# US 2014/0194484 A1 · Method of Treating Cachexia and Sarcopenia

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- Number: US 2014/0194484 A1
- Document ID: US20140194484A1
- Status: Published application
- Kind: A1
- Application number: 14/101,272
- Filed: 2013-12-09
- Published: 2014-07-10
- Earliest claimed: 2012-07-25
- Inventors: Andrew Coats; John Beadle; Stefan Anker
- Web page: https://patentgrep.com/patent/US20140194484A1

## CPC

- A61K 31/404: Indoles, e.g. pindolol
- A61K 9/2018: {Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates}
- A61K 9/205: {Polysaccharides, e.g. alginate, gums; Cyclodextrin}
- A61P 3/00: Drugs for disorders of the metabolism (of the blood or the extracellular fluid A61P7/00)
- A61P 9/12: Antihypertensives
- A61P 21/00: Drugs for disorders of the muscular or neuromuscular system
- 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 present invention relates to a method of treating a cachexia and/or sarcopenia with an oral dose of S-pindolol or a pharmaceutical formulation thereof and to an oral formulation for use in said method of treatment. The method and oral formulation comprise administering a total daily dose of 2.5 to 20 mg of S-pindolol or a pharmaceutical formulation comprising the same.

## Claims

### Claim 1

A method of treating cachexia or sarcopenia or a combination thereof comprising administering to a human patient in need thereof a total daily oral dose of 2.5 to 20 mg of S-pindolol or a pharmaceutical formulation comprising the same.

### Claim 2 (depends on 1)

The method according to claim 1, wherein the total oral dose of S-pindolol is administered bi-daily as two sub-doses.

### Claim 3 (depends on 2)

The method according to claim 2, wherein each sub-dose is in the range 2.5 to 10 mg.

### Claim 4 (depends on 1)

The method according to claim 1, wherein the oral formulation is a solid dose formulation.

### Claim 5 (depends on 1)

The method according to claim 1, wherein the formulation comprises one or more excipients independently selected from microcrystalline cellulose, lactose, colloidal silicon dioxide, maize starch, povidone, magnesium stearate and crospovidone.

### Claim 6 (depends on 1)

The method according to claim 1, wherein the formulation is a liquid.

### Claim 7 (depends on 1)

The method of treating cachexia according to claim 1 wherein human patient has underlying disease selected from cancer, chronic heart failure, COPD, TB and HIV.

### Claim 8 (depends on 7)

The method of treating cachexia according to claim 7, wherein the cancer is selected from colorectal cancer, lung cancer, pancreatic cancer, bone cancer, stomach cancer, oesophageal cancer, prostate cancer and ovarian cancer, for example colorectal cancer and lung cancer such as non-small cell lung cancer.

### Claim 9 (depends on 8)

The method according to claim 8, wherein the S-pindolol formulation is administered pre, post and/or concomitant with a cancer treatment regime selected from surgery, chemotherapy and radiotherapy.

### Claim 10

An oral pharmaceutical formulation comprising 2.5 to 20 mg of S-pindolol per dose and at least one excipient.

### Claim 11 (depends on 10)

The oral pharmaceutical formulation according to claim 10 comprising 2.5 to 10 mg of S-pindolol per dose.

### Claim 12 (depends on 10)

The oral pharmaceutical formulation according to claim 10, wherein the formulation is a liquid.

### Claim 13 (depends on 10)

The oral pharmaceutical formulation according to claim 10, wherein the formulation is a solid dose formulation selected from a tablet and a capsule, for example for immediate release.

### Claim 14 (depends on 13)

The oral pharmaceutical formulation according to claim 13, wherein one or more excipients selected from the group comprising microcrystalline cellulose, lactose, colloidal silicon dioxide, maize starch, povidone, magnesium stearate and crospovidone.

### Claim 15 (depends on 10)

The oral formulation according to claim 10 wherein per dose formulated consists of: 2.5 mg S-pindolol, 3.0 mg povidone K30, 45.5 mg lactose monohydrate , 10.0 mg maize starch, 1.0 mg Aerosil 200, 17.5 mg avicel PH 101, 2.0 mg crospovidone, 17.5 mg avicel PH 102, and 1.0 mg magnesium stearate.