# US 8,043,624 B2 · Compositions and methods for treatment of microbial infections

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- Number: US 8,043,624 B2
- Document ID: US8043624B2
- Status: Granted
- Kind: B2
- Application number: 11/986,715
- Filed: 2007-11-26
- Published: 2010-01-07
- Granted: 2011-10-25
- Earliest claimed: 2002-02-13
- Assignees: Immunology Laboratories, Inc.
- Inventors: Jiri Pillich; John C. Balcarek
- Web page: https://patentgrep.com/patent/US8043624B2

## CPC

- A61K 39/085: Staphylococcus
- A61K 9/0019: {Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner (non-active ingredients are additionally classified in A61K47/00)}
- A61K 35/741: Probiotics (probiotic yeast, e.g. saccharomyces A61K36/06)
- A61K 39/02: Bacterial antigens
- A61K 39/0266: {Klebsiella}
- A61K 39/092: {Streptococcus}
- A61K 39/104: {Pseudomonadales, e.g.} Pseudomonas
- A61K 39/12: Viral antigens
- A61P 9/00: Drugs for disorders of the cardiovascular system
- A61P 11/00: Drugs for disorders of the respiratory system
- A61P 11/06: Antiasthmatics
- A61P 17/02: for treating wounds, ulcers, burns, scars, keloids, or the like
- A61P 19/00: Drugs for skeletal disorders
- A61P 19/02: for joint disorders, e.g. arthritis, arthrosis
- A61P 29/00: Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
- A61P 31/00: Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P 31/04: Antibacterial agents
- A61P 37/04: Immunostimulants
- C12N 1/205: Bacterial isolates
- C12N 7/00: Viruses; Bacteriophages; Compositions thereof; Preparation or purification thereof (preparing medicinal viral antigen or antibody compositions, e.g. virus vaccines, A61K39/00)
- C12P 1/04: by using bacteria
- A61K 2039/521: {inactivated (killed)}
- A61K 2039/54: {characterised by the route of administration}
- A61K 2039/543: {intranasal}
- A61K 2039/545: {characterised by the dose, timing or administration schedule}
- A61K 2039/57: {characterised by the type of response, e.g. Th1, Th2}
- A61K 2039/58: {raising an immune response against a target which is not the antigen used for immunisation}
- C12N 2795/00011: Details
- C12N 2795/00034: Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein
- C12N 2795/00071: Demonstrated in vivo effect
- C12R 2001/22: Klebsiella
- C12R 2001/385: Pseudomonas aeruginosa
- C12R 2001/445: Staphylococcus aureus
- 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
- C12N: MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA (microbiological testing media C12Q1/00)
- C12P: FERMENTATION OR ENZYME-USING PROCESSES TO SYNTHESISE A DESIRED CHEMICAL COMPOUND OR COMPOSITION OR TO SEPARATE OPTICAL ISOMERS FROM A RACEMIC MIXTURE {(brewing of beer C12C; producing vinegar C12J; producing specific peptides or proteins C07K; producing enzymes C12N9/00; DNA or RNA concerning genetic engineering, vectors, e.g. plasmids, or their isolation, preparation or purification C12N15/00; measuring or testing processes involving enzymes or microorganisms C12Q; measuring or testing processes involving nucleic acid amplification reactions C12Q1/6844; fermentation processes to form a food composition, A21 or A23; compounds in general, see the relevant compound class, e.g. C01, C07)}
- C12R: INDEXING SCHEME ASSOCIATED WITH SUBCLASSES C12C - C12Q, RELATING TO MICROORGANISMS

## Abstract

The present invention relates to methods and compositions for treatment of microbial infections and for the enhancement of resistance to infection. The invention comprises administration of an effective amount of a protein isolated from bacterial lysate compositions for the treatment of pathological conditions of microbial infections. The present invention can also be used to enhance the immune system to prevent infections by the administration of an effective amount of the compositions.

## Claims

### Claim 1

A method of treating pathological conditions resulting from a Staphylococcus aureus (S. aureus) infection in humans or animals, comprising, administering to a human or animal having said pathological condition, a composition comprising at least one phage capsid protein isolated from a bacterial lysate derived from the infection of at least one bacterial strain of S. aureus, deposited with the Czech Collection of Microorganisms (CCM) under accession number CCM 4992 with at least one bacteriophage deposited with the Deutsche Sammlung von Mikroorganismen and Zellkulturen GmBH (DSM) having accession number DSM 14614, DSM 14615, or DSM 14616 and wherein the phage capsid protein has a molecular weight of 50 kDa.

### Claim 2 (depends on 1)

The method of claim 1, wherein the composition is administered subcutaneously, intradermally, intramuscularly, nasally, or parenterally.

### Claim 3 (depends on 1)

The method of claim 1, wherein the pathological condition is chronic upper respiratory disease, mastitis, wound infection, osteomyelitis, endocarditis, skin polymicrobial infections, bronchial asthma, chronic sinusitis, cystic fibrosis or acne vulgaris.

### Claim 4 (depends on 1)

The method of claim 1, further comprising a bacterial lysate derived from at least one bacterial strain deposited with the CCM under accession number CCM 4992, CCM 4993, CCM 4994, CCM 4995, CCM 4996, CCM 4997, or CCM 4998.

### Claim 5 (depends on 1)

The method of claim 1, further comprising one or more antigenic protein that is a phage major tail sheath protein, a S. aureus enolase enzyme, fructose-bisphosphate aldolase of S. aureus, S. aureus phosphoenolpyruvate-protein, S. aureus putative transport system binding lipoprotein, S. aureus elongation factor Ts, phage proteins ORF 45, ORF 57, ORF 95, and phage putative bacteriophage baseplate protein, S. aureus 30S ribosomal protein S2, S. aureus 50S ribosomal protein Ll, S. aureus ABC (periplasmic amino acid-binding protein) transporter, S. aureus triosephosphate isomerase, or phage proteins ORF 95 or ORF 55, or combinations thereof.

### Claim 6

A method of preventing a Staphylococcus aureus (S. aureus) infection or pathological conditions resulting from said S. aureus infection comprising administering to a human or animal a composition comprising at least one phage capsid protein isolated from a bacterial lysate derived from the infection of at least one bacterial strain of S. aureus deposited with the Czech Collection of Microorganisms (CCM) under accession number CCM 4992 with a bacteriophage deposited with the Deutsche Sammlung von Mikroorganismen and Zellkulturen GmBH (DSM) having accession number DSM 14614, DSM 14615, or DSM 14616 and wherein the phage capsid protein has a molecular weight of 50 kDa.

### Claim 7 (depends on 6)

The method of claim 6, further comprising a lysate derived from a S. aureus bacterial strain deposited with the CCM under accession number CCM 4992, CCM 4993, CCM 4994, CCM 4995, CCM 4996, CCM 4997, or CCM 4998.

### Claim 8 (depends on 6)

The method of claim 6, wherein the composition is administered subcutaneously, intradermally, intramuscularly, nasally, or parenterally.

### Claim 9 (depends on 6)

The method of claim 6, further comprising one or more antigenic protein that is a phage major tail sheath protein, a S. aureus enolase enzyme, fructosebisphosphate aldolase of S. aureus, S. aureus phosphoenolpyruvate-protein, S. aureus putative transport system binding lipoprotein, S. aureus elongation factor Ts, phage proteins ORF 45, ORF 57, ORF 95, and phage putative bacteriophage baseplate protein, S. aureus 30S ribosomal protein S2, S. aureus 50S ribosomal protein Ll, S. aureus ABC (periplasmic amino acid-binding protein) transporter, S. aureus triosephosphate isomerase, or phage proteins ORF 95 or ORF 55, or combinations thereof.