Cancer drug developer Antisoma plc announced that the US Food and Drug Administration (FDA) has granted Fast Track designation to the company's novel DNA intercalator, AS1413 (amonafide L-malate), for the treatment of secondary acute myeloid leukaemia (secondary AML).

The US FDA's Fast Track programme is designed to facilitate the development of new drugs that have shown the potential to address an unmet medical need in a serious or life-threatening disease. Fast Track designated drugs ordinarily qualify for Priority Review, an expedited review process available to drugs that offer major advances in treatment or provide a treatment where no adequate therapy exists.

Glyn Edwards, CEO of Antisoma, said, "We're very pleased to have gained US FDA Fast Track status for AS1413. This drug could represent a major advance in the options available to patients with secondary AML, and we look forward to completing the ongoing phase-III trial and sharing the data with US FDA and other regulators."

AS1413 (amonafide L-malate) was added to Antisoma's pipeline through the acquisition of Xanthus Pharmaceuticals, Inc. in June 2008. AS1413 is a novel DNA intercalator that induces apoptotic signalling by blocking topoisomerase II binding to DNA.

Antisoma develops novel products for the treatment of cancer. The company has operations in the UK and the US.