Aeterna Zentaris Announces that ZoptEC Phase 3 Clinical Study of Zoptrex™ Did Not Achieve its Primary Endpoint
May 01 2017 - 8:00AM
Business Wire
Company Expects to Submit Macrilen™ NDA in Third Quarter of
2017
Aeterna Zentaris Inc. (NASDAQ:AEZS) (TSX:AEZS) (the “Company”)
today announced that the ZoptEC Phase 3 clinical study of Zoptrex™
(zoptarelin doxorubicin) in women with locally advanced, recurrent
or metastatic endometrial cancer did not achieve its primary
endpoint of demonstrating a statistically significant increase in
the median period of overall survival of patients treated with
Zoptrex™ as compared to patients treated with doxorubicin.
Dr. Richard Sachse, the Company’s Chief Scientific Officer,
stated, “The median overall survival period for patients treated
with Zoptrex™ was 10.9 months compared to 10.8 months for patients
treated with doxorubicin. This is not a statistically significant,
clinically meaningful increase in overall survival and thus the
ZoptEC Phase 3 clinical study did not meet its primary endpoint. In
addition, Zoptrex™ generally performed no better than the
comparator drug with respect to the secondary efficacy endpoints.
For example, the median period of progression-free survival of the
patients in the Zoptrex™ arm of the study was identical to that for
patients in the doxorubicin arm. Finally, there was no meaningful
difference between the two arms with respect to safety; the number
of patients with cardiac disorders was similar – eight in the
Zoptrex™ arm and nine in the doxorubicin arm. Therefore, the
results of the study are not supportive to pursue regulatory
approval.”
David A. Dodd, the President and Chief Executive Officer of the
Company, stated, “We are very disappointed with the outcome of the
ZoptEC Phase 3 clinical study. Based on this outcome, we do not
anticipate conducting clinical trials of Zoptrex™ with respect to
any other indications. I would like to thank my colleagues within
Aeterna Zentaris and our external team of clinical investigators
for their dedication to and contributions on this project.”
Commenting on the Company’s plans, Mr. Dodd continued, “Our focus
has now shifted entirely to filing our new drug application for
Macrilen™ and, if the product is approved, to its commercial launch
as soon as possible. We will also optimize our resources to be
consistent with our focus on Macrilen™-related efforts. We continue
to believe in the potential that Macrilen™ provides for us to
become a focused specialty pharmaceutical company. Our intention is
to submit the Macrilen™ NDA in the third quarter of 2017 and, if
the product receives FDA approval, to commercially launch the
product in the first quarter of 2018.”
Conference Call
The Company will host a conference call to discuss the results
of the ZoptEC Phase 3 clinical study of Zoptrex ™ on Monday, May 1,
2017, at 8:30 AM, Eastern Time. Participants may access the
conference call by using the following number: 201-689-8029,
Confirmation 13660857.
About the ZoptEC Pivotal Phase 3 Trial
The ZoptEC pivotal Phase 3 trial was a fully-recruited (512
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
were centrally randomized in a 1:1 ratio and received either
Zoptrex™ (267 mg/m2) or doxorubicin (60 mg/m2) intravenously, every
three weeks and for up to nine cycles. Response was evaluated every
three cycles during treatment, and thereafter, every 12 weeks until
progression. All patients were followed for survival as the primary
efficacy endpoint (“EP”). Secondary EPs include progression-free
survival, objective response-rate, and clinical benefit rate. The
trial was 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 Aeterna Zentaris
Aeterna Zentaris is a specialty biopharmaceutical company
engaged in developing and commercializing novel treatments in
oncology, endocrinology and women’s health. We are engaged in drug
development activities and in the promotion of products for others.
We recently completed Phase 3 studies of two internally developed
compounds. The focus of our business development efforts is the
acquisition of licenses to products that are relevant to our
therapeutic areas of focus. We also intend to license out certain
commercial rights of internally developed products to licensees in
non-U.S. territories where such out-licensing would enable us to
ensure development, registration and launch of our product
candidates. Our goal is to become a growth-oriented specialty
biopharmaceutical company by pursuing successful development and
commercialization of our product portfolio, achieving successful
commercial presence and growth, while consistently delivering value
to our shareholders, employees and the medical providers and
patients who will benefit from our products. For more information,
visit www.aezsinc.com.
Forward-Looking Statements
This press release contains forward-looking statements made
pursuant to the safe harbor provision of the U.S. Securities
Litigation Reform Act of 1995, which reflect our current
expectations regarding future events. Forward-looking statements
may include, but are not limited to, statements preceded by,
followed by, or that include the words “expects,” “believes,”
“intends,” “anticipates,” and similar terms that relate to future
events, performance, or our results. Forward-looking statements
involve known risks and uncertainties, many of which are discussed
under the caption “Key Information – Risk Factors” in our most
recent Annual Report on Form 20-F filed with the relevant Canadian
securities regulatory authorities in lieu of an annual information
form and with the U.S. Securities and Exchange Commission (“SEC”).
Such statements include, but are not limited to, statements about
the progress of our research, development and clinical trials and
the timing of, and prospects for, regulatory approval and
commercialization of our product candidates, the timing of expected
results of our studies, anticipated results of these studies,
statements about the status of our efforts to establish a
commercial operation and to obtain the right to promote or sell
products that we did not develop and estimates regarding our
capital requirements and our needs for, and our ability to obtain,
additional financing. Known and unknown risks and uncertainties
could cause our actual results to differ materially from those in
forward-looking statements. Such risks and uncertainties include,
among others, the availability of funds and resources to pursue our
research and development 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 rejection or non-acceptance of
any new drug application by one or more regulatory authorities and,
more generally, uncertainties related to the regulatory process,
the ability of the Company to efficiently commercialize one or more
of its products or product candidates, the degree of market
acceptance once our products are approved for commercialization,
our ability to take advantage of business opportunities in the
pharmaceutical industry, our ability to protect our intellectual
property, and 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 securities commissions and the SEC for additional
information on risks and uncertainties. Given these uncertainties
and risk factors, readers are cautioned not to place undue reliance
on these forward-looking statements. We disclaim any obligation to
update any such factors or to publicly announce 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 applicable law.
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Aeterna Zentaris Inc.Philip A. Theodore, 843-900-3223Senior Vice
Presidentir@aezsinc.com
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