Aeterna Zentaris Announces Completion of Zoptrex™ Pivotal Phase 3 Clinical Trial in Advanced Endometrial Cancer; Expects to...
January 30 2017 - 5:30PM
Business Wire
Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZ) (the “Company”)
today announced the occurrence of the 384th death in the pivotal
Phase 3 ZoptEC (Zoptarelin Doxorubicin in Endometrial
Cancer) study with Zoptrex™ (zoptarelin doxorubicin) in
women with advanced, recurrent or metastatic endometrial cancer,
representing the clinical endpoint of the study. The Company
currently expects to lock the clinical database and to report
top-line results in April 2017. Zoptrex™ is the Company’s proposed
tradename for zoptarelin doxorubicin. The proposed tradename is
subject to approval by the United States Food and Drug
Administration (the “FDA”).
Dr. Richard Sachse, the Company’s Chief Scientific Officer,
stated, “We are pleased to announce the completion of the clinical
phase of our pivotal Phase 3 clinical study of Zoptrex™, which was
conducted under a Special Protocol Assessment with the FDA.
Reaching this important milestone took longer than we anticipated
because the rate of events slowed significantly during the past
year. As previously reported, the study was fully enrolled in June
2015 and the final dosing occurred in January 2016. Therefore, a
significant number of patients survived more than 18 months since
enrollment in the study. We are thankful that these patients
continued to survive a devastating disease and are hopeful that
their lives are continuing successfully. We are close to locking
the clinical database and are focused on producing the top-line
results of the study. Currently, we expect to release top-line
results in April 2017.”
David A. Dodd, President and Chief Executive Officer of the
Company stated, “With the completion of the clinical portion of
this trial, we will now focus on analyzing the data and, if
warranted by the results, submitting a new drug application later
this year. There is a significant unmet medical need for a
treatment for women with advanced, recurrent or metastatic
endometrial cancer and we are hopeful that Zoptrex™ will provide
clinicians and their patients with an effective therapy for
treating the disease. We are indebted to all 512 patients who
participated in this important clinical program and, hopefully, we
will advance to providing a very important new therapy for this
devastating cancer.”
About the ZoptEC Pivotal Phase 3 Trial
The ZoptEC pivotal Phase 3 trial was 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
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 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
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 the first
targeted oncological therapy using a peptide as the targeting agent
and, therefore, it represents potentially a new tool in the
treatment of cancer 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. Based on the results of
Phase 2 studies, the Company believes it may be efficacious for the
treatment of ovarian and prostate cancer. If Zoptrex™ is approved
as a therapy for endometrial cancer, the Company intends to develop
it for these additional indications. The Company has licensed
marketing rights to Zoptrex™ to Sinopharm A-Think for China, Hong
Kong and Macau; to Orient EuroPharma for Taiwan and Southeast Asia;
to Rafa Labs for Israel and the Palestinian territories and to
Specialised Therapeutics for Australia and New Zealand.
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 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 recently concluded 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-US 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, 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, except if
required to do so.
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Aeterna Zentaris Inc.Philip A. Theodore, 843-900-3223Senior Vice
Presidentir@aezsinc.com
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