Clinical-stage biopharmaceutical company OXiGENE's acute myelogenous leukemia (AML) drug candidate, OXi4503, has received FDA orphan drug status.
The second-generation anticancer agent with a dual-mechanism vascular disrupting feature integrates vascular disrupting activity and direct cytotoxicity.
With the issuance of orphan drug designation, the company gains market exclusivity for specific indication in the US besides eligibility for few research grants and certain tax credits.
OXiGENE chief executive officer Peter Langecker said OXi4503 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," Langecker added.
"We look forward to having initial results from the ongoing Phase 1 trial in AML before the end of 2012."
OXi4503 (combretastatin A1 diphosphate /CA1P) is being studied in a Phase 1 study supported by The Leukemia & Lymphoma Society's Therapy Acceleration Program in AML patients or myelodysplastic syndrome sufferers.
