Facilitation of wound healing with CM101/GBS toxin

Abstract

The method of the present invention provides a means of treating a patient having a wound, especially by minimizing scarring and accelerating wound healing, by administering CM101 or GBS toxin isolated from Group B β-hemolytic streptococcus bacteria. The method of the present invention also includes administration of CM101 or GBS toxin to surgery patients having tumors in order to facilitate wound healing and minimize the likelihood of tumor progression.

What is claimed is:  
     
         1 . A method for treating a patient having a wound, which method comprises: 
 administering a GBS toxin to the patient in a quantity sufficient to reduce scarring at a site of the wound.    
     
     
         2 . The method of  claim 1  wherein healing of the wound is accelerated.  
     
     
         3 . The method of  claim 1  wherein the GBS toxin is CM101.  
     
     
         4 . The method of  claim 3  wherein the CM101 is substantially pure.  
     
     
         5 . The method of  claim 4  wherein the CM101 has a purity of at least approximately 90%.  
     
     
         6 . The method of  claim 1  wherein the GBS toxin is administered to the patient in a quantity sufficient to provide reduced vessel density at the site of the wound with GBS toxin treatment relative to vessel density at the site of a comparable wound without GBS treatment.  
     
     
         7 . The method of  claim 6  wherein the reduced vessel density is within the range of 0.0 to 0.2 (1-AC).  
     
     
         8 . The method of  claim 1  wherein the GBS toxin is administered to the patient in a quantity sufficient to provide improved tensile strength at the site of the wound with GBS toxin treatment relative to tensile strength at the site of the wound without GBS treatment.  
     
     
         9 . The method of  claim 1  wherein the GBS toxin is administered to the patient parenterally.  
     
     
         10 . The method of  claim 9  wherein the GBS toxin is administered to the patient intravenously.  
     
     
         11 . The method of  claim 1  wherein the GBS toxin is administered proximate to the site of the wound.  
     
     
         12 . The method of  claim 1  wherein the GBS toxin is administered to the patient at a dosage in the range of 1 to 100 μg/kg body weight.  
     
     
         13 . The method of  claim 12  wherein the GBS toxin is administered to the patient at a dosage in the range of 1 to 25 μg/kg body weight.  
     
     
         14 . The method of  claim 12  wherein the dosage is administered in a single infusion of thirty minute duration or less.  
     
     
         15 . The method of  claim 12  wherein the dosage is administered once weekly.  
     
     
         16 . The method of  claim 1  wherein the GBS toxin is administered to the patient in a quantity sufficient to reduce vascularization at the site of the wound.  
     
     
         17 . The method of  claim 16  wherein the GBS toxin is administered to the patient in a quantity sufficient to reduce hypoxia-induced, VEGF-driven neovascularization at the site of the wound.  
     
     
         18 . The method of  claim 1  wherein the patient has a tumor.  
     
     
         19 . The method of  claim 1  wherein the patient has no known tumor.  
     
     
         20 . The method of  claim 1  wherein the patient is at least four days old.  
     
     
         21 . The method of  claim 20  wherein the patient is at least seven days old.  
     
     
         22 . The method of  claim 1  wherein the wound is the result of trauma.  
     
     
         23 . The method of  claim 1  wherein the wound is the result of surgery.  
     
     
         24 . A method of treating a patient having a wound, which method comprises: 
 administering a GBS toxin to the patient in an amount sufficient to accelerate wound healing.    
     
     
         25 . The method of  claim 24  wherein the wound healing is achieved with minimal scarring.  
     
     
         26 . The method of  claim 24  wherein the GBS toxin is CM101.  
     
     
         27 . The method of  claim 26  wherein the CM101 is substantially pure.  
     
     
         28 . The method of  claim 27  wherein the CM101 has a purity of at least approximately 90%.  
     
     
         29 . The method of  claim 24  wherein the GBS toxin is administered to the patient in a quantity sufficient to provide reduced vessel density at the site of the wound with GBS toxin treatment relative to vessel density at the site of a comparable wound without GBS treatment.  
     
     
         30 . The method of  claim 29  wherein the reduced vessel density is within the range of 0.0 to 0.2 (1-AC).  
     
     
         31 . The method of  claim 24  wherein the GBS toxin is administered to the patient in a quantity sufficient to provide improved tensile strength at the site of the wound with GBS toxin treatment relative to tensile strength at the site of the wound without GBS treatment.  
     
     
         32 . The method of  claim 24  wherein the GBS toxin is administered to the patient parenterally.  
     
     
         33 . The method of  claim 32  wherein the GBS toxin is administered to the patient intravenously.  
     
     
         34 . The method of  claim 24  wherein the GBS toxin is administered proximate to the site of the wound.  
     
     
         35 . The method of  claim 24  wherein the GBS toxin is administered to the patient at a dosage in the range of 1 to 100 μg/kg body weight.  
     
     
         36 . The method of  claim 35  wherein the GBS toxin is administered to the patient at a dosage in the range of 1 to 25 μg/kg body weight.  
     
     
         37 . The method of  claim 35  wherein the dosage is administered in a single infusion of thirty minute duration or less.  
     
     
         38 . The method of  claim 35  wherein the dosage is administered once weekly.  
     
     
         39 . The method of  claim 24  wherein the GBS toxin is administered to the patient in a quantity sufficient to reduce vascularization at the site of the wound.  
     
     
         40 . The method of  claim 39  wherein the GBS toxin is administered to the patient in a quantity sufficient to reduce hypoxia-induced, VEGF-driven neovascularization at the site of the wound.  
     
     
         41 . The method of  claim 24  wherein the patient has a tumor.  
     
     
         42 . The method of  claim 24  wherein the patient has no known tumor.  
     
     
         43 . The method of  claim 24  wherein the patient is at least four days old.  
     
     
         44 . The method of  claim 43  wherein the patient is at least seven days old.  
     
     
         45 . The method of  claim 24  wherein the wound is the result of trauma.  
     
     
         46 . The method of  claim 24  wherein the wound is the result of surgery.  
     
     
         47 . A method of treating a patient having a keloid, which method comprises: 
 (a) excising the keloid to create a wound, and    (b) administering a GBS toxin to the patient in a quantity sufficient to reduce scarring at a site of the wound.    
     
     
         48 . The method of  claim 47  wherein the GBS toxin is CM101.  
     
     
         49 . The method of  claim 48  wherein the CM101 has a purity of at least approximately 90%.  
     
     
         50 . A method of reducing the likelihood of metastatic tumor implantation proximate to a site of surgery in a surgery patient, which method comprises: 
 administering GBS toxin to the surgery patient in a quantity sufficient to reduce scarring or accelerate wound healing at the site of surgery.    
     
     
         51 . The method of  claim 50  wherein the GBS toxin is CM101.  
     
     
         52 . The method of  claim 51  wherein the CM101 has a purity of at least approximately 90%.  
     
     
         53 . The method of  claim 50  wherein the GBS toxin is administered to the patient intravenously.  
     
     
         54 . A method of reducing the likelihood of tumor proliferation in a surgery patient, which method comprises: 
 administering GBS toxin to the surgery patient in a quantity sufficient to reduce scarring or accelerate wound healing at a site of surgery.    
     
     
         55 . The method of  claim 54  wherein the GBS toxin is CM101.  
     
     
         56 . The method of  claim 55  wherein the CM101 has a purity of at least approximately 90%.  
     
     
         57 . The method of  claim 54  wherein the GBS toxin is administered to the patient intravenously.  
     
     
         58 . An article of manufacture comprising: 
 (a) a pharmaceutical composition having 
 (i) a GBS toxin, and  
 (ii) a pharmaceutically acceptable carrier, and  
   (b) instructions for administering the pharmaceutical composition to a patient having a wound.    
     
     
         59 . The article of  claim 58  wherein the GBS toxin is CM101.  
     
     
         60 . The article of  claim 59  wherein the CM101 has a purity of at least approximately 90%.  
     
     
         61 . The article of  claim 58  wherein the instructions describe administration of the pharmaceutical composition to the patient in a quantity sufficient to reduce scarring at a site of the wound.  
     
     
         62 . The article of  claim 58  wherein the instructions describe administration of the pharmaceutical composition to the patient in a quantity sufficient to accelerate wound healing.  
     
     
         63 . The article of  claim 58  wherein the instructions describe administration of the pharmaceutical composition to the patient to treat a keloid by excising the keloid and administering the pharmaceutical composition in a quantity sufficient to reduce scarring at a site of the wound.  
     
     
         64 . The article of  claim 58  wherein the instructions describe administration of the pharmaceutical composition to the patient to reduce the likelihood of metastatic tumor implantation proximate to a site of surgery in the patient by administering the pharmaceutical composition in a quantity sufficient to reduce scarring or accelerate wound healing at the site of surgery.  
     
     
         65 . The article of  claim 58  wherein the instructions describe administration of the pharmaceutical composition to the patient to reduce the likelihood of tumor proliferation in the patient by administering the pharmaceutical composition in a quantity sufficient to reduce scarring or accelerate wound healing at a site of surgery.  
     
     
         66 . A method of making an article of manufacture, which method comprises: 
 combining 
 (a) a container including a pharmaceutical composition comprising 
 (i) a GBS toxin, and  
 (ii) a pharmaceutically acceptable carrier, and  
 
   (b) labelling instructions for treating a patient having a wound by administering the pharmaceutical composition to the patient.    
     
     
         67 . The method of  claim 66  wherein the instructions describe administration of the pharmaceutical composition to the patient in a quantity sufficient to reduce scarring at a site of the wound.  
     
     
         68 . The method of  claim 66  wherein the instructions describe administration of the pharmaceutical composition to the patient in a quantity sufficient to accelerate wound healing.  
     
     
         69 . The method of  claim 66  wherein the instructions describe administration of the pharmaceutical composition to the patient to treat a keloid by excising the keloid and administrating the pharmaceutical composition in a quantity sufficient to reduce scarring at a site of the wound.  
     
     
         70 . The method of  claim 66  wherein the instructions describe administration of the pharmaceutical composition to the patient to reduce the likelihood of metastatic tumor implantation proximate to a site of surgery in the patient by administering the pharmaceutical composition in a quantity sufficient to reduce scarring or accelerate wound healing at the site of surgery.  
     
     
         71 . The method of  claim 66  wherein the instructions describe administration of the pharmaceutical composition to the patient to reduce the likelihood of tumor proliferation in the patient by administering the pharmaceutical composition in a quantity sufficient to reduce scarring or accelerate wound healing at a site of surgery.  
     
     
         72 . A method for reducing scarring in a patient, which method comprises: 
 administering CM101 to the patient.    
     
     
         73 . The method of  claim 72  wherein the CM101 has a purity of at least approximately 90%.