Mr. David Dodd reports
AETERNA ZENTARIS ANNOUNCES COMPLETION OF ZOPTREX PIVOTAL PHASE 3 CLINICAL TRIAL IN ADVANCED ENDOMETRIAL CANCER; EXPECTS TO REPORT TOP-LINE RESULTS IN APRIL 2017
Aeterna Zentaris Inc. notes 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
end point 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 trade name for zoptarelin doxorubicin. The
proposed trade name is subject to approval by the United States Food and
Drug Administration (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 enrolment 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 Aeterna Zentaris
Aeterna Zentaris is a specialty biopharmaceutical company engaged in
developing and commercializing novel treatments in oncology,
endocrinology, and women's health.
We seek Safe Harbor.
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