Aeterna Zentaris Inc. AEZS announced that it has completed patient enrolment (n=500) in the open-label, randomized-controlled phase III ZoptEC (Zoptarelin Doxorubicin in Endometrial Cancer) study on its oncology candidate zoptarelin doxorubicin. The company said that patient enrolment in this study was completed earlier than expected.
The study is being conducted under the FDA’s Special Protocol Assessment and compares the efficacy and safety of zoptarelin doxorubicin to doxorubicin alone for the treatment of advanced, recurrent or metastatic endometrial cancer. The primary efficacy endpoint of the study is improvement in overall survival.
We note that the first interim analysis of the study was conducted in Apr 2015, when the IDMC recommended continuation of the study. Aeterna Zentaris expects the second interim analysis to be conducted in the fourth quarter of 2015 at approximately 192 events. The study should be completed by the end of 2016 with the final analysis planned at 384 events.
Currently, Aeterna Zentaris is working on its commercialization plans for zoptarelin doxorubicin for advanced, recurrent or metastatic endometrial cancer. The company is actively establishing deals with other companies for zoptarelin doxorubicin’s commercialization in regions where the company will be unable to sell the product (if approved). Aeterna Zentaris owns worldwide rights to zoptarelin doxorubicin except in China (including Hong Kong and Macau) where the company out-licensed the rights to Sinopharm A-Think Pharmaceuticals.
Meanwhile, zoptarelin doxorubicin is also being evaluated in an investigator-initiated phase II study for prostate cancer. Aeterna Zentaris stated that subject to the success of the ZoptEC program, the company will plan the development of therapies for ovarian, prostate and triple-negative breast cancers.
Aeterna Zentaris carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector are Avalanche Biotechnologies, Inc. AAVL, Abbott Laboratories ABT and Roche Holding AG RHHBY. All these stocks carry a Zacks Rank #2 (Buy).
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