As part of the analysis, performed at more than 80 US locations, patients were given the combination of ZYBRESTAT (fosbretabulin tromethamine or CA4P) and Avastin (bevacizumab) and evaluated the toxicity.
Patients are randomized with bevacizumab 15 mg/kg IV in one arm and bevacizumab plus fosbretabulin tromethamine 60 mg/m2 IV in the other arm on the first day as part of the therapy and every three weeks.
After evaluating first 53 patients who underwent four months of therapy, the Safety Review Committee (SRC) of the study conveyed that the protocol did not come across with any additional pre-specified safety concerns, thereby clearing path for full enrollment.
The company is planning to wind up the patient accrual for the study in the next three to four months and make top-line data available by the end of 2013.
OXiGENE vice president for clinical development Jai Balkissoon said "We are pleased that the second and final interim safety review was acceptable, and that enrollment has significantly increased due to the addition of platinum-resistant ovarian cancer patients, who have very few treatment options available to them".
Patients with measurable or detectable recurrent or persistent epithelial ovarian, fallopian tube or primary peritoneal carcinoma, who had the prior history of one-time platinum-based chemotherapeutic regimen, were considered eligible for the study.
OXiGENE said that the progression-free survival is the primary endpoint of the study, while safety, overall survival and objective responses by treatment arm are the secondary end points.
Gynecologic Oncology Group (GOG) has conducted the study under the sponsorship of the Cancer Therapy Evaluation Program (CTEP) of the National Cancer Institute (NCI).