# US 7,132,246 B2 · Use of soluble cytokeratin-1-fragments in diagnostics and therapy

> Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt

- Number: US 7,132,246 B2
- Document ID: US7132246B2
- Status: Granted
- Kind: B2
- Application number: 10/480,848
- Filed: 2002-06-12
- Published: 2004-11-04
- Granted: 2006-11-07
- Earliest claimed: 2001-06-27
- Inventors: Andreas Bergmann; Joachim Struck; Monika Ühlein
- Web page: https://patentgrep.com/patent/US7132246B2

## CPC

- C07K 14/4741: {Keratin; Cytokeratin}
- A61P 29/00: Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
- A61P 31/04: Antibacterial agents
- G01N 33/6893: {related to diseases not provided for elsewhere}
- G01N 2333/4742: Keratin; Cytokeratin
- G01N 2800/26: Infectious diseases, e.g. generalised sepsis
- C07K: PEPTIDES (peptides in foodstuffs A23; obtaining protein compositions for foodstuffs, working-up proteins for foodstuffs A23J; preparations for medicinal purposes A61K; peptides containing beta-lactam rings C07D; cyclic dipeptides not having in their molecule any other peptide link than those which form their ring, e.g. piperazine-2,5-diones, C07D; ergot alkaloids of the cyclic peptide type C07D519/02; macromolecular compounds having statistically distributed amino acid units in their molecules, i.e. when the preparation does not provide for a specific; but for a random sequence of the amino acid units, homopolyamides and block copolyamides derived from amino acids C08G69/00; macromolecular products derived from proteins C08H1/00; preparation of glue or gelatine C09H; single cell proteins, enzymes C12N; genetic engineering processes for obtaining peptides C12N15/00; compositions for measuring or testing processes involving enzymes C12Q; investigation or analysis of biological material G01N33/00)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- G01N: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES (measuring or testing apparatus or processes other than immunoassay, involving enzymes or microorganisms C12M, C12Q)

## Abstract

Use of novel soluble cytokeratin 1 fragments from body fluids or body tissues as marker peptides for the diagnosis, prognosis and monitoring of the course of inflammations and infections and/or as a target for the therapeutic influencing of the course of inflammations and/or infections.

## Claims

### Claim 1

A method for diagnosis of systemic inflammation and/or systemic infection in an animal or patient, comprising testing a biological sample from said animal or patient for the presence of a soluble cytokeratin 1 fragment or soluble cytokeratin 1 fragments, wherein the soluble cytokeratin 1 fragment consists of the amino acid sequence of amino acids 151–510 of the complete amino acid sequence of cytokeratin 1 (SEQ ID NO: 3) or the soluble cytokeratin 1 fragment has a molecular weight, as determined by gel electrophoresis of, 15,700±500 Dalton, has an amino acid sequence comprising amino acids 185–297 (SEQ ID NO: 5) of the complete amino acid sequence of cytokeratin 1 (SEQ ID NO: 3) and one or more additional amino acids at one or both ends of SEQ ID NO: 5 for a total of up to 20 adjacent amino acids of the complete amino acid sequence of cytokeratin 1 and wherein the presence of said fragment or fragments is indicative of the presence of sepsis, sepsis-like systemic inflammation and/or infection.

### Claim 2 (depends on 1)

The method according to claim 1, wherein said biological sample is a biological fluid or a tissue sample.

### Claim 3 (depends on 1)

The method according to claim 1, wherein the soluble cytokeratin 1 fragment has a molecular weight, as determined by gel electrophoresis, of 15,700±500 Dalton, has an amino acid sequence of amino acids 185–297 (SEQ ID NO: 5) and one or more additional amino acids at one or both ends of SEQ ID NO: 5 for a total of up to 20 adjacent amino acids wherein said amino acid sequence corresponds to the complete amino acid sequence of cytokeratin 1 or a sequence of at least 90% identity with the complete amino acid sequence of cytokeratin 1 and wherein said fragment is detectable by an antibody specific for an epitope of a peptide consisting of amino acids 214 to 229 of SEQ ID NO: 3.

### Claim 4 (depends on 1)

The method according to claim 1, wherein the presence of a soluble cytokeratin fragment or soluble cytokeratin fragments is determined by an immunodiagnostic method of determination.

### Claim 5 (depends on 3)

The method according to claim 3, wherein the soluble cytokeratin 1 fragment determined has the amino acid sequence of amino acids 185–297 (SEQ ID NO: 5) of the complete amino acid sequence of cytokeratin 1 (SEQ ID NO: 3) and up to 20 adjacent amino acids of the complete amino acid sequence of cytokeratin 1.

### Claim 6 (depends on 5)

The method according to claim 5, wherein the soluble cytokeratin 1 fragment determined has the amino acid sequence of amino acids 185–297 (SEQ ID NO: 5) of the complete amino acid sequence of cytokeratin 1 (SEQ ID NO: 3).

### Claim 7 (depends on 1)

The method according to claim 1, wherein said soluble cytokeratin 1 fragment or fragments are present at a concentration of at least 3 ng/ml.