Vion Pharmaceuticals' hopes for a special protocol assessment intended to win an approval for its anti-cancer drug Onrigin have been dashed by the FDA. Regulators rejected the SPA request from Vion, which filed for Chapter 11 bankruptcy protection two weeks ago. Vion now has several weeks to file for an "alternative randomized Phase III trial" of the therapy.
"The FDA raised concerns with the HOVON trial design as submitted regarding the primary endpoint and study regimen," the company says in a statement. "The modifications requested by the FDA would require a new Phase III trial at significant additional time and expense."
- here's the Vion release
- check out the story from Mass High Tech