Vion Pharmaceuticals files SPA for Onrigin-LDAC combination Phase II/III trial

Jan 12 2010

VION PHARMACEUTICALS, INC. (OTC Bulletin Board: VION) announced today that it had filed a Special Protocol Assessment (SPA) with the U.S. Food and Drug Administration (FDA) related to a randomized Phase II/III trial of its oncology therapeutic Onrigin™ (laromustine) Injection in combination with low-dose Ara-C (LDAC) in elderly patients with newly diagnosed acute myeloid leukemia (AML).  The primary objective for the Phase III part of this study is to determine if Onrigin™ plus LDAC improves overall survival compared with LDAC alone.

The SPA process is intended to evaluate a Phase III protocol whose data will form the primary basis for an efficacy claim.  The Phase II/III randomized trial for which the Company filed the SPA has been designed in response to the FDA's complete response letter to the Company's New Drug Application for Onrigin™ that required 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. Additional information about Vion's Chapter 11 case is available on the website of the court's claims agent at www.delclaims.com.