Antisoma's AS1411 gains US and EU Orphan Drug Status for acute myeloid leukaemia
Antisoma plc announces that its aptamer drug AS1411 has been granted orphan drug status in both the United States and the European Union 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.
Positive phase II data for AS1411 in AML were presented at the 2008 ASH and 2009 ASCO meetings. Addition of AS1411 to high-dose cytarabine increased response rates without significantly increasing side-effects in patients with relapsed or refractory AML. Phase IIb trials are now planned: the first is expected to start in early 2010. Should this yield positive findings, rapid progress into a registration trial is anticipated.
AS1411 already has orphan drug status in both the US and the EU for the treatment of renal cancer. A phase II trial in renal cancer is ongoing, and expected to report initial data before the end of this year.
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