Abstract: An adjuvant composition which is a stable oil-in-water emulsion comprising a metabolizable oil, one or more surfactants, an antioxidant and a compound to make the emulsion isotonic is described and claimed. The stable emulsion has a hydrophobic-lipophilic balance (HLB) of from about 7.5 to about 10.5 and a particle size of less than 3 &mgr;m.

Abstract: An adjuvant composition which is a stable oil-in-water emulsion comprising a metabolizable oil, one or more surfactants, an antioxidant and a compound to make the emulsion isotonic is described and claimed. The stable emulsion has a hydrophobic-lipophilic balance (HLB) of from about 7.5 to about 10.5 and a particle size of less than 3 &mgr;m. In a preferred embodiment, the stable emulsion comprises 10% volume to volume squalene, 0.09% weight to volume PLURONIC F-68 block co-polymer, 1.9% weight to volume egg phosphatidyl choline, 1.75% volume to volume glycerol and 0.05% weight to volume &agr; tocopherol. The preferred emulsion has a HLB of 8.0 and a particle size of about 0.2 &mgr;m. In a particularly preferred embodiment, the stable emulsion is combined with an attenuated lipid A derivative such as monophosphoryl lipid A or 3-deacylated monophosphoryl lipid A to enhance the adjuvanticity of the composition.

Abstract: Aminoalkyl glucosamine phosphate compounds that are adjuvants and immunoeffectors are described and claimed. The compounds have a 2-deoxy-2-amino glucose in glycosidic linkage with an aminoalkyl (aglycon) group. Compounds are phosphorylated at the 4 or 6 carbon on the glucosamine ring and comprise three 3-alkanoyloxyalkanoyl residues. The compounds augment antibody production in immunized animals as well as stimulate cytokine production and activate macrophages. Methods for using the compounds as adjuvants and immunoeffectors are also disclosed.

Abstract: The invention concerns a novel phosphoglycolipid compound. The compound of the subject invention is 2-Deoxy-6-O-[2-deoxy-4-O-phosphono-3-O-[(R)-3-tetradecanoyloxytetradecanoy l]-2-[(R)-3-octadecanoyloxytetradecanoylamino]-.beta.-D-glucopyranosyl]-2-[ (R)-3-hexadecanoyloxytetradecanoylamino]-D-glucopyranose and pharmaceutically acceptable salts thereof. The compound is not immunoreactive, not pyrogenic, not toxic but is active in ameliorating tissue damage due to ischemia/reperfusion injury. Methods for using the subject compound to protect against reversible and irreversible damage due to ischemia/reperfusion injury are also disclosed.

Abstract: Methods and compositions for treating type I immunoglobin E (IgE)-dependent hypersensitivity by the administration of monophosphoryl lipid A (MLA) or 3-deacylated monophosphoryl lipid A (3D-MLA) are disclosed. MLA or 3D-MLA administered alone or in combination with an allergen to a patient suffering from type I hypersensitivity reduces levels of total or allergen specific IgE and increases levels of IgG antibody in that patient. MLA and 3D-MLA can be administered as part of a desensitization regimen or as a component of a prophylactic vaccine to prevent a type I hypersensitivity reaction.

Abstract: A method of inhibiting tissue damage in warm blooded animals related to reperfusion of tissues after extended periods of ischemia is presented. The method comprises treatment prior to a planned ischemic event or up to six hours after an unplanned ischemic event with an effective amount of monophosphoryl lipid A or 3-deacylated monophosphoryl lipid A. Pharmaceutical compositions for the treatment are also disclosed.

Abstract: Novel derivatives of monophosphoryl lipid A and a process for their preparation are provided. The derivatives contain one or more free groups, such as an amine, on a side chain attached to the primary hydroxyl groups of the monophosphoryl lipid A nucleus through an ester group. The derivatives provide a convenient method for coupling the lipid A through coupling agents to various biologically active materials, substrates, and the like, wherein the immunostimulant properties of lipid A are desired.

Abstract: Modified lipopolysaccharides, particularly de-3-0-acylated monophosphoryl lipid A and de-3-0-acylated diphosphoryl lipid A, are provided by an alkaline hydrolysis under controlled conditions which removes only the .beta.-hydroxymyristic acyl residue that is ester-linked to the reducing-end glucosamine at position 3. The modified products are less endotoxic and maintain their antigenic and immuno-stimulating properties.

Abstract: Vaccines are provided which are composed of (a) non-toxic and highly effective adjuvants obtained from microbial sources, together with (b) tumor antigens. A wide variety of antigens can be employed in the vaccines and include, antigens obtained from tumors or cultures of tumor cells, such as ovarian cancers, melanomas, colorectal cancers, pancreatic cancers, renal cancers and the like. By adding tumor antigens to potent but non-toxic immunostimulants, a protective and lasting tumor immunity can be obtained.

Abstract: A method is provided for producing an effective adjuvant response or stimulating the immune response of a warm blooded animal which comprises administering to said warm blooded animal an effective amount of a composition comprising refined detoxified endotoxin in combination with a pharmaceutically acceptable carrier.

Abstract: The present invention is directed to a method of inhibiting to onset of septicemia and endotoxemia. The methods comprise administering to a warm-blooded animal an effective amount of a pharmaceutical composition comprising Monophosphoryl lipid A in combination with a pharmaceutically acceptable carrier.

Abstract: An immunological adjuvant is provided which enhances the immune response against antigens, and accordingly is useful in vaccines. The adjuvant system is comprised of (1) a lipid emulsion system containing a metabolizable oil, a low molecular weight polyol and lecithin and (2) at least one refined detoxified bacterial biological adjuvant.

Abstract: An immunological adjuvant for polysaccharide vaccines is provided whereby polysaccharide antigens are rendered more immunogenic and thus stimulate more antibody production including an IgG response and immunological memory. The adjuvant is comprised of (1) either (A) an emulsion system containing a metabolizable oil, a low molecular weight polyol and lecithin, or (B) an oil-in-water emulsion system containing a light hydrocarbon non-biodegradable oil or a biodegradable oil, and a detergent; and (2) a refined detoxified endotoxin. The adjuvant can optionally also contain trehalose dimycolate.

Abstract: A pharmaceutical composition comprising a purified pyridine-soluble extract of a microorganism and a refined detoxified endotoxin which is effective in producing an immunological response in warm blooded animals and humans. Methods of using the composition for these purposes are also disclosed.

Abstract: The present invention is directed to a method of inhibiting the onset of acute radiation syndrome caused by the exposure of warm-blooded animals to a whole body dose of at least about 100 rads of x-radiation. The invention is also directed to a method of inhibiting the onset of septicemia. The methods comprise administering to a warm-blooded animal an effective amount of a pharmaceutical composition comprising refined detoxified endotoxin in combination with a pharmaceutically acceptable carrier.

Abstract: A purified pyridine-soluble extract of a microorganism is disclosed. The extract in a pharmaceutically acceptable medium is useful as an anti-animal tumor agent in the treatment of animals.

Abstract: A method of purifying crude trehalose dimycolates (TDM) is disclosed which comprises dissolving crude TDM in a solvent and then subjecting said solution to a low pressure silica gel column operating at a pressure between about 10 and 300 psi wherein the silica gel comprises particles in the range of between about 15 and 63 microns. The product of this process is also disclosed.

Abstract: A stable composition containing cell wall skeleton (CWS) and trehalose dimycolates (TDM) which may be effectively reconstituted after lyophilization. The composition is useful in the treatment of various cancerous tumors in animals without side effects. Also disclosed is a method of producing the composition and a method of treating cancerous tumors in animals using said composition.

Abstract: A pharmaceutical composition comprising refined detoxified endotoxin, cell wall skeleton and trehalose dimycolate is disclosed which is effective for the treatment of cancerous tumors. Methods of using the composition for these purposes are also disclosed.

Abstract: A pharmaceutical composition comprising refined detoxified endotoxin, trehalose dimycolate, and an acetone precipitated by-product of endotoxic glycolipids extracted with chloroform-methanol (ACP) is disclosed which is useful for the treatment of cancerous tumors. Methods of using the composition for these purposes are also disclosed.