Use of bacterial phage associated lysing enzymes for the prophylactic and therapeutic treatment of various illnesses

Abstract

A method for the prophylactic and therapeutic treatment of bacterial infections of the skin is disclosed which comprises the treatment of an individual with an effective amount of a native or altered version of a lytic enzyme produced by a bacteria infected with a bacteriophage specific for said bacteria. The lytic enzyme is selected from a group consisting of shuffled lytic enzymes, chimeric lytic enzymes, wherein the lytic enzyme is in an environment having a pH which allows for activity of said lytic enzyme; and a carrier for delivering said lytic enzyme. Additionally, a holin protein for puncturing the membrane may be included in the composition.

1 ) A method for the prophylactic or therapeutic treatment of bacterial infections, comprising: 
 administering to the site of the infection an effective amount of a modified version of at least one lytic enzyme produced by a bacteria infected with a bacteriophage specific for said bacteria wherein said modified version of said at least one lytic enzyme is selected from the group consisting of shuffled lytic enzymes, chimeric lytic enzymes, and combinations thereof    
     
     
         2 ) The method according to  claim 1 , further comprising administering at least one holin enzyme with said at least one lytic enzyme.  
     
     
         3 ) The method according to  claim 2 , wherein said at least one holin enzyme is a shuffled holin enzyme.  
     
     
         4 ) The method according to  claim 2 , wherein said holin enzyme is a chimeric holin enzyme.  
     
     
         5 ) The method according to  claim 1 , further comprising at least one lytic enzyme which is neither said shuffled lytic enzyme nor said chimeric lytic enzyme.  
     
     
         6 ) The method according to  claim 1 , further comprising delivering said modified lytic enzyme in a carrier suitable for delivering said lytic enzyme to the site of the infection.  
     
     
         7 ) The method according to  claim 1 , wherein the at least one modified lytic enzyme is for the treatment of Hemophilus influenza.  
     
     
         8 ) The method according to  claim 1 , wherein the at least one modified lytic enzyme is for the treatment of Pseudomonas.  
     
     
         9 ) The method according to  claim 1 , wherein the at least one modified lytic enzyme is for the treatment of Streptococcus pneumoniae  
     
     
         10 ) The method according to  claim 1 , wherein the at least one modified lytic enzyme is for the treatment of Streptococcusfasciae  
     
     
         11 ) The method according to  claim 1 , wherein the at least one modified lytic enzyme is for the treatment of Listeria.  
     
     
         12 ) The method according to  claim 1 , wherein the at least one modified lytic enzyme is for the treatment of Salmonella.  
     
     
         13 ) The method according to  claim 1 , wherein the at least one modified lytic enzyme is for the treatment of E. coli.  
     
     
         14 ) The method according to  claim 1 , wherein the at least one modified lytic enzyme is for the treatment of Campylobacter.  
     
     
         15 ) The method according to  claim 1 , wherein the at least one modified lytic enzyme is for the treatment of Pseudomonas.  
     
     
         16 ) The method according to  claim 1 , wherein the at least one modified lytic enzyme is for the treatment of Streptococcus mutans.  
     
     
         17 ) The method according to  claim 1 , wherein the at least one modified lytic enzyme is for the treatment of Mycobacterium tuberculosis.  
     
     
         18 ) The method according to  claim 1 , wherein the at least one modified lytic enzyme is for the treatment of Streptococcus.  
     
     
         19 ) The method according to  claim 6 , wherein the carrier is an inhalant.  
     
     
         20 ) The method according to  claim 6 , wherein the carrier is a topical cream  
     
     
         21 ) The method according to  claim 6 , wherein the carrier is a nasal spray.  
     
     
         22 ) The method according to  claim 6 , wherein the carrier is a syrup.  
     
     
         23 ) The method according to  claim 6 , wherein the carrier is a tablet.  
     
     
         24 ) The method according to  claim 6 , wherein the carrier is a tampon.  
     
     
         25 ) The method according to  claim 6 , wherein the carrier is a suppository.  
     
     
         26 ) The method according to  claim 6 , wherein the carrier is an eye drop solution.  
     
     
         27 ) The method according to  claim 6 , wherein the carrier is a candy.  
     
     
         28 ) The method according to  claim 6 , wherein the carrier is a chewing gum.  
     
     
         29 ) The method according to  claim 6 , wherein the carrier is a lozenge.  
     
     
         30 ) The method according to  claim 6 , wherein the carrier is a troche.  
     
     
         31 ) The method according to  claim 6 , wherein the carrier is a powder.  
     
     
         32 ) The method according to  claim 6 , wherein the carrier is an aerosol.  
     
     
         33 ) The method according to  claim 6 , wherein the carrier is a liquid.  
     
     
         34 ) The method according to  claim 6 , wherein the carrier is a liquid spray.  
     
     
         35 ) The method according to  claim 6 , wherein the carrier is a bandage.  
     
     
         36 ) The method according to  claim 6 , wherein the carrier is a toothpaste.  
     
     
         37 ) The method according to  claim 6 , wherein the carrier is an oral wash.  
     
     
         38 ) A method for the prophylactic and therapeutic treatment of bacterial infections of an upper respiratory tract, comprising administering a composition comprising an effective amount of a modified version of a lytic enzyme produced by a bacteria infected with a bacteriophage specific for said bacteria wherein said modified version of said at least one lytic enzyme is selected from the group consisting of shuffled lytic enzymes, chimeric lytic enzymes, and combinations thereof.  
     
     
         39 ) The method according to  claim 38 , further comprising administering a holin enzyme with said modified lytic enzyme.  
     
     
         40 ) The method according to  claim 39 , wherein said holin enzyme is a shuffled holin enzyme.  
     
     
         41 ) The method according to  claim 39 , wherein said holin enzyme is a chimeric holin enzyme.  
     
     
         42 ) The method according to  claim 38 , further comprising at least one lytic enzyme which is neither said shuffled lytic enzyme nor said chimeric lytic enzyme.  
     
     
         43 ) The method according to  claim 38 , further comprising delivering said modified lytic enzyme in a carrier suitable for delivering said lytic enzyme to the mouth, the throat or the nasal passage.  
     
     
         44 ) The method according to  claim 38 , wherein said bacteria being treated is Streptococcus pneumoniae.  
     
     
         45 ) The method according to  claim 38 , wherein said bacteria being treated is Hemophilus influenza.  
     
     
         46 ) The method according to  claim 43 , wherein said carrier is a candy, chewing gum, lozenge, troche, tablet, a powder, an aerosol, a liquid and a liquid spray.  
     
     
         47 ) The method according to  claim 38 , wherein said composition further comprises a buffer that maintains pH of the composition at a range between about  4 . 0  and about  9 . 0 .  
     
     
         48 ) The method according to  claim 48 , wherein the buffer maintains the pH of the composition at the range between about  5 . 5  and about  7 . 5 .  
     
     
         49 ) The method according to  claim 47 , wherein said buffer comprises a reducing reagent.  
     
     
         50 ) The method according to  claim 49 , wherein said reducing reagent is dithiothreitol.  
     
     
         51 ) The method according to  claim 47 , wherein said buffer comprises a metal chelating reagent.  
     
     
         52 ) The method according to  claim 51 , wherein said metal chelating reagent is ethylenediaminetetracetic disodium salt.  
     
     
         53 ) The method according to  claim 47 , wherein said buffer is a citrate-phosphate buffer.  
     
     
         54 ) The method according to  claim 38 , wherein said at least one modified lytic enzyme is lyophilized.  
     
     
         55 ) The method according to  claim 43 , wherein said carrier further comprises a sweetener.  
     
     
         56 ) The method according  claim 38 , further comprising administering a concentration of about  100  to about  100 , 000  active enzyme units per milliliter of fluid in the wet environment of the nasal or oral passages.  
     
     
         57 ) The method according to  claim 56 , further comprising administering the concentration of about  100  to about  10 , 000  active enzyme units per milliliter of fluid in the wet environment of the nasal or oral passages.  
     
     
         58 ) The method according to  claim 38 , further comprising using said composition in the therapeutic treatment of Streptococcus infections.  
     
     
         59 ) The method according to  claim 38 , further comprising using said composition in the prophylactic treatment of Streptococcus infections.  
     
     
         60 ) The method according to  claim 38 , further comprising using said composition in the prophylactic treatment of Hemophilus infections.  
     
     
         61 ) The method according to  claim 38 , further comprising using said composition in the therapeutic treatment of Hemophilus infections.  
     
     
         62 ) A composition for use in the therapeutic or prophylactic treatment of a bacterial infection of an upper respiratory tract, comprising: 
 an effective amount of a modified version of a lytic enzyme produced by a bacteria infected with a bacteriophage specific for said bacteria wherein said modified version of said at least one lytic enzyme is selected from the group consisting of shuffled lytic enzymes, chimeric lytic enzymes, and combinations thereof, and a carrier for delivering said at least one lytic enzyme to a mouth, throat, or nasal passage.    
     
     
         63 ) The composition according to  claim 62 , further comprising a holin enzyme.  
     
     
         64 ) The composition according to  claim 63 , wherein said holin enzyme is a shuffled holin enzyme.  
     
     
         65 ) The composition according to  claim 63 , wherein said holin enzyme is a chimeric holin enzyme.  
     
     
         66 ) The composition according to  claim 62 , wherein said bacteria being treated is Streptococcus pneumoniae.  
     
     
         67 ) The composition according to  claim 62 , wherein said bacteria being treated is Hemophilus influenza.  
     
     
         68 ) The composition according to  claim 62 , 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.  
     
     
         69 ) The composition according to  claim 62 , wherein said composition further comprises a buffer that maintains pH of the composition at a range between about  4 . 0  and about  9 . 0 .  
     
     
         70 ) The composition according to  claim 62 , wherein the buffer maintains the pH of the composition at the range between  5 . 5  and  7 . 5 .  
     
     
         71 ) The composition according to  claim 62 , further comprising a bactericidal or bacteriostatic agent  5  as a preservative.  
     
     
         72 ) The composition according to  claim 62 , wherein said modified lytic enzyme is lyophilized.  
     
     
         73 ). The composition according  claim 62 , wherein said at least one lytic enzyme is present in a concentration of about  100  to about  100 , 000  active enzyme units per milliliter of fluid in the wet environment of the nasal or oral passages.  
     
     
         74 ). The composition according to  claim 71 , wherein said at least one lytic enzyme is present in a concentration of about  100  to about  10 , 000  active enzyme units per milliliter of fluid in the wet environment of the nasal or oral passages.  
     
     
         75 ) A method for the treatment of bacterial infections of the digestive tract, comprising administering to the digestive tract a composition comprising an effective amount of a modified version of a lytic enzyme produced by a bacteria infected with a bacteriophage specific for said bacteria wherein said modified version of said at least one lytic enzyme is selected from the group consisting of shuffled lytic enzymes, chimeric lytic enzymes, and combinations thereof.  
     
     
         76 ) The method according to  claim 75 , further comprising administering a holin enzyme with said modified lytic enzyme.  
     
     
         77 ) The method according to  claim 76 , wherein said holin enzyme is a shuffled holin enzyme.  5   
     
     
         78 ) The method according to  claim 76 , wherein said holin enzyme is a chimeric holin enzyme.  
     
     
         79 ) The method according to  claim 75 , further comprising delivering said lytic enzyme in a carrier suitable for delivering said lytic enzyme to the digestive tract.  10   
     
     
         80 ) The method according to  claim 75 , wherein said bacterial infections are caused by gram negative bacteria selected from the group consisting of Listeria, Salmonella, E. coli, and Campylobacter.  
     
     
         81 ) The method according to  claim 73 , wherein said carrier is selected from the group consisting of suppository enemas, syrups, and enteric coated pills.  
     
     
         82 ) A composition for treating for the treatment of bacterial infections of the digestive tract, comprising: an effective amount of a modified version of a lytic enzyme produced by a bacteria  20  infected with a bacteriophage specific for said bacteria wherein said modified version of said at least one lytic enzyme is selected from the group consisting of shuffled lytic enzymes, chimeric lytic enzymes, and combinations thereof, and a carrier for delivering said lytic enzyme to the digestive tract.  
     
     
         83 ) The composition according to  claim 82 , further comprising a holin enzyme  
     
     
         84 ) The composition according to  claim 83 , wherein said holin enzyme is a shuffled holin enzyme.  
     
     
         85 ) The composition according to clai  84 , wherein said holin enzyme is a chimeric holin enzyme.  
     
     
         86 ) The composition according to  claim 82 , wherein said bacteria to be treated are selected from the group consisting of Listeria, Salmonella, E. coli, and Campylobacter.  
     
     
         87 ) The composition according to  claim 82 , wherein said carrier for delivering said at least one modified lytic enzyme to the digestive tract is selected from the group consisting of suppository enemas, syrups, or enteric coated pills.  
     
     
         88 ) The composition according to  claim 82 , wherein said composition further comprises a buffer that maintains pH of the composition at a range between about  4 . 0  and  9 . 0 .  
     
     
         89 ). The composition according  claim 82 , wherein said at least one modifed lytic enzyme is present in a concentration of about  100  to about  100 , 000  active enzyme units per milliliter of fluid in the wet environment of the digestive tract  
     
     
         90 ) The composition according to  claim 89 , wherein said at least one modified lytic enzyme is present in a concentration of about  100  to about  10 , 000  active enzyme units per milliliter of fluid in the wet environment of the digestive tract.  
     
     
         91 ) A composition for the therapeutic or prophylactic treatment of bacterial infections of bums and wounds of the skin, comprising: 
 an effective amount of a modified version of a lytic enzyme produced by a bacteria infected with a bacteriophage specific for said bacteria wherein said modified version of said at least one lytic enzyme is selected from the group consisting of shuffled lytic enzymes, chimeric lytic enzymes, and combinations thereof; and    a carrier for delivering said at least one lytic enzyme to the skin.    
     
     
         92 ) The composition according to  claim 91 , further comprising a holin enzyme.  
     
     
         93 ) The composition according to  claim 92 , wherein said holin enzyme is a shuffled holin enzyme.  
     
     
         94 ) The composition according to  claim 92 , wherein said holin enzyme is a chimeric holin enzyme.  
     
     
         95 ) The composition according to  claim 91 , wherein said carrier is a bandage.  
     
     
         96 ) The composition according to  claim 91 , further comprising using said composition in the prophylactic treatment of bacterial infections.  
     
     
         97 ) The composition according to  claim 91 , further comprising using said composition in the therapeutic treatment of bacterial infections.  
     
     
         98 ) The composition according to  claim 91 , wherein said bacteria being treated is Pseudomonas.  
     
     
         99 ) The composition according to  claim 91 , wherein said bacteria being treated is Staphylococcus.  
     
     
         100 ) The composition according to  claim 91 , wherein said bacterium being treated are Staphylococcus and Pseudomonas.  
     
     
         101 ) A method for the therapeutic or prophylactic treatment of bacterial infections of bums and wounds of the skin, comprising: 
 administering to an infected area of the skin a composition comprising an effective amount of a modified version of a lytic enzyme produced by a bacteria infected with a bacteriophage specific for said bacteria wherein said modified version of said at least one lytic enzyme is selected from the group consisting of shuffled lytic enzymes, chimeric lytic enzymes, and combinations thereof    
     
     
         102 ) The composition according to claim O 1 , further comprising a holin enzyme.  
     
     
         103 ) The composition according to  claim 102 , wherein said holin enzyme is a shuffled holin enzyme.  
     
     
         104 ) The composition according to  claim 102 , wherein said holin enzyme is a chimeric holin enzyme.  
     
     
         105 ) The method according to  claim 101 , further comprising delivering said at least one modified lytic enzyme in a carrier suitable for delivering said lytic enzyme to the skin.  
     
     
         106 ) The method according to  claim 105 , wherein said carrier is a bandage.  
     
     
         107 ) The method according to  claim 101 , further comprising using said composition in the prophylactic treatment of bacterial infections.  
     
     
         108 ) The method according to  claim 101 , further comprising using said composition in the therapeutic treatment of bacterial infections.  
     
     
         109 ) The method according to  claim 101 , wherein said bacteria being treated is Pseudomonas.  
     
     
         110 ) The method according to  claim 101 , wherein said bacteria being treated is Staphylococcus.  
     
     
         111 ) The method according to  claim 101 , wherein said bacterium being treated are Staphylococcus and Pseudomonas.  
     
     
         112 ) A method for the prophylactic and therapeutic treatment of vaginal infections, comprising: 
 administering to the vagina composition an effective amount of a modified version of a lytic enzyme produced by a bacteria infected with a bacteriophage specific for said bacteria wherein said modified version of said at least one lytic enzyme is selected from the group consisting of shuffled lytic enzymes, chimeric lytic enzymes, and combinations thereof.    
     
     
         113 ) The method according to  claim 1   12 , further comprising administering a holin enzyme with said modified lytic enzyme.  
     
     
         114 ) The method according to  claim 113 , wherein said holin enzyme is a shuffled holin enzyme.  
     
     
         115 ) The method according to  claim 113 , wherein said holin enzyme is a chimeric holin enzyme.  
     
     
         116 ) The method according to  claim 11   1 , further comprising delivering said modified lytic enzyme in a carrier suitable for delivering said modified lytic enzyme to the vagina.  
     
     
         117 ) The method according to  claim 115 , wherein said carrier is to be placed in the vagina.  
     
     
         118 ) The method according to  claim 116 , wherein said carrier is a tampon.  
     
     
         119 ) The method according to  claim 1   16 , wherein said carrier is a pad.  
     
     
         120 ) The method according to  claim 116 , wherein said carrier is a douche.  
     
     
         121 ) The method according to  claim 112 , wherein said lytic enzyme is specific for Group B Streptococcus.  
     
     
         122 ) A composition for the prophylactic and therapeutic treatment of treatment of vaginal infections, comprising: 
 an effective amount of a modified version of a lytic enzyme produced by a bacteria infected with a bacteriophage specific for said bacteria wherein said modified version of said at least one lytic enzyme is selected from the group consisting of shuffled lytic enzymes, chimeric lytic enzymes, and combinations thereof; and    a carrier for delivering said lytic enzyme to a vagina.    
     
     
         123 ) The method according to  claim 122 , further comprising administering a holin enzyme with said modified lytic enzyme.  
     
     
         124 ) The method according to  claim 123 , wherein said holin enzyme is a shuffled holin enzyme.  
     
     
         125 ) The method according to  claim 122 , wherein said holin enzyme is a chimeric holin enzyme.  
     
     
         126 ) The composition according to  claim 122 , wherein said carrier is a tampon.  
     
     
         127 ) The composition according to  claim 122 , wherein said carrier is a douche.  
     
     
         128 ) The composition according to  claim 122 , wherein said carrier is a pad.  
     
     
         129 ) The composition according to  claim 122 , wherein said lytic enzyme is specific for Group B Streptococcus.  
     
     
         130 ) A method for the prophylactic and therapeutic treatment of eye infections, comprising: 
 administering to an eye a composition comprising an effective amount of a modified version of a lytic enzyme produced by a bacteria infected with a bacteriophage specific for said bacteria wherein said modified version of said at least one lytic enzyme is selected from the group consisting of shuffled lytic enzymes, chimeric lytic enzymes, and combinations thereof.    
     
     
         131 ) The method according to  claim 130 , further comprising administering a holin enzyme with said modified lytic enzyme.  
     
     
         132 ) The method according to  claim 131 , wherein said holin enzyme is a shuffled holin enzyme.  
     
     
         133 ) The method according to  claim 131 , wherein said holin enzyme is a chimeric holin enzyme.  
     
     
         134 ) The method according to  claim 130 , further comprising delivering said lytic enzyme in a carrier suitable for delivering said lytic enzyme to the eye.  
     
     
         135 ) The method according to  claim 130 , wherein said bacteria being treated is Hemophilus.  
     
     
         136 ) The method according to  claim 130 , wherein said bacteria being treated is Staphylococcus.  
     
     
         137 ) The method according to  claim 134 , wherein the carrier is an eye drop solution.  
     
     
         138 ) The method according to  claim 134 , wherein the carrier is an eye wash solution.  
     
     
         139 ) The method according to  claim 138 , wherein said solution is an isotonic solution.  
     
     
         140 ) A composition for use in the therapeutic or prophylactic treatment of an eye infection,, comprising an effective amount of a modified version of a lytic enzyme produced by a bacteria infected with a bacteriophage specific for said bacteria wherein said modified version of said at least one lytic enzyme is selected from the group consisting of shuffled lytic enzymes, chimeric lytic enzymes, and combinations thereof; and 
 a carrier for delivering said lytic enzyme to the eye.    
     
     
         141 ) The composition according to  claim 140 , further comprising administering a holin enzyme with said modified lytic enzyme.  
     
     
         142 ) The composition according to  claim 141 , wherein said holin enzyme is a shuffled holin enzyme.  
     
     
         143 ) The composition according to  claim 141 , wherein said holin enzyme is a chimeric holin enzyme.  
     
     
         144 ) The composition according to  claim 140 , wherein said bacteria being treated is Hemophilus.  
     
     
         145 ) The composition according to  claim 140 , wherein said bacteria being treated is Staphylococcus.  
     
     
         146 ) The composition according to  claim 140 , wherein said carrier is an isotonic solution.  
     
     
         147 ) The composition according to  claim 146 , wherein said isotonic solution is in an eye drop dispenser.  
     
     
         148 ) A method for the prophylactic or therapeutic treatment of dermatological infections comprising: 
 topically applying to an infected area of the skin a composition comprising an effective amount of a modified version of a lytic enzyme produced by a bacteria infected with a bacteriophage specific for said bacteria wherein said modified version of said at least one lytic enzyme is selected from the group consisting of shuffled lytic enzymes, chimeric lytic enzymes, and combinations thereof.    
     
     
         149 ) The method according to  claim 148 , further comprising administering a holin enzyme with said modified lytic enzyme.  
     
     
         150 ) The method according to  claim 149 , wherein said holin enzyme is a shuffled holin enzyme.  
     
     
         151 ) The method according to  claim 149 , wherein said holin enzyme is a chimeric holin enzyme.  
     
     
         152 ) The method according to  claim 148 , further comprising delivering said composition in a pharmaceutically acceptable carrier.  
     
     
         153 ) The method according to  claim 152 , 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.  
     
     
         154 ) The method according to  claim 152 , wherein the form in which the composition is delivered is selected from the group consisting of a spray, a smear, a time release patch, a liquid absorbed wipe, and any combinations thereof.  
     
     
         155 ) The method according to  claim 148 , wherein the lytic enzyme is in an environment having a pH which allows for activity of said lysin enzyme.  
     
     
         156 ) The method according to  claim 155 , wherein said composition further comprises a buffer that maintains pH of the composition at a range between about  4 . 0  and about  9 . 0 .  
     
     
         157 ) The method according to  claim 148 , wherein said composition further comprises a mild surfactant in an amount effective to potentiate effects of the lytic enzyme.  
     
     
         158 ) The method according to  claim 148 , 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.  
     
     
         159 ) The method according to  claim 148 , wherein the composition further comprises lysostaphin for the treatment of any Staphylococcus aureus bacteria.  
     
     
         160 ) The method according to  claim 148 , wherein said lytic enzyme is present in an amount ranging from about  100  to about  500 , 000  units per milliliter.  
     
     
         161 ) A composition for the treatment of dermatological infections comprising: 
 an effective amount of a modified version of a lytic enzyme produced by a bacteria infected with a bacteriophage specific for said bacteria wherein said modified version of said at least one lytic enzyme is selected from the group consisting of shuffled lytic enzymes, chimeric lytic enzymes, and combinations thereof; and    a carrier.    
     
     
         162 ) The composition according to  claim 161 , 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.  
     
     
         163 ) The composition according to  claim 161 , wherein said composition is in the form selected from the group consisting of a spray, a smear, a time release patch, a liquid absorbed wipe, and any combinations thereof.  
     
     
         164 ) The composition according to  claim 161 , wherein the at least one lytic enzyme is in an environment having a pH which allows for activity of said lytic enzyme.  
     
     
         165 ) The composition according to  claim 164 , wherein said composition further comprises a buffer  5  that maintains pH of the composition at a range between about  4 . 0  and about  9 . 0 .  
     
     
         166 ) The composition according to  claim 165 , wherein said buffer maintains the pH of the composition at the range of between about  5 . 5  and about  7 . 5 .  
     
     
         167 ) The composition according to  claim 166 , further comprising a bactericidal or bacteriostatic agent as a preservative.  
     
     
         168 ) The composition according to  claim 167 , further comprising a surfactant in an amount effective to potentiate a therapeutic effect of the composition.  
     
     
         169 ) The composition according to  claim 161 , 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 chelating agents, and combinations thereof in an amount effective to synergistically enhance the therapeutic effect of the lytic enzyme.  
     
     
         170 ) The composition according to  claim 161 , wherein the composition further comprises lysostaphin for the treatment of any Staphylococcus aureus bacteria.  
     
     
         171 ) The composition according to  claim 161 , wherein the composition further comprises lysozyme.  
     
     
         172 ) The composition according to  claim 161 , further comprising at least one emulsifier.  
     
     
         173 ) The composition according to  claim 161 , further comprising at least one antioxidant.  
     
     
         174 ) The composition according to  claim 161 , further comprising at least one sunscreen.  
     
     
         175 ) The composition according to  claim 161 , further comprising at least one anti-inflammatory agent.  
     
     
         176 ) A composition for the therapeutic or prophylactic treatment of bacterial infections of the upper respiratory system, comprising an effective amount of a modified version of a lytic enzyme produced by a bacteria infected with a bacteriophage specific for said bacteria wherein said modified version of said at least one lytic enzyme is selected from the group consisting of shuffled lytic enzymes, chimeric lytic enzymes, and combinations thereof, and a pharmaceutically acceptable carrier in an inhaler allowing for the administration of the at least one lytic enzyme to the bronchial tubes and lungs.  
     
     
         177 ) The composition according to  claim 176 , further comprising administering a holin enzyme with said modified lytic enzyme.  
     
     
         178 ) The composition according to  claim 177 , wherein said holin enzyme is a shuffled holin enzyme.  
     
     
         179 ) The composition according to  claim 177 , wherein said holin enzyme is a chimeric holin enzyme.  
     
     
         180 ) The composition according to  claim 176 , wherein said composition is for the therapeutic treatment of bacterial infections of the upper respiratory system.  
     
     
         181 ) The composition according to  claim 176 , wherein said composition is for the prophylactic treatment of bacterial infections of the upper respiratory system.  
     
     
         182 ) A composition for the therapeutic or prophylactic treatment of bacterial infections of the mouth or teeth, comprising an effective amount of a modified version of a lytic enzyme produced by a bacteria infected with a bacteriophage specific for said bacteria wherein said modified version of said at least one lytic enzyme is selected from the group consisting of shuffled lytic enzymes, chimeric lytic enzymes, and combinations thereof and a pharmaceutically acceptable carrier for topical application of the at least one lytic enzyme.  
     
     
         183 ) The composition according to  claim 182 , further comprising administering a holin enzyme with said modified lytic enzyme.  
     
     
         184 ) The method according to  claim 183 , wherein said holin enzyme is a shuffled holin enzyme.  
     
     
         185 ) The method according to  claim 183 , wherein said holin enzyme is a chimeric holin enzyme.  
     
     
         186 ) The composition according to  claim 182 , wherein said composition is used for the prophylactic treatment of dental caries.  
     
     
         187 ) The composition according to  claim 182 , wherein said composition is used for the therapeutic treatment of dental caries.  
     
     
         188 ) The composition according to  claim 182 , wherein said carrier is toothpaste.  
     
     
         189 ) The composition according to  claim 182 , wherein said carrier is an oral wash.  
     
     
         190 ) The composition according to  claim 182 , wherein said carrier is a chewing gum.  
     
     
         191 ) The composition according to  claim 182 , wherein said carrier is a lozenge.  
     
     
         192 ) The composition according to  claim 182 , wherein said bacteria being treated is Streptococcus mutans.  
     
     
         193 ) The composition according to  claim 182 , wherein said lytic enzyme is present in an amount ranging from about  100  to about  500 , 000  units per milliliter.  
     
     
         194 ) The composition according to  claim 193 , wherein said lytic enzyme is present in an amount ranging from about  10 , 000  to about  100 , 000  units per milliliter.