Antisoma has received some much-needed good news after regulators in the USA granted fast-track status to one of the firm’s investigational leukaemia treatments.
The US Food and Drug Administration has awarded a fast-track designation to the company’s AS1413 (amonafide), for the treatment of secondary acute myeloid leukaemia. Drugs with fast-track status usually qualify for priority review, if they offer “major advances in treatment or provide a treatment where no adequate therapy exists”.
Glyn Edwards, Antisoma, chief executive, believes AS1413, a novel DNA intercalator, “could represent a major advance in the options available to patients with secondary AML”. The plan now is to complete an ongoing Phase III trial and share the data with the FDA and other regulators, he said.
Meantime, Antisoma has presented new data supporting AS1413 at the American Society of Clinical Oncology meeting in Chicago. These included an analysis of Phase II data showing comparable activity with AS1413 plus cytarabine in the two subgroups of secondary AML patients in the ongoing late-stage trial (ie patients with prior myelodysplastic syndrome and people previously treated for other cancers).
AS1413 is a key compound for Antisoma after its previous lead candidate ASA404 failed in a Phase III trial at the end of March. The company’s shares sank after the study, in patients with previously untreated non-small cell lung cancer, indicated that “there is little or no prospect of demonstrating a survival benefit”.
