OREANDA-NEWS. August 17, 2015. Ergomed plc, (LSE: ERGO or 'Ergomed') a profitable UK-based company, dedicated to the provision of specialised services to the pharmaceutical industry and the development of new drugs, is pleased to note that its co-development partner Aeterna Zentaris (NASDAQ: AEZS) (TSX: AEZ), has announced that the Data and Safety Monitoring Board is scheduled to complete the second interim analysis of the Phase 3 ZoptEC (Zoptarelin Doxorubicin in Endometrial Cancer) pivotal study with zoptarelin doxorubicin in women with advanced, recurrent or metastatic endometrial cancer in early October.

The announcement issued by Aeterna Zentaris follows:

Aeterna Zentaris Announces Data and Safety Monitoring Board Scheduled to Complete Second Interim Analysis of the ZoptEC Phase 3 Trial in Endometrial Cancer in Early October

Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZ) (the "Company") today announced that the independent Data and Safety Monitoring Board ("DSMB") for the pivotal Phase 3 ZoptEC (Zoptarelin Doxorubicin in Endometrial Cancer) study with zoptarelin doxorubicin in women with advanced, recurrent or metastatic endometrial cancer, will complete a pre-specified second interim efficacy and safety analysis of the compound in early October 2015.

David Dodd, Chairman and CEO of Aeterna Zentaris, commented, "This past June 30, we announced that we had reached our goal of recruiting 500 patients for the Phase 3 ZoptEC study, marking the achievement of an important milestone in our efforts to commercialize this novel compound. Recently, we learned that the number of events required for the DSMB to conduct its second interim analysis had occurred. We are informed that the DSMB will conduct its review of the data in early October of this year, and we expect to be able to announce the results of the review soon thereafter. This review will be an important event in our development of zoptarelin doxorubicin. We are looking forward to learning the results of the DSMB's analysis."

Commenting on the compound, Dr. Richard Sachse, the Company's Chief Medical and Chief Scientific Officer, stated, "We believe that zoptarelin doxorubicin has the potential to become the first FDA approved medical therapy for advanced, recurrent endometrial cancer. This could result in its rapid adoption as a novel core therapy for treatment and management of advanced, recurrent endometrial cancer. Our hope is that the compound will improve and extend the quality of the lives of patients with this devastating disease."

About the ZoptEC Phase 3 trial

The ZoptEC Phase 3 trial is an open-label, randomized-controlled study, comparing the efficacy and safety of zoptarelin doxorubicin, a hybrid molecule composed of a synthetic peptide carrier and a well known chemotherapy agent, doxorubicin, to doxorubicin alone. The trial is fully recruited (over 500 patients) and is being conducted under a Special Protocol Assessment with the U.S. Food and Drug Administration ("FDA"). Patients are centrally randomized in a 1:1 ratio and receive either zoptarelin doxorubicin (267 mg/m2) or doxorubicin (60 mg/m2) intravenously, every 3 weeks and for up to 9 cycles.  Response will be evaluated every 3 cycles during treatment, thereafter, every 12 weeks until progression. All patients will be followed for survival as the primary efficacy endpoint ("EP"). Secondary EPs include progression free survival, objective response-rate, and clinical benefit rate.