Combination Preparation of a Biological Response Modifier and an Anticancer Agent and Uses Thereof

A pharmaceutical kit comprising:

• (a) a dosage unit of a composition and a pharmaceutically acceptable carrier wherein the composition comprises small molecular weight components of less than 3000 daltons, and has the following properties:
• (i) is extracted from bile of animals;
• (ii) is capable of stimulating monocytes and/or macrophages;
• (iii) is capable of modulating tumor necrosis factor production and/or release;
• (iv) contains no measurable level of IL-1α, IL-1β, TNF, IL-6, IL-8, IL-4, GM-CSF or IFN-gamma;
• (v) is not cytotoxic to human peripheral blood mononuclear cells;
• and
• (vi) is not an endotoxin;
• and
• (b) a dosage unit of one or more anticancer compounds and a pharmaceutically acceptable carrier,
• said (a) and (b) being provided in amounts that have therapeutic synergy or that improve the therapeutic index in the treatment of cancer over the composition or the one or more anticancer compounds alone.

A pharmaceutical composition comprising:

• (a) a composition comprising small molecular weight components of less than 3000 daltons, and having the following properties:
• (i) is extracted from bile of animals;
• (ii) is capable of stimulating monocytes and/or macrophages;
• (iii) is capable of modulating tumor necrosis factor production and/or release;
• (iv) contains no measurable level of IL-1α, IL-1β, TNF, IL-6, IL-8, IL-4, GM-CSF or IFN-gamma;
• (v) is not cytotoxic to human peripheral blood mononuclear cells;
• and
• (vi) is not an endotoxin;
• (b) one or more anticancer compounds;
• and
• (c) a pharmaceutically acceptable carrier;
• wherein said pharmaceutical composition has therapeutic synergy or improves the therapeutic index in the treatment of cancer over the composition or the one or more anticancer compounds alone.