Bacteriophage preparations and methods of use thereof

Patent metadata

Field	Value
Publication number	US-9404089-B2
Application number	US-201414121412-A
Country	US
Kind code	B2
Filing date	Sep 2, 2014
Priority date	Dec 13, 2007
Publication date	Aug 2, 2016
Grant date	Aug 2, 2016

Abstract

Disclosed herein are purified bacteriophage preparations that effectively lyse a plurality of C. perfringens strains. In one embodiment, a purified bacteriophage preparation includes four or more C. perfringens -specific bacteriophage, wherein each bacteriophage has lytic activity against at least five Clostridium species strains. In another embodiment, the purified bacteriophage preparation includes five or more C. perfringens -specific bacteriophage.

First claim

The invention claimed is:

1. A method of reducing chicken mortality due to C. perfringens infections comprising administering a purified bacteriophage preparation comprising CPAS-12 (accession number PTA-8479), CPAS-15 (accession number PTA-8480), CPAS-16 (accession number PTA-8481) and CPLV-42 (accession number PTA-8483) wherein each bacteriophage has lytic activity against at least five C. perfringens strains which cause necrotic enteritis in poultry.

2. The method of claim 1 , wherein the at least five C. perfringens strains comprise ATCC strain 3624 and ATCC strain 9856.

3. The method of claim 1 , wherein the C. perfringens strains comprise at least five of ATCC strain 25768, ATCC strain 3624, ATCC strain 9856, ATCC strain 3628, ATCC strain 13124, ATCC strain PTA-8495, NRRL strain B-50143, NRRL strain B-50144, NRRL strain B-50145, or a combination thereof.

4. The method of claim 1 , wherein the preparation has lytic activity against ATCC strain 25768, ATCC strain 3624, ATCC strain 9856, ATCC strain 3628, ATCC strain 13124, ATCC strain PTA-8495, NRRL strain B-50143, NRRL strain B-50144, NRRL strain B-50145.

5. The method of claim 4 , wherein the bacteriophage preparation is incapable of infecting at least ten strains of E. coli, L. monocytogenes, S. enterica , and P. aeruginosa.

6. A method of, reducing chicken mortality due to C. perfringens infections comprising administering a purified bacteriophage preparation comprising CPAS-12 (accession number PTA-8479), CPAS-15 (accession number PTA-8480), CPAS-16 (accession number PTA-8481), CPLV-42 (accession number PTA-8483) and CPAS-7 (accession number PTA-8482, wherein each bacteriophage has lytic activity against at least five C. perfringens strains which cause necrotic enteritis in poultry.

7. The method of claim 6 , wherein the at least five C. perfringens strains comprise ATCC strain 3624 and ATCC strain 9856.

8. The method of claim 6 , wherein the C. perfringens strains comprise at least five of ATCC strain 25768, ATCC strain 3624, ATCC strain 9856, ATCC strain 3628, ATCC strain 13124, ATCC strain PTA-8495, NRRL strain B-50143, NRRL strain B-50144, NRRL strain B-50145, or a combination thereof.

9. The method of claim 6 , wherein the preparation has lytic activity against ATCC strain 25768, ATCC strain 3624, ATCC strain 9856, ATCC strain 3628, ATCC strain 13124, ATCC strain PTA-8495, NRRL strain B-50143, NRRL strain B-50144, NRRL strain B-50145.

10. The method of claim 9 , wherein the bacteriophage preparation is incapable of infecting at least ten strains of E. coli, L. monocytogenes, S. enterica , and P. aeruginosa.

11. The method of claim 1 , wherein the bacteriophage preparation lyses greater than or equal to 85% of at least 40 screened C. perfringens strains, and wherein the bacteriophage preparation is incapable of infecting at least ten strains of E. coli, L. monocytogenes, S. enterica , and P. aeruginosa.

12. The method of claim 11 , wherein the bacteriophage preparation lyses greater than or equal to 85% of at least 45 screened C. perfringens strains.

13. The method of claim 12 , wherein each of the individual C. perfringens -specific bacteriophage lyses 15% to 90% of the screened C. perfringens strains.

14. The method of claim 1 , further comprising a pharmaceutically acceptable excipient.

15. The method of claim 14 , wherein the pharmaceutically acceptable excipient is a water-conditioning agent.

16. The method of claim 15 , wherein the water-conditioning agent is a 50 mM citrate-phosphate-thiosulfate buffer comprising about 40 mg sodium thiosulfate, 6.0 gm disodium phosphate (anhydrous), 1.1 gm citric acid (anhydrous) per liter of deionized water, pH 7.0, added at a 1:10 or greater ratio.

17. The method of claim 16 , wherein the administration of the purified bacteriophage preparation comprises administration in water at temperatures of up to 50° C.

Assignees

• Zoetis Services Llc
• Zoctis Services LLC
• Intrlytix Inc

Inventors

• Mathers Jeremy
• Sulakvelidze Alexander

Classifications

• A61K35/76

  Viruses; Subviral particles; Bacteriophages · CPC title

• C12N2795/00032

  Use of virus as therapeutic agent, other than vaccine, e.g. as cytolytic agent · CPC title

• C12N2795/00051

  Methods of production or purification of viral material · CPC title

• C12N7/00 Primary

  Viruses; Bacteriophages; Compositions thereof; Preparation or purification thereof (preparing medicinal viral antigen or antibody compositions, e.g. virus vaccines, A61K39/00) · CPC title

• Y02A50/30

  Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change · CPC title