Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZ) announced the opening of a new clinical site at the Hollings Cancer Center of the Medical University of South Carolina in Charleston, South Carolina, for the Company’s ongoing multinational, pivotal ZoptEC (Zoptarelin doxorubicin in Endometrial Cancer) Phase 3 trial in women with advanced, recurrent or metastatic endometrial cancer. The Hollings Cancer center is the only National Cancer Institute designated cancer center in South Carolina and the state’s largest academic‑based cancer program. Furthermore, the Company announced that patient recruitment for this trial now stands at over 320 patients out of a projected total of 500 patients.
David Dodd, Chairman, CEO at Aeterna Zentaris stated, “Patient recruitment for our ZoptEC Phase 3 trial in endometrial cancer, our lead oncology program, is in line with our projected timelines to secure a first interim analysis in the first half of 2015 by an independent Data Safety Monitoring Board. Today, there is no FDA approved therapy for treating women suffering from advanced, recurrent or metastatic endometrial cancer. Our hope is that our novel product will be successful in this trial and subsequently, become a core tool in improving the lives of women with this type of cancer. Also, we are very pleased to be working with the Hollings Cancer Center at the Medical University of South Carolina for this trial, and look forward to other future collaborations with this most prestigious institution as part of our plan to establish activities in the Charleston area, one of the most thriving and exciting business communities in the United States.”
Jennifer Young Pierce, MD, Assistant Professor of Obstetrics & Gynecology and Principal Investigator at the Hollings Cancer Center, Medical University of South Carolina added, “Metastatic endometrial cancer is a devastating disease, and we see a disproportionate number of cases at Hollings Cancer Center. Given the limited therapeutic options for these patients and few clinical trials available, we are especially excited to collaborate with Aeterna Zentaris to offer our patients this promising new therapy.”
The ZoptEC Phase 3 trial in endometrial cancer -This is an open-label, randomized, multicenter Phase 3 trial currently being conducted in North America, Europe and Israel, under a Special Protocol Assessment, comparing zoptarelin doxorubicin 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 over 120 sites and approximately 500 patients with improvement in median overall survival as the primary efficacy endpoint. To date, more than 120 sites are in operation and more than 320 of the expected 500 patients have been entered into the trial.
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.
