Aug 11 2015
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."