Aeterna Zentaris has announced the first patient has been recruited and dosed for the phase III 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," said David Dodd, president and chief executive officer 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."
This is an open-label, randomized, multicenter phase III 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, M.D., from the University of Texas Southwestern Medical Center, and Hani Gabra, M.D., from the Imperial College London Hammersmith Campus. 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.