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Aeterna Zentaris: Data and Safety Monitoring Board Recommends Continuation of ZoptEC Phase 3 Trial in Advanced Endometrial Cancer
Aeterna Zentaris: Data and Safety Monitoring Board Recommends Continuation of ZoptEC Phase...
About this update from Cosciens Biopharma Inc.
[{"type":"text","content":"\n\n\n\nAeterna Zentaris: Data and Safety Monitoring Board Recommends Continuation of ZoptEC Phase 3 Trial in Advanced Endometrial Cancer\n\n/* Style Definitions */\nspan.prnews_span\n{\nfont-size:8pt;\nfont-family:\"Arial\";\ncolor:black;\n}\na.prnews_a\n{\ncolor:blue;\n}\nli.prnews_li\n{\nfont-size:8pt;\nfont-family:\"Arial\";\ncolor:black;\n}\np.prnews_p\n{\nfont-size:0.62em;\nfont-family:\"Arial\";\ncolor:black;\nmargin:0in;\n}\n\n\n\n\n\n\nAeterna Zentaris: Data and Safety Monitoring Board Recommends Continuation of ZoptEC Phase 3 Trial in Advanced Endometrial Cancer\nCanada NewsWire\nQUEBEC CITY, Oct. 13, 2015\n\n\n\nDSMB's recommendation follows 2nd interim efficacy and safety analysis \n\n\n\nQUEBEC CITY, Oct. 13, 2015 /CNW Telbec/ - Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZ) (the \"Company\") today announced that the independent Data and Safety Monitoring Board (\"DSMB\") has recommended that the pivotal Phase 3 ZoptEC (Zoptarelin Doxorubicin in Endometrial Cancer) study with zoptarelin doxorubicin in women with advanced, recurrent or metastatic endometrial cancer, continue as planned. The DSMB's decision follows completion of its pre‑specified second interim analysis on efficacy and safety for the ZoptEC Phase 3 trial at approximately 192 events. In April 2015, the DSMB made the same recommendation following its first pre-specified analysis on safety and futility at approximately 124 events. A final analysis of the data is expected at approximately 384 events.\n\nDavid Dodd, Chairman and CEO of Aeterna Zentaris, commented, \"This positive second recommendation from the DSMB is an important milestone since it supports our continuation of the ZoptEC Phase 3 trial in endometrial cancer until its completion. The DSMB recommendation was based upon a comprehensive review of the data on efficacy and safety.  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 patient treatment and management, and therefore, would 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 pa...