Oxigene Inc. (OXGN) announced Monday that it has come to agreement with the U.S. Food and Drug Administration or FDA on a Special Protocol Assessment or SPA for its Phase 3 clinical trial or FACT 2 of Zybrestat for the treatment of anaplastic thyroid cancer or ATC.
The company noted that the FACT 2 study is designed as a randomized, placebo-controlled, double-blinded study of 300 subjects randomized 1:1 to receive carboplatin and paclitaxel plus fosbretabulin versus carboplatin and paclitaxel plus placebo. The primary endpoint of the study will be to compare the median overall survival between the two arms.
Zybrestat has been evaluated in a Phase 2/3 study of patients with anaplastic thyroid cancer and other clinical trials. Oxigene believes that Zybrestat is poised to become an important product in a novel class of small-molecule drug candidates called vascular disrupting agents (VDAs). Through interaction with vascular endothelial cell cytoskeletal proteins, Zybrestat selectively targets and collapses tumor vasculature, thereby depriving the tumor of oxygen and causing death of tumor cells, the company noted.
In clinical trials in solid tumors, Zybrestat has demonstrated potent and selective activity against tumor vasculature, as well as clinical activity against ATC, ovarian cancer and various other solid tumors, the company said.
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