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Phase II Trial of Cloretazine Initiated

NEW HAVEN, Conn., March 29 /PRNewswire-FirstCall/ -- VION PHARMACEUTICALS, INC. (Nasdaq: VION - News) announced today that it had initiated a Phase II trial of its anticancer agent CLORETAZINE(TM) (VNP40101M) as a single agent in patients with acute myeloid leukemia (AML) or myelodysplastic syndromes (MDS). Vion expects to accrue up to a total of 80 patients to the trial, which will be conducted in multiple sites in the U.S. and Europe. The objective of the study is to determine the response rate of CLORETAZINE(TM) (VNP40101M) in the following patient groups: patients with AML or high-risk MDS (high-risk indicates disease with poor prognostic characteristics) who are older than 60 years old and have not received prior chemotherapy; and AML patients of any age who have relapsed after a first complete remission that lasted less than twelve months.

Dr. Mario Sznol, Vice President, Clinical Affairs, stated, "Despite the substantial amount of prior treatment for most patients in the Phase I trial of CLORETAZINE(TM) (VNP40101M) in advanced hematologic malignancies, evidence of activity was demonstrated, and CLORETAZINE(TM) (VNP40101M) was well- tolerated. Therefore, we are optimistic that in the current Phase II trial, which includes patients with less prior treatment, CLORETAZINE(TM) (VNP40101M) will show promising single-agent activity."

He added, "We also hope to confirm the good safety profile for CLORETAZINE(TM) (VNP40101M) which would make the drug attractive in the elderly population and create an opportunity for more effective treatment in combination with standard agents. This trial is an important component of the overall development plan for CLORETAZINE(TM) (VNP40101M)."

CLORETAZINE(TM) (VNP40101M) has been evaluated in four Phase I trials to date, two in leukemia and two in solid tumors. Of these trials, a Phase I trial of CLORETAZINE(TM) (VNP40101M) in combination with Ara-C in patients with advanced leukemia continues to accrue patients. Results from this trial will be presented at the Annual Meeting of the American Society of Clinical Oncology (ASCO) in June 2004.

In March 2004, the U.S. Food and Drug Administration designated CLORETAZINE(TM) (VNP40101M) as a fast track program in relapsed or refractory acute myeloid leukemia.

Source: Vion Pharmaceuticals

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