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Last Updated: March 28, 2024

Claims for Patent: 5,100,663


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Summary for Patent: 5,100,663
Title: Tyr-Gly compositions useful in increasing immune response
Abstract:Compositions for delaying the progression from AIDS to ARC, and for alleviating symptoms of AIDS and ARC are disclosed together with clinical results of use of such compositions in clinical trials with of actual human patients suffering from these diseases. The compositions are based on a Tyr-Gly amino acid residue sequence. Typical dosage amounts are in the range of femtomoles/kg of body weight.
Inventor(s): Gottlieb; A. Arthur (New Orleans, LA)
Assignee: Imreg, Inc. (New Orleans, LA)
Application Number:07/469,778
Patent Claims:1. A pharmaceutical composition comprising a pharmaceutically acceptable inert carrier and an effective dosage amount of YG Product, essentially free of endotoxin and pyrogen.

2. A packaged pharmaceutical composition according to claim 1 wherein said YG product is endogenous YG-product.

3. A pharmaceutical composition according to claim 1 wherein said YG product is endogenous YG-product.

4. A composition according to claim 1 wherein said YG product is synthetic.

5. A composition according to claim 1 wherein said YG product is mixed with YGG product, and said YG product and said YGG product are respectively present in relative proportions (w/w) of from 10:1 to 25:1.

6. A composition according to claim 1 wherein phenylalanine is also included.

7. A composition according to claim 6 wherein at least one of the following is also included: Phe-Ser, Gly-Gly, Gly-Glu.

8. A composition according to claim 4 wherein said synthetic YG product is N-methylated.

9. A composition according to claim 4 wherein said synthetic YG product is synthetic YG product whose C-terminal carboxyl group is amidified, esterified, or replaced with a pharmaceutically acceptable alcohol.

10. A composition according to claim 1 wherein an effective dosage amount of diagnostic antigen is also included.

11. The composition of claim 10 wherein said antigen is tuberculin.

12. A composition according to claim 1 wherein a dosage amount of an antigen or pathogen associated with a disease is also included and:

(a) said disease-associated antigen or pathogen ordinarily does not provide more than a negligible cell-mediated immune-system response when a person's immune system is challenged with injection of said antigen or pathogen in vaccine form; and

(b) said dosage amount of YG product is effective to provoke a cell-mediated immune-system response when a person's immune system is challenged with said antigen or pathogen in vaccine form in the presence of said dosage amount of amplifier.

13. A composition according to claim 12 wherein said antigen or pathogen is for histoplasmosis, malaria, American trypanosomiasis, leishmaniasis, or pseudorabies.

14. A pharmaceutical composition comprising a pharmaceutically acceptable inert carrier and an effective dosage amount of inhibited YG product.

15. A composition according to claim 14 wherein said YG product is inhibited by mixture with bacitracin, puromycin, or amastatin.

16. A pharmaceutical composition comprising a pharmaceutically acceptable inert carrier and an effective dosage amount of expanded YG product.

17. A composition according to claim 16 wherein said amount is more than 3.times.10.sup.-19 mole per dosage unit and less than 3 f mole per dosage unit.

18. A composition according to claim 16 wherein said expanded YG product is Tyr-D-Ala-Gly and said amount is more than 1 fg per dosage unit and is less than 1 pg per dosage unit.

19. A pharmaceutical composition comprising a pharmaceutically acceptable inert carrier and a predetermined amount of an artificial polypeptide, said polypeptide being one which metabolizes to YG as a result of the action of at least one endogenous human enzyme, and said predetermined amount being sufficient to provide said YG in an effective dosage amount.

20. A composition according to claim 19 wherein said dosage amount is one effective to increase human immune responsiveness to recall antigen.

21. A pharmaceutical composition comprising an amount of Tyr-gly dissolved or suspended in a pharmaceutically acceptable carrier suitable for injection, said amount being effective for stimulating the human immune system and said composition being substantially free of pyrogens and endotoxins.

22. A composition according to claim 21 wherein said carrier is sterile saline.

23. A composition according to claim 22 wherein said carrier is sterile water.

24. A pharmaceutical composition comprising Tyr-Gly, essentially free of endotoxin and pyrogen, and a pharmaceutically acceptable carrier.

25. A pharmaceutical composition comprising an amount of Beta-1.13 that is effective for stimulating the human immune system, and dissolved or suspended in a pharmaceutically acceptable carrier suitable for injection, said composition being substantially free of pyrogen and endotoxin.

26. A pharmaceutical composition comprising an amount of at lest one of the following amplifiers--Beta-1.0, Beta-1.1, Beta-1.11, Beta-1.13--dissolved or suspended in a pharmaceutically acceptable carrier suitable for injection, wherein said amount of amplifier is effective for stimulating the human immune system and wherein said composition is substantially free of pyrogen and endotoxin.

27. A composition according to claim 26 wherein phenylalanine is also present.

28. In a vaccinal composition comprising a carrier and a vaccine-dosage amount of a disease-associated antigen or pathogen known not to provoke more than a negligible cell-mediated immune-system response when a person's immune system is challenged therewith, the improvement consisting of: a YG-dosage amount of YG product mixed with, or chemically linked to, said antigen or pathogen, said YG-dosage amount being sufficient to provoke more than a negligible cell-mediated immune-system response when a persons's immune system is challenged with said vaccine-dosage amount of antigen or pathogen in the presence of said YG-dosage amount of YG-material.

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