Aeterna Zentaris recruits patients for ZoptEC Phase 3 study in women with advanced endometrial cancer

Jun 30 2015

Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZ) (the "Company") today announced it has reached its goal of recruiting 500 patients for its pivotal Phase 3 ZoptEC (Zoptarelin Doxorubicin in Endometrial Cancer) clinical study with zoptarelin doxorubicin in women with advanced, recurrent or metastatic endometrial cancer. The trial is being conducted in over 120 sites in North America, Europe and Israel. The primary efficacy endpoint is improvement in overall survival.

Following its first pre‑specified interim analysis last April, a Data and Safety Monitoring Board recommended that the ZoptEC Phase 3 study continue as planned. A second interim analysis is expected during Q4, 2015 at approximately 192 events, with the final analysis planned at an anticipated 384 events. The trial is expected to be completed by the end of 2016.

David A. Dodd, Chairman and CEO of Aeterna Zentaris, commented, "We are very excited to have completed patient recruitment for our ZoptEC Phase 3 trial in endometrial cancer earlier than expected, and I would like to thank everyone involved in this project for their steadfast commitment. We believe zoptarelin doxorubicin has the potential to become the first FDA approved medical therapy for advanced, recurrent endometrial cancer. This could result in its rapid adoption as a novel core therapy for patient treatment and management, and therefore, could represent a significant market opportunity for the Company. Moving forward, we are continuing to develop our commercialization plans regarding zoptarelin doxorubicin in this indication, including establishing additional partnerships in territories that we do not intend to pursue ourselves. Furthermore, contingent on the success of the ZoptEC program, we have additional areas of interest for further therapeutic development, including ovarian, prostate and triple negative breast cancer. Our commitment is to provide therapies to patients and their physicians that can potentially improve and extend the quality of lives."

SOURCE Aeterna Zentaris Inc.