Cell Therapeutics, Inc. (CTI) (NASDAQ and MTA: CTIC) today announced that the Gynecologic Oncology Group (GOG) informed CTI that it has completed patient enrollment in the GOG-0212 Phase 3 clinical trial of investigational agent paclitaxel poliglumex (Opaxio™ ) as maintenance therapy in ovarian cancer.
"Although initial treatment is effective in putting this disease in remission, there is a high relapse rate for patients with ovarian cancer and there are limited treatment options when their cancer returns," said Larry J. Copeland, M.D., Department of Obstetrics and Gynecology, Ohio State University Comprehensive Cancer Center, Group Vice Chair of the GOG and chair of the GOG-0212 study. "This study was designed to investigate whether Opaxio when used in a maintenance setting could keep these women in remission and as a result extend the lives of these patients. We are very pleased to have completed enrollment in this important study."
"This is a significant achievement for the GOG being the largest maintenance study for patients with ovarian cancer ever conducted having enrolled 1,150 patients," said James A. Bianco, M.D., President and CEO of CTI. "There is a significant unmet need in keeping a patient's cancer from returning following initial treatment, and we are hopeful that Opaxio has the potential to serve this role in ovarian cancer."
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.