# US 11,998,585 B2 · Methods and compositions for increasing the dose of a chemotherapeutic agent

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- Number: US 11,998,585 B2
- Document ID: US11998585B2
- Status: Granted
- Kind: B2
- Application number: 17/684,057
- Filed: 2022-03-01
- Published: 2022-09-22
- Granted: 2024-06-04
- Earliest claimed: 2012-03-30
- Assignees: Stealth BioTherapeutics Inc.
- Applicants: Stealth BioTherapeutics Inc.
- Inventors: D. Travis Wilson
- Web page: https://patentgrep.com/patent/US11998585B2

## CPC

- A61K 38/07: Tetrapeptides
- A61K 31/137: Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine {or methadone}
- A61K 31/185: Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids (hydroxamic acids A61K31/16; peroxy acids A61K31/327)
- A61K 31/337: having four-membered rings, e.g. taxol
- A61K 31/366: having six-membered rings, e.g. delta-lactones
- A61K 31/4245: Oxadiazoles
- A61K 31/4748: forming part of bridged ring systems (strychnine A61K31/475; morphinan derivatives A61K31/485)
- A61K 31/55: having seven-membered rings, e.g. azelastine, pentylenetetrazole
- A61K 31/7042: Compounds having saccharide radicals and heterocyclic rings
- A61K 33/243: Platinum; Compounds thereof
- A61K 38/08: Peptides having 5 to 11 amino acids {(A61K38/043 - A61K38/046 take precedence)}
- A61P 25/02: for peripheral neuropathies
- A61P 25/04: Centrally acting analgesics, e.g. opioids
- A61P 35/00: Antineoplastic agents
- A61P 39/02: Antidotes
- A61P 43/00: Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
- 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 disclosure relates to methods for treating a subject suffering from hyperalgesia caused by drug-induced neuropathy by administering to the subject an effective amount of an aromatic-cationic peptide. The disclosure also relates to methods for protecting a subject from hyperalgesia caused by drug-induced neuropathy by administering an effective amount of an aromatic-cationic peptide to a subject at risk for developing the condition.

## Claims

### Claim 1

A method for increasing the dose of a chemotherapeutic agent in a subject in need thereof, comprising administering to the subject an effective amount of a peptide having the formula Phe-D-Arg-Phe-Lys-NH2, or a pharmaceutically acceptable salt thereof, wherein the peptide treats or prevents one or more dose-limiting neuropathic conditions induced by the chemotherapeutic agent, thereby permitting an increase in the dose of the chemotherapeutic agent.

### Claim 2 (depends on 1)

The method of claim 1, wherein the one or more dose-limiting neuropathic conditions is selected from a group consisting of myalgia, painful burning paresthesia, glove-and-stocking sensory neuropathy, hyperalgia, and allodynia.

### Claim 3 (depends on 1)

The method of claim 1, wherein the subject is a human.

### Claim 4 (depends on 1)

The method of claim 1, wherein the peptide is administered prior the onset of the one or more dose-limiting neuropathic conditions.

### Claim 5 (depends on 1)

The method of claim 1, wherein the pharmaceutically acceptable salt comprises acetate.

### Claim 6 (depends on 1)

The method of claim 1, wherein the chemotherapeutic agent is procarbazine, nitrofurazone, podophyllum, mustine, ethoglucid, cisplatin, suramin, paclitaxel, chlorambucil, altretamine, carboplatin, cytarabine, docetaxel, dacarbazine, etoposide, ifosfamide with mesna, fludarabine, tamoxifen, teniposide, thioguanine, or vincristine.

### Claim 7 (depends on 6)

The method of claim 6, wherein the chemotherapeutic agent is vincristine.

### Claim 8 (depends on 6)

The method of claim 6, wherein the peptide is administered simultaneously with the chemotherapeutic agent.

### Claim 9 (depends on 6)

The method of claim 6, wherein the peptide is administered subsequent to the chemotherapeutic agent.