CTI BioPharma Corp. announced that the Gynecologic Oncology Group, now part of NRG Oncology, informed CTI BioPharma that an independent Data Monitoring Committee (DMC) recommended continuation of the GOG-0212 phase 3 clinical study of Opaxio (paclitaxel poliglumex) as maintenancetherapy in ovarian cancer with no changes following a second of four planned interim analyses for survival and futility. CTI BioPharma remains blinded to the interim analysis results. GOG-0212 is the largest maintenance study in this setting, having enrolled 1,150 patients.

The trial is being conducted and managed by the Gynecologic Oncology Group, now part of NRG Oncology, which is one of the National Cancer Institute's funded cooperative cancer research groups with a focus on the study of gynecologic malignancies.

"We believe that there remains a significant unmet need in keeping a patient's cancer from returning following initial treatment for ovarian cancer," said James A. Bianco, M.D., CTI BioPharma's president and chief executive officer. "The GOG-0212 study is designed to investigate whether Opaxio, when used in a maintenance setting in ovarian cancer, could keep these women in remission and potentially extend their lives."


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 January 2013, and at that time the DMC recommended continuation with no changes.

Ovarian cancer is the seventh most commonly diagnosed cancer in women and the leading cause of cancer death among women worldwide. Annually, over 238,000 women will be diagnosed with ovarian cancer around the world and approximately 152,000 will die from the disease. In 2015, it is estimated that 21,290 new cases of ovarian cancer will be diagnosed in the US and 14,180 deaths will result. 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 tumour 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 tumours due to their leaky blood vessels and trapped in the tumour bed, allowing significantly more of the dose of chemotherapy to localize in the tumour than with standard paclitaxel. Once inside the tumour cell, enzymes metabolize the protein polymer, releasing active paclitaxel. Unlike standard radiosensitizing agents, Opaxio appears tumour selective and does not appear to enhance radiation toxicity to normal tissues.

The legacy Gynecologic Oncology Group (GOG), now part of NRG Oncology, is a non-profit international organization with the purpose of promoting excellence in the quality and integrity of clinical and basic scientific research in the field of Gynecologic malignancies.

CTI BioPharma Corp.is a biopharmaceutical company focused on the acquisition, development and commercialization of novel targeted therapies covering a spectrum of blood-related cancers that offer a unique benefit to patients and healthcare providers.