Vion Pharmaceuticals, Inc, announced that the US Food and Drug Administration (FDA) had responded to its Special Protocol Assessment (SPA) request to evaluate the phase-III randomized trial Hovon AML 92 sponsored by the Dutch-Belgian Cooperative Group for Haematology Oncology of its lead product Onrigin. The US FDA raised concerns with the Hovon trial design as submitted regarding the primary endpoint and study regimen. The modifications requested by the US FDA would require a new phase-III trial at significant additional time and expense.
Vion will evaluate whether to file another SPA for an alternative randomized phase-III trial within the next two weeks. In this context, the SPA process is intended to evaluate a phase-III protocol whose data will form the primary basis for an efficacy claim. The phase-III randomized trial in acute myeloid leukaemia (AML) is in response to the US FDA’s complete response letter to Vion’s New Drug Application for Onrigin requiring that a randomized trial be conducted to support the approval of Onrigin for the treatment of AML.
On December 17, 2009, Vion filed a voluntary petition for relief under Chapter 11 of the United States Bankruptcy Code in the United States Bankruptcy Court in the District of Delaware. Vion has retained the services of Roth Capital Partners, LLC to assist with the sale of the Company and/or its key assets during the Chapter 11 proceeding.