Drug – bio-affecting and body treating compositions – Lymphokine – Interleukin
Patent
1992-07-14
1995-09-12
Wityshyn, Michael G.
Drug, bio-affecting and body treating compositions
Lymphokine
Interleukin
530351, A61K 4505
Patent
active
054495156
DESCRIPTION:
BRIEF SUMMARY
This invention relates to therapeutic compositions and methods for the treatment of inflammation.
Inflammation is associated with many disease states, such as rheumatoid arthritis, psoriasis, asthma and allergies, and it is generally thought to be caused by inflammatory mediators such as interleukin-1 (IL-1), tumour necrosis factor-.alpha. (TNF-.alpha.), histamine and prostaglandin E.sub.2 (PGE.sub.2).
Therapeutics used for the treatment of inflammation fall into two principle classes, namely glucocorticoids and non-steroidal anti-inflammatory agents. Glucocorticoids (also known as corticosteroids) are among the most potent and widely used anti-inflammatory agents and include naturally occurring corticosteroids such as cortisone and hydrocortisone, and synthetic analogues such as betamethasone, dexamethasone, fluprednisolone, prednisone and paramethasone. Non-steroidal anti-inflammatory agents include aspirin, indomethacin, ibuprofen, phenylbutazone and diflusinal.
These prior therapeutic agents are often characterised by adverse side effects such as oedema,. hypertension, osteoporosis, delayed wound healing, increased susceptibility to infection, menorrhea, liver disfunction, nausea and vomiting.
Interleukin-4 (IL-4), a product of activated T lymphocytes has a variety of stimulatory effects on B cells, T cells and mast cells and may be regarded as a proimmune, proinflammatory molecule. As described in International Patent Application No. WO 87/02990, IL-4 may stimulate mast cells to produce molecules such as histamines and prostaglandins. These agents have been implicated as inflammatory mediators.
To date, conventional compositions and methods for the treatment of inflammation have been associated with significant disadvantageous side effects as detailed above. Accordingly, a need exists for compositions and methods which avoid these disadvantages while providing effective treatment of inflammation.
The present invention solves the problems referred to above by providing therapeutic compositions and methods for treating inflammation. This invention is based on the surprising and unexpected finding that IL-4 and anti-inflammatory agents interact synergistically in the treatment of inflammation, that is, IL-4 potentiates the activity of steroidal and non-steroidal anti-inflammatory drugs. As a consequence, significantly less anti-inflammatory drug may be required in the treatment of inflammation, with a reduction An attendant side effects which typically characterise anti-inflammatory treatments.
According to one aspect of the present invention there is provided a composition for the treatment of inflammation which comprises: carriers or excipients.
As has been previously stated in this specification, anti-inflammatory drugs fall into the categories of glucocorticoids or steroidal anti-inflammatory agents, and non-steroidal anti-inflammatory agents. Any steroidal anti-inflammatory agent may be utilized in the present invention. For example, steroidal anti-inflammatory drugs may be selected from cortisone, betamethasone, dexamethasone, fluprednisolone, hydrocortisone, methylprednisolone, paramethasone, prednisolone, prednisone and triamcinolone. Any non-steroidal anti-inflammatory drug may also be utilized in the invention. For example, non-steroidal anti-inflammatory drugs may be selected from aspirin, inodomethacin, ibuprophen, phenylbutasone and diflusinal. Compositions may contain a combination of steroidal anti-inflammatory agents, non-steroidal anti-inflammatory agents, or both-steroidal and non-steroidal anti-inflammatory agents.
Reference to IL-4 is to be taken as reference to principally the human lymphokine IL-4, as described, for example, in International Patent Application No. WO 87/02990 which is incorporated herein in its entirety by reference. Notwithstanding the above definition, IL-4 also refers to animal IL-4, as produced for example by mice, rats, horses, cats, dogs and sheep. The definition IL-4 includes all proteins, polypeptides and peptides which are natural or recombinant IL-4's or d
REFERENCES:
patent: 4985241 (1991-01-01), Zimmerman et al.
Schleimer, R. P. et al., "Regulation of Human Basophil mediator . . . ", J. Immuno., vol. 143, (4), Aug. 15, 1989, pp. 1310-1317.
Hart et al., "Augmentation of Glucocorhicoid Action on Human . . . " Lymphokine Research, vol. 9 (2), 1990, pp. 147-153.
Hart, P. H. et al., "Potential antiinflammatory effects of IL-4", Proc. Natl. Acad. Sci., vol. 86, pp. 3803-3807, May 1989.
Hart, et al., Proc. Natl. Acad Sci., vol. 86 pp. 3803-3807, May (1989).
Hamilton John A.
Hart Prudence H.
Brunelle Jan P.
Dreger Walter H.
Sayala C.
University Of Melbourne
Wityshyn Michael G.
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