IP Library Granted Patent US 8,911,724
Granted Patent B2
US 8,911,724 · App. 13/720,080 · Granted Dec 16, 2014

Nutrient compositions and methods for enhanced effectiveness of the immune system

Inventor: Jon D. Kaiser (Mill Valley, CA)
Assignee: K-PAX Pharmaceuticals, Inc.
A61K33/34A61K31/455A61K33/22A61K33/00A61K31/51A61K31/519A23L1/302A61K31/525A23L1/3051A61K33/24A61K31/122A61K33/30A61K31/195A61K31/4188A61K33/26A61K33/18A61K45/06A61K31/352A61K33/04A61K31/7076A61K31/385A61K33/06A61K31/375A61K31/714A61K31/381A61K31/198A23L1/3004A61K31/205A23L1/304A61K31/593A61K33/32A61K31/7056
View Patent ↗
Loading inventors, assignments & file history…
Monitor This Case
Get email alerts when status or documents change.
Order Certified Copies
Most orders are placed with the USPTO same day — all within 24 business hours.
Order via The Patent Place →
Pre-filled with this patent's details
Quick Facts
Patent No.
US 8,911,724
App. No.
13/720,080
Granted
Dec 16, 2014
Kind
B2
Abstract

Provided are methods and compositions for increasing CD4 + cell count in mammals, preferably by at least 25%, while undergoing treatment for various conditions whose treatment can have detrimental effects on immune system function. Such conditions include, but are not limited to, HIV infection, cancer, and hepatitis. The compositions include alpha lipoic acid; acetyl L-carnitine; N-acetyl-cysteine; and optionally: zinc, selenium, vitamin C, bioflavinoid complex, vitamin E, co-enzyme Q10, glutathione, beta-carotene, vitamin A, vitamin B1, vitamin B2, vitamin B6, niacinamide, calcium pantothenate, folic acid, vitamin B12, copper, manganese, chromium, and molybdenum.

Claims (44)

1. A method of increasing a mammal's CD4+ cell count while undergoing therapy for treatment of a condition selected from the group consisting of immune-mediated diseases, cancer, heart disease, neurodegenerative disease, and infectious disease, comprising:

administering to the mammal, during a treatment period, a nutrient composition and at least one drug effective for treatment of said condition;

the nutrient composition comprising, in per kg body weight per day:

1.43 mg to 11.42 mg alpha lipoic acid;

3.57 mg to 28.58 mg acetyl L-carnitine; and

4.28 mg to 34.28 mg N-acetyl-cysteine;

whereby the mammal's CD4+ cell count is increased during the treatment period.

2. The method of claim 1 , wherein the nutrient composition further comprises one or more vitamins or minerals selected from the group consisting of zinc, selenium, vitamin C, bioflavinoid complex, vitamin E, beta-carotene, vitamin A, vitamin B1, vitamin B2, vitamin B6, niacinamide, calcium panthothenate, folic acid, vitamin B12, copper, manganese, chromium, and molybdenum.

3. The method of claim 1 , wherein the alpha-lipoic acid, acetyl L-carnitine, and N-acetyl-cysteine are present in the nutrient composition in a ratio from 1:1:1 to 1:4:6.

4. The method of claim 1 , wherein the treatment period is from about three to about twelve weeks.

5. The method of claim 1 , wherein the treatment period is at least fifteen weeks.

6. The method of claim 1 , wherein the nutrient composition is administered orally from one to four times per day.

7. The method of claim 1 , wherein the nutrient composition further comprises one or more antioxidants selected from the group consisting of co-enzyme Q10 and glutathione.

8. The method of claim 2 , wherein the nutrient composition further comprises one or more vitamins or minerals selected from the group consisting of choline, inositol, biotin, vitamin D3, calcium, magnesium, iron, iodine, potassium, boron, betaine, and glutamic acid.

9. The method of claim 1 , wherein the mammal's CD4+ cell count increases by at least 25% compared to pre-administration levels.

10. The method of claim 1 , wherein the mammal's CD4+ cell count increases by at least 40% compared to pre-administration levels.

11. The method of claim 1 , wherein said condition is selected from the group consisting of multiple sclerosis, lupus, rheumatoid arthritis, scleroderma, coronary artery disease, atherosclerotic vessel disease, Madalung's disease, neoplastic conditions, solid tumor malignancies, non-solid malignancies, Alzheimer's disease, Parkinson's disease, infectious hepatitis, toxic hepatitis, drug-induced hepatitis, herpes, human immunodeficiency virus (HIV) infection, and acquired immunodeficiency syndrome (AIDS).

12. A method of treating a human patient suffering from HIV infection or cancer while increasing the patient's CD4+ cell count, comprising:

administering to the patient at least one anti-retroviral drug; and

administering to the patient a nutrient composition comprising, in per patient kg body weight per day:

1.43 mg to 11.42 mg alpha lipoic acid;

3.57 mg to 28.58 mg acetyl L-carnitine; and

4.28 mg to 34.28 mg N-acetyl-cysteine.

13. The method of claim 12 , wherein the nutrient composition further comprises one or more vitamins or minerals selected from the group consisting of zinc, selenium, vitamin C, bioflavinoid complex, vitamin E, vitamin A, and vitamin B.

14. The method of claim 12 , wherein the nutrient composition further comprises at least one of glutathione and co-enzyme Q10.

15. The method of claim 13 , wherein the nutrient composition further comprises one or more vitamins or minerals selected from the group consisting of beta-carotene, vitamin B1, vitamin B2, niacinamide, calcium panthothenate, choline, inositol, folic acid, biotin, vitamin D3, vitamin B12, calcium, magnesium, iron, iodine, copper, manganese, potassium, chromium, molybdenum, boron, betaine, and glutamic acid.

16. The method of claim 12 , wherein the nutrient composition further comprises a vitamin antioxidant selected from the group consisting of vitamin B6 and beta-carotene.

17. The method of claim 12 , wherein the patient's CD4+ cell count is increased by at least 25% compared to pre-administration levels.

18. The method of claim 12 , wherein the patient's CD4+ cell count is increased by at least 40% compared to pre-administration levels.

19. The method of claim 12 , wherein the at least one anti-retroviral drug is a reverse transcriptase inhibitor.

20. The method of claim 19 , wherein the reverse transcriptase inhibitor is a nucleoside inhibitor.

21. The method of claim 12 , wherein the at least one anti-retroviral drug is an HIV protease inhibitor.

22. The method of claim 12 , wherein the anti-retroviral drug is selected from the group consisting of stavudine or didanosine.

23. A nutrient composition comprising a daily dosage of at least:

400 mg alpha lipoic acid;

1000 mg acetyl L-carnitine;

1200 mg N-acetyl-cysteine; and

wherein the alpha-lipoic acid, acetyl L-carnitine, and N-acetyl-cysteine are present in the nutrient composition in a ratio from 1:1:1 to 1:4:6.

24. The composition of claim 23 , further comprising one or more vitamins or minerals selected from the group consisting of zinc, selenium, vitamin C, bioflavinoid complex, vitamin E, beta-carotene, vitamin A, vitamin B1, vitamin B2, vitamin B6, niacinamide, calcium panthothenate, folic acid, vitamin B12, copper, manganese, chromium, and molybdenum.

25. The composition of claim 23 , wherein the daily dosage is in tablet form comprising a total of up to 6 tablets per day.

26. The composition of claim 25 , wherein the tablets comprise at least one multivitamin tablet and at least one multimineral tablet.

27. The composition of claim 23 , further comprising one or more antioxidants selected from the group consisting of co-enzyme Q10 and glutathione.

28. The composition of claim 23 , further comprising one or more vitamins or minerals selected from the group consisting of choline, inositol, biotin, vitamin D3, calcium, magnesium, iron, iodine, potassium, boron, betaine, and glutamic acid.

29. The composition of claim 23 , further comprising vitamin B6 and beta-carotene.

Assignments (1)
CHANGE OF NAME Recorded May 22, 2013
From: K-PAX VITAMINS, INC.
To: K-PAX PHARMACEUTICALS, INC.
Reel/Frame 030470/0821 →
Continuity (4)
Continuation 13117811 · May 27, 2011
Continuation 12044907 · Mar 7, 2008
Continuation 10750545 · Dec 31, 2003
Related Publication 20130183277A1 · Jul 18, 2013