Cancer drug developer Antisoma (LON:ASM) this morning reported that the US Food and Drug Administration (FDA) had granted Fast Track designation to its novel DNA intercalator, AS1413, for the treatment of secondary acute myeloid leukaemia (secondary AML). The FDA’s Fast Track programme is designed to aid 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 usually qualify for Priority Review, which is a quicker review process available to drugs that offer major advances in treatment or provide a treatment where no adequate therapy exists.

Glyn Edwards, Antisoma’s chief executive, said: “We're very pleased to have gained 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 FDA and other regulators.”

Shares in Antisoma rose by nearly 6% to 5.3p on today’s news, but remain some way off the 32p trading level they were enjoying at the end of March. Back then, the company was forced to ditch its flagship ASA404 lung cancer treatment following unsuccessful phase III trials. Since that shock, it has endeavoured to regroup and focus on driving forward the development of AS1413 along with AS1411, where phase IIb trials are ongoing with results expected next year.

The failure of ASA404 dealt a major blow to the business, forcing it to reduce headcount and slash costs. In the aftermath, chief executive, Glyn Edwards, said the company was seeing interest from potential licensing partners for AS1413. He added that it had also decided to take a pragmatic stance to realising the value of the drug, and widened its partnering discussions to include US rights, which it had previously planned to retain. However, Edwards insisted that he would only strike a deal ahead of the phase III data if the terms were sufficiently favourable. AS1413 already has orphan drug status in both the US and the EU, which means it is recognised as an agent for the treatment of very specific diseases, in this case AML.

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