Method for inducing a sustained immune response

• US 10,695,343 B2
• Filed: 10/08/2018
• Issued: 06/30/2020
• Est. Priority Date: 02/18/2016
• Status: Active Grant

• Current Assignee: Cytocom Inc.
• Original Assignee: Immune-One Therapeutics, Inc.
• Inventors: Griffin, Noreen, Shan, Fengping, Plotnikoff, Nicholas
• Primary Examiner(s): Weddington, Kevin E
• Application Number:
  US16/154,333
• Publication Number:
  US 20190321357A1
• Time in Patent Office: 631 Days
• Field of Search: 514282
• 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 31/17 having the group >N—C(O)—N< or >N—C(S)—N<, e.g. urea, thiourea, carmustine isoureas, isothioureas A61K31/155; sulfonylureas A61K31/64
• CPC Class Codes: A61K 31/282 Platinum compounds
• CPC Class Codes: A61K 31/337 having four-membered rings, e.g. taxol
• CPC Class Codes: A61K 31/485 Morphinan derivatives, e.g. morphine, codeine
• CPC Class Codes: A61K 31/505 Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
• CPC Class Codes: A61K 31/506 not condensed and containing further heterocyclic rings
• CPC Class Codes: A61K 31/513 having oxo groups directly attached to the heterocyclic ring, e.g. cytosine
• CPC Class Codes: A61K 31/52 Purines, e.g. adenine
• CPC Class Codes: A61K 31/5377 not condensed and containing further heterocyclic rings, e.g. timolol
• CPC Class Codes: A61K 31/635 having a heterocyclic ring, e.g. sulfadiazine
• CPC Class Codes: A61K 31/655 Azo (—N=N—), diazo (=N2), azoxy (>N—O—N< or N(=O)—N<), azido (—N3) or diazoamino (—N=N—N<) compounds
• CPC Class Codes: A61K 31/675 having nitrogen as a ring hetero atom, e.g. pyridoxal phosphate
• CPC Class Codes: A61K 31/704 attached to a condensed carbocyclic ring system, e.g. sennosides, thiocolchicosides, escin, daunorubicin digitoxin A61K31/7048
• CPC Class Codes: A61K 31/7048 having oxygen as a ring hetero atom, e.g. leucoglucosan, hesperidin, erythromycin, nystatin , digitoxin or digoxin
• CPC Class Codes: A61K 31/7068 having oxo groups directly attached to the pyrimidine ring, e.g. cytidine, cytidylic acid
• CPC Class Codes: A61K 31/7076 containing purines, e.g. adenosine, adenylic acid
• CPC Class Codes: A61K 33/243 Platinum; Compounds thereof
• CPC Class Codes: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• CPC Class Codes: A61K 9/0053 Mouth and digestive tract, i.e. intraoral and peroral administration rectal administration A61K9/0031
• CPC Class Codes: A61K 9/48 : Preparations in capsules, e.g. of gelatin, of chocolate A61K9/0004 takes precedence; bite capsules A61K9/0056
• CPC Class Codes: A61K 9/7007 : Drug-containing films, membranes or sheets A61K9/0041, A61K9/0043, A61K9/006, A61K9/0063 take precedence
• CPC Class Codes: A61P 1/00 : Drugs for disorders of the alimentary tract or the digestive system
• CPC Class Codes: A61P 31/12 : Antivirals
• CPC Class Codes: A61P 35/00 : Antineoplastic agents
• CPC Class Codes: A61P 37/00 : Drugs for immunological or allergic disorders
• CPC Class Codes: A61P 9/00 : Drugs for disorders of the cardiovascular system
• CPC Class Codes: Y02A 50/30 : Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

Abstract

A method for inducing a sustained immune response in humans or animal patient suffering from human immunodeficiency virus (HIV) acquired immune deficiency syndrome (AIDS, autoimmune disease, cancer, inflammation, and neurodegenerative diseases comprises daily administration to such patients a single oral tablet, rapidly dissolving film, capsule, liquid or cream dose of an Immediate release naltrexone composition comprising between about 0.01 to about 10 mg of naltrexone. In order to provide a benefit the naltrexone must be an Immediate release composition comprising between about 0.01 and about 10 mg of naltrexone.

Claims

1. A method for treating or preventing an autoimmune and inflammatory diseases chosen from the group consisting of chronic rheumatoid arthritis inflammatory bowel disease multiple sclerosis, Crohn'"'"'s disease, ulcerative colitis, Hashimoto'"'"'s thyroiditis, systemic sclerosis, myasthenia gravis, chronic obstructive pulmonary disorder (COPD) and diabetic nephropathy comprising administering to a mammal in need thereof an Immediate release pharmaceutical composition comprising between about 0.01 mg and about 10.0 mg of naltrexone or a pharmaceutically acceptable salt thereof.

2. The method of claim 1, wherein the amount of naltrexone is between about 1.0 mg and about 8.0 mg.

3. The method of claim 1, wherein the amount of naltrexone is between about 0.05 mg and about 6.0 mg.

4. The method of claim 1, wherein the amount of naltrexone is between about 0.05 mg and about 4.5 mg.

5. The method of claim 1, wherein the autoimmune and inflammatory disease is Crohn'"'"'s disease.

6. The method of claim 1, wherein said administration is once in a 24 hour period.

7. The method of claim 1, wherein said mammal is a human.

8. The method of claim 1, wherein said pharmaceutically acceptable salt is the hydrochloride salt.

9. The method of claim 1, wherein said Immediate release composition releases the pharmaceutically acceptable salt of naltrexone completely within about 60 minutes.

10. The method of claim 1, wherein said administration is chosen from the group consisting of oral, sublingual, subcutaneous, intramuscular, intravenous, topical, local, intratracheal, intranasal, transdermal and rectal administration.

11. The method of claim 1, wherein said Immediate release composition is in the form of a capsules or tablet.

12. The method of claim 1, wherein said Immediate release composition is in the form of a rapidly dissolving film.