Aeterna Zentaris Reconfirms Commitment to LHRH-receptor Targeting Zoptrex™ During 2016 ASCO Annual Meeting
June 06 2016 - 5:00PM
Business Wire
Pivotal Phase III Trial for Endometrial Cancer Expected to be
Completed in Q3 2016
Aeterna Zentaris Inc. (NASDAQ: AEZS; TSX: AEZ) (the
“Company”) today reconfirmed its commitment to LHRH-receptor
targeted therapy and its expectation that the pivotal, phase 3
trial for Zoptrex™ (zoptarelin doxorubicin) in women with advanced,
recurrent endometrial cancer, is expected to be completed in the
third quarter of 2016. During the 2016 Annual Meeting of the
American Society of Clinical Oncologists (“ASCO”), the Company also
discussed its plans to develop Zoptrex™ for additional indications,
based upon achieving a positive outcome in the current clinical
program.
Zoptrex™ (zoptarelin doxorubicin), a novel synthetic peptide
carrier linked to doxorubicin as a New Chemical Entity (NCE), is
the Company’s lead oncology compound. Zoptrex™ is currently in a
fully-enrolled Phase 3 clinical trial in endometrial cancer. The
Company expects to complete the Phase 3 clinical trial in the third
quarter of 2016 and, if the results of the trial warrant doing so,
to file a new drug application for Zoptrex™ in the first half of
2017.
Commenting on the significance of Zoptrex™ to oncologists and
their patients, Dr. Richard Sachse, the Company’s Chief Scientific
Officer, explained, “Zoptrex™ is the first targeted oncological
therapy using a peptide as the targeting agent and, therefore, it
represents potentially a new tool in the treatment of tumors that
overexpress the LHRH receptor. The design of the compound allows
for the specific binding and selective uptake of the cytotoxic
conjugate by LHRH receptor-positive tumors, typically found in
gynecological cancers, prostate cancer and some forms of breast
cancer. Potential benefits of this targeted approach may include
enhanced efficacy and a more favorable safety profile with lower
incidence and severity of adverse events, as compared to
doxorubicin. If Zoptrex™ is approved as a therapy for endometrial
cancer, we intend to develop it for these additional indications.
In addition, based on the results of Phase 2 studies, we believe
that Zoptrex™ holds promise to prove its efficacy for the treatment
of ovarian and prostate cancer.”
During the ASCO Annual Meeting, the Company provided an update
regarding its progress with Zoptrex™ during one-on-one meetings
with oncological key opinion leaders. Dr. Sachse described his
interactions with ASCO attendees as promising, stating as follows:
“I’m pleased and gratified by the continuing expressions of support
for our work on Zoptrex™. The oncologists with whom we met were
pleased to learn of our progress toward the completion of our Phase
3 clinical trial and seemed to be as excited as we are about the
contribution that our new targeted oncology therapy could make to
the treatment of one of the most severe forms of cancer.”
About Aeterna Zentaris Inc.
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 are now conducting 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
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 provisions of the US Securities
Litigation Reform Act of 1995. 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 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 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, 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.
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version on businesswire.com: http://www.businesswire.com/news/home/20160606006290/en/
Aeterna ZentarisPhilip TheodoreSenior Vice
President843-900-3223ptheodore@aezsinc.com
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