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FDA grants fast track designation to OXi4503 for AML

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The FDA granted fast track designation to OXi4503 for the treatment of acute myeloid leukemia, according to the drug’s manufacturer.

OXi4503 (combretastatin A1-diphosphate, Mateon Therapeutics) is a dual-mechanism vascular disrupting agent. Preclinical and clinical studies have shown the agent compromises tumor vasculature, leading to extensive tumor cell death and necrosis, and potentially affecting cell shape and attachment of hematopoietic stem cells, according to a company-issued press release.

The phase 1b/phase 2 OX1222 study is underway to evaluate OXi4503 in combination with cytarabine for the treatment of patients with relapsed/refractory AML and myelodysplastic syndrome.

The FDA previously granted orphan drug designation to OXi4503 for treatment of AML.

“The receipt of fast track designation from the FDA represents an important milestone for our OXi4503 program and follows promising results, including three complete remissions, from the initial cohorts of our ongoing OX1222 study in patients with relapsed/refractory AML,” William D. Schwieterman, MD, president and CEO of Mateon Therapeutics, said in the release. “This latest development provides further momentum for this groundbreaking study, and occurs in advance of the completion of the fifth patient cohort in OX1222, which we expect by the end of this year.”