Aeterna Zentaris Inc. has recruited and dosed its first patient in 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," 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."
This is an open-label, randomized, multi-centre 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, MD, from the University of Texas Southwestern Medical Centre, 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 organisation, Ergomed will also assume 30 per cent (up to $10 million) of the clinical and regulatory costs for this trial.
Zoptarelin doxorubicin (AEZS-108) represents a new targeting concept in oncology using a hybrid molecule composed of a synthetic peptide carrier and a well-known chemotherapy agent, doxorubicin. Zoptarelin doxorubicin (AEZS-108) is the first intravenous drug in advanced clinical development that directs the chemotherapy agent specifically to LHRH-receptor expressing tumors, resulting in a more targeted treatment with less damage to healthy tissue. The Company is currently conducting a phase III trial in endometrial cancer under a Special Protocol Assessment, while zoptarelin doxorubicin (AEZS 108) is also in phase II trials for triple-negative breast cancer, prostate cancer and bladder cancer. Aeterna Zentaris owns the worldwide rights to zoptarelin doxorubicin (AEZS-108).
Aeterna Zentaris is a specialty biopharmaceutical company engaged in developing novel treatments in oncology and endocrinology.