# US 11,304,943 B2 · Combination for use in the treatment of lung cancer

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- Number: US 11,304,943 B2
- Document ID: US11304943B2
- Status: Granted
- Kind: B2
- Application number: 16/499,168
- Filed: 2018-03-28
- Published: 2020-04-02
- Granted: 2022-04-19
- Earliest claimed: 2017-03-28
- Assignees: LDN Pharma Limited
- Applicants: LDN Pharma Limited
- Inventors: Angus Dalgleish; Wai Lui
- Web page: https://patentgrep.com/patent/US11304943B2

## CPC

- A61K 31/485: Morphinan derivatives, e.g. morphine, codeine
- A61K 31/59: Compounds containing 9, 10- seco- cyclopenta[a]hydrophenanthrene ring systems
- A61K 31/592: 9,10-Secoergostane derivatives, e.g. ergocalciferol, i.e. vitamin D2
- A61K 31/593: 9,10-Secocholestane derivatives, e.g. cholecalciferol, i.e. vitamin D3
- A61P 35/00: Antineoplastic agents
- 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

The invention is based on the finding that co-administration of 6-β-naltrexol alongside vitamin D together with a chemotherapeutic agent, results in a further reduction in lung cancer cell growth. The combination of 6-β-naltrexol with vitamin D results in a greater decrease in the growth of cancer cells compared to the sum of the effects of each agent when administered in isolation.

## Claims

### Claim 1

A method of treating lung cancer comprising administering 6-β-naltrexol sequentially, separately or simultaneously with vitamin D or an active metabolite thereof to a subject having lung cancer.

### Claim 2 (depends on 1)

The method of claim 1, wherein the subject is undergoing or is selected to undergo treatment with an anti-cancer agent.

### Claim 3 (depends on 1)

The method of claim 1, wherein said 6-β-naltrexol is to be administered to the subject in need thereof in a first treatment phase, followed by a recovery period, then subsequent administration of an anti-cancer agent in a second treatment phase.

### Claim 4 (depends on 3)

The method of claim 3, wherein the recovery period is from 1 to 7 days.

### Claim 5 (depends on 2)

The method of claim 2, wherein the 6-β-naltrexol and anti-cancer agent are to be administered simultaneously.

### Claim 6 (depends on 2, 3, 4, 5)

The method of any of claims 2 to 5, wherein the anti-cancer agent is a cell cycle inhibitor or an agent that induces cytostasis.

### Claim 7 (depends on 6)

The method of claim 6, wherein the cell cycle inhibitor is selected from the group consisting of flavopiridol, ribocilib, staurosporine, UCN-01, abemaciclib and palbociclib, and any combination thereof.

### Claim 8 (depends on 1)

The method of claim 1, wherein the 6-β-naltrexol is to be administered at a dosage level sufficient to raise the blood plasma concentration of 6-β-naltrexol to about from 0.34 ng/ml to 3,400 ng/ml.

### Claim 9

A method for the treatment of a subject with lung cancer, comprising administering a therapeutically effective amount of 6-β-naltrexol, wherein the subject is also administered vitamin D or an active metabolite thereof.

### Claim 10 (depends on 9)

A method according to claim 9, wherein the subject is undergoing or is selected to undergo treatment with an anti-cancer agent.

### Claim 11 (depends on 10)

A method according to claim 10, wherein said anti-cancer agent is a cell cycle inhibitor or an agent that induces cytostasis.

### Claim 12 (depends on 11)

A method according to claim 11, wherein said cell cycle inhibitor is selected from the group consisting of flavopiridol, ribocilib, staurosporine, UCN-01, abemaciclib and palbociclib, and any combination thereof.

### Claim 13 (depends on 9, 10, 11, 12)

A method according to any of claims 9 to 12, wherein said 6-β-naltrexol is administered at a dosage level of less than sufficient to raise the blood plasma concentration of 6-β-naltrexol to about from 0.34 ng/ml to 3,400 ng/ml.

### Claim 14 (depends on 1, 2, 3, 4, 5)

The method of any of claims 1 to 5, wherein the Vitamin D or the active metabolite thereof is administered in a dose sufficient to raise the Vitamin D blood concentration from 0.34 ng/ml to 3,400 ng/ml.