# US 8,388,946 B2 · Bacteriophage-containing therapeutic agents > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 8,388,946 B2 - Document ID: US8388946B2 - Status: Granted - Kind: B2 - Application number: 13/333,684 - Filed: 2011-12-21 - Published: 2012-05-10 - Granted: 2013-03-05 - Earliest claimed: 2003-07-23 - Assignees: Biocontrol Limited - Applicants: James Soothill; Catherine Hawkins; David Harper - Inventors: James Soothill; Catherine Hawkins; David Harper - Web page: https://patentgrep.com/patent/US8388946B2 ## CPC - A61K 35/76: Viruses; Subviral particles; Bacteriophages - A61K 31/424: condensed with heterocyclic ring systems, e.g. clavulanic acid - A61K 31/43: Compounds containing 4-thia-1-azabicyclo [3.2.0] heptane ring systems, i.e. compounds containing a ring system of the formula [IMAGE cpc-sch-A61K-0952.gif], e.g. penicillins, penems - A61K 38/51: Lyases (4) - A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca - A61P 11/00: Drugs for disorders of the respiratory system - A61P 17/02: for treating wounds, ulcers, burns, scars, keloids, or the like - A61P 27/02: Ophthalmic agents - A61P 27/04: Artificial tears; Irrigation solutions - A61P 27/16: Otologicals - A61P 31/00: Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics - A61P 31/04: Antibacterial agents - A61P 43/00: Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00 - 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 14/21: from Pseudomonadaceae (F) - C07K 16/1214: Pseudomonadaceae (F) - C12N 2795/00031: Uses of virus other than therapeutic or vaccine, e.g. disinfectant - C12N 2795/00032: Use of virus as therapeutic agent, other than vaccine, e.g. as cytolytic agent - 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 in its broadest aspect to combined phage/antibiotic therapy. More particularly, it relates to use of (i) one or more bacteriophages and (ii) one or more antibiotics in the manufacture of a combined product for simultaneous, separate or sequential administration of (i) and (ii) to treat a bacterial infection characterized by biofilm formation, for example an infection comprising or consisting of P. aeruginosa. Treatment in this context may be either therapeutic or prophylactic treatment. Also provided are deposited bacteriophages each exhibiting different strain specificity against P. aeruginosa and combinations of such bacteriophages, e.g. a panel of six deposited bacteriophages which was found to be effective against a high percentage of clinical isolates of P. aeruginosa from canine ear infections. ## Claims ### Claim 1 A method of treatment of a bacterial infection characterized by biofilm formation, wherein the bacterial infection comprises Pseudomonas aeruginosa, and wherein the method comprises: (a) administering to a human or non-human animal in need thereof one or more bacteriophage preparations comprising one or more bacteriophages, wherein said bacteriophages target and kill Pseudomonas aeruginosa present in the biofilm; and (b) administering one or more antibiotics active against a bacterial species present in the biofilm, at least one day after administration of said one or more bacteriophages, wherein said one or more antibiotics is administered after the bacteriophages have commenced replication in a targeted Pseudomonas aeruginosa present in the biofilm. ### Claim 2 (depends on 1) The method according to claim 1, wherein the one or more bacteriophages are employed in the form of a single combined preparation. ### Claim 3 (depends on 1) The method according to claim 1, wherein the bacteriophage preparation comprises a plurality of bacteriophages capable of infecting the Pseudomonas aeruginosa, each member of said plurality of bacteriophages having a different strain specificity. ### Claim 4 (depends on 1) The method according to claim 1, wherein the infection is selected from the group consisting of an infection of a skin burn or other skin wound, a lung infection, an ocular infection, an ear infection, a urinary infection and an infection associated with a medical device or implant. ### Claim 5 (depends on 4) The method according to claim 4, wherein said infection is a canine ear infection. ### Claim 6 (depends on 1) The method according to claim 1, further comprising administering an alginase. ### Claim 7 (depends on 6) The method according to claim 6, wherein the alginase is administered in combination with the administering of the one or more bacteriophages. ### Claim 8 (depends on 1) The method according to claim 1, wherein the one or more bacteriophage preparations are administered as a contact lens solution or additive. ### Claim 9 A method of treatment for a Pseudomonas aeruginosa bacterial infection, comprising: (a) administering to a subject in need thereof a bacteriophage, wherein the bacteriophage kills Pseudomonas aeruginosa present in a biofilm; and, (b) administering an antibiotic, wherein the administering of the antibiotic is at least one day after the administrating of the bacteriophage. ### Claim 10 (depends on 9) The method according to claim 9, wherein the administering of a bacteriophage comprises administering a plurality of bacteriophages capable of infecting the Pseudomonas aeruginosa present in the biofilm, each member of said plurality of bacteriophages having a different strain specificity. ### Claim 11 (depends on 10) The method according to claim 10, wherein the bacteriophages are employed in the form of a single combined preparation. ### Claim 12 (depends on 9) The method according to claim 9, wherein the infection is selected from the group consisting of an infection of a skin burn or other skin wound, a lung infection, an ocular infection, an ear infection, a urinary infection and an infection associated with a medical device or implant. ### Claim 13 (depends on 12) The method according to claim 12, wherein the infection is a canine ear infection. ### Claim 14 (depends on 9) The method according to claim 9, further comprising administering an alginase. ### Claim 15 (depends on 14) The method according to claim 14, wherein the alginase is administered in combination with the administering of the bacteriophage. ### Claim 16 (depends on 9) The method according to claim 9, wherein the subject is a mammal. ### Claim 17 (depends on 16) The method according to claim 16, wherein the mammal is a human. ### Claim 18 (depends on 9) The method according to claim 9, wherein the bacteriophage is administered as a contact lens solution or additive.