USE OF LEPTIN FOR TREATING HUMAN LIPOATROPHY AND METHOD OF DETERMINING PREDISPOSITION TO SAID TREATMENT

• US 20190321447A1
• Filed: 11/19/2018
• Published: 10/24/2019
• Est. Priority Date: 10/22/2001
• Status: Abandoned Application

• Current Assignee: Amgen Inc., United States Secretary of Health and Human Services is the head of the United States Department of Health and Human Services, Board of Regents of the University of Texas System (University of Texas System)
• Original Assignee: Amgen Inc., The United States of America As Represented By The Secretary of Agriculture, Board of Regents of the University of Texas System (University of Texas System)
• Inventors: DePaoli, Alexander M., Oral, Elif A., Taylor, Simeon I., Garg, Abhimanyu
• Application Number:
  US16/195,661
• Publication Number:
  US 20190321447A1
• Time in Patent Office: Days
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 31/155 Amidines (), e.g. guanidine (H2N—C(=NH)—NH2), isourea (N=C(OH)—NH2), isothiourea (—N=C(SH)—NH2)
• CPC Class Codes: A61K 31/426 1,3-Thiazoles
• CPC Class Codes: A61K 38/2264 Obesity-gene products, e.g. leptin
• CPC Class Codes: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• CPC Class Codes: A61P 1/16 for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
• CPC Class Codes: A61P 21/00 Drugs for disorders of the muscular or neuromuscular system
• 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 3/04 Anorexiants; Antiobesity agents
• CPC Class Codes: A61P 3/06 Antihyperlipidemics
• CPC Class Codes: A61P 3/08 for glucose homeostasis pancreatic hormones A61P5/48
• CPC Class Codes: A61P 3/10 for hyperglycaemia, e.g. antidiabetics
• CPC Class Codes: A61P 31/18 for HIV
• CPC Class Codes: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
• 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: G01N 33/68 involving proteins, peptides or amino acids involving lipoproteins G01N33/92
• CPC Class Codes: G01N 33/74 involving hormones or other non-cytokine intercellular protein regulatory factors such as growth factors, including receptors to hormones and growth factors

Abstract

Leptin, leptin analogs, and leptin derivatives are used to treat patients with lipoatrophy. Leptin is effective against conditions of lipoatrophy for both genetic and acquired forms of the disease. A therapeutically effective amount of leptin can be administered in a variety of ways, including subcutaneously and using gene therapy methods. Methods of the present invention contemplate administration of leptin, leptin analogs, and leptin derivatives to patients having a leptin level of approximately 4 ng/ml or less before treatment.

Claims

1-24. -24. (canceled)

25. A method of determining a predisposition of a lipoatrophic patient to respond to treatment with leptin, leptin analog, or leptin derivative, the method comprising:

(a) determining a leptin level in the patient prior to said treatment; and

(b) ascertaining whether the leptin level is less than or equal to approximately 4 ng/ml.

26. The method of claim 25, wherein said patient is a male and said leptin level is less than or equal to approximately 2 ng/ml prior to treatment.

27. The method of claim 25, wherein said patient is a female.

28. A method of determining a predisposition of a lipoatrophic patient to respond to treatment with leptin, leptin analog, or leptin derivative, the method comprising:

(a) determining a leptin level in the patient prior to said treatment; and

(b) ascertaining whether the leptin level of (i) a male patient is less than or equal to approximately 2 ng/ml, or (ii) a female patient is less than or equal to approximately 4 ng/ml.

29-31. -31. (canceled)

32. An improved kit for determining the predisposition of a human patient with lipoatrophy to respond to treatment with leptin, leptin analog or leptin derivative, the improvement comprising means for determining whether the leptin level of the patient prior to said leptin treatment is:

(i) less than or equal to approximately 2 ng/ml if said patient is male, or

(ii) less than or equal to approximately 4 ng/ml if said patient is female.