Aeterna : DSMB Recommends To Continue Phase 3 Study Of Zoptarelin Doxorubicin

(RTTNews) - Aeterna Zentaris Inc. (AEZS, AEZ.TO) announced that the independent Data Safety Monitoring Board or "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, has completed a pre-specified first interim futility analysis. The DSMB has recommended that the Phase 3 study continue as planned.

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. It is being conducted under a Special Protocol Assessment with the U.S. Food and Drug Administration or "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.

At this time, sites initiation has been completed with over 120 sites in operation in North America, Europe and Israel. More than 465 patients out of an expected total of 500 have been recruited. A second interim analysis will be conducted according to protocol at approximately 192 events, with the final analysis planned at an anticipated 384 events.

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, there will be more than 50,000 new cases of endometrial cancer in the U.S. alone in 2015, with about 20% of recurring disease.