SunesisPharmaceuticals, Inc. today announced that the U.S. Food andDrug Administration has granted voreloxin orphan drug designation for thetreatment of acute myeloid leukemia (AML). Sunesis is currently conducting twoPhase 2 clinical trials of voreloxin in AML: a single-agent study, known asREVEAL-1, of voreloxin in newly diagnosed elderly AML patients unlikely tobenefit from standard induction chemotherapy and a study evaluating voreloxinin combination with cytarabine in relapsed/refractory AML.
"This designation recognizes the acute need for more options in treatingthis poor-prognosis disease," stated Steven B. Ketchum, Ph.D., Senior VicePresident of Research and Development at Sunesis. "We believe voreloxin hasthe potential to impact the standard of care for AML and we continue to beencouraged by our progress. We are finalizing a registration strategy forvoreloxin in AML and anticipate launching a pivotal trial in 2010."
Orphan drug designation is granted by the FDA Office of Orphan DrugProducts to novel drugs or biologics that treat a rare disease or conditionaffecting fewer than 200,000 patients in the U.S. The designation provideseligibility for a seven-year period of market exclusivity in the United Statesafter product approval and an exemption from user fees.