FDA granted paediatric disease designation for OXi-4503

Mateon Therapeutics

16 September 2020 - Treatment of acute myeloid leukaemia due to genetic mutations that disproportionately affect paediatric patients.

Mateon Therapeutics announced today that the US FDA granted its request and designate OXi4503 (combretastatin A1-diphosphate; CA1P) for treatment of acute myeloid leukaemia due to genetic mutations that disproportionately affect paediatric patients as a drug for a “rare paediatric disease,” as defined in Section 529(a)(3) of the Federal Food, Drug, and Cosmetic Act.

OXi4503 in combination with standard chemotherapy drug cytarabine was generally well tolerated by adult patients with acute myeloid leukaemia and a maximum tolerated dose level of OXi4503 was identified as the recommended dose for further clinical development of this novel two-drug combination.

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Michael Wonder

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Michael Wonder