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Print Edition StoriesWednesday, December 30, 2009
FDA rejects SPA for Vion anti-cancer drug candidate
By Mass High Tech staff
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Vion Pharmaceuticals Inc. has received notice from the U.S. Food and Drug Administration that its request for a special protocol assessment (SPA) of its Onrigin anti-cancer compound require enough changes to warrant a new Phase 3 clinical trial. The FDA cited concerns with the primary endpoint and study regimen of the trial.
The New Haven, Conn.-based oncology drug maker announced two weeks ago that it had voluntarily filed for Chapter 11 bankruptcy protection. Without completing its Phase 3 trial, Vion officials had hoped for an SPA to receive FDA approval for the acute myeloid leukemia-focused drug candidate. Vion conducted a randomized trial, sponsored by the Dutch-Belgian Cooperative Group for Hematology Oncology (HOVON), following the FDA’s request after the company submitted a new drug application for Onrigin.
Vion now has two weeks to decide whether it will file another SPA for an “alternative randomized Phase 3 trial.”
Vion’s Onrigin was intended to be a single agent for remission treatment for patients 60 years old or older with de novo poor-risk acute myeloid leukemia.
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