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.
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