# US 8,785,414 B2 · Differentially expressed microRNAs as biomarkers for the diagnosis and treatment of Sjögren's syndrome

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

- Number: US 8,785,414 B2
- Document ID: US8785414B2
- Status: Granted
- Kind: B2
- Application number: 13/262,125
- Filed: 2010-03-31
- Published: 2012-02-02
- Granted: 2014-07-22
- Earliest claimed: 2009-03-31
- Assignees: The United States of America, as represented by the Secretary, Department of Health and Human Services
- Applicants: Ilias Alevizos; Gabor Illei
- Inventors: Ilias Alevizos; Gabor Illei
- Web page: https://patentgrep.com/patent/US8785414B2

## CPC

- C12N 15/113: Non-coding nucleic acids modulating the expression of genes, e.g. antisense oligonucleotides; {Antisense DNA or RNA; Triplex- forming oligonucleotides; Catalytic nucleic acids, e.g. ribozymes; Nucleic acids used in co-suppression or gene silencing (when used in plants C12N15/8218)}
- A61K 31/7105: Natural ribonucleic acids, i.e. containing only riboses attached to adenine, guanine, cytosine or uracil and having 3'-5' phosphodiester links
- A61P 37/00: Drugs for immunological or allergic disorders
- A61P 37/02: Immunomodulators
- C12Q 1/6883: for diseases caused by alterations of genetic material
- C12N 2310/113: targeting other non-coding nucleic acids, e.g. antagomirs
- C12N 2310/14: interfering nucleic acids [NA]
- C12Q 2600/178: miRNA, siRNA or ncRNA
- C12N: MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA (microbiological testing media C12Q1/00)
- 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
- C12Q: MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS (immunoassay G01N33/53); COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES

## Abstract

The identification of differentially expressed microRNAs in patients with Sjögren's syndrome is disclosed herein. Provided is a method of diagnosing a subject as having Sjögren's syndrome by measuring the level of at least one differentially expressed miR gene product identified herein. An alteration in the level of the at least one miR gene product in the biological sample of the subject relative to a control indicates the subject has Sjögren's syndrome. Also provided is a method of treating a patient with Sjögren's syndrome by administering to the patient a therapeutically effective amount of an agent that inhibits expression of a miR gene product that is up-regulated in the patient with Sjögren's syndrome relative to a control, or by administering to the patient a therapeutically effective amount of an isolated miR gene product that is down-regulated in the patient with Sjögren's syndrome relative to a control. A method of restoring salivary flow in a patient with Sjögren's syndrome is also provided.

## Claims

### Claim 1

A method of treating a patient with Sjögren's syndrome, comprising administering to the patient a therapeutically effective amount of an agent that inhibits expression of a miR gene product that is up-regulated in the patient with Sjögren's syndrome relative to a control, or a therapeutically effective amount of an isolated miR gene product that is down-regulated in the patient with Sjögren's syndrome relative to a control, wherein the up-regulated miR gene product is ebv-miR-BART13 and the down-regulated miR gene product is miR-22 or miR-183.

### Claim 2 (depends on 1)

The method of claim 1, wherein the agent that inhibits expression of a miR gene product is an antisense compound specific for the miR gene product.

### Claim 3 (depends on 2)

The method of claim 2, wherein the antisense compound is an antisense oligonucleotide, siRNA or ribozyme.

### Claim 4 (depends on 1)

The method of claim 1, wherein the down-regulated miR gene product is a miR-183 gene product.

### Claim 5 (depends on 1)

The method of claim 1, wherein the treatment comprises restoring salivary flow in the subject with Sjögren's syndrome.

### Claim 6 (depends on 1)

The method of claim 1, wherein the control is a biological sample from a healthy subject.

### Claim 7 (depends on 1)

The method of claim 1, wherein the isolated miR gene product is a mature miR.

### Claim 8 (depends on 1)

The method of claim 1, wherein the isolated miR gene product is a synthetic miR gene product.

### Claim 9 (depends on 1)

The method of claim 1, wherein administering a therapeutically effective amount of the isolated miR gene product comprises administering a vector encoding the miR gene product.

### Claim 10 (depends on 1)

The method of claim 1, wherein the down-regulated miR gene product is a miR-22 gene product.

### Claim 11 (depends on 2)

The method of claim 2, wherein the antisense compound comprises one or more modifications.

### Claim 12 (depends on 11)

The method of claim 11, wherein the one or more modifications comprise a modified internucleoside linkage, a modified sugar moiety, a modified base, or any combination thereof.