Antisoma Starts Phase II trial of AS1411 in Acute Myeloid Leukemia

Antisoma announced that it has started a randomized Phase II trial of AS1411 in AML (acute myeloid leukemia).

According to Antisoma, approximately 70 patients will be recruited at major cancer centers in the U.S.

The trial will test AS1411 in patients with relapsed or refractory AML, the company said, and will evaluate the addition of AS1411 to the current standard therapy, cytarabine.

Patients will be randomly assigned to one of three groups: cytarabine alone, cytarabine plus 10 mg/kg/day AS1411 or cytarabine plus 40 mg/kg/day AS1411, according to the company.

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, the company added.

The company said it expects initial results in 2008.