DSMB's recommendation follows 1rst interim
analysis
QUÉBEC CITY, April 27, 2015 /CNW
Telbec/ - Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZ)
(the "Company") today announced that the independent Data
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, has completed a pre‑specified
first interim futility analysis. The DSMB has recommended that the
Phase 3 study continue as planned.
David Dodd, Chairman and CEO of
Aeterna Zentaris, commented, "We are very pleased with this
positive recommendation from the DSMB on our ZoptEC Phase 3 trial
in endometrial cancer, and I would like to thank everyone involved
in this project for their unwavering dedication. With approximately
90 % of patients enrolled at this time, we are well on our way of
completing patient recruitment ahead of the anticipated timeline.
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 & 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 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. Our commitment
is to ensure that patients and their physicians have such therapies
that can potentially improve and extend the quality of
lives."
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.
At this time, sites initiation has been completed with over 120
sites in operation in North
America, Europe and
Israel. More than 465 patients out
of an expected total of 500 have been recruited. A second interim
analysis will be conducted according to protocol at approximately
192 events, with the final analysis planned at an anticipated 384
events.
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 more than 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.