FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs / Research and Development

Oxigene Trumpets Positive Phase II Results of Ovarian Cancer Drug Candidate

March 13, 2014

A Phase II randomized study of Oxigene’s lead vascular disrupting agent Zybrestat has returned positive results, bringing the San Francisco company closer to winning its first product approval.

The GOG186I study, supporting a proposed ovarian cancer indication for Zybrestat (fosbretabulin tromethamine/ combretastatin-A4 phosphate), is being conducted under a cooperative research and development agreement with the National Cancer Institute for both the Oxigene drug and Genentech’s Avastin (bevacizumab), which is used a comparator in GOG186I.

The study met its primary endpoint of progression-free survival for the combination of Avastin and Zybrestat as compared to Avastin monotherapy, Oxigene said Tuesday. The trial is the first and only randomized study to test an angiogenic agent alongside a vascular disrupting agent without cytotoxic chemotherapy, according to the drugmaker.

Oxigene says that all of the 107 patients enrolled in the Phase II trial are still being followed to evaluate the secondary endpoint of overall survival.

Zybrestat, which Oxigene is also studying as a treatment for solid tumors, is designed to reduce the blood supply necessary for a tumor’s growth. The drug was granted orphan drug status for ovarian cancer in 2006.

The drugmaker’s other candidate, OXi4503, is currently in Phase I for relapsed and refractory acute myelogenous leukemia and myelodysplastic syndromes. — Lena Freund

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