# US 2021/0275467 A1 · Tumor reduction formulations and methods of use thereof

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- Number: US 2021/0275467 A1
- Document ID: US20210275467A1
- Status: Published application
- Kind: A1
- Application number: 17/259,477
- Filed: 2019-07-02
- Published: 2021-09-09
- Earliest claimed: 2018-07-09
- Assignees: Tyme, Inc.
- Applicants: Tyme, Inc
- Inventors: Steven Hoffman; John Rothman
- Web page: https://patentgrep.com/patent/US20210275467A1

## CPC

- A61K 31/08: acyclic, e.g. paraformaldehyde
- A61K 9/0019: {Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner (non-active ingredients are additionally classified in A61K47/00)}
- A61K 31/045: Hydroxy compounds, e.g. alcohols; Salts thereof, e.g. alcoholates
- A61K 31/4015: having oxo groups directly attached to the heterocyclic ring, e.g. piracetam, ethosuximide
- A61K 31/575: substituted in position 17 beta by a chain of three or more carbon atoms, e.g. cholane, cholestane, ergosterol, sitosterol
- A61K 47/16: containing nitrogen, {e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates}
- A61K 31/167: having the nitrogen of a carboxamide group directly attached to the aromatic ring, e.g. lidocaine, paracetamol
- 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)

## Abstract

The invention relates to tumor reducing compositions and methods thereof. Specifically, the invention relates to compositions comprising a combination of a sclerosing agent and a penetrating agent.

## Claims

### Claim 1

A pharmaceutical composition comprising a combination of a sclerosing agent and a penetrating agent.

### Claim 2 (depends on 1)

The pharmaceutical composition of claim 1, wherein the sclerosing agent is nonaethylene glycol monododecyl ether.

### Claim 3 (depends on 1)

The pharmaceutical composition of claim 1, wherein the penetrating agent is anhydrous 1-methyl-2-pyrrolidinone.

### Claim 4 (depends on 1)

The pharmaceutical composition of claim 1, wherein the sclerosing agent and the penetrating agent are present in combination in an amount effective to reduce a size of a tumor in a subject.

### Claim 5 (depends on 4)

The composition of claim 4, wherein the subject is a mammal.

### Claim 6 (depends on 5)

The composition of claim 5, wherein the mammal is a human.

### Claim 7 (depends on 1)

The composition of claim 1, further comprising an alcohol.

### Claim 8 (depends on 7)

The composition of claim 7, wherein the alcohol is benzyl alcohol.

### Claim 9 (depends on 1)

The composition of claim 1, further comprising an acid or a salt thereof.

### Claim 10 (depends on 9)

The composition of claim 9, wherein the acid is a bile acid.

### Claim 11 (depends on 10)

The composition of claim 10, wherein, the bile acid salt is sodium deoxycholate.

### Claim 12 (depends on 1)

The composition of claim 1, further comprising a pain reducing agent.

### Claim 13 (depends on 12)

The composition of claim 12, wherein the pain reducing agent is lidocaine.

### Claim 14 (depends on 1)

The composition of claim 1, wherein the combination penetrates a tissue in presence of an acid.

### Claim 15

A pharmaceutical composition comprising a bile acid, nonaethylene glycol monododecyl ether, and anhydrous 1-methyl-2-pyrrolidinone.

### Claim 16 (depends on 15)

The pharmaceutical composition of claim 15, wherein the bile acid is sodium deoxycholate.

### Claim 17

A method of reducing a size of a tumor in a subject, comprising contacting a tumor with a composition comprising a therapeutically effective amount of a combination of a sclerosing agent and a penetrating agent.

### Claim 18

A method of reducing a size of a tumor in a subject, comprising contacting a tumor with a composition comprising a therapeutically effective amount of a combination of a sclerosing agent and a penetrating agent, and a bile acid.

### Claim 19 (depends on 17)

The method of claim 17, wherein the contacting comprises intratumoral injection.

### Claim 20 (depends on 17)

The method of claim 17, wherein the tumor is present in a tissue of the breast, prostate, lung, colon, stomach, pancreas, ovary, brain, skin, bone, fat, lymph, gastrointestinal tract, liver, or soft tissue.

### Claim 21 (depends on 17)

The method of claim 17, wherein the sclerosing agent is nonaethylene glycol monodecyl ether.

### Claim 22 (depends on 17)

The method of claim 17, wherein the penetrating agent is anhydrous 1-methyl-2-pyrrolidinone.

### Claim 23 (depends on 18)

The method of claim 18, wherein the bile acid is deoxycholic acid, cholic acid, glycocholic acid, taurocholic acid, chenodeoxycholic acid, glycochenodeoxycholic acid, taurochenodeoxycholic acid, or lithocholic acid.

### Claim 24 (depends on 17)

The method of claim 17, wherein the subject is a mammal.

### Claim 25 (depends on 24)

The method of claim 24, wherein the mammal is a human.

### Claim 26 (depends on 17)

The method of claim 17, wherein the composition further comprises an alcohol.

### Claim 27 (depends on 26)

The method of claim 26, wherein the alcohol is benzyl alcohol.

### Claim 28 (depends on 17)

The method of claim 17, wherein the composition further comprises a pain reducing agent.

### Claim 29 (depends on 28)

The method of claim 28, wherein the pain reducing agent is lidocaine.

### Claim 30 (depends on 18)

The method of claim 18, wherein the composition comprises benzyl alcohol, sodium deoxycholate, nonaethylene glycol monododecyl ether, and anhydrous 1-methyl-2-pyrrolidinone.

### Claim 31 (depends on 17)

The method of claim 17, wherein the tumor contacted with the composition comprises an increase in intratumoral necrosis compared to a tumor contacted with a control comprising bacteriostatic water.

### Claim 32 (depends on 17)

The method of claim 17, wherein the tumor is cancerous.

### Claim 33 (depends on 1)

A method of treating a lesion in a subject, comprising contacting the lesion with the pharmaceutical composition of claim 1.

### Claim 34 (depends on 33)

The method of claim 33, wherein the lesion is present in a tissue of the breast, prostate, lung, colon, stomach, pancreas, ovary, brain, skin, bone, fat, lymph, gastrointestinal tract, liver, or soft tissue.

### Claim 35 (depends on 33)

The method of claim 33, wherein the lesion is noncancerous.
