DSMB recommends continuation of CTI’s OPAXIO Phase 3 trial on ovarian cancer

Published on January 31, 2013 at 3:36 AM · No Comments

Cell Therapeutics, Inc. (CTI) (NASDAQ and MTA: CTIC) today announced that the Gynecologic Oncology Group (GOG) informed CTI that an independent Data Safety Monitoring Board (DSMB) recommended continuation of the GOG-0212 Phase 3 clinical trial of OPAXIOTM (paclitaxel poliglumex) as maintenance therapy in ovarian cancer with no changes following a planned interim survival analysis. CTI remains blinded to the interim analysis results. GOG-0212 is the largest maintenance study in this setting, having enrolled approximately 1,000 of the planned 1,100 patients. Enrollment is expected to be completed in 2013.

The trial is being conducted and managed by the GOG, which is one of the National Cancer Institute's (NCI) funded cooperative cancer research groups focused on the study of gynecologic malignancies.

"This is an important milestone for our OPAXIO clinical development program and potentially for women with advanced ovarian cancer," noted Steve Benner , M.D., Chief Medical Officer of CTI. "GOG-0212 seeks to address an important question on the role OPAXIO may play in maintenance therapy for ovarian cancer and potentially other solid tumors." 

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