Methods and compositions for the treatment of influenza

• US 9,511,125 B2
• Filed: 10/21/2010
• Issued: 12/06/2016
• Est. Priority Date: 10/21/2009
• Status: Active Grant

• Current Assignee: Curemark LLC
• Original Assignee: Curemark LLC
• Inventors: Fallon, Joan M., Heil, Matthew F., Fallon, James J., Szigethy, James
• Primary Examiner(s): Claytor, Renee
• Assistant Examiner(s): Papciak, Sharon M
• Application Number:
  US13/502,989
• Publication Number:
  US 20120258149A1
• Time in Patent Office: 2,238 Days
• US Class Current: 1/1
• CPC Class Codes: A61K 2039/5252 inactivated (killed)
• CPC Class Codes: A61K 2039/5254 avirulent or attenuated
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 38/465 acting on ester bonds (3.1), e.g. lipases, ribonucleases
• CPC Class Codes: A61K 38/47 acting on glycosyl compounds (3.2), e.g. cellulases, lactases
• CPC Class Codes: A61K 38/4826 Trypsin (3.4.21.4) Chymotrypsin (3.4.21.1)
• CPC Class Codes: A61K 38/4873 Cysteine endopeptidases (3.4.22), e.g. stem bromelain, papain, ficin, cathepsin H
• CPC Class Codes: A61K 38/54 Mixtures of enzymes or proenzymes covered by more than a single one of groups A61K38/44 - A61K38/46 or A61K38/51 - A61K38/53
• CPC Class Codes: A61K 39/145 Orthomyxoviridae, e.g. influenza virus
• CPC Class Codes: A61K 9/0014 Skin, i.e. galenical aspects of topical compositions non-active ingredients are additionally classified in A61K47/00; A61K9/0009, A61K9/0021, A61K9/7015, A61K9/7023 take precedence; cosmetic preparations A61K8/00, A61Q; preparations for wound dressings or bandages A61L26/00
• CPC Class Codes: A61K 9/0053 Mouth and digestive tract, i.e. intraoral and peroral administration rectal administration A61K9/0031
• CPC Class Codes: A61P 31/16 for influenza or rhinoviruses
• CPC Class Codes: C12N 2760/16134 Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein
• CPC Class Codes: C12N 7/00 Viruses; Bacteriophages; Compositions thereof; Preparation or purification thereof preparing medicinal viral antigen or antibody compositions, e.g. virus vaccines, A61K39/00

Abstract

A method to treat Influenza, and more particularly Influenza A Virus Subtype H1N1, with the use of a pharmaceutical composition comprising one or more digestive enzymes, such as pancreatic enzymes and porcine pancreatic enzymes, is disclosed. The method includes the use of an individual'"'"'s fecal chymotrypsin level as an indicator e.g., biomarker of whether an individual may be more susceptible to Influenza, e.g., Influenza A Subtype H1N1, and/or whether an individual will benefit from administration of the described pharmaceutical compositions. Use of the compositions as sanitizers, antiseptics, disinfectants, and detergents, e.g., to reduce or eradicate influenza virus present on living or inanimate surfaces is also contemplated.

Claims

1. A method for treating Influenza in a mammal or a bird, comprising orally administering to the mammal or bird suffering from said influenza a therapeutically effective amount of a pharmaceutical composition containing a sole bioactive substance that consists of digestive enzymes wherein the digestive enzymes comprise at least one protease and at least one lipase, wherein the protease and lipase in the pharmaceutical composition in U.S.P. units are present in a ratio of protease to lipase of from about 1:

1 to about 20;

1, and wherein influenza is treated by said composition.

2. The method of claim 1, wherein the Influenza is Influenza Type A or Subtype H1N1.

3. The method of claim 1, wherein the digestive enzymes further comprise at least one amylase, cellulase, sucrase or maltase.

4. The method of claim 1, wherein the digestive enzymes are pancreatin.

5. The method of claim 1, wherein the at least one protease comprises chymotrypsin and trypsin.

6. The method of claim 1, wherein the digestive enzymes are, independently, derived from an animal source, a microbial source, a fungal source, or are synthetically prepared.

7. The method of claim 6, where the animal source is a pig pancreas.

8. The method of claim 1, wherein the mammal is a pig, horse, cow, dog, cat, monkey, rat, mouse, sheep, goat or human.

9. The method of claim 1, wherein the digestive enzymes further comprise at least one amylase.

10. The method of claim 9, wherein the pharmaceutical composition comprises:

amylase from about 10,000 to about 60,000 in U.S.P., units protease from about 10,000 to about 70,000 in U.S.P., units lipase from about 4,000 to about 30,000 U.S.P., chymotrypsin from about 2 to about 5 mg, and trypsin from about 60 to about 100 mg.

11. The method of claim 9, wherein the at least one amylase of the pharmaceutical composition is present in the pharmaceutical composition in an amount of from about 10,000 to about 60,000 U.S.P. units per dose.

12. The method of claim 1, further comprising vaccinating the mammal or bird with a trivalent inactivated influenza vaccine (TIV) or live attenuated influenza vaccine (LAIV), treating the mammal or bird with an anti-viral medication, or both.

13. The method of claim 1, wherein the protease and lipase in the pharmaceutical composition in U.S.P. units are present in a ratio of protease to lipase of from about 4:

1 to about 10;

1.

14. The method of claim 1, wherein the pharmaceutical composition is a dosage formulation selected from the group consisting of:

a pill, a tablet, a capsule, a microcapsule, a mini-capsule, a time released capsule, a mini-tab, a sprinkle, and a combination thereof.

15. The method of claim 1, wherein the at least one protease of the pharmaceutical composition is present in the pharmaceutical composition in an amount of from about 10,000 to about 70,000 U.S.P. units per dose.

16. The method of claim 1, wherein the at least one lipase of the pharmaceutical composition is present in the pharmaceutical composition in an amount of from about 4,000 to about 30,000 U.S.P. units per dose.

17. The method of claim 1, wherein the protease activity of the composition is not less than about 156 U.S.P. units/mg.

18. The method of claim 1, wherein the protease activity of the composition is not less than about 175 U.S.P. units/mg.

19. The method of claim 1, wherein the protease activity of the composition is not less than about 195 U.S.P. units/mg.

20. The method of claim 1, wherein the protease and lipase in the pharmaceutical composition in U.S.P. units are present in a ratio of protease to lipase of 4:

1, 7;

1, 10;

1 or 12;

1.