Drug – bio-affecting and body treating compositions – Antigen – epitope – or other immunospecific immunoeffector – Hormone or other secreted growth regulatory factor,...
Patent
1996-11-13
1998-07-07
Feisee, Lila
Drug, bio-affecting and body treating compositions
Antigen, epitope, or other immunospecific immunoeffector
Hormone or other secreted growth regulatory factor,...
514 12, 514 21, A61K 3900, A61K 3818
Patent
active
057764646
DESCRIPTION:
BRIEF SUMMARY
TECHNICAL FIELD
The present invention relates to an agent for relieving side effects caused by immunosuppressants. More particularly, the present invention relates to an agent for relieving side effects which can ease side effects caused by immunosuppressants and which contains HGF (Hepatocyte Growth Factor) as an effective component.
BACKGROUND ART
An immunosuppressant is conventionally used for treatment of an autoimmune disease and malignant tumor, suppression of graft rejection reaction in organ transplantation and the like. An immunosuppressant is a medicine which suppresses an excessively occurring immune response, and is largely classified into a non-specific immunosuppressant or a specific immunosuppressant depending on its specificity of immunosuppression.
Examples of the non-specific immunosuppressant include an adrenocortical hormone (for example, cortisone, dexamethasone or the like), antimetabolic (for example, 6-mercaptopurine, azathiopurine, 5-fluorouracil, methotrexate or the like), alkylating agent (for example, cyclophosphamide, busulfan or the like), alkaloid (for example, vinblastine, vincristine or the like), antibiotic (for example, cyclosporin A and G, FK506 (tacrolimus), mitomycin C, daunorubicin or the like), and the like. Examples of the specific immunosuppressant include an anti-lymphocyte globulin, monoclonal antibodies (for example, anti-CD3 antibody, anti-CD4 antibody and the like) against various antigens expressed on the surface of a lymphocyte, and the like.
Among the above-described immunosuppressants, cyclosporin and FK506 have strong immunosuppression action and accomplish excellent results in suppression of graft rejection reaction in organ transplantation of a kidney, liver, heart, pancreas and the like, therefore, are noted medicine. Both of cyclosporin and FK506 are antibiotic immunosuppressants having a cyclic peptide structure, and is believed to express immunosuppressant effect by blocking an intracellular signal transfer path which introduces expression of a cytokine gene such as IL-2 or the like via activation of a T-cell antigen receptor (TCR) due to antigen stimulation in a T-cell system. More specifically, each one of cyclosporin and FK506 is known to be bound in a cell to a binding protein thereof, and cyclosporin is bound to cyclophilin and FK506 is bound to an FK506 binding protein. These binding proteins are called immunophilin, including their families. The following study revealed that a complex of immunophilin with FK506 or cyclosporin is bound to a serine/threonine dephosphorylation enzyme, calcineurin, and inhibits its enzymatic activity. And now, cyclosporin and FK506 are believed to express immunosuppressant action since a complex of immunophilin with them inhibits enzymatic activity of calcineurin. This theory is supported by the fact that there is a correlation between strength of inhibition of enzymatic activity of calcineurin by a derivative of cyclosporin and FK506 and strength of inhibition of IL-2 synthesis in their T-cells, or the like.
As described above, a lot of immunosuppressants are used, however, any medicine has side effects. For example, multiple-organ or systemic side effects have been reported, such as bone marrow suppression, leukopenia, thrombocytopenia, severe infectious disease, hepatic disorder, kidney disorder, neuropathy, lung disorder, gastrointestinal disorder, anorexia, nausea, vomiting, diarrhea, anemia, gingivostomatitis, alopecia, piloerection, chromatosis, hypotension, arrhythmia, fever, convulsion, infecundity, azoospermia, malaise and the like. Thus, immunosuppressants now used have problems that side effect is strong, dose thereof is restricted and careful attention is necessary in use.
More particularly, an immunosuppressant having strong bone marrow suppression causes leukopenia and easily manifests severe infectious disease, therefore, the dose thereof is necessary to be restricted. Then, acute rejection reaction easily to be manifested in organ transplantation, and dysfunction of transplanted organs often
REFERENCES:
Takada et al., Transplantation Proceedings, vol. 28, No. 2, 1089-1090 (Apr. 1996).
Amaike et al., Cytokine, vol. 8, No. 5, 387-394 (May 1996).
Physicians' Desk reference, 48th Edition (1994).
Strain et al, J. Clin. Invest. 1991 (May), 87(5): 1853-7.
Matsumoto et al, Bioch Bioply Res Comm 1992 vol. 188 pp. 235-243.
Li et al In Vitro Cellular & Developmental Biol. May 1992, vol. 28A:364-8.
Weidmer et al Proc. Natl Acad Sci 1991 Aug. 15 vol. 88: 7001-5.
Shiota et al Proc. Natl Acad Sci. 1992 Jan. 1 89:373-7.
Bussolino et al Joy Cell Biol 1992 Nov. 119:629-41.
Bansal Geetha P.
Feisee Lila
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