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Antisoma’s novel leukaemia treatment fast-track­ed by FDA

Cancer focused biotechnol­ogy company, Antisoma (LON:ASM, OTC: ATSMY) told investors that its novel leukaemia treatment – the AS1413 DNA intercalat­or – has been granted a Fast Track designatio­n by the US Food and Drug Administra­tion (FDA).

The news has been welcomed by investors as the company’s shares advanced over 6.5% on the London Stock Exchange this morning.

FDA 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. The novel DNA intercalat­or, AS1413 (amonafide­ L-malate),­ is being developed for the treatment of secondary acute myeloid leukaemia (secondary­ AML).

“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", Antisoma Chief Executive Glyn Edwards commented.­ "We're very pleased to have gained FDA Fast Track status for AS1413”.

The 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. The drug already has orphan drug status in both the US and the EU for the treatment of AML.