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Full text of "USPTO Patents Application 09919224"

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WHAT IS CLAIMED IS: 



1 1 . A method of inhibiting the proliferation of a peripheral blood 

2 mononuclear cell population, comprising contacting the peripheral blood mononuclear cell 

3 population with an amount of rhesus or human CMV IL-10 sufficient to inhibit the proliferation 

4 of the peripheral blood mononuclear cell population. 

1 2. The method of claim 1 , wherein the peripheral blood mononuclear 

2 population is contacted with rhesus CMV IL-1 0. 

1 3 . The method of claim 1 , wherein the peripheral blood mononuclear 

2 population is contacted with human CMV IL- 1 0. 

1 4. The method of claim 1 , wherein peripheral blood mononuclear, cells are 

2 proliferating when the contacting step is performed. 

1 5. The method of claim 1, wherein the contacting occurs in vitro. 

1 6. The method of claim 1 , further comprising adding an agent that induces 

2 the peripheral blood mononuclear cells to proliferate. 

1 7. The method of claim 1 , wherein the level of IFN-y secreted by the 

2 peripheral blood mononuclear is cells is detectably reduced responsive to the contacting step. 

1 8. The method of claim 1 , wherein the level of TNF-a secreted by the 

2 peripheral blood monocular cells is detectably reduced responsive to the contacting step. 

1 9. The method of claim 1 , further comprising monitoring the proliferation 

2 level of the peripheral blood mononuclear cells to determine a reduction in the proliferation level 

3 responsive to the contacting step. 

1 10. The method of claim 1 , further comprising monitoring secretion of IFN-y 

2 or TNF-a to determine a reduction in level of secreted IFN-y or TNF-a responsive to the 

3 contacting step. 



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1 1 L The method of claim 1 , wherein the mononuclear proliferating cells 

2 are rhesus or human cells. 

1 12. A method of reducing cytokine production of a monocyte cell population, 

2 comprising contacting the monocyte cell population with an amount of rhesus or human CMV 

3 IL-10 sufficient to reduce cytokine production by the monocyte cell population. 

1 13. The method of claim 12, wherein the contacting occurs in vitro. 

1 14. The method of claim 12, wherein the level of IFN-y secreted by the 

2 monocytes is detectably reduced responsive to the contacting step. 

1 15. The method of claim 1 2, wherein the level of TNF-a secreted by the 

2 monocytes is detectably reduced responsive to the contacting step. 

1 16. The method of claim 12, wherein the level of GM-CSF secreted by the 

2 monocytes is detectably reduced responsive to the contacting step. 

1 17. The method of claim 1 2, wherein the level of IL- 1 a secreted by the 

2 monocytes is detectably reduced responsive to the contacting step. 

1 18. The method of claim 1 2, wherein the level of IL-6 secreted by the 

2 monocytes is detectably reduced responsive to the contacting step. 

1 19 The method of claim 12, further comprising monitoring the cytokine 

2 levels of the monocytes to determine a reduction in the proliferation level responsive to the 

3 contacting step. 

1 20. The method of claim 12, further comprising monitoring secretion of IFN- 

2 y> TNF-a, GM-CSF, IL-la or IL-6 to determine a reduction in level of secreted IFN-y, TNF-a, 

3 GM-CSF, IL-la or IL-6, responsive to the contacting step. 

1 21 . A method of preventing or treating an immune disorder in a patient, 

2 comprising: 



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3 administering rhesus CMV IL-10 or human CMV IL-10 to a patient suffering 

4 from or susceptible to the disorder in a dosage sufficient to inhibit proliferation of 

5 lymphocytes in the patient, and thereby prevent or treat the disorder. 

1 22. The method of claim 2 1 , wherein the rhesus CMV IL- 1 0 or human CMV 

2 IL-10 is a component of a pharmaceutical composition further comprising a pharmaceutically 

3 acceptable carrier. 

1 23 . The method of claim 2 1 , wherein the pharmaceutical composition is 

2 sterile, substantially isotonic and prepared under GMP conditions. 

1 24. The method of claim 2 1 , wherein the patient is suffering from or 

2 susceptible to an immune disorder selected from the group consisting of graft versus host 

3 disease, an autoimmune disease, an inflammatory response, a pathologic delayed type 

4 hypersensitivity response, endotoxin-induced toxic shock, granulomatis disease, psoriasis, 

5 uveitis, systemic lupus erythematous, multiple sclerosis and contact-dermatitis. 

1 25. The method of claim 21, further comprising monitoring proliferation of 

2 the lymphocytes in the patient to detect a reduction in the level of proliferation responsive to the 

3 administering step. 

1 26. The method of claim 2 1 , further comprising monitoring a symptom of the 

2 patient, to detect amelioration or prevention of the symptom responsive to the administering 

3 step. 

1 27. The method of claim 2 1 , wherein the patient is suffering from the 

2 disorder. 

1 28. The method of claim 21, wherein the patient is susceptible to the disorder. 

1 29. The method of claim 28, wherein the patient is an organ transplant patient. 

1 30. The method of claim 29, wherein the organ is a kidney. 



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1 31. The method of claim 30, wherein the IFN-a levels are detectably 

2 decreased responsive to the administering of rhesus or human CMV IL- 1 0. 

1 32. The method of claim 2 1 , wherein the inflammatory disorder is a chronic 

2 inflammatory response. 

1 33. The method of claim 32 wherein the chronic inflammatory disease is 

2 selected from the group consisting of rheumatoid arthritis, inflammatory bowel disease, Crohn's 

3 disease, ulcerative colitis, Graves' disease, Hashimoto's thyroiditis, systemic lupus 

4 erythematosus, multiple sclerosis, scleroderma, and insulin-dependent diabetes mellitus. 

1 34. The method of claim 21, wherein the inflammatory disorder is an allergic 

2 response. 

1 35. The method of claim 34, wherein the inflammatory disorder is asthma. 

1 36. The method of claim 21, wherein the patient is suffering from a type ThI 

2 immune response to transplanted graft. 

1 37. The method of claim 36, wherein the transplanted graft is an organ 

2 selected from the group consisting of cornea, lung, heart, liver, bone marrow, kidney, pancreas, 

3 blood, and skin. 

1 38. The method of claim 25 wherein the immune disorder is leukemia 

1 39. A method of ameliorating symptoms of hepatitis in an animal host, 

2 comprising administering to the animal infected with hepatitis virus an effective dosage CMV 

3 IL-10 sufficient to ameliorate at least one of the symptoms of hepatitis. 

1 40. The method of claim 39, wherein the administering step ameliorates 

2 damage liver in the patient. 

1 41. The method of claim 39, wherein the administering step ameliorates liver 

2 disease or liver fibrosis. 



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1 42. A method of treating or preventing a respiratory viral infection in a 

2 patient, comprising administering rhesus or human CMV IL- 1 0 to the patient suffering from or 

3 susceptible to a virally infected respiratory system in a dosage sufficient to ameliorate at least 

4 one symptom of the respiratory viral infection. 

1 43. A method for reducing an in vivo inflammatory response characterized by 



2 substantially elevated levels of at least one cytokine selected from the group consisting of IL- 1 a, 

3 GM-CSF, IFN-y and TNF-a, comprising administering to the patient afflicted with such an 

4 inflammatory response or at risk for developing such an inflammatory response, an effective 

5 dosage of rhesus CMV IL-10 or human CMV IL-10 to substantially lower the levels of said 



6 cytokines. 

1 44. A method of preventing or treating the symptoms of an inflammatory 

2 response, comprising administering rhesus CMV IL-10 or human CMV IL-10 to the patient 

3 suffering from or susceptible to an inflammatory response in a dosage sufficient to ameliorate at 

4 least some of the symptoms of the inflammatory condition. 

1 45 . The method of claim 44, further comprising monitoring proliferation of 

2 the lymphocytes in the patient to detect a reduction in the level of proliferation responsive to the 

3 administering step. 

1 46. The method of claim 44, further comprising monitoring a symptom of the 

2 patient, to detect amelioration or prevention of the symptom responsive to the administering 

3 step. 

1 47. The method of claim 44, wherein the patient is suffering from the 

2 disorder. 

1 48. The method of claim 44 wherein the inflammatory response is a chronic 

2 inflammatory response. 



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1 49. The method of claim 48 wherein the chronic inflammatory disease is 

2 selected from the group consisting of rheumatoid arthritis, Crohn's disease, ulcerative colitis, 

3 Graves' disease, Hashimoto's thyroiditis and insulin-dependent diabetes mellitus. 



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