XANTHUS' AML DRUG GRANTED ORPHAN DRUG DESIGNATION

Xanthus Pharmaceuticals announced that the FDA has granted orphan drug designation to Xanafide (amonafide malate) for the treatment of acute myeloid leukemia (AML). Xanthus has recently completed enrollment in a Phase II trial of Xanafide in patients with secondary AML.

"No therapies are currently approved by the FDA for patients with secondary AML, a condition with a grim prognosis. This designation is part of Xanthus' plan to continue to progress its Xanafide program with the goal of giving patients with secondary AML a new treatment option," Richard Dean, CEO of Xanthus, said.

The FDA grants orphan drug designation to promising products that address diseases affecting fewer than 200,000 people in the United States. If Xanafide receives FDA approval, this designation will entitle Xanthus to exclusive marketing rights for Xanafide for seven years. Orphan drug designation also provides companies with financial and regulatory incentives.

Xanafide is an ATP-independent topoisomerase 2 inhibitor that the company is developing for the treatment of secondary acute myeloid leukemia (AML) and related disorders. Secondary AML patients have had either antecedent myelodysplastic syndrome or prior exposure to leukemogenic therapy and represent a poor-prognosis population. While de novo AML has approved treatments, no therapies are approved specifically for patients with secondary AML.