05:58:26 EDT Tue 23 Apr 2024
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Aeterna Zentaris Inc (3)
Symbol AEZ
Shares Issued 12,917,995
Close 2017-01-30 C$ 3.45
Market Cap C$ 44,567,083
Recent Sedar Documents

Aeterna Zentaris completes Zoptrex clinical phase study

2017-01-30 17:53 ET - News Release

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.

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