# US 5,703,038 A · Therapeutic uses of bactericidal-permeability-increasing protein dimer products

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- Number: US 5,703,038 A
- Document ID: US5703038A
- Status: Granted
- Kind: A
- Application number: 08/470,366
- Filed: 1995-06-06
- Granted: 1997-12-30
- Earliest claimed: 1994-03-11
- Assignees: Xoma Corporation
- Inventors: William Steve Ammons; Roger G. Little
- Web page: https://patentgrep.com/patent/US5703038A

## CPC

- C07K 14/4742: {Bactericidal/Permeability-increasing protein [BPI]}
- A61P 29/00: Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
- A61P 31/04: Antibacterial agents
- A61P 35/00: Antineoplastic agents
- A61K 38/00: Medicinal preparations containing peptides (peptides containing beta-lactam rings A61K31/00; cyclic dipeptides not having in their molecule any other peptide link than those which form their ring, e.g. piperazine-2,5-diones, A61K31/00; ergot alkaloids of the cyclic peptide type A61K31/48; containing macromolecular compounds having statistically distributed amino acid units A61K31/74; medicinal preparations containing antigens or antibodies A61K39/00; medicinal preparations characterised by the non-active ingredients, e.g. peptides as drug carriers, A61K47/00)
- 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
- 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)

## Abstract

Improved therapeutic uses of bactericidal/permeability-increasing protein (BPI) involve use of BPI protein product formulations in the form of physiologically stable dimeric associations of BPI protein product monomers characterized by enhanced in vivo biological activity. Preferred formulations include 50 percent or more by weight dimeric product.

## Claims

### Claim 1

A method of therapeutic use of a bactericidal/permeability-increasing protein product, wherein the improvement comprises advertising to a patent a bactericidal/permeability-increasing protein product formulation containing greater than 50 percent of said product in the form of a stable covalently or non-covalently linked dimeric product characterized by enhanced in vivo biological activity in comparison to the monomeric form of said product.

### Claim 2 (depends on 1)

The improvement of claim 1 wherein said product formulation contains greater than 75 percent dimeric bactericidal/permeability-increasing protein product.

### Claim 3 (depends on 1)

The improvement of claim 1 wherein said product formulation contains greater than 90 percent dimeric bactericidal/permeability-increasing protein product.

### Claim 4 (depends on 1)

The improvement of claim 1 wherein said product formulation contains greater than 95 percent dimeric bactericidal/permeability-increasing protein product.

### Claim 5 (depends on 1)

The improvement of claim 1 wherein the monomeric bactericidal/permeability-increasing protein product is full length bactericidal/permeability-increasing protein.

### Claim 6

A bactericidal/permeability-increasing protein product pharmaceutical composition containing greater than 50 percent of a stable covalently or non-covalently linked dimeric product characterized by an enhanced in vivo biological activity in comparison to the monomeric form of said product and a pharmaceutically acceptable diluent, adjuvant or carrier.

### Claim 7

A bactericidal/permeability-increasing protein product pharmaceutical composition containing greater than 75 percent of a stable covalently or non-covalently linked dimeric product characterized by an enhanced in vivo biological activity in comparison to the monomeric form of said product and a pharmaceutically acceptable diluent, adjuvant or carrier.

### Claim 8

A bactericidal/permeability-increasing protein product pharmaceutical composition containing greater than 90 percent of a stable covalently or non-covalently linked dimeric product characterized by an enhanced in vivo biological activity in comparison to the monomeric form of said product and a pharmaceutically acceptable diluent, adjuvant or carrier.

### Claim 9

A bactericidal/permeability-increasing protein product pharmaceutical composition containing greater than 95 percent of a stable covalently or non-covalently linked dimeric product characterized by an enhanced in vivo biological activity in comparison to the monomeric form of said product and a pharmaceutically acceptable diluent, adjuvant or carrier.
