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Antisoma starts phase II trial of AS1411 in acute myeloid leukaemia

07 Aug 2007 - Antisoma plc announced that it has started a randomised phase II trial of AS1411 in AML (acute myeloid leukaemia). Around 70 patients will be recruited at major cancer centres in the USA.
 
The trial tests AS1411 in patients with relapsed or refractory AML. It evaluates addition of AS1411 to the current standard therapy, cytarabine (Ara-C). Patients are being randomly assigned to one of three groups: cytarabine alone, cytarabine plus 10 mg/kg/day AS1411 or cytarabine plus 40 mg/kg/day AS1411. Efficacy and safety will be compared to see whether patients receiving a cytarabine-AS1411 combination do better than those receiving cytarabine alone and whether the two doses of AS1411 have different effects. Initial results are expected in 2008.
 
According to Antisoma, AS1411 was the first anti-cancer aptamer to start clinical trials and today becomes the first to progress to phase II. Preclinical data suggest that AS1411 has potential against various blood cancers and solid tumours. AML was selected as the lead blood-cancer indication because cancer cells from AML patients and AML cell lines show particularly high sensitivity to AS1411. There is also evidence for a synergistic effect when AS1411 is combined with cytarabine.
 
Phase I testing of AS1411 was conducted in solid tumours. This showed a favourable safety profile and evidence of anti-cancer activity in renal cancer. A phase II trial in renal cancer is expected to start shortly.