NEW HAVEN, Conn., June 13 VION PHARMACEUTICALS,INC. (Nasdaq: VION) today announced that data from a previously conductedPhase II trial of its lead anticancer agent Cloretazine(R) (VNP40101M) inelderly patients with acute myelogenous leukemia (AML) and high-riskmyelodysplastic syndromes (MDS) had been presented at the 13th Congress of theEuropean Hematology Association (EHA) at the Bella Center in Copenhagen,Denmark. At the Congress, data were presented in a subset of 26 patients withhigh-risk MDS by French-American-British (FAB) Group criteria.
The median age of the patients in the subset was 71 years (range of 59-82years). Twelve patients were diagnosed with refractory anemia with excessblasts (RAEB) and 9 patients were diagnosed with RAEB-t. Five patients werediagnosed with either chronic myelomonocytic leukemias (CMML) (3) or asunknown (2). Fifteen patients had intermediate cytogenetics and 11 hadunfavorable cytogenetics. Sixteen of the patients were classified asIntermediate-2 risk by the International Prognostic Scoring System (IPSS)system (1.5-2.0), and 10 were classified as high risk (greater than or equalto 2.5).
Eight of the 26 patients had received prior treatment for their disease.Prior agents used included arsenic trioxide, thalidomide, Ara-C, imatinibmesylate, interferon, amifostine, melphalan, hydroxyurea and 5-azacitiadine.
The overall complete response rate was 38% (7 CR and 3 CRp). Three of 10responders received prior treatment; 8 of the 10 responders receivedconsolidation. The median (range) of overall survival for the entire patientgroup was 3.4 months (0.6-28.6) and the median (range) of overall survival forresponders was 3.9 months (2.5-28.6).
The most common grade 3-5 adverse events, regardless of relation totreatment, were febrile neutropenia in 8 patients, and neutropenia andthrombocytopenia in 7 patients respectively. One patient died within 30 daysof first induction treatment due to pneumonia.
Dr. Ghulam Mufti, Department Head and Professor of Hematological Medicineat the University of London King's College Hospital, and an investigator onthe trial, said, "The activity demonstrated in this study is encouraging,particularly the complete responses observed in those patients that hadreceived prior treatment for MDS." He concluded, "Despite recent advances inthe treatment of MDS, most patients will relapse, and it is important that wecontinue to develop new therapies to treat these patients."
Alan Kessman, Chief Executive Officer, said, "These data demonstrateCloretazine(R) (VNP40101M)'s potential utility in patients with high-risk MDS.We believe that this signal should be pursued with further clinicalinvestigation 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 inNorth America and Europe. Enrollment of the study was completed in May 2006.
The study was designed for patients over the age of 60 with previouslyuntreated AML and high-risk MDS (patients were not to have received priorcytotoxic chemotherapy, excluding hydroxyurea, low-dose araC, decitabine, or5-azacytidine). Study objectives were: (i) overall complete response ratemeasured as either complete remission (CR) or CRp, a complete response withincomplete platelet recovery; (ii) the toxicity; and (iii) pharmacokinetics ofCloretazine(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 waspermitted in patients with bone marrow improvement but residual disease.Patients who responded could receive consolidation therapy of 400 mg/m2 ofCloretazine(R) (VNP40101M).
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