QUEBEC CITY, Aug. 11, 2015 /CNW Telbec/ - Aeterna Zentaris
Inc. (NASDAQ: AEZS) (TSX: AEZ) (the "Company") today announced that
the independent Data and Safety Monitoring Board ("DSMB") for the
pivotal Phase 3 ZoptEC (Zoptarelin Doxorubicin
in Endometrial Cancer) study with
zoptarelin doxorubicin in women with advanced, recurrent or
metastatic endometrial cancer, will complete a pre-specified second
interim efficacy and safety analysis of the compound in early
October 2015.
David Dodd, Chairman and CEO of
Aeterna Zentaris, commented, "This past June
30, we announced that we had reached our goal of recruiting
500 patients for the Phase 3 ZoptEC study, marking the achievement
of an important milestone in our efforts to commercialize this
novel compound. Recently, we learned that the number of events
required for the DSMB to conduct its second interim analysis had
occurred. We are informed that the DSMB will conduct its review of
the data in early October of this year, and we expect to be able to
announce the results of the review soon thereafter. This review
will be an important event in our development of zoptarelin
doxorubicin. We are looking forward to learning the results of the
DSMB's analysis."
Commenting on the compound, Dr. Richard
Sachse, the Company's Chief Medical and Chief Scientific
Officer, stated, "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 treatment and management
of advanced, recurrent endometrial cancer. Our hope is that the
compound will improve and extend the quality of the lives of
patients with this devastating disease."
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.
The trial is fully recruited (over 500 patients) and 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 tested 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 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 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.