# US 11,077,139 B2 · Combination of an arsenic compound and at least one retinoid for treating acute myeloid leukemia

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- Number: US 11,077,139 B2
- Document ID: US11077139B2
- Status: Granted
- Kind: B2
- Application number: 15/107,749
- Filed: 2014-12-30
- Published: 2016-11-03
- Granted: 2021-08-03
- Earliest claimed: 2013-12-30
- Assignees: Inserm (Institut National De La Sante Et De La Recherche Medicale); Universite Paris Diderot—Paris 7; Centre National de la Recherche Scientifique (CNRS); Universita Di Perugia; American University of Beirut; Assistance Publique-HôPitaux De Paris (Aphp)
- Applicants: INSERM (Institut National de la Sante et de la Recherche Medicale); Universite Paris Diderot—Paris 7; Centre National de la Recherche Scientifique (CNRS); Universita di Perugia; American University of Beirut; Assistance Publique-Hopitaux de Paris (APHP)
- Inventors: Hugues De The; Ali Bazarbachi; Hiba El Hajj; Maria Paula Martelli; Brunangelo Falini
- Web page: https://patentgrep.com/patent/US11077139B2

## CPC

- A61K 33/36: Arsenic; Compounds thereof
- A61K 31/203: Retinoic acids {; Salts thereof}
- A61K 31/555: containing heavy metals, e.g. hemin, hematin, melarsoprol
- A61P 35/02: specific for leukemia
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS

## Abstract

The present invention relates to methods and pharmaceutical compositions for the treatment of acute myeloid leukemia. In particular, the present invention relates to a method for treating NPM-1-driven acute myeloid leukemia (AML) in a subject in need thereof comprising administering the subject with a therapeutically effective amount of at least one arsenic compound and with a therapeutically effective amount of at least one retinoid.

## Claims

### Claim 1

A method for reversing, alleviating, or inhibiting the progress of acute myeloid leukemia (AML) driven by mutation of the NPM-1 gene in a subject in need thereof comprising administering to the subject a therapeutically effective amount of at least one arsenic compound and a therapeutically effective amount of at least one retinoid, wherein the subject has a normal karyotype, wherein the therapeutically effective amount of the at least one arsenic compound provides a serum concentration of 0.1 μM to 1 μM, wherein the therapeutically effective amount of the at least one retinoid provides a serum concentration of 0.3 μM to 1 μM, wherein the subject is not receiving chemotherapy prior to said administering step, and wherein the at least one arsenic compound is arsenic trioxide (As2O3) and the at least one retinoid is a retinoic acid.

### Claim 2 (depends on 1)

The method of claim 1, wherein the ratio of As2O3 to retinoic acid administered to the subject is from 1:1 to 1:3.

### Claim 3

A method for reversing, alleviating, or inhibiting the progress of acute myeloid leukemia (AML) driven by mutation of the NPM-1 gene in a subject in need thereof comprising administering to the subject a therapeutically effective amount of at least one arsenic compound and a therapeutically effective amount of at least one retinoid, wherein the subject has a normal karyotype, wherein the therapeutically effective amount of the at least one arsenic compound provides a serum concentration of 0.1 μM to 1 μM, wherein the therapeutically effective amount of the at least one retinoid provides a serum concentration of 0.3 μM to 1 μM, wherein the at least one arsenic compound and the at least one retinoid are administered without any other chemotherapeutic agent, and wherein the at least one arsenic compound is arsenic trioxide (As2O3) and the at least one retinoid is a retinoic acid.

### Claim 4 (depends on 3)

The method of claim 3, wherein the ratio of As2O3 to retinoic acid administered to the subject is from 1:1 to 1:3.