NEW YORK (TheStreet) -- OXiGENE (OXGN) shares are up 6.94% to $1.54 in afternoon trading on Monday after the cancer treatment developer announced that the FDA gave positive feedback for the proposed phase 3 study of its platinum-resistant ovarian cancer treatment candidate, fosbretabulin.
"We are extremely pleased by the agency's support for advancing to a Phase 3 trial and their guidance in defining a registration pathway for fosbretabulin in platinum-resistant ovarian cancer," said CEO Bill Schwieterman, M.D.
The FDA agreed with the company that the trials should focus on fosbretabulin in conjunction with bevacizumab directly against a chemotherapy treated control group with progression-free survival as the primary endpoint of the trial.
The company said that it plans to submit an application to the FDA for a Special Protocol Assessment (SPA) later this year. An SPA is a declaration by the regulatory agency that a yet to be completed phase 3 drug trial's design and clinical endpoints are acceptable for approval.OXGN data by YCharts