Vion announces positive data from Phase II myelodysplastic syndromes trial

The company presented the data in a subset of 26 patients with high-risk myelodysplastic syndromes (MDS) by French-American-British Group criteria. The median age of the patients in the subset was 71 years (range of 59-82 years). Approximately 12 patients were diagnosed with refractory anemia with excess blasts (RAEB) and nine patients were diagnosed with RAEB-t. Five patients were diagnosed with either chronic myelomonocytic leukemias (CMML) or as unknown.

Approximately 15 patients had intermediate cytogenetics and 11 had unfavorable cytogenetics. Approximately 16 of the patients were classified as Intermediate-2 risk by the International Prognostic Scoring System (1.5-2.0), and 10 were classified as high risk (greater than or equal to 2.5).

Eight of the 26 patients had received prior treatment for their disease. Prior agents used included arsenic trioxide, thalidomide, Ara-C, imatinib mesylate, interferon, amifostine, melphalan, hydroxyurea and 5-azacitiadine.

The overall complete response rate was 38% (7 CR and 3 CRp). Three of 10 responders received prior treatment; eight of the 10 responders received consolidation. The median (range) of overall survival for the entire patient group was 3.4 months (0.6-28.6) and the median (range) of overall survival for responders was 3.9 months (2.5-28.6).

Ghulam Mufti, department head and professor of hematological medicine at the University of London King’s College Hospital, said: “The activity demonstrated in this study is encouraging, particularly the complete responses observed in those patients that had received prior treatment for MDS.”