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Vion Pharmaceuticals Announces FDA Lift of Clinical Hold on Phase III Study of Cloretazine(R) (VNP40101M) and Cytarabine in Relapsed AML
Date:1/8/2008

rate, the Company has proposed an amended trial to continue its interest in the relapsed setting.

An agreement has been reached with the FDA on modifications to Vion Study CLI-037. The revised study includes a lower dose of Cloretazine(R) (VNP40101M) in the experimental arm of the trial and prophylactic therapy with antibiotics, antifungals and growth factors for all patients. In order to maintain the Special Protocol Assessment (SPA) with the FDA for this trial, the next step is to submit an SPA to the FDA with these modifications before recommencing the trial.

Dr. Frank Giles, Chief of the Division of Hematology and Medical Oncology at the University of Texas Health Science Center at San Antonio, and lead investigator on the Cloretazine(R) clinical program stated, "Cloretazine(R) has recently shown very significant single agent activity in a the difficult to treat elderly AML patient population. It is important that we now establish the optimal dosing schedule in combination with other chemotherapeutic agents, such as cytarabine." He concluded, "Modifications to this Phase III trial in patients with relapsed AML will allow us to examine a combination schedule that should maintain the activity observed in the initial portion of the study with an acceptable marrow toxicity profile."

The Company also announced plans to file an abstract on data from Vion Study CLI-037 for the Annual Meeting of the American Society of Clinical Oncology (ASCO(R)) in June 2008.

Ann Cahill, Vice President, Clinical Development, commented, "Cloretazine(R) (VNP40101M) is an active agent in AML, and we continue to believe that it will have clinical utility in both the frontline and second line settings, as either a single agent or in combination with other therapies."

The Company has announced previously that it plans to file a New Drug Application with the FDA in 2008 based on a pivotal Phase II study of Cloretazine(R) (VNP40101M) as a single agent in eld
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SOURCE Vion Pharmaceuticals, Inc.
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