Abstract: This invention describes of a means of stabilizing lipophilic drugs for long-term storage by incorporating them into a “thermally stabilized nanoemulsion” that has a phase transition temperature that is at or below the body temperature of 37 C and above a storage temperature of 4-8 C. One or more lipid soluble drugs are incorporated into the nanoemulsion at an elevated temperature above the phase transition temperature of the nanoemulsion and then stabilized for extended storage by lowering the temperature to below its phase transition temperature. This causes the nanoemulsion to transform into solid lipid nanospheres entrapping the drug within the solid lipid matrix. Upon rewarming the lipid nanospheres they will reconvert to an oil-in-water nanoemulsion suitable for administration to the patient in need.

Abstract: This invention teaches a targeted apheresis device that contains a plurality of different immobilized binding agents that can simultaneously target and bind out multiple proinflammatory factors belonging to three distinct proinflammatory systems: These systems are 1) proinflammatory factors that bind to the cell membrane; 2) the complement system; and 3) proinflammatory cytokines. This invention teaches a unique targeted apheresis device to remove a) C-Reactive Protein (CRP); and b) complement C1q; and c) Tumor Necrosis Factor (TNF); and optionally d) one or more other complement components, and/or one or more other proinflammatory cytokines. In one embodiment of this invention the targeted apheresis device is modified such that it will remove blood leukocytes in addition to removing CRP, C1q and TNF. Removing both cellular and humoral proinflammatory factors will further inhibit the harmful inflammatory process that occurs in many diseases and following tissue injury.

Abstract: This invention teaches a targeted apheresis method of treating a pregnant woman with preeclampsia, or who is predisposed to developing preeclampsia, utilizing immobilized binding agents contained within an apheresis device to remove sVEGFR-1 and sVEGFR-2, and one or more other harmful factors associated with preeclampsia selected from a list that includes: sEndoglin, Endothelin-1, TNF, IL-1, IL-6, IL-12, IL-18, digitalis-like factor, ouabain-like factor, marinobufagenin, .marinobufotoxenin, and telocinobufagin. The binding agents used are antibodies or aptamers or binding peptides. Reducing the concentration of sVEGFR-1, sVEGFR-2 and other harmful factors in the pregnant woman's blood using targeted apheresis will alleviate or delay the symptoms of preeclampsia, and thus postpone premature delivery of the baby so that the baby is born at term or as close to term as possible.

Abstract: Disclosed herein are immunogenic compositions for producing immediate and sustained immunity to infectious viral and bacteriological pathogens. A univalent immunogenic composition is disclosed comprising an isolated antigen and a polynucleotide formulated into a nanoparticle or liposome. Furthermore, multivalent immunogenic compositions are disclosed comprising multiple univalent immunogenic compositions. Also disclosed, are methods of inducing protective or therapeutic immune responses in individuals comprising administering one or more univalent immunogenic compositions.

Abstract: A system for detecting potential for infection includes a wound dressing and an electronics component. The wound dressing includes a temperature sensing layer and a cover layer comprising a substrate and a backing layer. The electronics component includes a power source, an electronic control unit (ECU), and a communications interface positioned within a housing and removably coupled to the temperature sensing layer of the wound dressing. The electronics component is configured to receive a plurality of temperature readings from the temperature sensing layer, and provide an indication of potential infection of the wound based the plurality of temperature readings. In various embodiments, each of the plurality of temperature readings corresponds to a temperature of an area around a wound. Methods for preventing infections using the system are also described.

Abstract: This invention teaches a means of rapidly producing a vaccine following a viral outbreak and using said vaccine to prevent the outbreak from becoming a pandemic. Said vaccine is composed of multiple immunostimulatory agents (agonists) incorporated in liposomes. Each agonist will bind to its specific cellular receptor and induce the cell to produce type 1 interferons which has strong anti-viral activity. The agonists are Poly IC, ssRNA, CpG-ODN and MPL-A incorporated in a liposomal vaccine. Using multiple different agonists in the vaccine will elicit a stronger innate immune response than using a single agonist. This vaccine can be enhanced by combining a viral antigen with the agonists in the liposome. Said enhanced vaccine will provide immediate and prolonged immunity to viral infection by stimulating both the innate immune response and the adaptive immune response against the virus.

Abstract: This invention teaches a targeted apheresis method of treating a pregnant woman with preeclampsia, or who is predisposed to developing preeclampsia, utilizing immobilized binding agents contained within an apheresis device to remove sVEGFR-1 and sVEGFR-2, and one or more other harmful factors associated with preeclampsia selected from a list that includes: sEndoglin, Endothelin-1, TNF, IL-1, IL-6, IL-12, IL-18, digitalis-like factor, ouabain-like factor, marinobufagenin, .marinobufotoxenin, and telocinobufagin. The binding agents used are antibodies or aptamers or binding peptides. Reducing the concentration of sVEGFR-1, sVEGFR-2 and other harmful factors in the pregnant woman's blood using targeted apheresis will alleviate or delay the symptoms of preeclampsia, and thus postpone premature delivery of the baby so that the baby is born at term or as close to term as possible.

Abstract: Cancer patients have circulating tumor cell components in their blood. When a therapeutic biologic or biosimilar is administered intravenously into the patient it can bind to these tumor cell components causing adverse side-effects. This invention teaches a targeted apheresis method of removing these interfering tumor cell components by binding them out using an immobilized binding agent contained within an apheresis device, and returning the treated blood back to the patient. Reducing the level of circulating tumor cell components before administering a biologic or biosimilar will increase its safety and efficacy in treating the tumor.

Abstract: This invention discloses a pharmaceutical composition for treating tumors wherein said pharmaceutical comprises a proinflammatory cytokine such as Tumor Necrosis Factor alpha (TNF-a) combined with one or more small molecule cancer drugs within the same liposome. The liposomes are sized to be below 250 nm in diameter to enable them to localize within the tumor due to the Enhanced Permeability and Retention (EPR) effect. This liposomal formulation will ensure that the proinflammatory cytokine and the cancer drug are localized together within the tumor and with less exposure to normal tissues. This invention also discloses that the safety and efficacy of said proinflammatory cytokine/drug liposomes could be further enhanced by coating the exterior of said liposomes with a tumor targeting agent.

Abstract: This invention teaches a method of increasing the bioavailability, safety and efficacy of a cancer drug incorporated in a nanocarrier such as liposomes, micelles, dendrimeres, nanoemulsion, nanoparticles and antibody drug conjugates. It does so by administering pre-blocking blank liposomes to the patient several hours before the drug incorporated nanocarrier is administered. Blocking the reticuloendothelial system (RES) will prevent it from taking up the drug incorporated nanocarrier and hence improve the safety and efficacy of the drug.

Abstract: A means of treating both the “dry” and/or “wet” forms of Age-Related Macular Degeneration (ARMD) using a disease targeting drug delivery system in which an anti-inflammatory drug is incorporated into nanoparticles such as liposomes, micelles, dendrimers, lipid nanospheres, nanoemulsions and the like. The nanoparticles are coated with an anti-Vascular Endothelial Growth Factor Receptor (VEGFR) targeting agent such as anti-VEGFR antibodies, anti-VEGFR aptamers, anti-VEGFR binding peptides and the like. Upon administration into the eye of a patient with ARMD the targeting agent on the nanoparticle will bind to VEGFR on neovascular cells in the retina and inhibit the abnormal proliferation of new blood vessels. In addition to its therapeutic action the targeting agent by binding to its receptor will anchor the drug delivery vehicle at the site of inflammation where the anti-inflammatory drug is released for maximum effect in inhibiting the local inflammatory response.

Abstract: This invention describes of a means of stabilizing lipophilic drugs for long-term storage by incorporating them into a “thermally stabilized nanoemulsion” that has a phase transition temperature that is at or below the body temperature of 37 C and above a storage temperature of 4-8 C. One or more lipid soluble drugs are incorporated into the nanoemulsion at an elevated temperature above the phase transition temperature of the nanoemulsion and then stabilized for extended storage by lowering the temperature to below its phase transition temperature. This causes the nanoemulsion to transform into solid lipid nanospheres entrapping the drug within the solid lipid matrix. Upon rewarming the lipid nanospheres they will reconvert to an oil-in-water nanoemulsion suitable for administration to the patient in need.

Abstract: There are certain factors in the blood of pregnant women with pre-eclampsia that appear to be associated with the disease. These include a soluble variant of the fms-like tyrosine kinase receptor (sFlt-1), soluble Endoglin (sEndoglin), and Endothelin-1. There is also evidence that hypertension may be caused by Na/K ATPase inhibitors such as digitalis-like factor, ouabain-like factors, marinobufogenin and marinobufotoxin. This invention teaches the removal of multiple harmful factors using a combination of targeted apheresis and dialysis and/or ultrafiltration. Harmful factors that are proteins are bound out using immobilized binding agents such as antibodies, aptamers and binding peptides, while small molecule harmful factors are dialyzed out or filtered out. Removal of multiple harmful factors is expected to ameliorate the symptoms of pre-eclampsia and prolong pregnancy.

Abstract: A system for detecting potential for infection includes a wound dressing and an electronics component. The wound dressing includes a temperature sensing layer and a cover layer comprising a substrate and a backing layer. The electronics component includes a power source, an electronic control unit (ECU), and a communications interface positioned within a housing and removably coupled to the temperature sensing layer of the wound dressing. The electronics component is configured to receive a plurality of temperature readings from the temperature sensing layer, and provide an indication of potential infection of the wound based the plurality of temperature readings. In various embodiments, each of the plurality of temperature readings corresponds to a temperature of an area around a wound. Methods for preventing infections using the system are also described.

Abstract: A process for treating tumors by administering a mixture of cancer fighting drugs incorporated into a stabilized liposomal formulation. Each cancer drug is selected to target a different phase of the cell-cycle of the cancer cell thus expanding the number of cancer cells that can be killed at one time without compromising the safety of the patient. The stabilized multi-drug liposomes are designed to extravasate thru “leaky” blood capillaries supplying the tumor and enter the tumor tissue where they will accumulate over time and ultimately release the mixture of cancer drugs to kill surrounding tumor cells. The multi-drug liposomes are likewise unable to extravasate thru normal blood capillaries and will thus be less toxic to normal tissues.

Abstract: This invention uses “Targeted Apheresis” to treat patients with Rheumatoid Arthritis and other autoimmune and inflammatory disorders. “Targeted Apheresis” is a process whereby only the pathogenic and pro-inflammatory elements associated with the disease symptoms are simultaneously and selectively removed from the blood by passing the blood through an extracorporeal affinity device containing selective binding agents. Removal of these pathogenic and pro-inflammatory elements will ameliorate the symptoms of autoimmune disease and may prolong the period of disease remission.

Abstract: This invention uses “Targeted Apheresis” to treat patients with Rheumatoid Arthritis and other autoimmune and inflammatory disorders. “Targeted Apheresis” is a process whereby only the pathogenic and pro-inflammatory elements associated with the disease symptoms are simultaneously and selectively removed from the blood by passing the blood through an extracorporeal affinity device containing selective binding agents. Removal of these pathogenic and pro-inflammatory elements will ameliorate the symptoms of autoimmune disease and may prolong the period of disease remission.

Abstract: Disclosed herein are immunogenic compositions for producing immediate and sustained immunity to infectious viral and bacteriological pathogens. A univalent immunogenic composition is disclosed comprising an isolated antigen and a polynucleotide formulated into a nanoparticle or liposome. Furthermore, multivalent immunogenic compositions are disclosed comprising multiple univalent immunogenic compositions. Also disclosed, are methods of inducing protective or therapeutic immune responses in individuals comprising administering one or more univalent immunogenic compositions.

Abstract: This invention describes the use of anti-IL-1 antibody as a targeting agent attached to liposomes incorporating anti-inflammatory drugs to treat arthritis and other inflammatory diseases. A variety of steroidal and non-steroidal drugs and disease modifying drugs and other anti-inflammatory compounds may be incorporated into the anti-IL-1 antibody coated liposomes. The anti-IL-1 antibody coated drug liposomes will accumulate within the inflamed site where the drug is released for maximum therapeutic effect. Other nanosized drug delivery vehicles such as dendrimers, micelles, nanocapsules and nanoparticles may be similarly coated with anti-IL-1 antibody and used to deliver the drug to the site of inflammation. Also in lieu of the anti-IL-1 antibody other IL-1 binding agents such as anti-IL-1 aptamers and anti-IL-1 binding peptides may be used to coat various nanosized drug delivery vehicles in order to deliver the drug to the site of inflammation.

Abstract: This invention describes the use of anti-TNF-a antibody as a targeting agent attached to liposomes incorporating anti-inflammatory drugs to treat arthritis and other inflammatory diseases. A variety of steroidal and non-steroidal drugs and disease modifying drugs and other anti-inflammatory compounds may be incorporated into the anti-TNF-a coated liposomes. The anti-TNF-a coated drug liposomes will accumulate within the inflamed site where the drug is released for maximum therapeutic effect. Other nanosized drug delivery vehicles such as dendrimers, micelles, nanocapsules and nanoparticles may be similarly coated with anti-TNF-a antibody and used to deliver the drug to the site of inflammation. Also in lieu of the anti-TNF-a antibody other TNF-a binding agents such as aptamers and binding peptides may be used to coat the various nanosized drug delivery vehicles such as micelles, dendrimers, nanocapsules and nanoparticles in order to deliver the drug to the site of inflammation.