SOUTH SAN FRANCISCO, Calif., Feb. 6, 2013 (GLOBE NEWSWIRE) -- OXiGENE, Inc. (Nasdaq:OXGN), a clinical-stage biopharmaceutical company developing novel therapeutics to treat cancer, announced today that the randomized Phase 2 study evaluating the combination of ZYBRESTAT® (fosbretabulin tromethamine or CA4P) and Avastin® (bevacizumab) to treat patients with persistent or recurrent ovarian cancer has again demonstrated acceptable tolerability in the second and final scheduled interim toxicity analysis. As specified in the study protocol, no additional pre-specified safety concerns were observed, according to a meeting of the study's Safety Review Committee (SRC). OXiGENE anticipates that patient accrual for the study will be completed within the next 3-4 months, and that top-line data will be available at the end of the year.
The Phase 2 study (GOG 186I) is being conducted by the Gynecologic Oncology Group (GOG) under the sponsorship of the Cancer Therapy Evaluation Program (CTEP) of the National Cancer Institute (NCI). Fosbretabulin tromethamine is being provided to CTEP under a Cooperative Research and Development Agreement (CRADA) with OXiGENE and the bevacizumab is being provided under a CRADA with Genentech, Inc.
"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," said Jai Balkissoon, MD, FACS, Vice President Clinical Development, OXiGENE. "With our collaborators at the GOG and CTEP, we look forward to completing enrollment by mid-year and generating top-line data by year-end. We are hopeful that the efficacy and safety data could support advancing toward a pivotal registration program in ovarian cancer."This second interim toxicity analysis was based on the safety review of the first 53 evaluable patients who completed four months of therapy. There were no additional protocol specified serious adverse events seen during this review, and the study will continue to full enrollment.