Vion Pharmaceuticals, Inc. (VION) said Friday that data from a previously conducted Phase II trial of its anticancer agent Cloretazine in elderly patients with acute myelogenous leukemia and high-risk myelodysplastic syndromes was encouraging with overall complete response rate of 38%.
The Phase II trial, which started in March 2004 and was conducted in 14 sites in North America and Europe, was designed for patients over the age of 60 with previously untreated acute myelogenous leukemia, or AML, and high-risk myelodysplastic syndromes, or MDS. The company completed patient enrollment for the study in May 2006.
Objectives of the study were overall complete response rate, the toxicity and the pharmacokinetics of Cloretazine in the patient population.
In the trial, patients received an induction therapy of 600 mg/m2 of Cloretazine in a thirty to sixty minute infusion. Second induction was permitted in patients with bone marrow improvement but residual disease. Patients who responded could receive consolidation therapy of 400 mg/m2 of Cloretazine, the company noted.
In the trial, Median overall survival was 3.4 months for the entire patient group. The New Haven, Connecticut-based Vion said that the data had been presented at the 13th Congress of the European Hematology Association, or EHA, in Copenhagen, Denmark.
VION closed Thursday's trading at $1.31, down $0.01, on a volume of 6,200 shares.
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