# US 9,433,662 B2 · Fusion proteins and methods for treating HIV infection and AIDS related symptoms

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- Number: US 9,433,662 B2
- Document ID: US9433662B2
- Status: Granted
- Kind: B2
- Application number: 14/988,341
- Filed: 2016-01-05
- Published: 2016-06-23
- Granted: 2016-09-06
- Earliest claimed: 2016-01-05
- Assignees: Tianjin Xiji Biotechnology Co., Ltd.
- Applicants: Tianjin Xiji Biotechnology Co., Ltd.
- Inventors: Pingfan Rao; Shutao Liu
- Web page: https://patentgrep.com/patent/US9433662B2

## CPC

- A61K 38/446: {Superoxide dismutase (1.15)}
- A61K 9/0031: {Rectum, anus}
- A61K 9/006: {Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays}
- A61K 31/506: not condensed and containing further heterocyclic rings
- A61K 31/536: ortho- or peri-condensed with carbocyclic ring systems
- A61K 31/7072: having two oxo groups directly attached to the pyrimidine ring, e.g. uridine, uridylic acid, thymidine, zidovudine
- A61K 38/08: Peptides having 5 to 11 amino acids {(A61K38/043 - A61K38/046 take precedence)}
- A61K 38/45: Transferases (2)
- A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
- A61K 47/67: {Enzyme prodrug therapy, e.g. gene directed enzyme drug therapy [GDEPT] or VDEPT}
- A61P 31/18: for HIV
- B82Y 5/00: Nanobiotechnology or nanomedicine, e.g. protein engineering or drug delivery
- C07K 7/06: having 5 to 11 amino acids
- C07K 14/4711: {Alzheimer's disease; Amyloid plaque core protein}
- C12N 9/0089: {acting on superoxide as acceptor (1.15)}
- C12N 9/1088: {Glutathione transferase (2.5.1.18)}
- C12Y 115/01001: Superoxide dismutase (1.15.1.1)
- C12Y 205/01018: Glutathione transferase (2.5.1.18)
- C07K 2319/03: containing a transmembrane segment
- C07K 2319/036: targeting to the medium outside of the cell, e.g. type III secretion
- 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
- B82Y: SPECIFIC USES OR APPLICATIONS OF NANOSTRUCTURES; MEASUREMENT OR ANALYSIS OF NANOSTRUCTURES; MANUFACTURE OR TREATMENT OF NANOSTRUCTURES
- 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)
- C12Y: ENZYMES

## Abstract

Pharmaceutical compositions and methods for using a fusion protein having a superoxide dismutase and a transit peptide are described. Pharmaceutical compositions and methods for using the fusion protein in combination with other antiretroviral agents for treating patients with AIDS or HTV infection are also described.

## Claims

### Claim 1

A fusion protein comprising the amino acid sequence of SEQ ID NO: 2.

### Claim 2 (depends on 1)

A pharmaceutical composition comprising the fusion protein of claim 1 in a pharmaceutically acceptable carrier.

### Claim 3 (depends on 2)

A kit comprising the pharmaceutical composition of claim 2.

### Claim 4

A method for treating or inhibiting a Human Immunodeficiency Virus (HIV) infection, or treating or inhibiting Acquired Human Immunodeficiency Syndrome (AIDS), in a human patient, comprising: administering to the human patient a therapeutically effective amount of a fusion protein, or a pharmaceutical composition thereof, wherein the fusion protein comprises the amino acid sequence of SEQ ID NO: 2.

### Claim 5 (depends on 4)

The method of claim 4, wherein the human patient treated with the fusion protein or pharmaceutical composition shows, as compared to the untreated human patient, a decrease in HIV RNA production and CD4− T cell depletion.

### Claim 6 (depends on 4)

The method of claim 4, wherein the fusion protein or the pharmaceutical composition thereof is administered to the human patient in a pharmaceutically acceptable carrier by an oral, buccal, sublingual, rectal or parenteral route.

### Claim 7 (depends on 4)

The method of claim 4 further comprising administering a therapeutically effective amount of at least one other antiretroviral agent used for treatment of AIDS or HIV infection selected from the group consisting of nucleoside HIV reverse transcriptase inhibitors, non-nucleoside HIV reverse transcriptase inhibitors and HIV protease inhibitors, wherein the dosage range of the fusion protein is 0.01-10.00 MU (million units of superoxide dismutase (SOD) activity).

### Claim 8 (depends on 4)

The method of claim 4, wherein the human patient is resistant to antiretroviral therapy (ART).

### Claim 9 (depends on 4)

The method of claim 4, wherein the fusion protein, or the pharmaceutical composition thereof is administrated together with highly active antiretroviral therapy (HAART).