Note: Claims are shown in the official language in which they were submitted.
31
Claims:
1. A method of enhancing immune response in a patient suffering
from a condition selected from the group consisting of:
(a) immunodeficiency resultant from a viral infection;
(b) immunodeficiency resultant from one or more of the following,
bacterial, mycoplasmic, fungal and/or parasitic infections;
(c) immunodeficiency resultant from the growth of neoplastic
tissue;
(d) immunodeficiency resultant from any cytokine or hormone
imbalance or imbalance of any natural product within the patient;
(e) myalgic encephalomyelitis (ME);
(f) post inoculation or viral infection fatigue syndrome;
(g) tuberculosis infection; and
(h) malarial infection,
comprising administering to said patient an immune response enhancing
effective amount of a pharmaceutical formulation comprising at least one
polyclonal or monoclonal antibody, or at least one Fab fragment thereof,
generated to at least one compound selected from the group consisting of:
C-X-A-B-Y-Z;
C-X-A-B-D;
C-X-A-B;
D-A-B-Y-Z; and
A-B-Y-Z;
wherein:
X is a covalent bond or an amino acid sub-sequence comprising at
least one amino acid residue;
Y is a covalent bond or an amino acid sub-sequence comprising at
least one amino acid residue;
D is an amino acid sub-sequence comprising at least one amino
acid residue;
32
A is Lys, Arg or His;
B is Glu or Asp;
C is a carrier compound residue;
Z is a carrier compound residue.
2. A method as recited in claim 11 wherein said at least one
compound consists of 16 or fewer amino acid residues.
3. A method as recited in claim 1, wherein said at least one
compound consists of 8 or fewer amino acid residues.
4. A method as recited in claim 1, wherein said at least one
compound consists of 4 or fewer amino acid residues.
5. A method of enhancing immune response in a patient suffering
from a condition selected from the group consisting of:
(a) immunodeficiency resultant from a viral infection;
(b) immunodeficiency resultant from one or more of the following,
bacterial, mycoplasmic, fungal and/or parasitic infections;
(c) immunodeficiency resultant from the growth of neoplastic
tissue;
(d) immunodeficiency resultant from any cytokine or hormone
imbalance or imbalance of any natural product within the patient;
(e) myalgic encephalomyelitis (ME);
(f) post inoculation or viral infection fatigue syndrome;
(g) tuberculosis infection; and
(h) malarial infection,
comprising administering to said patient an immune response enhancing
effective amount of a pharmaceutical formulation comprising at least one
polyclonal or monoclonal antibody, or at least one Fab fragment thereof,
generated to at least one compound selected from the group consisting of:
D-A-B-E;
33
D-A-B; and
A-B-E;
wherein:
D is an amino acid sub-sequence comprising at least one amino
acid residue;
E is an amino acid sub-sequence comprising at least one amino acid
residue;
A is Lys, Arg or His;
B is Glu or Asp;
and wherein said at least one compound comprises at least 4 amino
acid residues.
6. A method as recited in claim 5, wherein said at least one
compound consists of 16 or fewer amino acid residues.
7. A method as recited in claim 5, wherein said at least one
compound consists of 8 or fewer amino acid residues.
8. A method of treating a condition selected from the group
consisting of:
(a) immunodeficiency resultant from a viral infection;
(b) immunodeficiency resultant from one or more of the following,
bacterial, mycoplasmic, fungal and/or parasitic infections;
(c) immunodeficiency resultant from the growth of neoplastic
tissue;
(d) immunodeficiency resultant from any cytokine or hormone
imbalance or imbalance of any natural product within the patient;
(e) myatgic encephalomyelitis (ME);
(f) post inoculation or viral infection fatigue syndrome;
(g) tuberculosis infection; and
(h) malarial infection,
in a patient in need of such treatment, comprising administering to said
34
patient an
(a) immunodeficiency resultant from a viral infection;
(b) immunodeficiency resultant from one or more of the following,
bacterial, mycoplasmic, fungal and/or parasitic infections;
(c) immunodeficiency resultant from the growth of neoplastic
tissue;
(d) immunodeficiency resultant from any cytokine or hormone
imbalance or imbalance of any natural product within the patient;
(e) myalgic encephalomyelitis (ME);
(f) post inoculation or viral infection fatigue syndrome;
(g) tuberculosis infection; or
(h) malarial infection,
treatment effective amount of a pharmaceutical formulation comprising at
least one polyclonal or monoclonal antibody, or at least one Fab fragment
thereof, generated to at least one compound selected from the group
consisting of:
C-X-A-B-Y-Z;
C-X-A-B-D;
C-X-A-B;
D-A-B-Y-Z, and
A-B-Y-Z;
wherein:
X is a covalent bond or an amino acid sub-sequence comprising at
least one amino acid residue;
Y is a covalent bond or an amino acid sub-sequence comprising at
least one amino acid residue;
D is an amino acid sub-sequence comprising at least one amino
acid residue;
A is Lys, Arg or His;
B is Glu or Asp;
C is a carrier compound residue;
Z is a carrier compound residue.
9. A method as recited in claim 8, wherein said at least one
compound consists of 16 or fewer amino acid residues.
10. A method as recited in claim 8, wherein said at least one
compound consists of 8 or fewer amino acid residues.
11. A method as recited in claim 8, wherein said at least one
compound consists of 4 or fewer amino acid residues.
12. A method of treating a condition selected from the group
consisting of:
(a) immunodeficiency resultant from a viral infection;
(b) immunodeficiency resultant from one or more of the following,
bacterial, mycoplasmic, fungal and/or parasitic infections;
(c) immunodeficiency resultant from the growth of neoplastic
tissue;
(d) immunodeficiency resultant from any cytokine or hormone
imbalance or imbalance of any natural product within the patient;
(e) myalgic encephalomyelitis (ME);
(f) post inoculation or viral infection fatigue syndrome;
(g) tuberculosis infection; and
(h) malarial infection,
in a patient in need of such treatment, comprising administering to said
patient an
(a) immunodeficiency resultant from a viral infection;
(b) immunodeficiency resultant from one or more of the following,
bacterial, mycoplasmic, fungal and/or parasitic infections;
(c) immunodeficiency resultant from the growth of neoplastic
tissue;
(d) immunodeficiency resultant from any cytokine or hormone
imbalance or imbalance of any natural product within the patient;
(e) myalgic Encephalomyelitis (ME);
36
(f) post inoculation or viral infection fatigue syndrome;
(g) tuberculosis infection; or
(h) malarial infection,
treatment effective amount of a pharmaceutical formulation comprising at
least one polyclonal or monoclonal antibody, or at least one Fab fragment
thereof, generated to at least one compound selected from the group
consisting of:
D-A-B-E;
D-A-B; and
A-B-E;
wherein:
D is an amino acid sub-sequence comprising at least one amino
acid residue;
E is an amino acid sub-sequence comprising at least one amino acid
residue;
A is Lys, Arg or His;
B is Glu or Asp;
and wherein said at least one compound comprises at least 4 amino
acid residues.
13. A method as recited in claim 12, wherein said at least one
compound consists of 16 or fewer amino acid residues.
14. A method as recited in claim 12, wherein said at least one
compound consists of 8 or fewer amino acid residues.
15. A method of enhancing immune response in a patient suffering
from immunodeficiency, comprising administering to said patient an
immune response enhancing effective amount of a pharmaceutical
formulation comprising at least one polyclonal or monoclonal antibody, or
at least one Fab fragment thereof, generated to at least one compound
selected from the group consisting of:
37
C-X-A-B-Y-Z;
C-X-A-B-D;
C-X-A-B;
D-A-B-Y-Z; and
A-B-Y-Z;
wherein:
X is a covalent bond or an amino acid sub-sequence comprising at
least one amino acid residue;
Y is a covalent bond or an amino acid sub-sequence comprising at
least one amino acid residue;
D is an amino acid sub-sequence comprising at least one amino
acid residue;
A is Lys, Arg or His;
B is Glu or Asp;
C is a carrier compound residue;
Z is a carrier compound residue.
16. A method of vaccinating against an immunodeficiency
producing infection or condition selected from the group consisting of:
(a) viral infections;
(b) one or more of bacterial, mycoplasmic, fungal and parasitic
infections;
(c) growth of neoplastic tissue;
(d) any cytokine or hormone imbalance or imbalance of any
natural product within the patient;
(e) myalgic encephalomyelitis (ME);
(f) post inoculation or viral infection fatigue syndrome;
(g) tuberculosis infection; and
(h) malarial infection,
in a patient in need of such vaccination, comprising administering to said
patient a vaccination effective amount of a pharmaceutical formulation
comprising:
38
at least one vaccine against said condition; and
at least one polyclonal or monoclonal antibody, or at least one Fab
fragment thereof, generated to at least one compound selected from the
group consisting of:
C-X-A-B-Y-Z;
C-X-A-B-D;
C-X-A-B;
D-A-B-Y-Z; and
A-B-Y-Z;
wherein:
X is a covalent bond or an amino acid sub-sequence comprising at
least one amino acid residue;
Y is a covalent bond or an amino acid sub-sequence comprising at
least one amino acid residue;
D is an amino acid sub-sequence comprising at least one amino
acid residue;
A is Lys, Arg or His;
B is Glu or Asp;
C is a carrier compound residue;
Z is a carrier compound residue.
17. A method as recited in claim 16, wherein said at least one
compound consists of 16 or fewer amino acid residues.
18. A method as recited in claim 16, wherein said at least one
compound consists of 8 or fewer amino acid residues
19. A method as recited in claim 16, wherein said at least one
compound consists of 4 or fewer amino acid residues.
20. A method of vaccinating against a condition selected from the
group consisting of:
39
(a) immunodeficiency resultant from a viral infection;
(b) immunodeficiency resultant from one or more of the following,
bacterial, mycoplasmic, fungal and/or parasitic infections;
(c) immunodeficiency resultant from the growth of neoplastic
tissue;
(d) immunodeficiency resultant from any cytokine or hormone
imbalance or imbalance of any natural product within the patient;
(e) myalgic encephalomyelitis (ME);
(f) post inoculation or viral infection fatigue syndrome;
(g) tuberculosis infection; and
(h) malarial infection,
in a patient in need of such vaccination, comprising administering to said
patient a vaccination effective amount of a pharmaceutical formulation
comprising:
at least one vaccine against said condition; and
at least one polyclonal or monoclonal antibody, or at least one Fab
fragment thereof, generated to at least one compound selected from the
group consisting of:
D-A-B-E;
D-A-B; and
A-B-E;
wherein:
D is an amino acid sub-sequence comprising at least one amino
acid residue;
E is an amino acid sub-sequence comprising at least one amino acid
residue;
A is Lys, Arg or His;
B is Glu or Asp;
and wherein said at least one compound comprises at least 4 amino
acid residues.
21. A method as recited in claim 20, wherein said at least one
compound consists of 16 or fewer amino acid residues.
22. A method as recited in claim 20, wherein said at least one
compound consists of 8 or fewer amino acid residues.
23. A method of enhancing immune response in a patient suffering
from a condition selected from the group consisting of:
(a) immunodeficiency resultant from a viral infection;
(b) immunodeficiency resultant from one or more of the following,
bacterial, mycoplasmic, fungal and/or parasitic infections;
(c) immunodeficiency resultant from the growth of neoplastic
tissue;
(d) immunodeficiency resultant from any cytokine or hormone
imbalance or imbalance of any natural product within the patient;
(e) myalgic encephalomyelitis (ME);
(f) post inoculation or viral infection fatigue syndrome;
(g) tuberculosis infection; and
(h) malarial infection,
comprising administering to said patient an immune response enhancing
effective amount of a pharmaceutical formulation comprising at least one
polyclonal or monoclonal antibody, or at least one Fab fragment thereof,
generated to at least one compound selected from the group consisting of:
C-X-H-A-B-Y-Z;
C-X-H-A-B-D;
C-X-H-A-B;
D-H-A-B-Y-Z;
H-A-B-Y-Z;
C-X-A-B-H-Y-Z;
C-X-A-B-H-D;
C-X-A-B-H;
D-A-B-H-Y-Z; and
A-B-H-Y-Z;
41
wherein:
H is selected from the group consisting of Ala, lle, Leu, Met, Phe,
Trp, Val and Tyr;
X is a covalent bond or an amino acid sub-sequence comprising at
least one amino acid residue;
Y is a covalent bond or an amino acid sub-sequence comprising at
least one amino acid residue;
D is an amino acid sub-sequence comprising at least one amino
acid residue;
A is Lys, Arg or His;
B is Glu or Asp;
C is a carrier compound residue;
Z is a carrier compound residue.
24. A method as recited in claim 23, wherein said at least one
compound consists of 16 or fewer amino acid residues.
25. A method as recited in claim 23, wherein said at least one
compound consists of 8 or fewer amino acid residues.
26. A method as recited in claim 23, wherein said at least one
compound consists of 4 or fewer amino acid residues.
27. A method of enhancing immune response in a patient suffering
from a condition selected from the group consisting of:
(a) immunodeficiency resultant from a viral infection;
(b) immunodeficiency resultant from one or more of the following,
bacterial, mycoplasmic, fungal and/or parasitic infections;
(c) immunodeficiency resultant from the growth of neoplastic
tissue;
(d) immunodeficiency resultant from any cytokine or hormone
imbalance or imbalance of any natural product within the patient;
42
(e) myalgic encephalomyelitis (ME);
(f) post inoculation or viral infection fatigue syndrome;
(g) tuberculosis infection; and
(h) malarial infection,
comprising administering to said patient an immune response enhancing
effective amount of a pharmaceutical formulation comprising at least one
polyclonal or monoclonal antibody, or at least one Fab fragment thereof,
generated to at least one compound selected from the group consisting of:
D-H-A-B-E;
D-H-A-B;
H-A-B-E;
D-A-B-H-E;
D-A-B-H; and
A-B-H-E;
wherein:
H is selected from the group consisting of Ala, lle, Leu, Met, Phe,
Trp, Val and Tyr;
D is an amino acid sub-sequence comprising at least one amino
acid residue;
E is an amino acid sub-sequence comprising at least one amino acid
residue;
A is Lys, Arg or His;
B is Glu or Asp;
and wherein said at least one compound comprises at least 4 amino
acid residues.
28. A method as recited in claim 27, wherein said at least one
compound consists of 16 or fewer amino acid residues.
29. A method as recited in claim 27, wherein said at least one
compound consists of 8 or fewer amino acid residues.
43
30. A method of treating a condition selected from the group
consisting of:
(a) immunodeficiency resultant from a viral infection;
(b) immunodeficiency resultant from one or more of the following,
bacterial, mycoplasmic, fungal and/or parasitic infections;
(c) immunodeficiency resultant from the growth of neoplastic
tissue;
(d) immunodeficiency resultant from any cytokine or hormone
imbalance or imbalance of any natural product within the patient;
(e) myalgic encephalomyelitis (ME);
(f) post inoculation or viral infection fatigue syndrome;
(g) tuberculosis infection; and
(h) malarial infection,
in a patient in need of such treatment, comprising administering to said
patient an
(a) immunodeficiency resultant from a viral infection;
(b) immunodeficiency resultant from one or more of the following,
bacterial, mycoplasmic, fungal and/or parasitic infections;
(c) immunodeficiency resultant from the growth of neoplastic
tissue;
(d) immunodeficiency resultant from any cytokine or hormone
imbalance or imbalance of any natural product within the patient;
(e) myalgic encephalomyelitis (ME);
(f) post inoculation or viral infection fatigue syndrome;
(g) tuberculosis infection; or
(h) malarial infection,
treatment effective amount of a pharmaceutical formulation comprising at
least one polyclonal or monoclonal antibody, or at least one Fab fragment
thereof, generated to at least one compound selected from the group
consisting of:
C-X-H-A-B-Y-Z;
C-X-H-A-B-D;
44
C-X-H-A-B;
D-H-A-B-Y-Z;
H-A-B-Y-Z;
C-X-A-B-H-Y-Z;
C-X-A-B-H-D;
C-X-A-B-H;
D-A-B-H-Y-Z; and
A-B-H-Y-Z;
wherein:
H is selected from the group consisting of Ala, lle, Leu, Met, Phe,
Trp, Val and Tyr;
X is a covalent bond or an amino acid sub-sequence comprising at
least one amino acid residue;
Y is a covalent bond or an amino acid sub-sequence comprising at
least one amino acid residue;
D is an amino acid sub-sequence comprising at least one amino
acid residue;
A is Lys, Arg or His;
B is Glu or Asp;
C is a carrier compound residue;
Z is a carrier compound residue.
31. A method as recited in claim 30, wherein said at least one
compound consists of 16 or fewer amino acid residues.
32. A method as recited in claim 30, wherein said at least one
compound consists of 8 or fewer amino acid residues.
33. A method as recited in claim 30, wherein said at least one
compound consists of 4 or fewer amino acid residues.
34. A method of treating a condition selected from the group
consisting of:
(a) immunodeficiency resultant from a viral infection;
(b) immunodeficiency resultant from one or more of the following,
bacterial, mycoplasmic, fungal and/or parasitic infections;
(c) immunodeficiency resultant from the growth of neoplastic
tissue;
(d) immunodeficiency resultant from any cytokine or hormone
imbalance or imbalance of any natural product within the patient;
(e) myalgic encephalomyelitis (ME);
(f) post inoculation or viral infection fatigue syndrome;
(g) tuberculosis infection; and
(h) malarial infection,
in a patient in need of such treatment, comprising administering to said
patient an
(a) immunodeficiency resultant from a viral infection;
(b) immunodeficiency resultant from one or more of the following,
bacterial, mycoplasmic, fungal and/or parasitic infections;
(c) immunodeficiency resultant from the growth of neoplastic
tissue;
(d) immunodeficiency resultant from any cytokine or hormone
imbalance or imbalance of any natural product within the patient;
(e) myalgic Encephalomyelitis (ME);
(f) post inoculation or viral infection fatigue syndrome;
(g) tuberculosis infection; or
(h) malarial infection,
treatment effective amount of a pharmaceutical formulation comprising at
least one polyclonal or monoclonal antibody, or at least one Fab fragment
thereof, generated to at least one compound selected from the group
consisting of:
D-H-A-B-E;
D-H-A-B;
H-A-B-E;
46
D-A-B-H-E;
D-A-B-H; and
A-B-H-E;
wherein:
H is selected from the group consisting of Ala, lle, Leu, Met, Phe,
Trp, Val and Tyr;
D is an amino acid sub-sequence comprising at least one amino
acid residue;
E is an amino acid sub-sequence comprising at least one amino acid
residue;
A is Lys, Arg or His;
B is Glu or Asp.
35. A method as recited in claim 34, wherein said at least one
compound consists of 16 or fewer amino acid residues.
36. A method as recited in claim 34, wherein said at least one
compound consists of 8 or fewer amino acid residues.
37. A method of enhancing immune response in a patient suffering
from immunodeficiency, comprising administering to said patient an
immune response enhancing effective amount of a pharmaceutical
formulation comprising at least one polyclonal or monoclonal antibody, or
at least one Fab fragment thereof, generated to at least one compound
selected from the group consisting of:
C-X-H-A-B-Y-Z;
C-X-H-A-B-D;
C-X-H-A-B;
D-H-A-B-Y-Z;
H-A-B-Y-Z;
C-X-A-B-H-Y-Z;
C-X-A-B-H-D;
47
C-X-A-B-H;
D-A-B-H-Y-Z; and
A-B-H-Y-Z;
wherein:
H is selected from the group consisting of Ala, lle, Leu, Met, Phe,
Trp, Val and Tyr;
X is a covalent bond or an amino acid sub-sequence comprising at
least one amino acid residue;
Y is a covalent bond or an amino acid sub-sequence comprising at
least one amino acid residue;
D is an amino acid sub-sequence comprising at least one amino
acid residue;
A is Lys, Arg or His;
B is Glu or Asp;
C is a carrier compound residue;
Z is a carrier compound residue.
38. A method of enhancing immune response in a patient suffering
from immunodeficiency, comprising administering to said patient an
immune response enhancing effective amount of a pharmaceutical
formulation comprising at least one polyclonal or monoclonal antibody, or
at least one Fab fragment thereof, generated to at least one compound
selected from the group consisting of:
R1-R2-R3-R4
wherein:
R1 is a region of up to 5AA within which there is one to three AA
from the group Lysine and/or Arginine;
R2 is a short region of up to 2AA which does not contain any of the
following Asp, Glu, Lys, Arg or His;
R3 is a region of up to 7AA within which there may be one or two AA
from the group Aspartic acid and/or Glutamic acid. The Aspartic acid or
Glutamic closest to the R4 region is positioned within R3 to allow a
48
minimum of two AA between these said acids and the R4 region; and
R4 is a region of two AA containing one AA of either Lysine or
Arginine attaching to region R3 and the other AA is either Aspartic acid or
Glutamic acid.
39. A method of enhancing immune response in a patient suffering
from immunodeficiency, comprising administering to said patient an
immune response enhancing effective amount of a pharmaceutical
formulation comprising at least one polyclonal or monoclonal antibody, or
at least one Fab fragment thereof, generated to at least one compound
selected from the group consisting of:
RA-RB-RC-RD, wherein:
RA is a region of up to 5 AA within which there is one to three AA
from the group Lysine and/or Arginine;
RB is a short region of up to 2AA which does not contain any of Asp,
Glu, Lys, Arg or His;
RC is a region of up to 7AA within which there may be one or two AA
from the group Aspartic acid and/or Glutamic acid wherein the Asp or Glu
closest to the RD region is positioned within RC to allow a minimum of two
AA between this said AA, if one exists, and the RD region; and
RD is a region of three or four AA containing one AA of either Lysine
or Arginine attaching to region RC and one or two amino acids in the
middle of the region containing AA from Polar and/or non-Polar with
another AA at the end of the region which is either Asp or Glu.
40. A method of providing an immunosuppressive or
immunoregulatory effect in a patient,
comprising administering to said patient an immunosuppressive or
immunoregulatory amount of a pharmaceutical formulation comprising at
least one polyclonal or monoclonal antibody, or at least one Fab fragment
thereof, generated to at least one compound selected from the group
consisting of:
49
C-X-A-B-Y-Z;
C-X-A-B-D;
C-X-A-B;
D-A-B-Y-Z; and
A-B-Y-Z;
wherein:
X is a covalent bond or an amino acid sub-sequence comprising at
least one amino acid residue;
Y is a covalent bond or an amino acid sub-sequence comprising at
least one amino acid residue;
D is an amino acid sub-sequence comprising at least one amino
acid residue;
A is Lys, Arg or His;
B is Glu or Asp;
C is a carrier compound residue;
Z is a carrier compound residue.
41. A method of providing an immunosuppressive or
immunoregulatory effect in a patient, comprising administering to said
patient an immunosuppressive or immunoregulatory effective amount of a
pharmaceutical formulation comprising at least two Th2 cytokines.
42. A method as recited in claim 41, wherein said at least two Th2
cytokines include Interleukin 10 and Interleukin 4.
43. A method of treatment of graft vs. host disease in a patient in
need of such treatment, comprising administering to said patient Interleukin
10 and Interleukin 4.
44. A method of providing an immunosuppressive or
immunoregulatory effect in a patient, comprising administering to said
patient Interleukin 10, Interleukin 4 and at least one of antagonist of
Interleukin 10 and antagonist of Interleukin 4.
45. A method of providing an immunosuppressive or
immunoregulatory effect in a patient, comprising administering to said
patient Interleukin 10 and Interleukin 4 and at least one of agonist of
Interleukin 10 and agonist of Interleukin 4.
46. A method of providing an immunosuppressive or
immunoregulatory effect in a patient, comprising administering to said
patient anti-serum to Interleukin 10 and anti-serum to Interleukin 4
47. A method of providing an immunosuppressive or
immunoregulatory effect in a patient, comprising administering to said
patient anti-serum to Interleukin 10 and at least one of antagonist of
Interleukin 4 and agonist of Interleukin 4.
48. A method of providing an immunosuppressive or
immunoregulatory effect in a patient, comprising administering to said
patient anti-serum to Interleukin 4 and at least one of antagonist of
Interleukin 10 and agonist of Interleukin 10.
49. A method of enhancing immune response in a patient suffering
from a condition selected from the group consisting of:
(a) immunodeficiency resultant from a viral infection;
(b) immunodeficiency resultant from one or more of the following.
bacterial, mycoplasmic, fungal and/or parasitic infections;
(c) immunodeficiency resultant from the growth of neoplastic
tissue;
(d) immunodeficiency resultant from any cytokine or hormone
imbalance or imbalance of any natural product within the patient;
(e) myalgic encephalomyelitis (ME);
(f) post inoculation or viral infection fatigue syndrome;
51
(g) tuberculosis infection; and
(h) malarial infection,
comprising administering to said patient an immune response enhancing
effective amount of a pharmaceutical formulation comprising at least one
polyclonal or monoclonal antibody, or at least one Fab fragment thereof,
generated to at least one compound selected from the group consisting of:
C-X-A-Q-B-Y-Z;
C-X-A-Q-B-D;
C-X-A-Q-B;
D-A-Q-B-Y-Z; and
A-Q-B-Y-Z;
wherein:
Q is a sub-sequence consisting of one or two amino acid residues;
X is a covalent bond or an amino acid sub-sequence comprising at
least one amino acid residue;
Y is a covalent bond or an amino acid sub-sequence comprising at
least one amino acid residue;
D is an amino acid sub-sequence comprising at least one amino
acid residue;
A is Lys,Arg or His;
B is Glu or Asp;
C is a carrier compound residue;
Z is a carrier compound residue.
50. A method of enhancing immune response in a patient suffering
from a condition selected from the group consisting of:
(a) immunodeficiency resultant from a viral infection;
(b) immunodeficiency resultant from one or more of the following,
bacterial, mycoplasmic, fungal and/or parasitic infections;
(c) immunodeficiency resultant from the growth of neoplastic
tissue;
(d) immunodeficiency resultant from any cytokine or hormone
52
imbalance or imbalance of any natural product within the patient;
(e) myalgic encephalomyelitis (ME);
(f) post inoculation or viral infection fatigue syndrome;
(g) tuberculosis infection; and
(h) malarial infection,
comprising administering to said patient an immune response enhancing
effective amount of a pharmaceutical formulation comprising at least one
polyclonal or monoclonal antibody, or at least one Fab fragment thereof,
generated to at least one compound selected from the group consisting of:
D-A-Q-B-E;
D-A-Q-B; and
A-Q-B-E;
wherein:
Q is a sub-sequence consisting of one or two amino acid residues;
D is an amino acid sub-sequence comprising at least one amino
acid residue;
E is an amino acid sub-sequence comprising at least one amino acid
residue;
A is Lys, Arg or His;
B is Glu or Asp;
and wherein said at least one compound comprises at least 4 amino
acid residues.
51. A method of vaccinating against an immunodeficiency
producing infection or condition selected from the group consisting of:
(a) viral infections;
(b) one or more of bacterial, mycoplasmic, fungal and parasitic
infections;
(c) growth of neoplastic tissue;
(d) any cytokine or hormone imbalance or imbalance of any
natural product within the patient;
(e) myalgic encephalomyelitis (ME);
53
(f) post inoculation or viral infection fatigue syndrome;
(g) tuberculosis infection; and
(h) malarial infection,
in a patient in need of such vaccination, comprising administering to said
patient a vaccination effective amount of a pharmaceuticai formulation
comprising:
at least one vaccine against said condition; and
at least one polyclonal or monoclonal antibody, or at least one Fab
fragment thereof, generated to at least one compound selected from the
group consisting of:
C-X-A-Q-B-Y-Z;
C-X-A-Q-B-D;
C-X-A-Q-B;
D-A-Q-B-Y-Z; and
A-Q-B-Y-Z;
wherein:
Q is a sub-sequence consisting of one or two amino acid residues;
X is a covalent bond or an amino acid sub-sequence comprising at
least one amino acid residue;
Y is a covalent bond or an amino acid sub-sequence comprising at
least one amino acid residue;
D is an amino acid sub-sequence comprising at least one amino
acid residue;
A is Lys, Arg or His;
B is Glu or Asp;
C is a carrier compound residue;
Z is a carrier compound residue.
52. A method of vaccinating against a condition selected from the
group consisting of:
(a) immunodeficiency resultant from a viral infection;
(b) immunodeficiency resultant from one or more of the following,
54
bacterial, mycoplasmic, fungal and/or parasitic infections;
(c) immunodeficiency resultant from the growth of neoplastic
tissue;
(d) immunodeficiency resultant from any cytokine or hormone
imbalance or imbalance of any natural product within the patient;
(e) myalgic encephalomyelitis (ME);
(f) post inoculation or viral infection fatigue syndrome;
(g) tuberculosis infection; and
(h) malarial infection,
in a patient in need of such vaccination, comprising administering to said
patient a vaccination effective amount of a pharmaceutical formulation
comprising:
at least one vaccine against said condition; and
at least one polyclonal or monoclonal antibody, or at least one Fab
fragment thereof, generated to at least one compound selected from the
group consisting of:
D-A-Q-B-E;
D-A-Q-B; and
A-Q-B-E;
wherein:
Q is a sub-sequence consisting of one or two amino acid residues;
D is an amino acid sub-sequence comprising at least one amino
acid residue,
E is an amino acid sub-sequence comprising at least one amino acid
residue;
A is Lys, Arg or His;
B is Glu or Asp;
and wherein said at least one compound comprises at least 4 amino
acid residues.
53. A method of enhancing immune response in a patient suffering
from a condition selected from the group consisting of:
(a) immunodeficiency resultant from a viral infection;
(b) immunodeficiency resultant from one or more of the following,
bacterial, mycoplasmic, fungal and/or parasitic infections;
(c) immunodeficiency resultant from the growth of neoplastic
tissue;
(d) immunodeficiency resultant from any cytokine or hormone
imbalance or imbalance of any natural product within the patient;
(e) myalgic encephatomyelitis (ME);
(f) post inoculation or viral infection fatigue syndrome;
(g) tuberculosis infection; and
(h) malarial infection,
comprising administering to said patient an immune response enhancing
effective amount of a pharmaceutical formulation comprising at least one
polyclonal or monoclonal antibody, or at least one Fab fragment thereof,
generated to at least one compound selected from the group consisting of:
C-X-H-A-Q-B-Y-Z;
C-X-H-A-Q-B-D;
C-X-H-A-Q-B;
D-H-A-Q-B-Y-Z;
H-A-Q-B-Y-Z;
C-X-A-Q-B-H-Y-Z;
C-X-A-Q-B-H-D;
C-X-A-Q-B-H;
D-A-Q-B-H-Y-Z; and
A-Q-B-H-Y-Z;
wherein:
Q is a sub-sequence consisting of one or two amino acid residues;
H is selected from the group consisting of Ala, lle, Leu, Met, Phe,
Trp, Val and Tyr;
X is a covalent bond or an amino acid sub-sequence comprising at
least one amino acid residue;
Y is a covalent bond or an amino acid sub-sequence comprising at
56
least one amino acid residue;
D is an amino acid sub-sequence comprising at least one amino
acid residue;
A is Lys, Arg or His;
B is Glu or Asp;
C is a carrier compound residue;
Z is a carrier compound residue.
54. A method of enhancing immune response in a patient suffering
from a condition selected from the group consisting of;
(a) immunodeficiency resultant from a viral infection;
(b) immunodeficiency resultant from one or more of the following
bacterial, mycoplasmic, fungal and/or parasitic infections;
(c) immunodeficiency resultant from the growth of neoplastic
tissue;
(d) immunodeficiency resultant from any cytokine or hormone
imbalance or imbalance of any natural product within the patient;
(e) myalgic encephalomyelitis (ME);
(f) post inoculation or viral infection fatigue syndrome;
(g) tuberculosis infection; and
(h) malarial infection,
comprising administering to said patient an immune response enhancing
effective amount of a pharmaceutical formulation comprising at least one
polyclonal or monoclonal antibody, or at least one Fab fragment thereof,
generated to at least one compound selected from the group consisting of
D-H-A-Q-B-E;
D-H-A-Q-B;
H-A-Q-B-E;
D-A-Q-B-H-E;
D-A-Q-B-H; and
A-Q-B-H-E;
wherein:
57
Q is a sub-sequence consisting of one or two amino acid residues;
H is selected from the group consisting of Ala, lle, Leu, Met, Phe,
Trp, Val and Tyr;
D is an amino acid sub-sequence comprising at least one amino
acid residue;
E is an amino acid sub-sequence comprising at least one amino acid
residue;
A is Lys, Arg or His;
B is Glu or Asp;
and wherein said at least one compound comprises at least 4 amino
acid residues.
55. A method of reducing immune response in a patient in need of
such treatment, comprising administering to said patient an immune
response reducing effective amount of a pharmaceutical formulation
comprising at least one compound selected from the group consisting of:
C-X-A-B-Y-Z;
C-X-A-B-D;
C-X-A-B;
D-A-B-Y-Z;
A-B-Y-Z;
D-A-B-E;
D-A-B; and
A-B-D;
wherein:
X is a covalent bond or an amino acid sub-sequence comprising at
least one amino acid residue;
Y is a covalent bond or an amino acid sub-sequence comprising at
least one amino acid residue;
D is an amino acid sub-sequence comprising at least one amino
acid residue;
E is an amino acid sub-sequence comprising at least one amino acid
58
residue;
A is Lys, Arg or His;
B is Glu or Asp;
C is a carrier compound residue;
Z is a carrier compound residue.
56. A method as recited in claim 55, wherein said patient is
suffering from one or more condition selected from the group consisting of:
(a) septic shock;
(b) multiple sclerosis;
(c) lupus erythematoses;
(d) auto-immune disease;
(e) replacement of corticosteroid and hydrocortisteroid in the
therapy of auto-immune and dermatological indications where these
steroids were used to induce immuno-suppression; and
(f) graft vs, host disease to reduce immune activity in organ and
tissue transplant rejection.
57. A method of reducing immune response in a patient in need of
such treatment, comprising administering to said patient an immune
response reducing effective amount of a pharmaceutical formulation
comprising at least one compound selected from the group consisting of:
C-X-H-A-B-Y-Z;
C-X-H-A-B-D;
C-X-H-A-B;
D-H-A-B-Y-Z;
H-A-B-Y-Z;
D-H-A-B-E;
D-H-A-B;
A-B-H-D;
C-X-A-B-H-Y-Z;
C-X-A-B-H-D;
59
C-X-A-B-H;
D-A-B-H-Y-Z;
A-B-H-Y-Z;
D-A-B-H-E;
D-A-B-H; and
A-B-H-D;
wherein:
H is selected from the group consisting of Ala, lle, Leu, Met, Phe,
Trp, Val and Tyr;
X is a covalent bond or an amino acid sub-sequence comprising at
least one amino acid residue;
Y is a covalent bond or an amino acid sub-sequence comprising at
least one amino acid residue;
D is an amino acid sub-sequence comprising at least one amino
acid residue;
E is an amino acid sub-sequence comprising at least one amino acid
residue;
A is Lys, Arg or His;
B is Glu or Asp;
C is a carrier compound residue;
Z is a carrier compound residue.
58. A method of vaccinating against at least one
immunosuppressive amino acid sequence selected from the group
consisting of:
Asp-Arg-Ala-Ala-Asp-Gly-Gln-Pro-Ala-Gly; (SEQ ID NO. 1)
HTLV-I gp21E Gln-Asn-Arg-Arg-Gly-Leu-Glu-Leu-Leu-Phe-Trp-
Glu-Gln-Gly-Gly-Leu-Cys-Lys-Ala-Leu-Gln-Glu-Gly-Cys-Arg-Phe; (SEQ ID
NO. 2)
HTLV-II gp21E Gln-Asn-Arg-Arg-Gly-Leu-Glu-Leu-Leu-Phe-Trp-
Glu-Gln-Gly-Gly-Leu-Cys-Lys-Ala-lle-Gln-Glu-Glu-Cys-Cys-Phe; (SEQ ID
NO. 3)
MoLV p15E Gln-Asn-Arg-Arg-Gly-Leu-Glu-Leu-Leu-Phe-Leu-
Lys-Glu-Gly-Gly-Leu-Cys-Ala-Ala-Leu-Lys-Glu-Glu-Cys-Cys-Phe; (SEQ ID
NO. 4)
FeLV p15E Gln-Asn-Arg-Arg-Gly-Leu-Glu-lle-Leu-Phe-Leu-
Gln-Glu-Gly-Gly-Leu-Cys-Ala-Ala-Leu-Lys-Glu-Glu-Cys-Cys-Phe; (SEQ ID
NO. 5) and
Vivax-1
the immunosuppressive effect of which is caused by the presence in said at
least one sequence of one or more positive/negative group, defined as a
two-amino acid sub-sequence where a positive amino acid selected from
Lys, Arg and His is adiacent to a negative amino acid selected from Glu
and Asp, in a patient in need of such vaccination, comprising administering
to said patient an immunosuppressive sequence vaccinating effective
amount of a pharmaceutical formulation comprising at least one modified
sequence, said modified sequence comprising a compound which is
identical to said at least one immunosuppressive sequence, except that at
least one amino acid residue of the two amino acid residues in said one or
more positive/negative group is replaced with:
an antimetabolite of said at least one amino acid residue;
the D-isomer of said at least one amino acid residue; or
an analog of said at least one amino acid residue.
59. A method of vaccinating against at least one
immunosuppressive amino acid sequence which, when present in an
animal, adversely affects the immune response of said animal, said
sequence having a formula selected from the group consisting of:
R-[M-R]n;
[M-S]n; and
[R-M]n;
wherein:
n is a positive integer;
each R is, independently an amino acid sub-sequence comprising at
61
least one amino acid residue;
each M is independently selected from Lys-Glu, Lys-Asp, Arg-Glu,
Arg-Asp, His-Glu, His-Asp, Glu-Lys, Asp-Lys, Glu-Arg, Asp-Arg, Glu-His
and Asp-His;
wherein the immunosuppressive effect of said at least one
immunosuppressive amino acid sequence is caused by the presence in the
sequence of the one or more instance of an M group, in a patient in need of
such vaccination, comprising administering to said patient an
immunosuppressive sequence vaccinating effective amount of a
pharmaceutical formulation comprising at least one compound which is
identical to said at least one immunosuppressive sequence, except that at
least one amino acid residue of the two amino acid residues in said one or
more instance of an M group is replaced with an antimetabolite of said at
least one amino acid residue, the D-isomer of said at least one amino acid
residue, or an analog of said at least one amino acid residue.
60. A method of treating a condition selected from the group
consisting of:
(a) immunodeficiency resultant from a viral infection;
(b) immunodeficiency resultant from one or more of the following.
bacterial, mycoplasmic, fungal and/or parasitic infections;
(c) immunodeficiency resultant from the growth of neoplastic
tissue;
(d) immunodeficiency resultant from any cytokine or hormone
imbalance or imbalance of any natural product within the patient;
(e) myalgic encephalomyelitis (ME);
(f) post inoculation or viral infection fatigue syndrome;
(g) tuberculosis infection; and
(h) malarial infection,
in a patient in need of such treatment, comprising deleting genetic
material from an infectious organism to prevent said genetic material from
generating one or both amino acids in an amino acid sub-sequence
62
selected from the group consisting of Lys-Glu, Lys-Asp, Arg-Glu, Arg-Asp,
His-Glu, His-Asp, Glu-Lys, Asp-Lys, Glu-Arg, Asp-Arg, Glu-His and Asp-
His.
61. A method of treating a condition selected from the group
consisting of:
(a) immunodeficiency resultant from a viral infection;
(b) immunodeficiency resultant from one or more of the following,
bacterial, mycoplasmic, fungal andlor parasitic infections;
(c) immunodeficiency resultant from the growth of neoplastic
tissue;
(d) immunodeficiency resultant from any cytokine or hormone
imbalance or imbalance of any natural product within the patient;
(e) myalgic encephalomyelitis (ME);
(f) post inoculation or viral infection fatigue syndrome;
(g) tuberculosis infection; and
(h) malarial infection,
in a patient in need of such treatment, comprising deleting genetic
material from an infectious organism to prevent said genetic material from
generating one or more amino acids in an amino acid sub-sequence
selected from the group consisting of:
H-K;
K-H; and
H-K-H;
wherein each H is independently selected from the group consisting
of Ala, lle, Leu, Met, Phe, Trp, Val and Tyr;
K is selected from the group consisting of Lys-Glu, Lys-Asp, Arg-
Glu, Arg-Asp, His-Glu, His-Asp, Glu-Lys, Asp-Lys, Glu-Arg, Asp-Arg, Glu-
His and Asp-His.
62. Polyclonal or monoclonal antibody, or at least one Fab fragment
thereof, generated to at least one compound selected from the group
63
consisting of:
C-X-A-B-Y-Z;
C-X-A-B-D;
C-X-A-B;
D-A-B-Y-Z; and
A-B-Y-Z;
wherein:
X is a covalent bond or an amino acid sub-sequence comprising at
least one amino acid residue;
Y is a covalent bond or an amino acid sub-sequence comprising at
least one amino acid residue;
D is an amino acid sub-sequence comprising at least one amino
acid residue;
A is Lys, Arg or His;
B is Glu or Asp;
C is a carrier compound residue;
Z is a carrier compound residue.
63. Polyclonal or monoclonal antibody as recited in claim 62,
wherein said at least one compound consists of 16 or fewer amino acid
residues.
64. Polyclonal or monoclonal antibody as recited in claim 62,
wherein said at least one compound consists of 8 or fewer amino acid
residues.
65. Polyclonal or monoclonal antibody as recited in claim 62,
wherein said at least one compound consists of 4 or fewer amino acid
residues.
66. Polyclonal or monoclonal antibody, or at least one Fab fragment
thereof, generated to at least one compound selected from the group
64
consisting of:
D-A-B-E;
D-A-B; and
A-B-E;
wherein:
D is an amino acid sub-sequence comprising at least one amino
acid residue;
E is an amino acid sub-sequence comprising at least one amino acid
residue;
A is Lys, Arg or His;
B is Glu or Asp;
and wherein said at least one compound comprises at least 4 amino
acid residues.
67. Polyclonal or monoclonal antibody as recited in claim 66,
wherein said at least one compound consists of 16 or fewer amino acid
residues.
68. Polyclonal or monoclonal antibody as recited in claim 66,
wherein said at least one compound consists of 8 or fewer amino acid
residues.
69. A peptide having the formula R1-R2-R3-R4, wherein
R1 is a region of up to 5AA within which there is one to three AA
from the group Lysine and/or Arginine;
R2 is a short region of up to 2AA which does not contain any of the
following: Asp, Glu, Lys, Arg or His;
R3 is a region of up to 7AA within which there may be one or two AA
from the group Aspartic acid and/or Glutamic acid, wherein the Aspartic
acid or Glutamic closest to the R4 region is positioned within R3 to allow a
minimum of two AA between these said acids and the R4 region; and
R4 is a region of two AA containing one AA of either Lysine or
Arginine attaching to region R3 and the other AA is either Aspartic acid or
Glutamic acid.
70. A pharmaceutical composition comprising at least one
compound selected from the group consisting of:
C-X-A-B-Y-Z;
C-X-A-B-D;
C-X-A-B;
D-A-B-Y-Z;
A-B-Y-Z;
D-A-B-E;
D-A-B; and
A-B-D;
wherein:
X is a covalent bond or an amino acid sub-sequence comprising at
least one amino acid residue;
Y is a covalent bond or an amino acid sub-sequence comprising at
least one amino acid residue;
D is an amino acid sub-sequence comprising at least one amino
acid residue;
E is an amino acid sub-sequence comprising at least one amino acid
residue;
A is Lys, Arg or His;
B is Glu or Asp;
C is a carrier compound residue;
Z is a carrier compound residue.
71. A compound selected from the group consisting of:
compounds corresponding to:
Asp-Arg-Ala-Ala-Asp-Gly-Gln-Pro-Ala-Gly; (SEQ ID NO. 1)
HTLV-I gp21E Gln-Asn-Arg-Arg-Gly-Leu-Glu-Leu-Leu-Phe-Trp-
Glu-Gln-Gly-Gly-Leu-Cys-Lys-Ala-Leu-Gln-Glu-Gly-Cys-Arg-Phe; (SEQ ID
66
NO. 2)
HTLV-II gp21E Gln-Asn-Arg-Arg-Gly-Leu-Glu-Leu-Leu-Phe-Trp-
Glu-Gln-Gly-Gly-Leu-Cys-Lys-Ala-Ile-Gln-Glu-Gln-Cys-Cys-Phe; (SEQ ID
NO.3)
MoLV p15E Gln-Asn-Arg-Arg-Gly-Leu-Glu-Leu-Leu-Phe-Leu-
Lys-Glu-Gly-Gly-Leu-Cys-Ala-Ala-Leu-Lys-Glu-Glu-Cys-Cys-Phe; (SEQ ID
NO.4)
FeLV p15E Gln-Asn-Arg-Arg-Gly-Leu-Glu-Ile-Leu-Phe-Leu-
Gln-Glu-Gly-Gly-Leu-Cys-Ala-Ala-Leu-Lys-Glu-Glu-Cys-Cys-Phe; (SEQ ID
NO.5) and
Vivax-1
wherein at least one sub-sequence of two amino acid residues where a
positive amino acid selected from Lys, Arg and His is adjacent to a
negative amino acid selected from Glu and Asp, is replaced with at least
one modified sequence, said modified sequence comprising a compound
which is identical to said at least one sub-sequence, except that at least
one amino acid residue of the two amino acid residues in said one or more
positive/negative group is replaced with:
an antimetabolite of said at least one amino acid residue;
the D-isomer of said at least one amino acid residue; or
an analog of said at least one amino acid residue.
72. A peptide having the formula RA-RB-RC-RD, wherein:
RA is a region of up to 5 AA within which there is one to three AA
from the group Lysine and/or Arginine;
RB is a short region of up to 2AA which does not contain any of Asp,
Glu, Lys, Arg or His;
RC is a region of up to 7AA within which there may be one or two AA
from the group Aspartic acid and/or Glutamic acid wherein the Asp or Glu
closest to the RD region is positioned within RC to allow a minimum of two
M between this said M, if one exists, and the RD region; and
RD is a region of three or four AA containing one AA of either Lysine
67
or Arginine attaching to region RC and one or two amino acids in the
middle of the region containing AA from Polar and/or non-Polar with
another AA at the end of the region which is either Asp or Glu.
73. A pharmaceutical composition comprising at least two Th2
cytokines.
74. A pharmaceutical composition as recited in claim 73, wherein
said at least two Th2 cytokines include Interleukin 10 and Interleukin 4.
75. A pharmaceutical composition comprising Interleukin 10,
Interleukin 4 and at least one of antagonist of Interleukin 10 and antagonist
of Interleukin 4.
76. A pharmaceutical composition comprising Interleukin 10,
Interleukin 4 and at least one of agonist of Interleukin 10 and agonist of
Interleukin 4.
77. A pharmaceutical composition comprising anti-serum to
Interleukin 10 and anti-serum to Interleukin 4.
78. A pharmaceutical composition comprising anti-serum to
Interleukin 10 and at least one of antagonist of Interleukin 4 and agonist of
Interleukin 4.
79. A pharmaceutical composition comprising anti-serum to
Interleukin 4 and at least one of antagonist of Interleukin 10 and agonist of
Interleukin 10.
80. Polyclonal or monoclonal antibody, or at least one Fab fragment
thereof, generated to at least one compound selected from the group
consisting of:
68
C-X-A-Q-B-Y-Z;
C-X-A-Q-B-D;
C-X-A-Q-B;
D-A-Q-B-Y-Z; and
A-Q-B-Y-Z;
wherein:
Q is a sub-sequence consisting of one or two amino acid residues;
X is a covalent bond or an amino acid sub-sequence comprising at
least one amino acid residue;
Y is a covalent bond or an amino acid sub-sequence comprising at
least one amino acid residue;
D is an amino acid sub-sequence comprising at least one amino
acid residue;
A is Lys, Arg or His;
B is Glu or Asp;
C is a carrier compound residue;
Z is a carrier compound residue.
81. Polyclonal or monoclonal antibody, or at least one Fab fragment
thereof, generated to at least one compound selected from the group
consisting of:
D-A-Q-B-E;
D-A-Q-B; and
A-Q-B-E;
wherein:
Q is a sub-sequence consisting of one or two amino acid residues;
D is an amino acid sub-sequence comprising at least one amino
acid residue;
E is an amino acid sub-sequence comprising at least one amino acid
residue;
A is Lys, Arg or His;
B is Glu or Asp;
69
and wherein said at least one compound comprises at least 4 amino
acid residues.
82. Polyclonal or monoclonal antibody, or at least one Fab fragment
thereof, generated to at least one compound selected from the group
consisting of:
C-X-A-Q-B-Y-Z;
C-X-A-Q-B-D;
C-X-A-Q-B;
D-A-Q-B-Y-Z; and
A-Q-B-Y-Z;
wherein:
Q is a sub-sequence consisting of one or two amino acid residues;
X is a covalent bond or an amino acid sub-sequence comprising at
least one amino acid residue;
Y is a covalent bond or an amino acid sub-sequence comprising at
least one amino acid residue;
D is an amino acid sub-sequence comprising at least one amino
acid residue;
A is Lys, Arg or His;
B is Glu or Asp;
C is a carrier compound residue;
Z is a carrier compound residue.
83. Polyclonal or monoclonal antibody, or at least one Fab fragment
thereof, generated to at least one compound selected from the group
consisting of:
D-A-Q-B-E;
D-A-Q-B; and
A-Q-B-E;
wherein:
Q is a sub-sequence consisting of one or two amino acid residues;
D is an amino acid sub-sequence comprising at least one amino
acid residue;
E is an amino acid sub-sequence comprising at least one amino acid
residue;
A is Lys, Arg or His;
B is Glu or Asp;
and wherein said at least one compound comprises at least 4 amino
acid residues.
84. Polyclonal or monoclonal antibody, or at least one Fab fragment
thereof, generated to at least one compound selected from the group
consisting of:
C-X-H-A-Q-B-Y-Z;
C-X-H-A-Q-B-D;
C-X-H-A-Q-B;
D-H-A-Q-B-Y-Z;
H-A-Q-B-Y-Z;
C-X-A-Q-B-H-Y-Z;
C-X-A-Q-B-H-D;
C-X-A-Q-B-H;
D-A-Q-B-H-Y-Z; and
A-Q-B-H-Y-Z;
wherein:
Q is a sub-sequence consisting of one or two amino acid residues;
H is selected from the group consisting of Ala, Ile, Leu, Met, Phe,
Trp, Val and Tyr;
X is a covalent bond or an amino acid sub-sequence comprising at
least one amino acid residue;
Y is a covalent bond or an amino acid sub-sequence comprising at
least one amino acid residue;
D is an amino acid sub-sequence comprising at least one amino
acid residue;
71
A is Lys, Arg or His;
B is Glu or Asp;
C is a carrier compound residue;
Z is a carrier compound residue.
85. Polyclonal or monoclonal antibody, or at least one Fab fragment
thereof, generated to at least one compound selected from the group
consisting of:
D-H-A-Q-B-E;
D-H-A-Q-B;
H-A-Q-B-E;
D-A-Q-B-H-E;
D-A-Q-B-H; and
A-Q-B-H-E;
wherein:
Q is a sub-sequence consisting of one or two amino acid residues;
H is selected from the group consisting of Ala, Ile, Leu, Met, Phe,
Trp, Val and Tyr;
D is an amino acid sub-sequence comprising at least one amino
acid residue;
E is an amino acid sub-sequence comprising at least one amino acid
residue;
A is Lys, Arg or His;
B is Glu or Asp;
and wherein said at least one compound comprises at least 4 amino
acid residues.
86. A method of assaying body fluid from an animal, comprising
contacting said body fluid with at least one antibody as recited in claim 62
or claim 66.
87. A method of screening a vaccine, comprising contacting said
72
vaccine with at least one antibody as recited in claim 62 or 66.
88. A method of treatment of a patent, either animal or human
against any one or more of the following indications or infections listed
below.
(a) Immunodeficiency resultant from a viral infection.
(b) Immunodeficiency resultant from one or more of the following,
bacterial, mycoplasmic, fungal and/or parasitic infections.
(c) Immunodeficiency resultant from the growth of neoplastic
tissue.
(d) Immunodeficiency resultant from any cytokine or hormone
imbalance or imbalance of any natural product within the patient.
(e) Myalgic Encephalomyelitis (ME).
(f) Post inoculation or viral infection fatigue syndrome.
(g) Tuberculosis infection.
(h) Malarial infection.
wherein the treatment comprises administering an effective dosage of a
pharmaceutical formulation comprising polyclonal or monoclonal antibodies
generated to any one or more sequences selected from the group
consisting of:
Ala-His-Asp; Ala-His-Glu; Ala-Lys-Asp; Ala-Lys-Glu; Ala-Arg-Asp;
Ala-Arg-Glu; Ile-His-Asp; Ile-His-Glu; Ile-Lys-Asp; Ile-Lys-Glu; Ile-Arg-Asp;
Ile-Arg-Glu;Leu-His-Asp;Leu-His-Glu;Leu-Lys-Asp;Leu-Lys-Glu;Leu-Arg-As
p; Leu-Arg-Glu; Met-His-Asp; Met-His-Glu; Met-Lys-Asp; Met-Lys-Glu;
Met-Arg-Asp; Met-Arg-Glu; Phe-His-Asp; Phe-His-Glu; Phe-Lys-Asp;
Phe-Lys-Glu; Phe-Arg-Asp;Phe-Arg-Glu; Pro-His-Asp; Pro-His-Glu;
Pro-Lys-Asp; Pro-Lys-Glu; Pro-Arg-Asp; Pro-Arg-Glu; Trp-His-Asp;
Trp-His-Glu; Trp-Lys-Asp; Trp-Lys-Glu; Trp-Arg-Asp; Trp-Arg-Glu;
Val-His-Asp; Val-His-Glu; Val-Lys-Asp; Val-Lys-Glu; Val-Arg-Asp;
Val-Arg-Glu; Ala-Asp-His; Ala-Glu-His; Ala-Asp-Lys; Ala-Glu-Lys;
Ala-Asp-Arg; Ala-Glu-Arg; Ile-Asp-His; Ile-Glu-His; Ile-Asp-Lys; Ile-Glu-Lys;
Ile-Asp-Arg; Ile-Glu-Arg; Leu-Asp-His; Leu-Glu-His; Leu-Asp-Lys;
73
Leu-Glu-Lys; Leu-Asp-Arg; Leu-Glu-Arg; Met-Asp-His; Met-Glu-His;
Met-Asp-Lys; Met-Glu-Lys; Met-Asp-Arg; Met-Glu-Arg; Phe-Asp-His;
Phe-Glu-His; Phe-Asp-Lys; Phe-Glu-Lys; Phe-Asp-Arg; Phe-Glu-Arg;
Pro-Asp-His; Pro-Glu-His; Pro-Asp-Lys; Pro-Glu-Lys; Pro-Asp-Arg;
Pro-Glu-Arg; Trp-Asp-His; Trp-Glu-His; Trp-Asp-Lys; Trp-Glu-Lys;
Trp-Asp-Arg; Trp-Glu-Arg; Val-Asp-His; Val-Glu-His; Val-Asp-Lys;
Val-Glu-Lys; Val-Asp-Arg; and Val-Glu-Arg.
89. A method of treatment of a patient, either animal or human
against any one or more of the following indications:
(a) Septic Shock
(b) Multiple Sclerosis
(c) Lupus Erythematoses
(d) Auto-immune diseases - myasthema gravis, rheumatoid
arthritis, sjogrens disease
(e) Replacement of corticosteroid and hydrocortisteroid in the
therapy of auto-immune and dermatological indications where these
steroids were used to induce immuno-suppression.
(f) Graft v host disease to reduce immune activity in organ and
tissue transplant rejection.
The treatment comprises administration of an effective dosage of
pharmaceutical formulation wherein the active constituent is one or more of
the amino-acid charged ion bridge pairs attached to a hydrophobic amino
acid or acids as outlined herein table
90. A method of preparation of a prophylactic vaccine antigen
using inactivated coat or capsid peptides. Since vaccine preparations
whose antigens contain the specified ion bridge pair hydrophobic amino
acid sequences identified in the patient will not be capable of engendering
protective immunity this preparation method for a vaccine that will produce
both T & B cell memory response requires that when preparing the
antigenic peptide it is necessary to delete or otherwise neutralise these
74
specific sequences by the use of antibodies or deletion during synthesis.
In live vaccine organism generation or synthesis this may be achieved by
using anti-sense RNA and/or DNA strands to prevent synthesis in the
organism of these cytokine like messenger signal sequences thus
producing a viable infecting organism for use in vaccine preparation but
one without the means to effect immunosuppression or avoidance of the T
cell defendant immune system deletion chiron corporation malaria vaccine.
Antigen Vivax-1 and SmithKline Beecham Malaria Vaccine NSI81 V20
sequence Asp-Arg-Ala-Ala-Asp-Gly-Gln-Pro-Ala-Gly (SEQ ID
NO. 6)
both contain the specified sequences which are immunologically privileged
and act as cytokine signal molecules similar to AFP and Interleukin 10. If
these sequences are deleted and the vaccine antigen for malaria contained
only the plasmodium vivax circumsporozoite (CS) protein minus ion bridge
pairs associated with hydrophobic amino acid/or acids together with
antibodies to these specific sequences as outlined in earlier claims then a
proper response by both the T & B cell components of the immune system
can be expected which will confer immunity. Another method capable of
conferring immunity to infection by organisms which have previously
resisted efforts to be good vaccine candidates and this applies to
organisms such as Plasmodium which causes human malaria and to the
HIV-1 HHV and influenza virus is to culture these organisms in the
presence of antisense RNA or DNA to these specific sequences and then
use the inactivated organisms produced to act as vaccine antigen. Also it
is possible to make deletions to the infectious organisms genetic material
so preventing it from generating these specific sequences, such genetically
modified organisms could be used because they would infect, replicate and
generate an immune system attack which would completely remove the
infection since it would have been disarmed by not having these
sequences to allow it shift the balance of the hosts immune attack on it and
the vaccinated subject would retain a balanced complement of B & T cell
memory defences against further infection.
91. A method whereby polyclonal or monoclonal antibodies
generated to the specific sequences listed under Claim X can be used as a
blood/serum or body fluid assay to determine the levels of these specific
peptides since no antibody response would be expected by the affected
human since these specific sequences are immunologically privileged and
do not present as foreign. Since we have identified elevated levels of
these peptides in patients suffering from Myalgic Encephalomyelitis this
assay could be used for both diagnosis and for determining the progress of
therapy in these and other conditions where elevated levels of these
peptide cause disease states.
92. A method of immune treatment in human and/or animal with
pharmaceutical formulations containing in whole or in part polyclonal or
monoclonal antibodies generated to amino acid sequences which exhibit
specific ion bridge charged pair arrays of a positively charged amino acid
and a negatively charged amino acid aligned together enclosed on one or
both sides by a hydrophobic transmembrane segment of amino acids.
There may be more than one ion bridge pair separated by polar or
non-polar amino acids present within the peptide to which the antibodies
are generated.
93. A method of immune treatment in human and/or animal with a
pharmaceutical formulation containing in whole or in part polyclonal or
monoclonal antibodies generated to the peptide of sequence
Leu-Arg-Asp-Leu-Arg-Asp-Ala (SEQ ID NO. 7)
which encloses two ion bridge pairs within non-polar amino acids on both
sides.
94. A method of immune treatment in human and/or animal with a
pharmaceutical formulation containing in whole or in part polyclonal or
monoclonal antibodies generated to the specific peptide sequence
Val-Glu-Arg-Tyr-Leu-Lys-Asp-Gln (SEQ ID NO. 8)
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which encloses two ion bridge pairs within both polar and non-polar amino
acids.
95. A method of immune treatment in human and/or animal with a
pharmaceutical formulation containing in whole or in part polyclonal or
monoclonal antibodies generated to one or a combination of these specific
peptide sequences:
(a) Pro-Lys-Glu-Ile-Ala (SEQ ID NO. 9)
(b) Ala-Asp-Lys-Val-Met (SEQ ID NO. 10)
Val-Glu-Lys-Tyr (SEQ ID NO. 11)
Leu-Glu-Lys-Tyr (SEQ ID NO. 12)
Tyr-Asp-Lys-Ile (SEQ ID NO. 13)
Leu-Glu-Lys-Ile (SEQ ID NO. 14)
Ser-Glu-Arg-Leu (SEQ ID NO. 15)
Gly-Glu-Lys-Ile (SEQ ID NO. 16)
Leu-Glu-Arg-Gly (SEQ ID NO. 17)
Tyr-Glu-His-Val (SEQ ID NO. 18)
Leu-Glu-Lys-Cys (SEQ ID NO. 19)
Gly-Asp-Arg-Ala (SEQ ID NO. 20)
Gly-Glu-Lys-Leu (SEQ ID NO. 21)
Thr-Glu-Arg-Val (SEQ ID NO. 22)
Thr-Asp-Arg-Val (SEQ ID NO. 23)
Val-Glu-Arg-Tyr (SEQ ID NO. 24)
Gln-Asp-Lys-Leu (SEQ ID NO. 25)
Thr-Glu-His-Leu (SEQ ID NO. 26)
Leu-Asp-Arg-Leu (SEQ ID NO. 27)
Phe-Glu-Lys-Thr (SEQ ID NO. 28)
Ser-Arg-Asp-Leu (SEQ ID NO. 29)
Leu-Glu-Lys-Tyr (SEQ ID NO. 30)
Asn-Glu-Arg-Leu (SEQ ID NO. 31)
Ile-Glu-Lys-Thr (SEQ ID NO. 32) and
Asn-Glu-Lys-Phe (SEQ ID NO. 33).
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96. A method according to Claims 88-91 wherein said antigenic
peptide is selected from the group consisting in whole or in part, of human,
animal, synthetic or recombinant alpha-fetoprotein (AFP) and/or cytokine
inhibitory factor (Interleukin 10), Malaria circumsporozite, Viral peptides.
97. A method for treating a patient, comprising administering a
pharmaceutical formulation containing polyclonal and/or monoclonal
antibodies to sequences as specified in Claims 88-91 as a therapeutic for
the binding and removal of peptides generated by the infected host or
infecting organism which have been specifically enhanced by the infecting
organism to render a down regulation in Th1 cell type dependent immune
resistance to infection.
98. A method as recited in any one of claims 1-61 and 88-97,
further comprising administering to said patient an antiviral therapy.
99. A method as recited in claim 98, wherein said antiviral therapy
comprises administration of AZT.
100. A pharmaceutical composition as recited in any one of claims
70 and 73-79, further comprising administering to said patient an antiviral
material.
101. A pharmaceutical formulation as recited in claim 100, wherein
said antiviral material comprises AZT.
102. A pharmaceutical formulation comprising at least one antibody
as recited in any one of claims 62-68 and 80-85, together with an antiviral
material.
103. A pharmaceutical formulation as recited in claim 102, wherein
said antiviral material comprises AZT.
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104. A pharmaceutical formulation comprising at least one peptide
as recited in any one of claims 69 and 72, together with an antiviral
material
105. A pharmaceutical formulation as recited in claim 104, wherein
said antiviral material comprises AZT.
106. A pharmaceutical formulation comprising at least one
compound as recited in claim 71, together with an antiviral material.
107. A pharmaceutical formulation as recited in claim 106, wherein
said antiviral material comprises AZT.
108. A treatment for animals and humans suffering from
immunosuppressive disease whereby the patient is administered a cellular
receptor to a Th2 cytokine.
109. A treatment for animals and humans suffering from
immunosuppressive disease whereby the patient is administered cellular
receptors to two or more Th2 cytokine in a combination therapy.
110. A treatment according to claim 108 or 109 wherein the
immunosuppressive disease is resultant from a viral infection.
111. A treatment according to Claim 108 or 109 wherein the
immunosuppressive disease is resultant from a bacterial infection.
112. A treatment according to Claim 108 or 109 wherein the
immunosuppressive disease is resultant from a fungal infection
113. A treatment according to Claim 108 or 109 where the cellular
receptor to the Th2 cytokine is one or more of the following Interleukin-4
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receptor, Interleukin-6 receptor and/or Interleukin-10 receptor.
114. A treatment according to Claim 109 wherein the cellular
receptors to the cytokines are administered in a specific ratio dependant on
the disease state.
115. A treatment according to any one of Claims 108-113 wherein
the cellular receptor to the cytokines is administered by IV, enema or
transdermal patch in dose amounts of between 10-500 ug per day.
116. A treatment according to any one of claims 108-113 wherein
the cellular receptor to the cytokines is administered as a soluble receptor.
117. A treatment according to claim 108 or 109 wherein the
treatment is for the removal of Th2 cytokines/AFP immunosuppressive
mimic peptides of viral/vacterial or parasitic origin.
118. A method of achieving improved immune response in a
patient, said method comprising administering an amount of an antagonist,
in the form of an amino acid sequence of greater than two amino acids in
length, of Interleukin 10 (IL-10) or part thereof wherein one or more of the
negatively charged R groups of IL-10 is a D amino acid.
119. A method of achieving improved immune response in a
patient, said method comprising administering an amount of an antagonist,
in the form of an amino acid sequence of greater than two amino acids in
length, of Interleukin 10 (IL-10) or part thereof wherein one or more of the
positively charged R groups of IL-10 is a D amino acid.
120. A method of achieving improved immune response in a
patient, said method comprising administering an amount of an antagonist,
in the form of an amino acid sequence of greater than two amino acids in
length, of Interleukin 10 (IL-10) or part thereof wherein one or more of
each of the negatively and positively charged R groups of IL-10 is a D
amino acid.
121. A method of achieving improved immune response in a
patient, said method comprising administering an amount of an antagonist,
in the form of an amino acid sequence of greater than two amino acids in
length, of Interleukin 10 (IL-10) or part thereof wherein one or more of the
polar uncharged R groups of IL-10 is a D amino acid.
122. A method of achieving improved immune response in a
patient, said method comprising administering an amount of an antagonist,
in the form of an amino acid sequence of greater than two amino acids in
length, of Interleukin 10 (IL-10) or part thereof wherein one or more of the
non-polar uncharged R groups of IL-10 is a D amino acid.
123. A method of achieving improved immune response in a
patient, said method comprising administering an amount of an antagonist,
in the form of an amino acid sequence of greater than two amino acids in
length, of Interleukin 10 (IL-10) or part thereof wherein one or more of each
of the non-polar and polar uncharged R groups of IL-10 is a D amino acid.
124. A method of achieving improved immune response in a
patient, said method comprising administering an amount of an antagonist,
in the form of an amino acid sequence of greater than two amino acids in
length, of Interleukin 10 (IL-10) or part thereof wherein one or more of each
of the negatively charged, non-polar and polar uncharged R groups of
IL-10 is a D amino acid.
125. A method of achieving improved immune response in a
patient, said method comprising administering an amount of an antagonist,
in the form of an amino acid sequence of greater than two amino acids in
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length, of Interleukin 10 (IL-10) or part thereof wherein one or more of each
of the positively charged, non-polar and polar uncharged R groups of IL-10
is a D amino acid.
126. A method of achieving improved immune response in a
patient, said method comprising administering an amount of an antagonist,
in the form of an amino acid sequence of greater than two amino acids in
length, of Interleukin 10 (IL-10) or part thereof wherein one or more of each
of the positively charged, negatively charged, non-polar and polar
uncharged R groups of IL-10 is a D amino acid.