Aeterna Zentaris: First Patient Dosed for Phase 3 Registration Trial in Endometrial Cancer with Zoptarelin Doxorubicin


Zentaris: for 3 in with (AEZS-108)

All amounts are in U.S. dollars (unless otherwise noted)

Québec City, Canada, July 31, 2013 – Aeterna Zentaris Inc. (NASDAQ: AEZS, TSX: AEZ) (the “Company”) today announced that the first patient has been recruited and dosed for the Phase 3 ZoptEC (Zoptarelin doxorubicin in Endometrial Cancer) trial in women with endometrial cancer resistant to platinum/taxane-based chemotherapy.

“We have reached another important milestone in the final clinical development stage for zoptarelin doxorubicin (AEZS-108) in treating endometrial cancer. Efforts are now focused on pursuing patient recruitment as swiftly as possible”, stated David Dodd, President and CEO of Aeterna Zentaris. “This compound’s innovative targeted approach potentially offers a much needed novel treatment option for  women with endometrial cancer and it provides the Company with a significant market opportunity.”

The Study

This is an open-label, randomized, multicenter Phase 3 trial to be conducted in over 120 sites in North America, Europe, Israel and other countries under a Special Protocol Assessment, comparing zoptarelin doxorubicin (AEZS-108) with doxorubicin as second line therapy for locally-advanced, recurrent or metastatic endometrial cancer. Lead investigators are David Scott Miller, MD, from the University of Texas Southwestern Medical Center, in Dallas, Texas, and Hani Gabra, MD, from the Imperial College London Hammersmith Campus in London, England. The trial will involve approximately 500 patients and the primary efficacy endpoint is improvement in median Overall Survival.

Selected as the contract clinical development organization, Ergomed will also assume 30% (up to $ 10 million) of the clinical and regulatory costs for this trial.

Details for this trial are available at…Read more

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