OXiGENE Inc., 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 bevacizumab to treat patients with advanced platinum-sensitive ovarian cancer has achieved an important safety objective in a scheduled interim toxicity analysis, and is expected to continue to full enrollment. The Phase 2 study (GOG186I) 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). The 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.
“This Phase 2 study is a major initiative for OXiGENE, potentially pointing the way to a promising new treatment option for patients with advanced ovarian cancer who have few if any therapeutic options,” said Jai Balkissoon, MD, FACS, Vice President Clinical Development, OXiGENE.
“Having shown that the combination of Zybrestat and bevacizumab has passed a critical safety hurdle, we look forward to continuing to collaborate with the GOG and CTEP to complete the trial, and are optimistic that the final efficacy and safety outcomes could inform the decision to move forward to a pivotal registration program.”
The interim toxicity analysis was based on 25 evaluable patients who received therapy. As only one patient had a protocol specified serious adverse event, the study met the safety criteria and is proceeding as planned.
Date: August 6, 2012
Source: OXiGENE Inc.
Filed Under: Drug Discovery
