The UK biotech said that it will recruit around 70 patients at major cancer centers in the US. The trial tests Antisoma’s anticancer aptamer AS1411 in patients with relapsed or refractory acute myeloid leukemia (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.
Preclinical data suggest that AS1411 has potential against various blood cancers and solid tumors, according to Antisoma. 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 tumors. This showed a favorable safety profile and evidence of anticancer activity in renal cancer. A Phase II trial in renal cancer is expected to start shortly.
Antisoma’s CEO, Glyn Edwards, said: “We intend to explore the potential of AS1411 in a number of cancers where new treatment options are needed. Our robust, randomized trials should provide clear evidence of any benefit associated with AS1411 and therefore have the potential to add significantly to its value over the next couple of years.”