Methods of treatment of diseases

• US 10,058,562 B2
• Filed: 04/27/2016
• Issued: 08/28/2018
• Est. Priority Date: 12/19/2012
• Status: Active Grant

• Current Assignee: Ampio Pharmaceuticals, Inc.
• Original Assignee: Ampio Pharmaceuticals, Inc.
• Inventors: Bar-Or, David
• Primary Examiner(s): TRAN, MY CHAU T
• Application Number:
  US15/139,938
• Publication Number:
  US 20160256475A1
• Time in Patent Office: 853 Days
• Field of Search: 514176, 424450
• CPC Class Codes: A61B 5/4839 combined with drug delivery
• CPC Class Codes: A61B 5/4872 Body fat
• CPC Class Codes: A61K 31/58 containing heterocyclic rings, e.g. danazol, stanozolol, pancuronium or digitogenin digitoxin A61K31/7048
• CPC Class Codes: A61K 9/0053 Mouth and digestive tract, i.e. intraoral and peroral administration rectal administration A61K9/0031
• CPC Class Codes: A61P 11/00 Drugs for disorders of the respiratory system
• CPC Class Codes: A61P 13/12 of the kidneys
• CPC Class Codes: A61P 25/02 for peripheral neuropathies
• CPC Class Codes: A61P 27/02 Ophthalmic agents
• CPC Class Codes: A61P 29/00 Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
• CPC Class Codes: A61P 3/00 Drugs for disorders of the metabolism of the blood or the extracellular fluid A61P7/00
• CPC Class Codes: A61P 3/10 for hyperglycaemia, e.g. antidiabetics
• CPC Class Codes: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
• CPC Class Codes: A61P 7/10 Antioedematous agents; Diuretics
• CPC Class Codes: A61P 9/00 Drugs for disorders of the cardiovascular system
• CPC Class Codes: A61P 9/10 for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
• CPC Class Codes: A61P 9/12 Antihypertensives
• CPC Class Codes: A61P 9/14 Vasoprotectives; Antihaemorrhoidals; Drugs for varicose therapy; Capillary stabilisers

Abstract

The invention provides a method of inhibiting vascular hyperpermeability in an animal in need thereof. The method comprises administering a vascular-hyperpermeability-inhibiting amount of a danazol compound to the animal. The method comprises administering an effective amount of a danazol compound to the animal accounting for the body fat content of the animal. The invention also provides a method of modulating the cytoskeleton of an endothelial cell in an animal.

Claims

1. A method of treating nephropathy in an animal in need thereof comprising:

a. determining the body fat content of the animal; and

b. administering to the animal a vascular-hyperpermeability-inhibiting amount of danazol corresponding to the body fat content of the animal.

2. The method of claim 1, wherein the step of determining comprises calculating the body mass index (BMI) of the animal.

3. The method of claim 1 wherein the danazol is administered orally.

4. The method of claim 2, wherein the danazol is administered in an amount between about 0.5 mg/BMI unit/day to about 1.0 mg/BMI unit/day.

5. The method of claim 1, wherein the danazol is administered twice daily.

6. The method of claim 2, wherein the amount of danazol is between about 2 mg/day and about 15 mg/day when the BMI of the animal is less than 26.

7. The method of claim 6, wherein the amount of danazol is about 5 mg/day when the BMI of the animal is less than 26.

8. The method of claim 2, wherein the amount of danazol is between about 2 mg/day and about 15 mg/day when the BMI of the animal is between 26 and 35.

9. The method of claim 8, wherein the amount of danazol is about 10 mg/day when the BMI of the animal is between 26 and 35.

10. The method of claim 2, wherein the amount of danazol is between about 5 mg/day and about 45 mg/day when the BMI of the animal is greater than 35.

11. The method of claim 10, wherein the amount of danazol is about 15 mg/day when the BMI of the animal is greater than 35.

12. The method of claim 1 wherein administration of the danazol is commenced immediately upon diagnosis of nephropathy.

13. The method of claim 1 wherein the animal is in need of danazol because of one or more early signs of, or a predisposition to develop nephropathy.

14. The method of claim 1, wherein the danazol is in a time-release formulation.

15. The method of claim 14, wherein the time-release formulation comprises a component selected from the group consisting of liposomes and polysaccharides.

16. The method claim 1 wherein the animal is a human.