Xanafide (amonafide malate) is an ATP-independent topoisomerase II inhibitor that the company is developing for the treatment of secondary acute myeloid leukemia (AML) and related disorders. Xanafide is currently in a pivotal Phase III trial in patients with secondary AML under a special protocol assessment with the Food and Drug Administration (FDA).
In December 2006, the US FDA awarded orphan drug designation to Xanafide for the treatment of AML.
Richard Dean, CEO of Xanthus, said: “There is need for new, promising treatment options, such as Xanafide, for patients with AML, a poor-prognosis disease. This designation is an important step in Xanthus’s development plan for the candidate, and offers us potential market benefits in connection with the commercialization of Xanafide in the European Union.”
The European Commission’s ‘orphan medicinal product designation’ is designed to promote the development of drugs which may provide significant benefit to patients suffering from rare diseases identified as life-threatening or very serious.