Methods of use of fibroblast growth factor, vascular endothelial growth factor and related proteins in the treatment of acute and chronic heart disease
First Claim
1. A method for monitoring the clinical effectiveness of the administration of a formulation comprising one or more therapeutic growth factor proteins in the treatment of coronary artery disease, the method comprising the steps of:
- a. selecting a patient displaying symptoms of coronary artery disease;
b. administering at least one dose of an effective amount of a first therapeutic growth factor protein formulation comprising a growth factor protein selected from the group consisting of FGF-1, FGF-2, VEGF-B, and mixtures thereof by inhalation therapy;
c. obtaining a sample of a biological fluid from the patient displaying symptoms of coronary artery disease;
d. performing an assay of the biological fluid to determine an amount of CPK-MB present in the fluid;
e. determining, based on monitoring the amount of CPK-MB present in the fluid, whether an additional dose of a therapeutic growth factor protein formulation is necessary;
f. depending on the results of the step e), administering one or more additional doses of a second growth factor protein formulation comprising a growth factor protein being selected from the group consisting of FGF-1, FGF-2, VEGF-B, and mixtures thereof; and
g. repeating steps c) through f) until the assayed levels of CPK-MB in the biological fluid indicates the clinical effectiveness of the administration of the pharmaceutical formulation and amelioration of the symptoms of coronary artery disease in the patient, or until there is a contraindication to continued treatment.
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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.
28 Citations
8 Claims
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1. A method for monitoring the clinical effectiveness of the administration of a formulation comprising one or more therapeutic growth factor proteins in the treatment of coronary artery disease, the method comprising the steps of:
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a. selecting a patient displaying symptoms of coronary artery disease; b. administering at least one dose of an effective amount of a first therapeutic growth factor protein formulation comprising a growth factor protein selected from the group consisting of FGF-1, FGF-2, VEGF-B, and mixtures thereof by inhalation therapy; c. obtaining a sample of a biological fluid from the patient displaying symptoms of coronary artery disease; d. performing an assay of the biological fluid to determine an amount of CPK-MB present in the fluid; e. determining, based on monitoring the amount of CPK-MB present in the fluid, whether an additional dose of a therapeutic growth factor protein formulation is necessary; f. depending on the results of the step e), administering one or more additional doses of a second growth factor protein formulation comprising a growth factor protein being selected from the group consisting of FGF-1, FGF-2, VEGF-B, and mixtures thereof; and g. repeating steps c) through f) until the assayed levels of CPK-MB in the biological fluid indicates the clinical effectiveness of the administration of the pharmaceutical formulation and amelioration of the symptoms of coronary artery disease in the patient, or until there is a contraindication to continued treatment. - View Dependent Claims (2, 3, 4, 5)
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6. A method for monitoring the clinical effectiveness of the administration of a potentially therapeutic pharmaceutical formulation selected from the group consisting of FGF-1, FGF-2, VEGF-B, and mixtures thereof, in the treatment of chronic coronary artery disease, the method comprising the steps of:
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a. selecting a patient displaying symptoms of chronic coronary artery disease; b. administering at least one dose of an effective amount of a first therapeutic growth factor protein formulation comprising a growth factor protein selected from the group consisting of FGF-1, FGF-2, VEGF-B, and mixtures thereof by inhalation therapy; c. monitoring one or more clinical indicators of chronic coronary artery disease; d. determining, based on monitoring the one or more clinical indicators of chronic coronary artery disease, whether an additional dose of a therapeutic growth factor protein formulation is necessary; e. depending on the results of the step e), administering one or more additional doses of a second growth factor protein formulation comprising a growth factor protein being selected from the group consisting of FGF-1, FGF-2, VEGF-B, and mixtures thereof; and f. repeating steps c) through f) until there is a clinical indication of amelioration of the symptoms of chronic coronary artery disease in the patient, or until there is a contraindication to continued treatment. - View Dependent Claims (7, 8)
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Specification