Angiogenically effective unit dose of fgf-2 and method of use

Abstract

The present invention provides a unit dose composition comprising 0.2 μg/kg to 48 μg/kg of an FGF-2 of SEQ ID NO:2, or an angiogenically active fragment or mutein thereof in a pharmaceutically acceptable carrier. Also provided is a method for treating a human patient for coronary artery disease, comprising administering into one or more coronary vessels or a peripheral vein of said patient a safe and angiogenically effective dose of a recombinant FGF-2, or an angiogenically active fragment or mutein thereof. Also provided is a pharmaceutical composition comprising a therapeutically effective amount of FGF-2, alone or in combination with heparin, in a therapeutically effective carrier.

What is claimed is: 
     
         1 . A method for treating a human patient for a myocardial infarction, comprising administering a single unit dose of a recombinant fibroblast growth factor-2 (FGF-2) or an angiogenically active fragment or an angiogenically active mutein thereof into one or more coronary vessels or into a peripheral vein in a human patient in need of treatment for coronary artery disease or a myocardial infarction, said unit dose comprising from about 0.008 mg to 7.2 mg of said recombinant FGF-2 or said angiogenically active fragment or said angiogenically active mutein thereof, wherein said recombinant FGF-2 has the amino acid sequence of human FGF-2, and wherein said angiogenically active mutein has at least 90% amino acid sequence identity with human FGF-2. 
     
     
         2 . The method of  claim 1 , further comprising the step of administering 10 U/kg to 80 U/kg of heparin to said patient within 30 minutes of administering said unit dose, wherein said heparin is administered by intravenous or intracoronary administration. 
     
     
         3 . The method of  claim 1 , wherein said unit dose is administered by infusion. 
     
     
         4 . A method for inducing angiogenesis in a heart of a human patient, comprising administering a single unit dose of a recombinant fibroblast growth factor-2 (FGF-2) or an angiogenically active fragment or an angiogenically active mutein thereof into one or more coronary vessels or into a peripheral vein in a human patient in need of treatment for coronary artery disease, said unit dose comprising from about 0.008 mg to 7.2 mg of said recombinant fibroblast growth factor-2 (FGF-2) or said angiogenically active fragment or said angiogenically active mutein thereof, wherein said recombinant FGF-2 has the amino acid sequence of human FGF-2, and wherein said angiogenically active mutein has at least 90% amino acid sequence identity with human FGF-2. 
     
     
         5 . The method of  claim 4 , wherein said single unit dose produces an improvement in one or more clinical endpoints in said human patient that lasts at least four months. 
     
     
         6 . The method of  claim 5 , wherein said single unit dose produces an improvement in one or more clinical endpoints in said human patient that lasts 6 months. 
     
     
         7 . The method of  claim 4 , wherein said unit dose is administered by infusion. 
     
     
         8 . A method for providing a human patient with relief from symptoms of angina, comprising administering a single unit dose of a recombinant fibroblast growth factor-2 (FGF-2) or an angiogenically active fragment or an angiogenically active mutein thereof into one or more coronary vessels or into a peripheral vein in a human patient in need of relief from symptoms of angina, said unit dose comprising from about 0.008 mg to 7.2 mg of said recombinant fibroblast growth factor-2 (FGF-2) or said angiogenically active fragment or said angiogenically active mutein thereof, wherein said recombinant FGF-2 has the amino acid sequence of human FGF-2, and wherein said angiogenically active mutein has at least 90% amino acid sequence identity with human FGF-2. 
     
     
         9 . The method of  claim 8 , wherein said unit dose is administered by infusion.