Provided herein are novel immunotherapeutic interventions comprising the use of cationic lipid-based compositions for direct tumor injection. The compositions are effective for reducing, eliminating and/or preventing tumor growth and cancer proliferation with local, targeted, systemic and distal effectiveness. The compositions may comprise one or more cationic lipids such as DOTAP and DOTMA, and may further comprise additional components such as antigens, therapeutic agents and/or pharmaceutically acceptable excipients.

Embodiments of the instant disclosure relate to novel compositions and methods for treating a subject having genetic homocystinuria (HCU or other form of genetic homocystinuria). In some embodiments, compositions and methods disclosed herein concern improving efficacy of standard treatments (e.g. trimethylglycine) to reduce dietary compliance requirements and improve outcomes. In accordance with these embodiments, a subject having or suspected of developing classical cystathionine beta-synthase deficient homocystinuria (HCU) or other genetic form of homocystinuria can be treated with a polyamine or diamine or a precursor thereof or a combination thereof for example, in combination with trimethylglycine (e.g. betaine) or other genetic homocystinuria treatment. In other embodiments, a subject having or suspected of developing HCU or other genetic homocystinuria can also be treated with formate or formate derivative, or zinc and/or zinc-containing agent or other standard treatment in combination with a polyamine composition to treat HCU or RD or other form of genetic homocystinuria in the subject.

Embodiments of the instant disclosure relate to novel compositions and methods for treating a subject having genetic homocystinuria (HCU or other form of genetic homocystinuria). In some embodiments, compositions and methods disclosed herein concern improving efficacy of standard treatments (e.g. trimethylglycine) to reduce dietary compliance requirements and improve outcomes. In accordance with these embodiments, a subject having or suspected of developing classical cystathionine beta-synthase deficient homocystinuria (HCU) or other genetic form of homocystinuria can be treated with a polyamine or diamine or a precursor thereof or a combination thereof for example, in combination with trimethylglycine (e.g. betaine) or other genetic homocystinuria treatment. In other embodiments, a subject having or suspected of developing HCU or other genetic homocystinuria can also be treated with formate or formate derivative, or zinc and/or zinc-containing agent or other standard treatment in combination with a polyamine composition to treat HCU or RD or other form of genetic homocystinuria in the subject.

Compositions and methods are provided to increase the healthspan of a subject. Most typically, contemplated compositions are formulated for oral administration and comprise a synergistic combination of a first and a second polyamine (e.g., spermine and spermidine).

Compositions and methods are provided to increase the healthspan of a subject. Most typically, contemplated compositions are formulated for oral administration and comprise a synergistic combination of a first and a second polyamine (e.g., spermine and spermidine).

The subject matter disclosed herein is generally directed to modulation of Th17 differentiation and pathogenicity by use of metabolic targets. The metabolic targets are the molecules of the polyamine pathway or glycolysis pathway. Modulation of the polyamine pathway can shift Th17 pathogenicity and shift the transcriptome of Th17 cells to a Treg or Th1 transcriptome. The polyamine analogue DFMO can be used to modulate an inflammatory response. Inhibitors of enzymes in the glycolysis pathway can shift Th17 pathogenicity.

The subject matter disclosed herein is generally directed to modulation of Th17 differentiation and pathogenicity by use of metabolic targets. The metabolic targets are the molecules of the polyamine pathway or glycolysis pathway. Modulation of the polyamine pathway can shift Th17 pathogenicity and shift the transcriptome of Th17 cells to a Treg or Th1 transcriptome. The polyamine analogue DFMO can be used to modulate an inflammatory response. Inhibitors of enzymes in the glycolysis pathway can shift Th17 pathogenicity.

The present invention contemplates a high dose finished pharmaceutical dosage form comprising colestipol hydrochloride in its commercially available form (i.e., beads) without the need for further milling. A manufacturing process used to manufacture the instant high dose finished pharmaceutical dosage form comprising colestipol hydrochloride, which monitors moisture content throughout the granulation process, is also disclosed herein.

The present invention contemplates a high dose finished pharmaceutical dosage form comprising colestipol hydrochloride in its commercially available form (i.e., beads) without the need for further milling. A manufacturing process used to manufacture the instant high dose finished pharmaceutical dosage form comprising colestipol hydrochloride, which monitors moisture content throughout the granulation process, is also disclosed herein.

The present invention relates to the development of a composition for the treatment of novel SARS-coronavirus-2 infection. The drug efficacy was evaluated through CPE (Cytopathic Effect)-based assay method that measures how long the cells survive by infecting SARS-CoV-2 after receiving a drug library previously approved as a treatment for a specific disease from the Korea Chemical Bank and treating Vero cells with the drug, and an image-based assay that measures how much virus is reduced in infected cells. Through this, 16 kinds of drugs effective in the treatment of SARS-CoV-2 were re-positioned.