# US 11,304,916 B2 · Methods and compositions for the treatment of Shiga Toxicosis

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- Number: US 11,304,916 B2
- Document ID: US11304916B2
- Status: Granted
- Kind: B2
- Application number: 16/890,710
- Filed: 2020-06-02
- Published: 2020-12-03
- Granted: 2022-04-19
- Earliest claimed: 2019-06-03
- Assignees: Board of Regents, The University of Texas System
- Applicants: Board of Regents, The University of Texas System
- Inventors: Somshuvra Mukhopadhyay; Andrey S. Selyunin; Stanton F. McHardy
- Web page: https://patentgrep.com/patent/US11304916B2

## CPC

- A61K 31/138: Aryloxyalkylamines, e.g. propranolol, tamoxifen, phenoxybenzamine (atenolol A61K31/165; pindolol A61K31/404; timolol A61K31/5377)
- A61K 31/4535: containing a heterocyclic ring having sulfur as a ring hetero atom, e.g. pizotifen
- A61K 31/55: having seven-membered rings, e.g. azelastine, pentylenetetrazole
- A61K 33/32: Manganese; Compounds thereof
- A61P 31/04: Antibacterial agents
- A61K 9/0053: {Mouth and digestive tract, i.e. intraoral and peroral administration}
- A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
- 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

Methods for treating Shiga toxicosis, caused by infection with Shiga toxin bacteria, are provided. The methods include administering to a subject in need thereof an effective amount of one or more active agents selected from tamoxifen, 4-hydroxytamoxifen, endoxifen, toremifene, raloxifene, bazedoxifene, and pharmaceutically acceptable salts thereof. In some embodiments, the methods further include the administration of an antibiotic or a manganese compound to the subject. Pharmaceutical compositions for the treatment of Shiga toxicosis are also described.

## Claims

### Claim 1

A method for treating Shiga toxicosis, the method comprising administering to a subject in need thereof an effective amount of an active agent selected from the group consisting of tamoxifen, 4-hydroxytamoxifen, endoxifen, toremifene, raloxifene, bazedoxifene, and pharmaceutically acceptable salts thereof.

### Claim 2 (depends on 1)

The method of claim 1, wherein the active agent is selected from the group consisting of tamoxifen, toremifene, raloxifene, and pharmaceutically acceptable salts thereof.

### Claim 3 (depends on 1)

The method of claim 1, wherein the subject is infected with a Shiga toxin-producing Escherichia species, a Shiga toxin-producing Shigella species, or a combination thereof.

### Claim 4 (depends on 3)

The method of claim 3, wherein the subject is infected with Shiga toxin-producing E. coli.

### Claim 5 (depends on 1)

The method of claim 1, wherein the active agent is administered to the subject within ten days of the infection.

### Claim 6 (depends on 1)

The method of claim 1, wherein the subject exhibits symptomatic diarrhea.

### Claim 7 (depends on 6)

The method of claim 6, wherein the active agent is administered to the subject within three days of the onset of symptomatic diarrhea.

### Claim 8 (depends on 1)

The method of claim 1, wherein the active agent is administered in an amount ranging from about 0.1 mg/kg/day to about 100 mg/kg/day.

### Claim 9 (depends on 8)

The method of claim 8, wherein the active agent is administered in an amount ranging from about 0.1 mg/kg/day to about 1.0 mg/kg/day.

### Claim 10 (depends on 1)

The method of claim 1, wherein the active agent is administered orally.

### Claim 11 (depends on 1)

The method of claim 1, further comprising administering an antibiotic to the subject.

### Claim 12 (depends on 1)

The method of claim 1, further comprising administering a manganese compound to the subject.