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."
The GOG-0212 study is a randomized, multicenter, open label Phase 3 trial of either monthly OPAXIO or Taxol® for up to 12 consecutive months compared to surveillance among women with advanced ovarian cancer who have no evidence of disease following first-line platinum-taxane based therapy. For purposes of registration, the primary endpoint of the study is overall survival of OPAXIO compared to surveillance. Secondary endpoints are progression-free survival, safety and quality of life. The statistical analysis plan calls for four interim analyses and one final analysis, each with boundaries for early closure for superior efficacy or for futility. The Company expects the next interim analysis to occur in the second half of 2013.Additional information about GOG-0212 may be found at www.clinicaltrials.gov, study ID NCT00108745.
In September 2006, CTI and Novartis entered into a worldwide licensing agreement to grant Novartis a right to develop and commercialize CTI's OPAXIO and an option to negotiate a license to pixantrone.