FDAnews Drug Daily Bulletin
Pharmaceuticals / Submissions and Approvals

Mateon Therapeutics Receives FDA Fast Track Designation for OXi4503

June 15, 2017
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The FDA granted a Fast Track designation to Mateon Therapeutics’ product candidate OXi4503 for the treatment of acute myeloid leukemia.

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 tumor cell death and necrosis while also possibly affecting the cell shape and attachment of hematopoietic stem cells.

OXi4503 has been granted Orphan Drug designations for AML in both the U.S. and Europe.

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