Composition and method for delivery of biologically-active factors

Abstract

In accordance with the present invention, a composition and method is provided that allows for the administration of a biologically-active factors to a human or animal. The present invention can be used to treat a disease with a biologically-active factor or combination of biologically-active factors, or can be used to safely vaccinate a human or animal against a biologically-active factor. It can also be used as a method for the delivery of biologically-active factors for the treatment of disease. Additionally, the present invention also includes a method of targeted drug delivery for the treatment of disease through the administration of custom complexes containing of one or more biologically active factors bound to a colloidal metal where at least one of the biologically-active factors is capable of binding a high affinity receptor on a cell surface.

What is claimed is:  
     
         1 . A composition comprising an admixture of a colloidal metal and a biologically-active factor.  
     
     
         2 . The composition of    claim 1   , wherein the colloidal metal is selected from the group consisting of colloidal gold and colloidal silver.  
     
     
         3 . The composition of    claim 1   , wherein the biologically-active factor is a cytokine, a growth factor, a chemotherapeutic agent, a target molecule, a glycoprotein or a combination of biologically-active factors.  
     
     
         4 . The composition of    claim 1   , wherein the immunologically toxic biologically-active factor is selected from the group consisting of Interleukin-2 (“IL-2”), lipid A, phospholipase A2, endotoxins, staphylococcal enterotoxin B, Type I Interferon, Type II Interferon, Tumor Necrosis Factor, IL-1, IL-6, IL-S, IL-4, Transforming Growth Factor-B, Lymphotoxin, IL-5, Migration Inhibition Factor, IL-3, Granulocyte Macrophage Colony-Stimulating Factor (“CS F”), Monocyte-Macrophage CSF, Granulocyte CSF, IL-7, IL-10, IL-11, IL-12, IL-13, vascular epithelial growth factor (“VEGF”), Angiogenin, transforming growth factor (“TGFα”), heat shock proteins, carbohydrate moieties of blood groups, Rh factors, hormones, receptors, DNA, glucose, antibodies, and fibroblast growth factor.  
     
     
         5 . The composition of    claim 1   , further comprising a pharmaceutically-acceptable component selected from the group consisting of excipients, buffers, antigen stabilizers, and sterilized carriers.  
     
     
         6 . The composition of    claim 1   , further comprising a pharmaceutically-acceptable adjuvant.  
     
     
         7 . The composition of    claim 6   , wherein the adjuvant is selected from the group consisting of Freund's Complete, lipopolysaccharide, monophosphoryl lipid A, muramyl dipeptide, liposomes containing lipid A, alum, muramyl tripeptide-phosphatidyl-ethanoloamine, keyhole limpet hemocyanin, and Freund's Incomplete Adjuvant.  
     
     
         8 . A composition capable of targeting a particular tissue comprising a colloidal metal associated with a target molecule and a biologically-active factor.  
     
     
         9 . A method of administering a biologically-active factor to a human or animal comprising the step of administering to the human or animal, an effective amount of a composition comprising an admixture of a colloidal metal and the biologically-active factor.  
     
     
         10 . The method of    claim 9   , wherein the toxic biologically-active factor is selected from the group consisting of Interleukin-2 (“IL-2”), lipid A, phospholipase A2, endotoxins, staphylococcal enterotoxin B, Type I Interferon, Type II Interferon, tumor necrosis factor, IL-1, IL-6, IL-8, IL-4, Transforming Growth Factor-B, Lymphotoxin, IL-S, Migration Inhibition Factor, IL-3, Granulocyte-Macrophage Colony-Stimulating Factor (“CSF”), Monocyte-Macrophage CSF, Granulocyte CSF, IL-7, IL-10, IL-11, IL-12, IL-13, vascular epithelial growth factor (“VEGF”), Angiogenin, transforming growth factor alpha (“TGFα”), transforming growth factor beta (“TGFβ”), heat shock proteins, carbohydrate moieties of blood groups, Rh factors, hormones, receptors, DNA, glucose, antibodies, and fibroblast growth factor.  
     
     
         11 . A method of vaccinating a human or animal against disease comprising the step of administering to the human or animal a composition comprising an immunologically effective amount of an admixture of a colloidal metal and a biologically-active factor.  
     
     
         12 . The method of    claim 11   , wherein the toxic biologically-active factor is selected from the group consisting of interleukin-2 (“IL-2”), lipid A, phospholipase A2, endotoxins, staphylococcal enterotoxin B, Type I Interferon, Type II Interferon, tumor necrosis factor, IL-1, IL-6, IL-8, IL-4, Transforming Growth Factor-B, Lymphotoxin, IL-5, Migration Inhibition Factor, IL-3, Granulocyte-Macrophage Colony-Stimulating Factor (“CSF”), Monocyte-Macrophage CSF, Granulocyte CSF, IL-7, IL-10, IL-11, IL-12, IL-13, vascular epithelial growth factor (“VEGF”), Angiogenin, transforming growth factor (“TGFa”), heat shock proteins, carbohydrate moieties of blood groups, Rh factors, hormones, receptors, DNA, glucose, antibodies, and fibroblast growth factor.  
     
     
         13 . The method of    claim 11   , wherein the composition is administered in a single dose.  
     
     
         14 . The method of    claim 11   , wherein the composition is administered in multiple doses.  
     
     
         15 . A method of treating a human or animal with a cancer or immune disease comprising the step of administering to the human or animal with the cancer or immune disease a therapeutically effective amount of a composition comprising an admixture of a colloidal metal and a toxic biologically-active factor.  
     
     
         16 . The method of    claim 15   , wherein the toxic biologically-active factor is selected from the group consisting of Interleukin-2 (“IL-2”), lipid A, phospholipase A2, endotoxins, staphylococcal enterotoxin B, Type I Interferon, Type II Interferon, tumor necrosis factor, IL-1, IL-6, IL-8, IL-4, Transforming Growth Factor-B, Lymphotoxin, IL-5, Migration Inhibition Factor, IL-3, Granulocyte-Macrophage Colony-Stimulating Factor (“CSF”), Monocyte-Macrophage CSF, Granulocyte CSF, IL-7, IL-10, IL-11, IL-12, IL-13, vascular epithelial growth factor (“VEGF”), Angiogenin, transforming growth factor alpha (“TGFα”), , transforming growth factor beta (“TGFβ”), heat shock proteins, carbohydrate moieties of blood groups, Rh factors, hormones, receptors, DNA, glucose, antibodies, and fibroblast growth factor.  
     
     
         17 . The method of    claim 15   , wherein the composition is administered in a single dose.  
     
     
         18 . The method of    claim 15   , wherein the composition is administered in multiple doses.  
     
     
         19 . A method for the delivery of one or more biologically-active factors comprising administering to a human or animal a composition comprising one or more biologically-active factors bound to a colloidal metal.  
     
     
         20 . The method of    claim 19    wherein the biologically active factor is selected from the group consisting of Interleukin-1α (“IL-1α”), Interleukin-1β (“IL-1β”), Interleukin-2 (“IL-2”), Interleukin-3 (“IL-3”), Interleukin-4 (“IL-4”), Interleukin-5 (“IL-5”), Interleukin-6 (“IL-6”), Interleukin-7 (“IL-7”), Interleukin-8 (“IL-8”), Interleukin-9 (“IL-9”), Interleukin-10 (“IL-10”), Interleukin-11 (“IL-11”), Interleukin-12 (“IL-12”), Interleukin-13 (“IL-13”), lipid A, phospholipase A2, endotoxins, staphylococcal enterotoxin B, Type I Interferon, Type II Interferon, tumor necrosis factor (“TNFα”), Transforming Growth Factor-β, Lymphotoxin, Migration Inhibition Factor, Granulocyte-Macrophage Colony-Stimulating Factor (“CSF”), Monocyte-Macrophage CSF, Granulocyte CSF, vascular epithelial growth factor (“VEGF”), Angiogenin, transforming growth factor alpha (“TGFα”), transforming growth factor beta (“TGFβ”), heat shock proteins, carbohydrate moieties of blood groups, Rh factors, fibroblast growth factor, chemotherapeutic drugs, AZT, DNA, RNA, sense, and antisense.  
     
     
         21 . A method for the targeted delivery of one or more biologically-active factors comprising administering to a human or animal a composition comprising one or more biologically-active factors wherein at least one of the biologically-active factors is a target molecule capable of binding a receptor on a cell membrane.  
     
     
         22 . The method of    claim 21    wherein the biologically-active factor is selected from the group consisting of Interleukin-1α (“IL-1α”), Interleukin-1β (“IL-1β”), Interleukin-2 (“IL-2”), Interleukin-3 (“IL-3”), Interleukin-4 (“IL-4”), Interleukin-5 (“IL-5”), Interleukin-6 (“IL-6”), Interleukin-7 (“IL-7”), Interleukin-8 (“IL-8”), Interleukin-9 (“IL-9”), Interleukin-10 (“IL-10”), Interleukin-11 (“IL-11”), Interleukin-12 (“IL-12”), Interleukin-13 (“IL-13”), lipid A, phospholipase A2, endotoxins, staphylococcal enterotoxin B, Type I Interferon, Type II Interferon, tumor necrosis factor (“TNFα”), Transforming Growth Factor-β, Lymphotoxin, Migration Inhibition Factor, Granulocyte-Macrophage Colony-Stimulating Factor (“CSF”), Monocyte-Macrophage CSF, Granulocyte CSF, vascular epithelial growth factor (“VEGF”), Angiogenin, transforming growth factor alpha (“TGFα”), transforming growth factor beta (“TGFβ”), heat shock proteins, carbohydrate moieties of blood groups, Rh factors, fibroblast growth factor, chemotherapeutic drugs, AZT, DNA, RNA, sense, and antisense.  
     
     
         23 . The method of    claim 21    wherein the target molecule is selected from the group consisting of Interleukin-1 (“IL-1”), Interleukin-2 (“IL-2”), Interleukin-3 (“IL-3”), Interleukin-4 (“IL-4”), Interleukin-5 (“IL-5”), Interleukin-6 (“IL-6”), Interleukin-7 (“IL-7”), Interleukin-8 (“IL-8”), Interleukin-10 (“IL-10”), Interleukin-11 (“IL-11”), Interleukin-12 (“IL-12”), Interleukin-13 (“IL-13”), Type I Interferon, Type II Interferon, Tumor Necrosis Factor (“TNFα”), Transforming Growth Factor-β (“TGF-β”), vascular epithelial growth factor (“VEGF”), receptor proteins, glucose, glycogen, phosphoipids, and monoclonal and/or polyclonal antibodies, and transforming growth factor (“TGFα”).  
     
     
         24 . A method of treating a human or animal with cancer or an immune disease comprising administering to a human or animal a composition comprising one or more biologically-active factors wherein at least one of the biologically-active factors is a target molecule capable of binding high affinity receptor on a cell membrane.  
     
     
         25 . The method of    claim 24    wherein the biologically-active factor is selected from the group consisting of Interleukin-1α (“IL-1α”), Interleukin-1β (“IL-1β”), Interleukin-2 (“IL-2”), Interleukin-3 (“IL-3”), Interleukin-4 (“IL-4”), Interleukin-5 (“IL-5”), Interleukin-6 (“IL-6”), Interleukin-7 (“IL-7”), Interleukin-8 (“IL-8”), Interleukin-9 (“IL-9”), Interleukin-10 (“IL-10”), Interleukin-11 (“IL-11”), Interleukin-12 (“IL-12”), Interleukin-13 (“IL-13”), lipid A, phospholipase A2, endotoxins, staphylococcal enterotoxin B, Type I Interferon, Type II Interferon, tumor necrosis factor (“TNFα”), Transforming Growth Factor-β, Lymphotoxin, Migration Inhibition Factor, Granulocyte-Macrophage Colony-Stimulating Factor (“CSF”), Monocyte-Macrophage CSF, Granulocyte CSF, vascular epithelial growth factor (“VEGF”), Angiogenin, transforming growth factor alpha (“TGFα”), transforming growth factor beta (“TGFβ”), heat shock proteins, carbohydrate moieties of blood groups, Rh factors, fibroblast growth factor, chemotherapeutic drugs, AZT, DNA, RNA, sense, and antisense.  
     
     
         26 . The method of claim  30  wherein the target molecule is selected from the group consisting of Interleukin-1 (“IL-1”), Interleukin-2 (“IL-2”), Interleukin-3 (“IL-3”), Interleukin-4 (“IL-4”), Interleukin-5 (“IL-5”), Interleukin-6 (“IL-6”), Interleukin-7 (“IL-7”), Interleukin-8 (“IL-8”), Interleukin-10 (“IL-10”), Interleukin-11 (“IL-11”), Interleukin-12 (“IL-12”), Interleukin-13 (“IL-13”), Type I Interferon, Type II Interferon, Tumor Necrosis Factor (“TNFα”), Transforming Growth Factor-β (“TGFβ”), vascular epithelial growth factor (“VEGF”), receptor proteins, glucose, glycogen, phosphoipids, and monoclonal and/or polyclonal antibodies, and transforming growth factor alpha (“TGFα”).