AS1411: Interim Phase II data

Antisoma discontinued development of AS1411 to treat RCC after interim data from an open-label, single-arm U.S. Phase II trial in 35 patients showed the compound's median PFS was inferior to everolimus' median PFS of 4.9 months in a recent double-blind, placebo-controlled Phase III trial in a similar patient population (n=416). The trials enrolled metastatic RCC patients who failed treatment with at least one prior treatment with Sutent sunitinib or Nexavar sorafenib. Antisoma said the trial did show anti-cancer activity with a favorable safety profile, so the company will focus on developing AS1411 in acute myeloid leukemia (AML), for which it has Orphan Drug designation in the U.S. and EU. The company plans to start a Phase IIb trial of AS1411 in AML in early 2010. ...