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

• US 7,514,401 B2
• Filed: 12/21/2006
• Issued: 04/07/2009
• Est. Priority Date: 04/06/2000
• Status: Expired due to Fees

• Current Assignee: Wayne P. Franco
• Original Assignee: Wayne P. Franco
• Inventors: Franco, Wayne P.
• Primary Examiner(s): Romeo; David S
• Assistant Examiner(s): Gamett; Daniel C
• Application Number:
  US11/643,601
• Publication Number:
  US 20070155651A1
• Time in Patent Office: 838 Days
• Field of Search: None
• US Class Current: 514/1.1
• CPC Class Codes: A61K 38/1825 Fibroblast growth factor [FGF]
• CPC Class Codes: A61K 38/1866 Vascular endothelial growth factor [VEGF]
• CPC Class Codes: G01N 2800/32 Cardiovascular disorders
• CPC Class Codes: G01N 2800/324 Coronary artery diseases, e.g. angina pectoris, myocardial infarction
• CPC Class Codes: G01N 33/6893 related to diseases not provided for elsewhere

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

1. A method for the administration of a therapeutic amount of a growth factor protein formulation in the treatment of a patient displaying the symptoms of acute coronary artery disease comprising the steps of:

a) administering at least one dose of an effective amount of a first therapeutic growth factor protein formulation, by oral inhalation therapy, comprising;

1. a growth factor protein selected from the group consisting of FGF-1 and FGF-2, and mixtures thereof; and

2. a growth factor protein selected from the group consisting of VEGF, VEGF-A, VEGF-B, and PIGF, and mixtures thereof;

b) monitoring one or more clinical indicators of acute coronary artery disease;

c) determining, based on monitoring the one or more clinical indicators of acute coronary artery disease, whether an additional dose of a therapeutic growth factor protein formulation is indicated;

d) depending on the results of step c), administering one or more additional doses of a second growth factor protein formulation, by either the same or an alternative method of delivery utilized for administration of the previous dose, comprising;

1. a growth factor protein being selected from the group consisting of FGF1 and FGF-2, and mixtures thereof; and

2. a growth factor protein selected from the group consisting of VEGF, VEGF-A, VEGF-B, and PIGF, and mixtures thereof;

and repeating steps b) through d) 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.

2. The method of claim 1, wherein said at least one dose of an effective amount of a second therapeutic growth factor protein formulation is administered via intracoronary infusion.

3. The method of claim 1, wherein said at least one dose of an effective amount of a second therapeutic growth factor protein formulation is administered via direct myocardial injection.

4. The method of claim 1, wherein said at least one dose of an effective amount of a second therapeutic growth factor protein formulation is administered via intracoronary infusion during bypass surgery or angioplasty.

5. The method of claim 1, wherein said at least one dose of an effective amount of a second therapeutic growth factor protein formulation is administered via direct myocardial injection during bypass surgery or angioplasty.

6. The method of claim 1, wherein said at least one dose of an effective amount of a second therapeutic growth factor protein formulation is administered via intravenous injection.

7. The method of claim 1, wherein said at least one dose of an effective amount of a first second therapeutic growth factor protein formulation is administered via intrapericardial injection.

8. The method of claim 1, wherein said at least one dose of an effective amount of a first second therapeutic growth factor protein formulation is administered via endomyocardial injection during heart catheterization.

9. The method of claim 1, wherein the symptoms of acute coronary artery disease are brought on by a condition selected from the group consisting of myocardial infarct, unstable angina, an acute anginal attack, and reperfusion injury.

10. The method of claim 9, wherein the reperfusion injury is induced by a procedure selected from the group consisting of thrombolytic therapy, bypass surgery and angioplasty.

11. The method of claim 1 wherein the second growth factor protein is administered by a method of delivery more invasive than the method of delivery utilized for administration of the first growth factor formulation.

12. The method of claim 1 wherein the second growth factor is administered by the same method of delivery utilized for administration of the previous dose.