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AEterna receives OK to continue zoptarelin study

2015-04-27 16:27 ET - News Release

Mr. David Dodd reports

AETERNA ZENTARIS: DATA SAFETY MONITORING BOARD RECOMMENDS CONTINUATION OF PHASE 3 STUDY OF ZOPTARELIN DOXORUBICIN IN ADVANCED ENDOMETRIAL CANCER

The independent Data 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, has completed a prespecified first interim futility analysis. The DSMB has recommended that the phase 3 study continue as planned.

David Dodd, chairman and chief executive officer of Aeterna Zentaris, commented: "We are very pleased with this positive recommendation from the DSMB on our ZoptEC phase 3 trial in endometrial cancer, and I would like to thank everyone involved in this project for their unwavering dedication. With approximately 90 per cent of patients enrolled at this time, we are well on our way of completing patient recruitment ahead of the anticipated timeline. We believe that zoptarelin doxorubicin has the potential to become the first Food and Drug Administration-approved medical therapy for advanced, recurrent endometrial cancer. This could result in its rapid adoption as a novel core therapy for patient treatment and management, and therefore, could represent a significant market opportunity for the company. Moving forward, we are continuing to develop our commercialization plans regarding zoptarelin doxorubicin in this indication, including establishing additional partnerships in territories that won't be pursued by AEterna Zentaris. In addition, contingent on the success of the ZoptEC program, we have additional areas of interest for further therapeutic development, including ovarian, prostate and triple negative breast cancer. Our commitment is to ensure that patients and their physicians have such therapies that can potentially improve and extend the quality of lives."

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 known chemotherapy agent, doxorubicin, to doxorubicin alone. It is being conducted under a special protocol assessment with the U.S. Food and Drug Administration. Patients are centrally randomized in a 1-to-1 ratio and receive either zoptarelin doxorubicin (267 milligram/square metre) or doxorubicin (60 mg/square m) intravenously, every three weeks and for up to nine cycles. Response will be evaluated every three cycles during treatment, thereafter, every 12 weeks until progression. All patients will be followed for survival as the primary efficacy end point (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.

We seek Safe Harbor.