Vion Pharmaceuticals Announces FDA Lift of Clinical Hold on Phase III Study of Cloretazine(R) (VNP40101M) and Cytarabine in Re...( Company to Hold Conference Call...),Health

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NEW HAVEN, Conn., Jan. 8 /PRNewswire-FirstCall/ -- VION PHARMACEUTICALS, INC. (Nasdaq: VION) today announced that the U.S. Food and Drug Administration (FDA) had lifted the clinical hold on the Phase III trial (Vion Study CLI-037) of its lead anti-cancer agent, Cloretazine(R) (VNP40101M), in combination with cytarabine in relapsed acute myelogenous leukemia (AML).

Alan Kessman, Chief Executive Officer, said, "We are pleased with the FDA's decision to lift the clinical hold on Cloretazine(R) (VNP40101M) in combination with cytarabine in relapsed AML, and are now poised to move forward with the clinical development of Cloretazine(R) (VNP40101M) in the relapsed setting."

While this trial remains blinded overall, a portion of data on 210 patients was unblinded for review at interim analysis. The Company's medical consultants and external independent reviewers performed a comprehensive safety analysis of Vion Study CLI-037. This analysis concluded that the combined myelosuppressive effects of Cloretazine(R) (VNP40101M) and cytarabine given at the dose and schedule at which they were combined in the trial, in conjunction with the poor hematologic reserve of patients with relapsed AML, were major factors in the difference in mortality seen between the two arms of the study. A review of records from patients who died did not suggest any previously unreported toxicity for Cloretazine(R) or cytarabine.

There was an increase in the response rate observed on the Cloretazine(R) (VNP40101M) and cytarabine arm of the trial relative to the cytarabine and placebo arm, despite the difference in deaths between the two arms. Given this observed increase in response
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