DSMB's recommendation follows 2nd interim efficacy
and safety analysis
QUEBEC CITY, Oct. 13, 2015 /CNW Telbec/ - Aeterna
Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZ) (the "Company") today
announced that the independent Data and Safety Monitoring Board
("DSMB") has recommended that the pivotal Phase 3 ZoptEC
(Zoptarelin Doxorubicin
in Endometrial Cancer) study with
zoptarelin doxorubicin in women with advanced, recurrent or
metastatic endometrial cancer, continue as planned. The DSMB's
decision follows completion of its pre‑specified second interim
analysis on efficacy and safety for the ZoptEC Phase 3 trial at
approximately 192 events. In April
2015, the DSMB made the same recommendation following its
first pre-specified analysis on safety and futility at
approximately 124 events. A final analysis of the data is expected
at approximately 384 events.
David Dodd, Chairman and CEO of
Aeterna Zentaris, commented, "This positive second recommendation
from the DSMB is an important milestone since it supports our
continuation of the ZoptEC Phase 3 trial in endometrial cancer
until its completion. The DSMB recommendation was based upon a
comprehensive review of the data on efficacy and safety. We
believe that 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, would 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 won't be pursued by Aeterna Zentaris. In addition,
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."
About the ZoptEC Pivotal Phase 3 trial
The ZoptEC pivotal Phase 3 trial is a fully-recruited (over 500
patients), 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. 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. The trial is being
conducted under a Special Protocol Assessment with the U.S. Food
and Drug Administration ("FDA").
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 Phase 2 trials in ovarian and prostate cancer have been
completed. 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 modification
of the manufacturing process resulting in significantly lower
cost.
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 50,000 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 effectively 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.