Vion Pharmaceuticals Presents Clinical Data from a Phase II Trial,of Cloretazine (VNP40101M) in Elderly AML Patients with Unfavorable,Cytogenetics at EHA Meeting ( NEW HAVEN Conn. June 11 2007 /PRNew...)

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Vion Pharmaceuticals Presents Clinical Data from a Phase II Trial,of Cloretazine (VNP40101M) in Elderly AML Patients with Unfavorable,Cytogenetics at EHA Meeting

NEW HAVEN, Conn., June 11, 2007 /PRNewswire-FirstCall/ -- Vion Pharmaceuticals, Inc. announced that it presented clinical data in a poster session at the 12th Congress of the European Hematology Association (EHA) Meeting in Vienna, Austria on its lead anticancer agent Cloretazine(R) (VNP40101M) as a single agent in a multi-center international Phase II clinical trial in a subset of elderly patients with acute myelogenous leukemia (AML) or high-risk myelodysplastic syndrome (MDS) and unfavorable cytogenetics.

The Phase II trial was conducted from March 2004 to May 2006. The study treated 129 patients of 60 years of age or older with previously untreated AML or high-risk MDS. Previously data were presented on 104 patients (Giles et al, Journal of Clinical Oncology, January 1, 2007). Treatment consisted of Cloretazine(R) (VNP40101M) in a 600 mg/m2 dose administered in a 30-60 minute infusion on day 1 (second induction allowed) and provided the option for an additional 400 mg/m2 as consolidation for responders (complete remission (CR) or complete remission with incomplete platelet count (CRp). The primary endpoint was overall response (CR and CRp). Overall survival and relapse-free survival were also analyzed.

Data were presented at the EHA Meeting in a subset of 59 patients with unfavorable cytogenetics. Of these patients, 28 (47%) had secondary AML, 21 (36%) had de novo AML, and 10 (17%) had high-risk MDS. Overall, the response rate in patients with unfavorable cytogenetics was 25%. Response by diagnosis was: de novo AML (48%); MDS (30%) and secondary AML (7%). Twelve (20%) patients died within 30 days of receiving induction treatment. The majority of early death was in patients with secondary AML and was due to disease progression.

Dr. Norbert Vey, head of the Leukemia Program, Department of Hematology, at the Institut Paoli-Calmettes in Marseille, France, commented, "Patients with unfavorab
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( NEW HAVEN Conn. June 11 2007 /PRNew...)Vion Pharmaceuticals Presents Clinical Data from a Phase II Trial,of Cloretazine (VNP40101M) in Elderly AML Patients with Unfavorable,Cytogenetics at EHA Meeting,Health