Abstract: Dendrimer compositions and methods for the treatment of cancer or autoimmune diseases are described. The compositions include dendrimers complexed or conjugated with one or more active agents for the treatment or alleviation of one or more symptoms of cancer or autoimmune diseases. The dendrimers may include one or more ethylene diamine-core poly(amidoamine) (PAMAM) hydroxyl-terminated generation-4, 5, 6, 7, 8, 9, or 10 dendrimers. The active agents may be immunomodulatory agents such as STING agonists, CSF1R inhibitors, PARP inhibitors, VEGFR tyrosine kinase inhibitors, MEK inhibitors, glutaminase inhibitors, TIE II antagonists, and CXCR2 inhibitors, and STING antagonists. Methods of using the dendrimer compositions to treat cancer, bone disease or inflammatory diseases are also provided.

Abstract: It has been established that dendrimers conjugated or complexed with the carbohydrate triantennary N-Acetylgalactosamine (triantennary-?-GalNAc) selectively accumulate within hepatocyte cells and selectively deliver therapeutic, prophylactic or diagnostic agents to the liver. Compositions of dendrimers complexed with triantennary-?-GalNAc and one or more agents to prevent, treat or diagnose a liver injury, liver disease or liver disorder in a subject in need thereof, and methods of use thereof, have been developed. The compositions are particularly suited for treating and/or ameliorating one or more symptoms of nonalcoholic fatty liver disease (NAFLD) and liver cancer, with decreased toxicity.

Abstract: Dendrimer compositions and methods for the treatment of cancer or autoimmune diseases are described. The compositions include dendrimers complexed or conjugated with one or more active agents for the treatment or alleviation of one or more symptoms of cancer or autoimmune diseases. The dendrimers may include one or more ethylene diamine-core poly(amidoamine) (PAMAM) hydroxyl-terminated generation-4, 5, 6, 7, 8, 9, or 10 dendrimers. The active agents may be immunomodulatory agents such as STING agonists, CSF1R inhibitors, PARP inhibitors, VEGFR tyrosine kinase inhibitors, MEK inhibitors, glutaminase inhibitors, TIE II antagonists, and CXCR2 inhibitors, and STING antagonists. Methods of using the dendrimer compositions to treat cancer, bone disease or inflammatory diseases are also provided.

Abstract: Dendrimer compositions and methods for the treatment of one or more inflammatory and/or angiogenic diseases and/or disorders of the eye include hydroxyl-terminated dendrimers complexed or conjugated with one or more active agents for the treatment or alleviation of one or more symptoms of the diseases of the eye, and/or for diagnosing the diseases and/or disorders of the eye. The dendrimers may include one or more ethylene diamine-core poly(amidoamine) (PAMAM) hydroxyl-terminated generation-4, 5, 6, 7, 8, 9, or 10 dendrimers. The active agents may be VEGFR tyrosine kinase inhibitors including sunitinib or analogues thereof. Preferably, the compositions are suitable for administration via a systemic route to target activated microglia/macrophages in retina/choroid.

Abstract: A method for treating or preventing one or more symptoms of severe inflammation in the lung of a subject in need thereof includes administering to the subject a composition comprising dendrimers complexed, covalently conjugated, or intra-molecularly dispersed or encapsulated with one or more therapeutic or prophylactic agents, in an amount effective to treat, alleviate or prevent one or more symptoms of severe inflammation. The compositions and methods are useful for treating disorders characterized by cytokine storm, for example, for treating or preventing acute lung injury (ALI) and/or acute respiratory distress syndrome (ARDS) results in from ventilator use or infection such as with COVID-19, sepsis, and systemic bacterial infections in a subject in need thereof have been established. Preferably, the dendrimers are generation 4, 5, 6, 7, or 8 poly(amidoamine) (PAMAM) dendrimers, and the therapeutic agents are one or more anti-inflammatory and/or anti-oxidant agents such as N-acetyl cysteine.

Abstract: Dendrimer compositions and methods for the treatment of cancer or autoimmune diseases are described. The compositions include dendrimers complexed or conjugated with one or more active agents for the treatment or alleviation of one or more symptoms of cancer or autoimmune diseases. The dendrimers may include one or more ethylene diamine-core poly(amidoamine) (PAMAM) hydroxyl-terminated generation-4, 5, 6, 7, 8, 9, or 10 dendrimers. The active agents may be immunomodulatory agents such as STING agonists, CSF1R inhibitors, PARP inhibitors, VEGFR tyrosine kinase inhibitors, MEK inhibitors, glutaminase inhibitors, TIE II antagonists, and CXCR2 inhibitors, and STING antagonists. Methods of using the dendrimer compositions to treat cancer, bone disease or inflammatory diseases are also provided.

Abstract: Dendrimer compositions and methods for the treatment of one or more inflammatory and/or angiogenic diseases and/or disorders of the eye include hydroxyl-terminated dendrimers complexed or conjugated with one or more active agents for the treatment or alleviation of one or more symptoms of the diseases of the eye, and/or for diagnosing the diseases and/or disorders of the eye. The dendrimers may include one or more ethylene diamine-core poly(amidoamine) (PAMAM) hydroxyl-terminated generation-4, 5, 6, 7, 8, 9, or 10 dendrimers. The active agents may be VEGFR tyrosine kinase inhibitors including sunitinib or analogues thereof. Preferably, the compositions are suitable for administration via a systemic route to target activated microglia/macrophages in retina/choroid.

Abstract: Methods for increasing the encapsulation or incorporation of Sunitinib into polymeric matrices have been developed. The resulting formulations provide for more sustained controlled release of sunitinib or its analog or a pharmaceutically acceptable salt thereof. Increased loading is achieved using an alkaline solvent system. The pharmaceutical compositions can be administered to treat or prevent a disease or disorder in or on the eye of a patient associated with vascularization, such as corneal neovascularization and acute macular degeneration. Upon administration, the sunitinib or its analog or salt is released over an extended period of time at concentrations which are high enough to produce therapeutic benefit, but low enough to avoid unacceptable levels of cytotoxicity.

Abstract: Methods for increasing the encapsulation or incorporation of Sunitinib into polymeric matrices have been developed. The resulting formulations provide for more sustained controlled release of sunitinib or its analog or a pharmaceutically acceptable salt thereof. Increased loading is achieved using an alkaline solvent system. The pharmaceutical compositions can be administered to treat or prevent a disease or disorder in or on the eye of a patient associated with vascularization, such as corneal neovascularization and acute macular degeneration. Upon administration, the sunitinib or its analog or salt is released over an extended period of time at concentrations which are high enough to produce therapeutic benefit, but low enough to avoid unacceptable levels of cytotoxicity.

Abstract: A composition comprises a protein, a polyol, and a metal. The protein is stabilized by the polyol and the metal, and is protected from denaturing when in contact with an organic solvent. The polyol may be a hydrocarbon containing two or more hydroxyl groups (—OH) bonded to carbon. The metal may be divalent.

Abstract: A process for recovering and purifying refolded heparin binding proteins produced in heterologous host cells includes the step of incubation of the solubilized protein with a polyanionic species such as dextran sulfate.

Abstract: The invention relates to anthraquinone compounds having activity for treating hyperproliferative disorders. Further, the invention relates to methods of using the compounds, alone or in combination with one or more other active agents or treatments, to treat hyperproliferative disorders.

Abstract: The invention provides injection vehicles suitable for administering particulate suspensions, such as polymer-based formulations, as well as associated pharmaceutical formulations, articles of manufacture, and kits. Other aspects of the invention included methods for producing and administering pharmaceutical formulations. The injection vehicles of the invention are superior to conventional injection vehicles in that they include a pseudoplastic composition that improves injectability, which facilitates delivery of the desired dose. The injection vehicles of the invention also allow the use of smaller-bore needles than are usually necessary to inject polymer-based formulations, reducing the pain associated with injection of such formulations.

Abstract: A stable lyophilized protein formulation is described which can be reconstituted with a suitable diluent to generate a high protein concentration reconstituted formulation which is suitable for subcutaneous administration. For example, anti-IgE and anti-HER2 antibody formulations have been prepared by lyophilizing these antibodies in the presence of a lyoprotectant. The lyophilized mixture thus formed is reconstituted to a high protein concentration without apparent loss of stability of the protein.

Abstract: Disclosed are pharmaceutical compositions comprising an active vitamin D compound in emulsion pre-concentrate formulations, as well as emulsions and sub-micron droplet emulsions produced therefrom. The compositions comprise a lipophilic phase component, one or more surfactants, and an active vitamin D compound. The compositions may optionally further comprise a hydrophilic phase component.

Abstract: The present invention relates to a method for treating, ameliorating, or preventing immune-mediated disorders in an animal by administering to the animal active vitamin D compounds or mimics thereof The invention further relates to a method for treating, ameliorating, or preventing immune-mediated disorders in an animal by administering to the animal active vitamin D compounds or mimics thereof in combination with other therapeutic agents.

Abstract: The present invention relates to a method for treating cancer in an animal by administering to the animal an active vitamin D compound or a mimic thereof in combination with a radiotherapeutic agent or treatment.

Abstract: The present invention relates to a method for treating or ameliorating lung cancer in an animal by administering to the animal active vitamin D compounds or mimics thereof by high dose pulse administration in combination with one or more chemotherapeutic agents or radiotherapeutic agents/treatments.