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Last Updated: March 29, 2024

Claims for Patent: 9,987,337


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Summary for Patent: 9,987,337
Title:Compositions and methods comprising serratia peptidase for inhibition and treatment of biofilms related to certain conditions
Abstract: Physiologically acceptable anti-biofilm compositions comprising Serratia peptidase and optionally one or more of bromelain, papain and a fibrinolytic enzyme. Additional components can include antimicrobials, antibiotics, antifungals, herbals, chelating agents, lactoferrin and related compounds, minerals, surfactants, binders, and fillers useful for the inhibition and treatment of gastrointestinal biofilms in humans. Physiologically acceptable anti-biofilm compositions containing these enzymes are useful in the inhibition, reduction and/or treatment of biofilms such as in the ear, vagina, joints, bones, gut, surgical sites and other locations, and are useful for the inhibition, reduction and/or treatment of associated systemic symptoms caused by biofilm associated microorganisms.
Inventor(s): Olmstead; Stephen Francis (Reno, NV)
Assignee: PROTHERA, INC. (Reno, NV)
Application Number:13/072,602
Patent Claims:1. A method of inhibiting a biofilm infection on a mucosal surface in a mammal, the method comprising: identifying the presence of the biofilm infection on a mucosal surface, further identifying the presence of at least one of Clostridium ssp, Klebsiella ssp, Pseudomonas ssp, Bacteroides ssp, Enterococcus ssp, Campylobacter ssp, Bacillus ssp, Yersinia ssp, Brucella ssp, Salmonella ssp, Shigella ssp, Fusobacterium ssp, Spirochaetes ssp, Entamoeba ssp, Candida ssp, Escherichia coli, Vibrio cholerae, Staphylococcus ssp, Streptococcus ssp, Hemophilus ssp, Aspergillus ssp and Gardnerella ssp in the mammal, and orally administering to the mammal a therapeutically effective amount of an enterically coated composition comprising at least one pharmaceutically acceptable carrier; Serratia peptidase; and an enzyme selected from the group consisting of bromelain, papain, nattokinase and lumbrokinase in an amount and for a time sufficient to cause reduction of said biofilm infection and a reduction of said Clostridium ssp, Klebsiella ssp, Pseudomonas ssp, Bacteroides ssp, Enterococcus ssp, Campylobacter ssp, Bacillus ssp, Yersinia ssp, Brucella ssp, Salmonella ssp, Shigella ssp, Fusobacterium ssp, Spirochaetes ssp, Entamoeba ssp, Candida ssp, Escherichia coli, Vibrio cholerae, Staphylococcus ssp, Streptococcus ssp, Hemophilus ssp, Aspergillus ssp and Gardnerella ssp on the mucosal surface within the mammal; said biofilm infection being characterized by microbial cells growing on a surface and enclosed in a matrix of extracellular polymeric material, which mediates adhesion of the cells to each other and to surfaces; and wherein said biofilm infection is selected from the group consisting of bacterial vaginosis, bacterial vaginitis, fungal vaginitis, chronic prostatitis and pathogenic gastrointestinal infections.

2. The method of claim 1, wherein the method further comprises administering at least one of lactoferrin and a chelating agent in an amount and for a time sufficient to cause significant biofilm reduction on the mucosal surface within the mammal.

3. The method of claim 1, wherein the method further comprises administering at least one of an anti-biofilm on a mucosal surface acid-stable cellulase or an anti-biofilm on a mucosal surface anti-polymeric .beta.-1,6-N-acetyl-D-glucosamine (poly-.beta.-1,6-GlcNAc) agent in an amount and for a time sufficient to cause significant biofilm reduction on the mucosal surface within the mammal.

4. The method of claim 1, wherein the method further comprises administering at least one of an acid-stable hemicellulase/pectinase complex, .beta.-gluconase, acid protease, or alkaline protease in an amount and for a time sufficient to cause significant biofilm reduction on the mucosal surface within the mammal.

5. The method of claim 1, wherein the method further comprises administering at least one an acid-stable agent in an amount and for a time sufficient to cause significant biofilm reduction on the mucosal surface within the mammal, the at least one agent selected from the following: a disaccharidase; amylase; .alpha.-amylase; .beta.-amylase; gluco-amylase; endoglucanase; xylanase; lipase; lysozyme; an enzyme with dipeptidyl peptidase IV (DPP-IV) activity; chitosanase; ficin; kiwi protease; any plant-derived protease or proteinase, or phytase.

6. The method of claim 1, wherein the method further comprises administering at least one an acid-stable enzyme in an amount and for a time sufficient to cause significant biofilm reduction on the mucosal surface within the mammal, the at least one enzyme selected from the following: 1,2-1,3-.alpha.-D-mannan mannohydrolase, 1,3-.beta.-D-xylan-xylanohydrolase, 1,3-.beta.-D-glucan glucanohydrolase, 1,3(1,3;1,4)-.alpha.-D-glucan 3-glucanohydrolase, 1,3(1,3;1,4)-.beta.-D-glucan 3(4)-glucanohydrolase, 1,3-1,4-.alpha.-D-glucan 4-glucanohydrolase, 1,4-.alpha.-D-glucan glucanehydrolase, 1,4-.alpha.-D-glucan glucohydrolase, 1,4-(1,3:1,4)-.beta.-D-glucan 4-glucanohydrolase, 1,4-.beta.-D-glucan glucohydrolase, 1,4-.beta.-D-xylan xylanohydrolase, 1,4-.beta.-D-mannan mannanohydrolase, 1,5-.alpha.-L-arabinanohydrolase, 1,4-.alpha.-D-glucan maltohydrolase, 1,6-.alpha.-D-glucan 6-glucanohydrolase, 2,6-.beta.-fructan fructanohydrolase, .alpha.-dextrin 6-glucanohydrolase, .alpha.-D-galactoside galactohydrolase, .alpha.-D-glucoside glucohydrolase, .alpha.-D-mannoside mannohydrolase, acylneuraminyl hydrolase, Aerobacter-capsular-polysaccharide galactohydrolase, .beta.-D-fructo-furanoside fructohydrolase, .beta.-D-fucoside fucohydrolase, .alpha.-D-fructan fructohydrolase, .beta.-D-galactoside galactohydrolase, .beta.-D-glucoside glucohydrolase, .beta.-D-glucuronoside, glucuronoso-hydrolase, .beta.-D-mannoside manno-hydrolase, .beta.-N-acetyl-D-hexosaminide N-acetylhexosamino hydrolase, cellulose-sulfate sulfohydrolase, collagenase, dextrin 6-.alpha.-D-glucanohydrolase, glyco-protein-phosphatidylinositol phosphatidohydrolase, hyaluronate 4-glycanohydrolase, hyalurono-glucuronidase, pectin pectyl-hydrolase, peptidoglycan N-acetylmuramoylhydrolase, phosphatidylcholine 2-acylhydrolase, phosphatidylcholine 1-acylhydrolase, poly(1,4-.alpha.-D-galacturonide), poly(1,4-(N-acetyl-.beta.-D-glucosaminide))-glycanohydrolase, proteases, sucrose .alpha.-glucosidase, triacylglycerol acyl-hydrolase, and triacylglycerol protein-acyl hydrolase.

7. The method of claim 1, wherein the method further comprises administering at least one of an acid-stable subtilisin and an acid-stable DNAse I in an amount and for a time sufficient to cause significant biofilm reduction on the mucosal surface within the mammal.

8. The method of claim 1, wherein the method further comprises administering a lactoferrin peptide in an amount and for a time sufficient to cause significant biofilm reduction on the mucosal surface within the mammal.

9. The method of claim 1, wherein the method further comprises administering a green tea extract in an amount and for a time sufficient to cause significant biofilm reduction on the mucosal surface within the mammal.

10. The method of claim 1, wherein the method further comprises administering in an amount and for a time sufficient to cause significant biofilm reduction on the mucosal surface within the mammal, a chelating agent selected from the group consisting of ethylenediamine-N,N,N',N'-tetraacetic acid (EDTA); the disodium, trisodium, tetrasodium, dipotassium, tripotassium, dilithium and diammonium salts of EDTA; the barium, calcium, cobalt, copper, dysprosium, europium, iron, indium, lanthanum, magnesium, manganese, nickel, samarium, strontium, and zinc chelates of EDTA; trans-1,2-diaminocyclohexane-N,N,N',N'-tetraacetic acid monohydrate; N,N-bis(2-hydroxyethyl)glycine; 1,3-diamino-2-hydroxy-propane-N,N,N',N'-tetra-acetic acid; 1,3-diaminopropane-N,N,N',N'-tetraacetic acid; ethylene-diamine-N,N'-diacetic acid; ethylenediamine-N,N'-dipropionic acid dihydrochloride; ethylene-diamine-N,N'-bis(methylene-phosphonic acid) hemihydrate; N-(2-hydroxyethyl)ethylenediamine-N,N',N'-triacetic acid; ethylenediamine-N,N,N',N'-tetrakis(methylenephosponic acid); O,O'-bis(2-aminoethyl)-ethylene-glycol-N,N,N',N'-tetraacetic acid; N,N-bis(2-hydroxybenzyl)ethylene di-amine-N,N-diacetic acid; 1,6-hexamethylenediamine-N,N,N',N'-tetraacetic acid; N-(2-hydroxy-ethyl)iminodiacetic acid; iminodiacetic acid; 1,2-diaminopropane-N,N,N',N'-tetraacetic acid; nitrilotriacetic acid; nitrilo-tripropionic acid; the trisodium salt of nitrilotris(methylenephosphoric acid); 7,19,30-trioxa-1,4,10,13,16,22,27,33-octaazabicyclo[11,11,11]pentatriacon- tane hexahydrobromide; triethylene-tetramine-N,N,N',N'',N''',N'''-hexaacetic acid; deferoxamine; deferiprone; and deferasirox.

11. The method of claim 1, wherein the method further comprises administering an antibiotic in conjunction with the Serratia peptidase, bromelain, papain and a fibrinolytic enzyme, in an amount and for a time sufficient to cause significant biofilm degradation within the mammal.

12. The method of claim 1, wherein the method further comprises not administering an antibiotic in conjunction with the Serratia peptidase, bromelain, papain and a fibrinolytic enzyme, in an amount and for a time sufficient to cause significant biofilm degradation within the mammal.

13. The method of claim 1, wherein the method further comprises administering a quercetin in conjunction with the Serratia peptidase, bromelain, papain and a fibrinolytic enzyme, in an amount and for a time sufficient to cause significant biofilm degradation within the mammal.

14. The method of claim 1, wherein the method further comprises administering seaprose in conjunction with the Serratia peptidase, bromelain, papain and a fibrinolytic enzyme, in an amount and for a time sufficient to cause significant biofilm degradation within the mammal.

15. The method of claim 1, wherein the method further comprises administering Fusarium protease in conjunction with the Serratia peptidase, bromelain, papain and a fibrinolytic enzyme, in an amount and for a time sufficient to cause significant biofilm degradation within the mammal.

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