Vion Pharmaceuticals Announces Presentation of Data of Cloretazine(R) (VNP40101M) in Elderly Patients with High-Risk Myelodysplastic Syndromes at the EHA Annu...(The most common grade 3-5 adverse events...),Health

Dr. Ghulam Mufti, Department Head and Professor of Hematological Medicine at the University of London King's College Hospital, and an investigator on the trial, said, "The activity demonstrated in this study is encouraging, particularly the complete responses observed in those patients that had received prior treatment for MDS." He concluded, "Despite recent advances in the treatment of MDS, most patients will relapse, and it is important that we continue to develop new therapies to treat these patients."

Alan Kessman, Chief Executive Officer, said, "These data demonstrate Cloretazine(R) (VNP40101M)'s potential utility in patients with high-risk MDS. We believe that this signal should be pursued with further clinical investigation to optimize the dose and schedule of Cloretazine(R) (VNP40101M) in this disease."

The Phase II trial started in March 2004 and was conducted in 14 sites in North America and Europe. Enrollment of the study was completed in May 2006.

The study was designed for patients over the age of 60 with previously untreated AML and high-risk MDS (patients were not to have received prior cytotoxic chemotherapy, excluding hydroxyurea, low-dose araC, decitabine, or 5-azacytidine). Study objectives were: (i) overall complete response rate measured as either complete remission (CR) or CRp, a complete response with incomplete platelet recovery; (ii) the toxicity; and (iii) pharmacokinetics of Cloretazine(R) (VNP40101M) in this patient population.

Patients received induction therapy of 600 mg/m2 of Cloretazine(R) (VNP40101M) in a thirty to sixty minute infusion. Second induction was permitted in patients with bone marrow improvement but residual disease. Patients wh
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