Antisoma reports initial AML trial data

Antisoma has reported initial findings from its Phase II trial of AS1411 in relapsed and refractory acute myeloid leukemia.

Patient enrollment has been completed in the first stage of the trial, in which 33 patients were randomly assigned to be treated with either 10mg/kg/day AS1411 plus cytarabine or cytarabine alone. Among 11 patients who received AS1411 plus cytarabine, one had a complete response (CR) and one had a complete response with incomplete recovery of platelet counts (CRp); a third patient had a "cytogenetic response" but had leukemic blasts remaining. Among five patients who received cytarabine alone, none had a CR, or a CRp and there were no cytogenetic responses. Patients who did not respond to cytarabine alone were crossed over to receive AS1411 plus cytarabine; two of the first five subjects crossed over, one of whom showed a 90% reduction in leukemic blast count after treatment with the combination.

Patients are now being enrolled into the second stage of the trial, which compares 40mg/kg/day AS1411 plus cytarabine with cytarabine alone. Further data from the AML Phase II trial will be submitted for presentation at forthcoming medical conferences. A second Phase II study of AS1411, in patients with renal cancer, is expected to start before the end of this year.