Antisoma initiates phase IIb trial of AS1411 in acute myeloid leukaemia
Antisoma plc announced that it has started a randomised, controlled, multi-territory, phase IIb trial of AS1411 in patients with acute myeloid leukaemia (AML).
The phase IIb trial is enrolling patients with AML in first relapse or refractory to one prior treatment. Around 90 patients are being randomised to three treatment groups. A control group is receiving high-dose cytarabine, a standard chemotherapy treatment for this patient population. The other two groups are receiving high-dose cytarabine combined with AS1411 at 40 or 80 mg/kg/day. The trial will compare the three treatment groups with respect to safety, response rates, period free of leukaemia and survival. Data are expected next year.
The phase IIb trial follows a randomised phase II trial in AML, which reported positive results at the 2009 Annual Meeting of the American Society of Clinical Oncology (ASCO).
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