Patient recruitment in line to secure expected interim analysis in H1 2015
All amounts are in U.S. dollars (unless otherwise noted)
QUÉBEC CITY, Nov. 20, 2014 /CNW Telbec/ - Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZ) (the "Company") today 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.
Details for this trial are available at www.clinicaltrials.gov (NCT01767155).
About Zoptarelin Doxorubicin
Zoptarelin doxorubicin 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 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 ZoptEC (Zoptarelin doxorubicin in Endometrial Cancer) Phase 3 trial in women with advanced, recurrent or metastatic endometrial cancer, while zoptarelin doxorubicin is also in an investigator-initiated Phase 2 trial in prostate cancer. Aeterna Zentaris owns the worldwide rights to this compound.
About Endometrial Cancer
Endometrial cancer is the most common gynecologic malignancy in developed countries and develops when abnormal cells amass to form a tumor in the lining of the uterus. It largely affects women over the age of 50 with a higher prevalence in Caucasians and a higher mortality rate among African Americans. According to the American Cancer Society, an estimated 49,560 new cases of endometrial cancer in the U.S., and 35,600 in Europe were expected during 2013, with about 20% of recurring disease.
About Aeterna Zentaris
Aeterna Zentaris is a specialty biopharmaceutical company engaged in developing and commercializing novel treatments in oncology, endocrinology and women's health. For more information, visit www.aezsinc.com.
About Hollings Cancer Center
Hollings Cancer Center at the Medical University of South Carolina is a National Cancer Institute-designated cancer center and the largest academic-based cancer program in South Carolina. In addition to the full range of clinical services, the cancer center has more than $42 million in cancer research funding and more than 200 clinical trials open to patients.
Hollings offers state-of-the-art diagnostic capabilities, therapies and surgical techniques with multidisciplinary clinics that include surgeons, medical oncologists, radiation therapists, radiologists, pathologists, psychologists and other specialists equipped to the full range of cancer care. For more information, please visit www.hcc.musc.edu.
This press release contains forward-looking statements made pursuant to the safe harbor provisions of the US Securities Litigation Reform Act of 1995. Forward-looking statements involve known and unknown risks and uncertainties that could cause the Company's actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue R&D projects, the successful and timely completion of clinical studies, the risk that safety and efficacy data from any of our Phase 3 trials may not coincide with the data analyses from previously reported Phase 1 and/or Phase 2 clinical trials, the ability of the Company to efficiently commercialize one or more of its products or product candidates, the ability of the Company to take advantage of business opportunities in the pharmaceutical industry, uncertainties related to the regulatory process, the specific outcome of our recently announced global resources optimization program and the financial impact on the Company resulting therefrom, and general changes in economic conditions. Investors should consult the Company's quarterly and annual filings with the Canadian and US securities commissions for additional information on risks and uncertainties relating to forward-looking statements. Investors are cautioned not to rely on these forward-looking statements. The Company does not undertake to update these forward-looking statements. We disclaim any obligation to update any such factors or to publicly announce the result of any revisions to any of the forward-looking statements contained herein to reflect future results, events or developments, unless required to do so by a governmental authority or by applicable law.
SOURCE: Aeterna Zentaris Inc.
For further information: Paul Burroughs, Director of Communications, (418) 652-8525 ext. 406, [email protected]