US2010305547A1PendingUtilityA1

Method of use of fibroblast growth factor, vascular endothelial growth factor and related proteins in the treatment of acute and chronic heart disease

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Individually held — no corporate assignee on recordPriority: Apr 6, 2000Filed: Sep 4, 2008Published: Dec 2, 2010
Est. expiryApr 6, 2020(expired)· nominal 20-yr term from priority
Inventors:Wayne P. Franco
G01N 33/6893A61K 38/1866A61K 38/1825G01N 2800/324G01N 2800/32
60
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Claims

Abstract

Disclosed herein is a rational, multi-tier approach to the administration of growth factor proteins in the treatment of heart disease. Also disclosed is a method to evaluate the effectiveness of the administration of growth factor proteins comprising the clinical assay of CPK-MB levels in a patient undergoing treatment with growth factor proteins. In addition, there is disclosed a method for treatment of heart disease comprising administration of a therapeutically effective amount of a growth factor protein by oral inhalation therapy.

Claims

exact text as granted — not AI-modified
1 - 15 . (canceled) 
     
     
         16 . A method for the treatment of coronary artery disease by delivering a formulation comprising one or more therapeutic growth factor proteins to the endocardium through a catheter, the method comprising the steps of:
 a) selecting a patient displaying symptoms of acute coronary artery disease;   b) selecting an effective amount of a therapeutic growth factor protein formulation comprising a growth factor protein selected from the group consisting of FGF-1, FGF-2, VEGF and mixtures thereof;   c) administering at least one dose of said effective amount of growth factor protein formulation through a catheter into the endocardium;   d) monitoring one or more clinical indicators of acute coronary artery disease;   e) determining, based on monitoring said one or more clinical indicators of coronary artery disease, whether an additional dose of therapeutic growth factor protein formulation is necessary; and   f) repeating steps b) through e) until there is a clinical indication of amelioration of the symptoms of acute coronary artery disease in the patient, or until there is a contraindication to continued treatment.   
     
     
         17 . The method of  claim 16 , wherein said effective amount of a therapeutic growth factor protein formulation consists of FGF-1. 
     
     
         18 . The method of  claim 16 , wherein said effective amount of a therapeutic growth factor protein formulation consists of FGF-2. 
     
     
         19 . The method of  claim 16 , wherein said effective amount of a therapeutic growth factor protein formulation consists of VEGF. 
     
     
         20 . A method for the treatment of coronary artery disease by delivering a formulation comprising one or more therapeutic growth factor proteins to the myocardium through a catheter, the method comprising the steps of:
 a) selecting a patient displaying symptoms of acute coronary artery disease;   b) selecting an effective amount of a therapeutic growth factor protein formulation comprising a growth factor protein selected from the group consisting of FGF-1, FGF-2, VEGF and mixtures thereof;   c) administering at least one dose of said effective amount of growth factor protein formulation through a catheter into the myocardium;   d) monitoring one or more clinical indicators of acute coronary artery disease;   e) determining, based on monitoring said one or more clinical indicators of coronary artery disease, whether an additional dose of therapeutic growth factor protein formulation is necessary; and   f) repeating steps b) through e) until there is a clinical indication of amelioration of the symptoms of acute coronary artery disease in the patient, or until there is a contraindication to continued treatment.   
     
     
         21 . The method of  claim 20 , wherein said effective amount of a therapeutic growth factor protein formulation consists of FGF-1. 
     
     
         22 . The method of  claim 20 , wherein said effective amount of a therapeutic growth factor protein formulation consists of FGF-2. 
     
     
         23 . The method of  claim 20 , wherein said effective amount of a therapeutic growth factor protein formulation consists of VEGF. 
     
     
         24 . A method for the treatment of coronary artery disease by delivering a formulation comprising one or more therapeutic growth factor proteins to the coronary arteries through a catheter, the method comprising the steps of:
 a) selecting a patient displaying symptoms of acute coronary artery disease;   b) selecting an effective amount of a therapeutic growth factor protein formulation comprising a growth factor protein selected from the group consisting of FGF-1, FGF-2, VEGF and mixtures thereof;   c) administering at least one dose of said effective amount of growth factor protein formulation through a catheter into the coronary arteries;   d) monitoring one or more clinical indicators of acute coronary artery disease;   e) determining, based on monitoring said one or more clinical indicators of coronary artery disease, whether an additional dose of therapeutic growth factor protein formulation is necessary; and   f) repeating steps b) through e) until there is a clinical indication of amelioration of the symptoms of acute coronary artery disease in the patient, or until there is a contraindication to continued treatment.   
     
     
         25 . The method of  claim 24 , wherein said effective amount of a therapeutic growth factor protein formulation consists of FGF-1. 
     
     
         26 . The method of  claim 24 , wherein said effective amount of a therapeutic growth factor protein formulation consists of FGF-2. 
     
     
         27 . The method of  claim 24 , wherein said effective amount of a therapeutic growth factor protein formulation consists of VEGF. 
     
     
         28 . A method for the treatment of coronary artery disease by delivering a formulation comprising one or more therapeutic growth factor proteins to the endocardium through a catheter, the method comprising the steps of:
 a) selecting a patient displaying symptoms of coronary artery disease;   b) selecting an effective amount of a therapeutic growth factor protein formulation comprising a growth factor protein selected from the group consisting of FGF-1, FGF-2, VEGF and mixtures thereof;   c) administering at least one dose of said effective amount of growth factor protein formulation through a catheter into the endocardium;   d) monitoring one or more clinical indicators of coronary artery disease;   e) determining, based on monitoring said one or more clinical indicators of coronary artery disease, whether an additional dose of therapeutic growth factor protein formulation is necessary; and   f) repeating steps b) through e) until there is a clinical indication of amelioration of the symptoms of coronary artery disease in the patient, or until there is a contraindication to continued treatment.   
     
     
         29 . The method of  claim 28 , wherein the amelioration of symptoms is achieved as a result of a clinically significant amount of angiogenesis 
     
     
         30 . The method of  claim 28 , wherein said effective amount of a therapeutic growth factor protein formulation consists of FGF-1. 
     
     
         31 . The method of  claim 28 , wherein said effective amount of a therapeutic growth factor protein formulation consists of FGF-2. 
     
     
         32 . The method of  claim 28 , wherein said effective amount of a therapeutic growth factor protein formulation consists of VEGF. 
     
     
         33 . A method for the treatment of coronary artery disease by delivering a formulation comprising one or more therapeutic growth factor proteins to the myocardium through a catheter, the method comprising the steps of:
 g) selecting a patient displaying symptoms of coronary artery disease;   h) selecting an effective amount of a therapeutic growth factor protein formulation comprising a growth factor protein selected from the group consisting of FGF-1, FGF-2, VEGF and mixtures thereof;   i) administering at least one dose of said effective amount of growth factor protein formulation through a catheter into the myocardium;   j) monitoring one or more clinical indicators of coronary artery disease;   k) determining, based on monitoring said one or more clinical indicators of coronary artery disease, whether an additional dose of therapeutic growth factor protein formulation is necessary; and   l) repeating steps b) through e) until there is a clinical indication of amelioration of the symptoms of coronary artery disease in the patient, or until there is a contraindication to continued treatment.   
     
     
         34 . The method of  claim 33 , wherein the amelioration of symptoms is achieved as a result of a clinically significant amount of angiogenesis 
     
     
         35 . The method of  claim 33 , wherein said effective amount of a therapeutic growth factor protein formulation consists of FGF-1. 
     
     
         36 . The method of  claim 33 , wherein said effective amount of a therapeutic growth factor protein formulation consists of FGF-2. 
     
     
         37 . The method of  claim 33 , wherein said effective amount of a therapeutic growth factor protein formulation consists of VEGF. 
     
     
         38 . A method for the treatment of coronary artery disease by delivering a formulation comprising one or more therapeutic growth factor proteins to the coronary arteries through a catheter, the method comprising the steps of:
 selecting a patient displaying symptoms of coronary artery disease;   selecting an effective amount of a therapeutic growth factor protein formulation comprising a growth factor protein selected from the group consisting of FGF-1, FGF-2, VEGF and mixtures thereof;   administering at least one dose of said effective amount of growth factor protein formulation through a catheter into the coronary arteries;   monitoring one or more clinical indicators of coronary artery disease;   determining, based on monitoring said one or more clinical indicators of coronary artery disease, whether an additional dose of therapeutic growth factor protein formulation is necessary; and   repeating steps b) through e) until there is a clinical indication of amelioration of the symptoms of coronary artery disease in the patient, or until there is a contraindication to continued treatment.   
     
     
         39 . The method of  claim 38 , wherein the amelioration of symptoms is achieved as a result of a clinically significant amount of angiogenesis. 
     
     
         40 . The method of  claim 38 , wherein said effective amount of a therapeutic growth factor protein formulation consists of FGF-1. 
     
     
         41 . The method of  claim 38 , wherein said effective amount of a therapeutic growth factor protein formulation consists of FGF-2. 
     
     
         42 . The method of  claim 38 , wherein said effective amount of a therapeutic growth factor protein formulation consists of VEGF.

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