IMMUNOMODULATING COMPOSITIONS FROM BILE FOR THE TREATMENT OF IMMUNE SYSTEM DISORDERS

The present invention relates to a composition for use as an immunomodulator comprising small molecular weight components of less than 3000 daltons, and having the following properties: (a) is extractable from bile of animals; (b) is capable of stimulating monocytes and macrophages in vitro and in vivo; (c) is capable of modulating tumor necrosis factor production; (d) contains no measurable IL-1'alpha', IL-1'beta', TNF, IL-6, IL-8, IL-4, GM-CSF or IFN-'gamma'; (e) has an anti-proliferative effect in a malignant mouse hybridoma cell line; (f) shows no cytotoxicity to human peripheral blood mononuclear cells or lymphocytes; and (g) is not an endotoxin. The invention also relates to a method of preparing the composition, its use as an immunomodulator, and its use in the treatment of diseases and conditions having an immunological component, such as cancer or endometriosis.