Jan. 28, 2014
/PRNewswire/ -- 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.
The GOG-0212 study is a randomized, multicenter, open label Phase 3 trial of either monthly Opaxio or paclitaxel 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 patients treated with Opaxio compared to no maintenance therapy. Secondary endpoints are progression-free survival, safety and quality of life. The statistical analysis plan calls for up to four interim analyses and one final analysis, each with boundaries for early closure for superior efficacy or for futility. The first interim analysis was conducted in
, which passed the futility boundary and continued with no changes. Additional information about GOG-0212 may be found at
, study ID NCT00108745.
About Ovarian Cancer
Ovarian cancer is the eighth most commonly diagnosed cancer in women and the seventh leading cause of cancer death among women worldwide. Annually, over 220,000 women will be diagnosed with ovarian cancer around the world and approximately 140,000 will die from the disease.
In 2013, it is estimated that 22,240 new cases of ovarian cancer were diagnosed in the U.S. and 14,230 deaths would result. Ovarian cancer is the most lethal of the gynecologic malignancies. Treatment for ovarian cancer usually involves advanced surgery and chemotherapy.
Opaxio™ (paclitaxel poliglumex, CT-2103), is an investigational, biologically enhanced chemotherapeutic that links paclitaxel, the active ingredient in Taxol®, to a biodegradable polyglutamate polymer, which results in a new chemical entity. When bound to the polymer, paclitaxel is inactive, potentially sparing normal tissue's exposure to high levels of paclitaxel and its associated toxicities. Blood vessels in tumor tissue, unlike blood vessels in normal tissue, are porous to macromolecules such as Opaxio. Based on preclinical studies, it appears that Opaxio is preferentially distributed to tumors due to their leaky blood vessels and trapped in the tumor bed, allowing significantly more of the dose of chemotherapy to localize in the tumor than with standard paclitaxel. Once inside the tumor cell, enzymes metabolize the protein polymer, releasing active paclitaxel. Unlike standard radiosensitizing agents, Opaxio appears tumor selective and does not appear to enhance radiation toxicity to normal tissues.