OXiGENE, Inc., a clinical-stage biopharmaceutical company developing novel therapeutics to treat cancer, has announced that its product candidate OXi4503 has been granted orphan designation by the FDA for the treatment of acute myelogenous leukemia, or AML.
Orphan drug designation qualifies a company for several benefits, including the potential for market exclusivity, development grants, and for certain tax credits.
OXi4503 is a second-generation anticancer agent that combines vascular disrupting activity with direct cytotoxicity. A phase I study of OXi4503 for the treatment of patients with AML or myelodysplastic syndrome (MDS) is currently under way, with support from The Leukemia & Lymphoma Society's Therapy Acceleration Program.
Peter Langecker, OXiGENE CEO: "OXi4503 is a valuable asset in our company's product portfolio of vascular disrupting agents, and has shown highly potent antitumor activity in preclinical and clinical studies. We believe that orphan designation in the US may increase the attractiveness of OXi4503 as a partnering asset, and we plan to seek orphan designation in the European Union as well.
"We look forward to having initial results from the ongoing phase I trial in AML before the end of 2012. AML is a highly lethal disease, and there is an urgent need for therapeutic approaches based on new mechanisms of action that can be used as monotherapy or in combination with current treatment regimens. We are optimistic that OXi4503 has the potential to represent a promising and novel way to treat AML, especially in resistant populations."