# US 11,433,145 B2 · Composition for treating pain

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- Number: US 11,433,145 B2
- Document ID: US11433145B2
- Status: Granted
- Kind: B2
- Application number: 15/754,849
- Filed: 2016-09-20
- Published: 2018-09-06
- Granted: 2022-09-06
- Earliest claimed: 2015-09-21
- Assignees: Kolon Life Science, Inc.
- Applicants: Kolon Life Science, Inc.
- Inventors: Sujeong Kim; Heonsik Choi; Kyoungbaek Choi; Minjung Kim; Hyeonyoul Lee; Minju Kim; Daewook Kim; Min Kim; Jangjoon Park
- Web page: https://patentgrep.com/patent/US11433145B2

## CPC

- A61K 48/005: {characterised by an aspect of the 'active' part of the composition delivered, i.e. the nucleic acid delivered}
- A61K 9/00: Medicinal preparations characterised by special physical form {(nuclear magnetic resonance contrast preparations or magnetic resonance imaging contrast preparations A61K49/18; preparations containing radioactive substances A61K51/12)}
- A61K 38/16: Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof {(enzyme inhibitors A61K38/005)}
- A61K 38/17: from animals; from humans {(enzyme inhibitors A61K38/005)}
- A61K 38/2066: {IL-10}
- A61K 38/51: Lyases (4)
- A61K 47/6901: {Conjugates being cells, cell fragments, viruses, ghosts, red blood cells or viral vectors}
- A61K 48/00: Medicinal preparations containing genetic material which is inserted into cells of the living body to treat genetic diseases; Gene therapy
- A61K 48/0033: {the non-active part being non-polymeric}
- A61P 29/00: Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
- C07K 14/54: Interleukins [IL]
- C12N 9/88: Lyases (4.)
- C12N 15/63: Introduction of foreign genetic material using vectors; Vectors; Use of hosts therefor; Regulation of expression
- 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
- 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)
- C12N: MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA (microbiological testing media C12Q1/00)

## Abstract

The present invention relates to: a composition for alleviating or treating pain, the composition comprising glutamate decarboxylase and a gene coding for an anti-inflammatory cytokine; and a method for alleviating or treating pain by using the composition.

## Claims

### Claim 1

A method for relieving or treating pain in a subject with pain comprising administering a composition to the subject,
wherein the composition comprises
(a) a first vector comprising a gene encoding glutamate decarboxylase (GAD); and
(b) a second vector comprising a gene encoding interleukin-10 (IL-10),
wherein the gene encoding GAD and the gene encoding IL-10 are operably linked to expression control sequences;
wherein the administering the composition relieves the pain, wherein the pain is nociceptive pain, inflammatory pain, or pathological pain; and
wherein the composition is directly administered to a central nervous system of the subject.

### Claim 2 (depends on 1)

The method of claim 1, wherein the pain is neuropathic pain, cancer pain, postoperative pain, trigeminal neuralgia, idiopathic pain, diabetic neuropathic pain, or migraine.

### Claim 3 (depends on 1)

The method of claim 1, wherein the first vector and the second vector are each a viral vector selected from the group consisting of adenovirus, adeno-associated virus (AAV), herpes simplex virus, lentivirus, retrovirus, and poxvirus; and
wherein a ratio of vector genomes (VG) of the first vector per μl of the composition and vector genomes (VG) of the second vector per μl of the composition is 1:1 to 1:50.

### Claim 4 (depends on 1)

The method of claim 1, wherein the GAD is one or more selected from the group consisting of GAD65 and GAD67.

### Claim 5 (depends on 1)

The method of claim 1, wherein the GAD consists of the amino acid sequence of SEQ ID NO: 1 or SEQ ID NO: 4.

### Claim 6 (depends on 1)

The method of claim 1, wherein the gene encoding GAD consists of the nucleotide sequence of SEQ ID NO: 2, SEQ ID NO: 3, or SEQ ID NO: 5.

### Claim 7 (depends on 1)

The method of claim 1, wherein the IL-10 consists of the amino acid sequence of SEQ ID NO: 6 or SEQ ID NO: 9.

### Claim 8 (depends on 1)

The method of claim 1, wherein the gene encoding IL-10 consists of the nucleotide sequence of SEQ ID NO: 7, SEQ ID NO: 8 or SEQ ID NO: 10.

### Claim 9 (depends on 1)

The method of claim 1, wherein the composition further comprises a physiologically acceptable carrier.

### Claim 10 (depends on 1)

The method of claim 1, wherein the composition is suitable for an injection.