Mr. David Dodd reports

AETERNA ZENTARIS ADDS HOLLINGS CANCER CENTER TO MULTI-NATIONAL PHASE 3 TRIAL IN ENDOMETRIAL CANCER; PATIENT RECRUITMENT IN LINE TO SECURE EXPECTED INTERIM ANALYSIS IN H1 2015

AEterna Zentaris Inc. has opened a new clinical site at the Hollings Cancer Center of the Medical University of South Carolina in Charleston, S.C., for the company's 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 centre 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 and chief executive officer 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."

Dr. Jennifer Young Pierce, MD, assistant professor of obstetrics and 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, multicentre 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 Dr. David Scott Miller, MD, from the University of Texas Southwestern Medical Center, in Dallas, Tex., and Dr. 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 end point. 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 per cent (up to $10-million) of the clinical and regulatory costs for this trial.

Details for this trial are available at the Clinical Trials website (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 chemotherapy agent, doxorubicin. Zoptarelin doxorubicin is the first intravenous drug in advanced clinical development that directs the chemotherapy agent specifically to LHRH-receptor expressing tumours, 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 tumour 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 United States and 35,600 in Europe were expected during 2013, with about 20 per cent of recurring disease.

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