Posted by Michael Wonder on 08 Jun 2017
Mateon Therapeutics receives FDA fast track designation for OXI4503 in patients with acute myeloid leukaemia
7 June 2017 - Mateon Therapeutics today announced that the U.S. FDA has granted fast track designation to the company's product candidate OXi4503 for the treatment of acute myeloid leukaemia.
OXi4503 (combretastatin A1-diphosphate or CA1P) is a dual-mechanism vascular disrupting agent. In preclinical and clinical studies, it has been observed to compromise the tumor vasculature, resulting in extensive tumour cell death and necrosis while also possibly affecting the cell shape and attachment of haematopoietic stem cells.
OXi4503 is being evaluated for relapsed/refractory acute myeloid leukaemia and myelodysplastic syndrome in combination with cytarabine in OX1222, a phase 1b/2 study. In addition to fast track status, OXi4503 has been granted orphan drug designation for the treatment of acute myeloid leukaemia in both the United States and Europe.
