Use of bacterial phage associated lysing enzymes for treating various illnesses

Abstract

A composition and method for treating bacterial infections is disclosed which comprises the treatment of an individual with an effective amount of at least one lytic enzyme produced by a bacteria infected with a bacteriophage specific for said bacteria wherein at least one lytic enzyme is selected from the group consisting of shuffled lytic enzymes, chimeric lytic enzymes, holin enzymes, and combinations thereof. A carrier may be used for delivering the lytic enzyme. This method, and composition can be used for the treatment of upper respiratory infections, skin infections, wounds, and burns, vaginal infections, eye infections, intestinal disorders and dental problems.

1 . A method for treating bacterial infections, comprising the steps: 
 a) obtaining a composition comprising an effective amount of at least one lytic enzyme; and    b) applying said composition to a site of the infection wherein the enzyme is produced by infecting a bacterium causing said infection with a bacteriophage specific for said bacteria and wherein said bacteria produces said at least one recombinant lytic enzyme selected from the group consisting of chimeric lytic enzymes, shuffled lytic enzymes, and combinations thereof.    
     
     
         2 . The method according to  claim 1 , wherein said method for treating bacterial infections is used for the prophylactic treatment of infections.  
     
     
         3 . The method according to  claim 1 , wherein said method for treating bacterial infections is used for the therapeutic treatment of infections.  
     
     
         4 . The method according to  claim 1 , wherein said method further comprises including at least one holin enzyme in said composition.  
     
     
         5 . (canceled)  
     
     
         6 . The method according to  claim 1 , wherein said composition further comprises at least one antibiotic that potentiates the bactericidal activity of the lytic enzyme.  
     
     
         7 . The method according to  claim 1 , comprising a first lytic enzyme that is recombinant and a second lytic enzyme that is not recombinant.  
     
     
         8 . The method according to  claim 1 , further comprising delivering said at least one lyticenzyme in a carrier suitable for delivering said lytic enzyme to the site of the infection.  
     
     
         9 . (canceled)  
     
     
         10 . A method according to  claim 1 , wherein at least one lytic enzyme is active against any gram negative or gram positive bacteria.  
     
     
         11 . The method according to  claim 1 , wherein the carrier is selected from the group consisting of an inhalant, a topical cream, a nasal spray, a syrup, a tablet, tampon, a suppository, an eye drop solution, a candy, a chewing gum, a lozenge, a troche, a powder, an aerosol, a liquid, a liquid spray, a bandage, a toothpaste and an oral wash.  
     
     
         12 . A method as described in  claim 1 , wherein the bacterial infection is an infection of the upper respiratory tract, and the carrier is suitable for delivery of said at least one lytic enzyme to a mouth, throat, or nasal passage.  
     
     
         13 . The method according to  claim 12 , wherein said method is used for the prophylactictreatment of infection.  
     
     
         14 - 17 . (canceled)  
     
     
         18 . The method according to  claim 10 , wherein said carrier is selected from the group consisting of a candy, chewing gum, lozenge, troche, tablet, a powder, an aerosol, a liquid and a liquid spray.  
     
     
         19 - 26 . (canceled)  
     
     
         27 . A composition for the treatment of a bacterial infection of an upper respiratory tract, prepared by a process comprising the steps: 
 a) obtaining at least one lytic enzyme produced by infecting a bacteria causing said bacterial infection with a bacteriophage specific for said bacteria wherein said bacteria produces said at least one lytic enzyme selected from the group consisting of chimeric lytic enzymes, shuffled lytic enzymes, and combinations thereof, and wherein said at least one lytic enzyme has the ability to digest a cell wall of said bacteria; and    b) admixing said at least one lytic enzyme with a carrier suitable for delivery to a mouth, throat, nasal passage, or digestive tract.    
     
     
         28 - 30 . (canceled)  
     
     
         31 . The composition according to  claim 27 , wherein said carrier is selected from the group consisting of a candy, chewing gum, lozenge, troche, tablet, a powder, an aerosol, a liquid and a liquid spray, suppository, enema, syrup or enteric coated pill.  
     
     
         32 - 46 . (canceled)  
     
     
         47 . A composition for the therapeutic or prophylactic treatment of bacterial infections of burns and wounds of the skin, comprising: 
 1) obtaining at least one lytic enzyme wherein said at least one lytic enzyme is produced by infecting a bacteria causing said bacterial infection with a bacteriophage specific for said bacteria wherein said bacteria produces said at least one lytic enzyme selected from the group consisting of chimeric lytic enzymes, shuffled lytic enzymes, and combinations thereof, and wherein said at least one lytic enzyme has the ability to digest a cell wall of said bacteria, and    2) admixing said at least one lytic enzyme with a carrier suitable for delivery of said at least one lytic enzyme, and a carrier for suitable for delivering said at least one lytic enzyme to the skin.    
     
     
         48 - 50 . (canceled)  
     
     
         51 . The composition according to  claim 47 , wherein said carrier is a bandage.  
     
     
         52 - 67 . (canceled)  
     
     
         68 . A method for the prophylactic and therapeutic treatment of vaginal infections, comprising: 
 obtaining a composition comprising an effective amount of at least one lytic enzyme, wherein said composition is prepared by the steps of:    a) obtaining a composition comprising an effective amount of at least one lytic enzyme, wherein said composition is prepared by the steps of: 
 1) obtaining at least one lytic enzyme wherein said at least one lytic enzyme is produced by infecting a bacteria causing said bacterial infection with a bacteriophage specific for said bacteria wherein said bacteria produces said at least one lytic enzyme selected from the group consisting of chimeric lytic enzymes, shuffled lytic enzymes, and combinations thereof, and wherein said at least one lytic enzyme has the ability to digest a cell wall of said bacteria, and  
 2) admixing said at least one lytic enzyme with a carrier suitable for delivery of said at least one lytic enzyme, and  
   b) applying said composition to the vagina.    
     
     
         69 - 80 . (canceled)  
     
     
         81 . The composition according to  claim 68 , wherein said carrier is a tampon.  
     
     
         82 - 85 . (canceled)  
     
     
         86 . A method for treating bacterial infections of an eye comprising the steps of: 
 a) obtaining a composition comprising an effective amount of at least one lytic enzyme, wherein said composition is prepared by the steps of 
 1) obtaining at least one lytic enzyme wherein said at least one lytic enzyme is produced by infecting a bacteria causing said bacterial infection with a bacteriophage specific for said bacteria wherein said bacteria produces said at least one lytic enzyme selected from the group consisting of chimeric lytic enzymes, shuffled lytic enzymes, and combinations thereof, and wherein said at least one lytic enzyme has the ability to digest a cell wall of said bacteria, and  
 2) admixing said at least one lytic enzyme with a carrier suitable for delivery of said at least one lytic enzyme, and a carrier for suitable for delivering said at least one lytic enzyme to said eye, and  
   b) applying said composition to said eye.    
     
     
         87 - 91 . (canceled)  
     
     
         92 . The method according to  claim 86 , wherein the carrier is an eye drop solution.  
     
     
         93 - 102 . (canceled)  
     
     
         103 . A method for the prophylactic or therapeutic treatment of dermatological infections comprising: 
 a) obtaining a composition comprising an effective amount of at least one lytic enzyme, wherein said composition is prepared by the steps of 
 1) obtaining at least one lytic enzyme wherein said at least one lytic enzyme is produced by infecting a bacteria causing said bacterial infection with a bacteriophage specific said bacteria produces said at least one lytic enzyme selected from the group consisting of chimeric lytic enzymes, shuffled lytic enzymes, and combinations thereof, and wherein said at least one lytic enzyme has the ability to digest a cell wall of said bacteria, and  
 2) admixing said at least one lytic enzyme with a carrier suitable for delivery of said at least one lytic enzyme, and  
   b) topically applying said composition to the skin.    
     
     
         104 - 106 . (canceled)  
     
     
         107 . The method according to  claim 103 , wherein said carrier is selected from the group consisting of an aqueous liquid, an alcohol base, a water soluble gel, a lotion, an ointment, a nonaqueous liquid base, a mineral oil base, a blend of mineral oil and petrolatum, lanolin, liposomes, hydrophilic gelling agents, cross-linked acrylic acid polymers (carbomer), cellulose polymers, hydroxy ethyl cellulose, cellulose gum, MVE/MA decadiene crosspolymers, PVM/MA copolymers, and any combinations thereof.  
     
     
         108 - 111 . (canceled)  
     
     
         112 . The method according to  claim 103 , wherein the composition further comprises at least one complementary agent which potentiates the bactericidal activity of the lytic enzyme, said complementary agent being selected from the group consisting of penicillin, synthetic penicillins bacitracin, methicillin, cephalosporin, polymyxin, cefaclor. Cefadroxil, cefamandole nafate, cefazolin, cefixime, cefmetazole, cefonioid, cefoperazone, ceforanide, cefotanme, cefotaxime, cefotetan, cefoxitin, cefpodoxime proxetil, ceftazidime, ceftizoxime, ceftriaxone, cefriaxone moxalactam, cefuroxime, cephalexin, cephalosporin C, cephalosporin C sodium salt, cephalothin, cephalothin sodium salt, cephapirin, cephradine, cefuroximeaxetil, dihydratecephalothin, moxalactam, loracarbef. mafate and chelating agents in an amount effective to synergistically enhance effects of the lytic enzyme.  
     
     
         113 - 114 . (canceled)  
     
     
         115 . A composition for the treatment of bacterial infections of the mouth or teeth, comprising prepared by a process comprising the steps of: 
 1) obtaining at least one lytic enzyme wherein said at least one lytic enzyme is produced by infecting a bacteria causing said bacterial infection with a bacteriophage specific for said bacteria wherein said bacteria produces said at least one lytic enzyme selected from the is lytic enzymes, shuffled lytic enzymes, and combinations thereof, and wherein said at least one lytic enzyme has the ability to digest a cell wall of said bacteria, and    2) admixing said at least one lytic enzyme with a carrier suitable for delivery of said at least one lytic enzyme, and a carrier for suitable for delivering said at least one lytic enzyme to said mouth or teeth.    
     
     
         116 - 120 . (canceled)  
     
     
         121 . The composition according to  claim 115 , wherein said carrier is selected from the group consisting of a toothpaste, an oral wash, a chewing gum and a lozenge.  
     
     
         122 - 124 . (canceled)  
     
     
         125 . A method for parenterally treating bacterial infections, comprising the steps of: 
 a) obtaining a composition comprising an effective amount of at least one lytic enzyme, wherein said composition is prepared by the steps of 
 1) obtaining at least one lytic enzyme wherein said at least one lytic enzyme is produced by infecting a bacteria causing said bacterial infection with a bacteriophage specific for said bacteria wherein said bacteria produces said at least one lytic enzyme selected from the group consisting of chimeric lytic enzymes, shuffled lytic enzymes, and combinations thereof, and wherein said at least one lytic enzyme has the ability to digest a cell wall of said bacteria, and  
 2) admixing said at least one lytic enzyme with a carrier suitable for parenterally delivering said at least one lytic enzyme, and  
   b) parenterally administering said composition to a site of the infection.    
     
     
         126 - 139 . (canceled)  
     
     
         140 . The method according to  claim 125 , wherein said composition is administered intravenously, intramuscularly or subcutaneously.  
     
     
         141 . The method according to  claim 125 , wherein said composition further comprises at least one complementary agent which potentiates the bactericidal activity of the lysine enzyme, said complementary agent being selected from the group consisting of penicillin, synthetic penicillins bacitracin, methicillin, cephalosporin, polymyxin, cefaclor. Cefadroxil, cefamandole nafate, cefazolin, cefixime, cefmetazole, cefonioid, cefoperazone, ceforanide, cefotanme, cefotaxime, cefotetan, cefoxitin, cefpodoxime proxetil, ceftazidime, ceftizoxime, ceftriaxone, cefriaxone moxalactam, cefuroxime, cephalexin, cephalosporin C, cephalosporin C sodium salt, cephalothin, cephalothin sodium salt, cephapirin, cephradine, cefuroximeaxetil, dihydratecephalothin, moxalactam, loracarbef mafate and chelating agents in an amount effective to synergistically enhance the therapeutic effect of the lysin enzyme.  
     
     
         142 - 151 . (canceled)