# US 8,541,469 B2 · Treatment of cell-mediated immune diseases

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- Number: US 8,541,469 B2
- Document ID: US8541469B2
- Status: Granted
- Kind: B2
- Application number: 11/432,965
- Filed: 2006-05-12
- Published: 2006-11-23
- Granted: 2013-09-24
- Earliest claimed: 1997-08-23
- Assignees: Glaxo Group Limited
- Applicants: Werner Bollag; Fritz Ott
- Inventors: Werner Bollag; Fritz Ott
- Web page: https://patentgrep.com/patent/US8541469B2

## CPC

- A61K 31/203: Retinoic acids {; Salts thereof}
- A61K 31/22: of acyclic acids, e.g. pravastatin
- 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

9-cis retinoic acid and pharmaceutically acceptable salts and pharmaceutically acceptable hydrolyzable esters thereof, 9-cis retinal and pharmaceutically acceptable acetals thereof, and 9-cis retinol and pharmaceutically acceptable hydrolyzable esters thereof as well as metabolites of 9-cis retinoic acid have been found to be efficacious in treating T-helper cell type 1 mediated immune diseases in well tolerated doses. Preferably, the active ingredient is formulated as a medicament for oral or topical administration.

## Claims

### Claim 1

A method of treating eczema in a human patient in need thereof, comprising orally administering to said patient a composition comprising a pharmaceutically active compound which is 9-cis retinoic acid or a pharmaceutically acceptable salt thereof, and a pharmaceutically acceptable carrier or diluent compatible with said active compound, and wherein the 9-cis retinoic acid is administered daily to said patient from about 0.05 to 1.5 mg per kg of body weight of the patient.

### Claim 2 (depends on 1)

The method according to claim 1, wherein the patient has active eczema lesions.

### Claim 3 (depends on 2)

The method according to claim 2, wherein the eczema is selected from the group consisting of irritant dermatitis, allergic contact dermatitis, tylotic eczema or pompholyx, seborrheic eczema, asteatotic eczema, and discoid eczema.

### Claim 4 (depends on 1)

The method according to claim 1, wherein the eczema comprises preexisting eczema lesions which are in remission.

### Claim 5 (depends on 4)

The method according to claim 4 , wherein the eczema is selected from the group consisting of irritant dermatitis, allergic contact dermatitis, tylotic eczema or pompholyx, seborrheic dermatitis, asteatotic eczema, and discoid eczema.

### Claim 6 (depends on 1)

The method according to claim 1, wherein the amount of the 9-cis retinoic acid is from about 0.3 to about 0.9 milligrams per kilogram of body weight.

### Claim 7 (depends on 6)

The method according to claim 6, wherein the composition is present in an oral unit dosage form.

### Claim 8 (depends on 7)

The method according to claim 7 , wherein the oral unit dosage form is a tablet, capsule, pill or sachet containing from five to fifty milligrams of 9-cis retinoic acid or a pharmaceutically acceptable salt thereof.

### Claim 9 (depends on 8)

The method according to claim 8, wherein the oral dosage form contains from about 10 to about 20 milligrams of 9-cis retinoic acid or a pharmaceutically acceptable salt thereof.

### Claim 10 (depends on 1)

The method according to claim 1, wherein the composition is present in an oral unit dosage form.

### Claim 11 (depends on 10)

The method according to claim 10 wherein the oral unit dosage form is a tablet, capsule, pill or sachet.

### Claim 12 (depends on 11)

The method according to claim 11 wherein the oral unit dosage form contains from five to fifty milligrams of 9-cis retinoic acid or a pharmaceutically acceptable salt thereof.

### Claim 13 (depends on 12)

A method according to claim 12, wherein the oral dosage form contains from about 10 to about 20 milligrams of 9-cis retinoic acid or a pharmaceutically acceptable salt thereof.