent on the success of the ZoptEC program, we have additional
areas of interest for further therapeutic development, including
ovarian, prostate and triple negative breast cancer. Our commitment
is to provide therapies to patients and their physicians that can
potentially improve and extend the quality of lives."
About the ZoptEC Phase 3 trial
The ZoptEC Phase 3 trial is an open-label, randomized-controlled
study, comparing the efficacy and safety of zoptarelin doxorubicin,
a hybrid molecule composed of a synthetic peptide carrier and a
well‑known chemotherapy agent, doxorubicin, to doxorubicin alone.
It is being conducted under a Special Protocol Assessment with the
U.S. Food and Drug Administration ("FDA"). 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. 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.
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, which could result
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 except in China (including Hong Kong and Macau) where rights have been
out-licensed to Sinopharm A-Think Pharmaceuticals, a subsidiary of
Sinopharm, the largest medical and healthcare group in China and on Fortune's Global 500 list. On
April 16, 2015, the Company announced
the filing of a patent application intended to strengthen the
exclusivity of zoptarelin doxorubicin through a unique,
significantly lower cost in the manufacturing process.
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, there will be approximately 55,000 new cases of
endometrial cancer in the U.S. alone in 2015, with about 20% of
recurring disease.
About Aeterna Zentaris
Aeterna Zentaris is a specialty biopharmaceutical company
engaged in developing and commercializing novel treatments in
oncology, endocrinology and women's health. For more information,
visit www.aezsinc.com.
Forward-Looking Statements
This press release contains forward-looking statements made
pursuant to the safe harbor 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 and clinical trials, 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, the ability to protect our intellectual property, the
potential of liability arising from shareholder lawsuits 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 place undue reliance 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.