Antisoma has presented positive final data from a mid-stage trial of AS1413 for patients with secondary acute myeloid leukaemia at the American Society of Hematology meeting in New Orleans.

The Phase II trial saw 88 patients with secondary AML treated with AS1413, a novel DNA intercalator, together with cytarabine as first-line therapy. The remission rate was 42%, with 39% of patients achieving a complete remission and the other 3% a complete remission with incomplete bone marrow recovery.

Antisoma noted that the median duration of remission was 9.4 months, and 30% of those who achieved remission were still alive two years after treatment. Patients over 60 achieved remission rates and durations similar to those of patients under that age, while median survival was 6.6 months.

The company noted that the safety profile of the regimen was “manageable and acceptable, and consistent with that expected for AML remission-induction therapy”. Chief executive Glyn Edwards said that AS1413 “has distinctive features that could translate into real benefits for patients” and “we look forward to seeing the Phase III data in secondary AML”, noting that the drug “could ultimately have potential in various blood cancer settings”.

The Phase III trial, called Accede, randomises 450 patients to AS1413 plus cytarabine or daunorubicin plus cytarabine. Recruitment is “proceeding rapidly”, Antisoma said, and data from the study are expected in late 2010 or early 2011.