OXiGENE, a clinical-stage biopharmaceutical company, has reported that the Phase 2 ovarian cancer study of Zybrestat (fosbretabulin tromethamine or CA4P) and bevacizumab has achieved an important safety objective in a scheduled interim toxicity analysis.
With the achievement of interim safety objective, the randomised study evaluating the combination of Zybrestat and bevacizumab to treat patients with advanced platinum-sensitive ovarian cancer is expected to continue to full enrolment.
OXiGENE clinical development vice president Jai Balkissoon said the Phase 2 study is a major initiative that could lead to a promising new treatment option for patients with advanced ovarian cancer, who currently have few therapeutic options.
"Having shown that the combination of Zybrestat and bevacizumab has passed a critical safety hurdle, we look forward to continuing to collaborate with the Gynecologic Oncology Group and Cancer Therapy Evaluation Program 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," Balkissoon added.
As only one patient of 25 evaluable patients who received therapy had a protocol specified serious adverse event according to interim analysis, the study met the safety criteria and is proceeding as scheduled.
The progression-free survival is the primary endpoint while the secondary endpoints include safety, overall survival and objective responses by treatment arm.
The Phase 2 study (GOG 186I) is being conducted by the Gynaecology Oncology Group under the sponsorship of the Cancer Therapy Evaluation Program (CTEP) of the National Cancer Institute.
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 Cooperative Research and Development Agreement with Genentech.
Image: A pathological specimen of ovarian carcinoma. Photo: Jmh649.