Antisoma’s AS1411 Gets Orphan Drug Status In US, EU

Antisoma has reported that its aptamer drug AS1411 has been granted orphan drug status in both the US and the EU for the treatment of acute myeloid leukaemia (AML). The grants will provide seven years of market exclusivity in the US and ten years of exclusivity in the EU if AS1411 is approved for use in AML.

The positive phase II data presented at the 2008 ASH and 2009 ASCO meeting suggested that addition of AS1411 to high-dose cytarabine increased response rates without significantly increasing side-effects in patients with relapsed or refractory AML. Reportedly, the company has planned phase IIb trials, the first is expected to start in early 2010.

Glyn Edwards, CEO at Antisoma, said: “Gaining orphan drug status in AML further strengthens the position of AS1411 in a setting where we have positive phase II data. This is an exciting time for AS1411, with phase II data in renal cancer coming soon and our investigation of the compound in AML progressing to the next stage.”