Abstract: Provided herein are compositions, systems, and methods for treating a disease, such as kidney and/or cardiovascular disease, with an agent that reduces the production of trimethylamine (TMA) or trimethylamine-n-oxide (TMAO) in a subject. In certain embodiments, the agent is: i) 3,3-dimethyl-1-butanol (DMB) or a DMB derivative or related compound, ii) acetylsalicylic acid or derivative thereof (e.g., with an enteric coating for delivery to the colon and/or cecum); iii) a flavin monooxygenase 3 (FMO3) inhibitor; iv) a gut TMA lyase inhibitor; v) an antibiotic or antimicrobial; vi) a probiotic or prebiotic; vii) an antiplatelet agent; or viii) a TMA and/or TMAO sequestering agent.

Abstract: Oral dosage forms of osteoclast inhibitors, such as neridronic acid, in an acid form or a salt form can be used to treat or alleviate pain or related conditions, such as allodynia associated with complex regional pain syndrome.

Abstract: The present invention includes compositions and methods for preventing one or more cardiac channelopathies or conditions resulting from irregularities or alterations in cardiac patterns caused by an active agent or a drug in a human or animal subject comprising: an amount of a lysophosphatidylglycerol adapted for oral administration effective to reduce or prevent one or more cardiac channelopathies or conditions resulting from irregularities or alterations in cardiac patterns caused by the active agent or drug.

Abstract: Novel marine lipid compositions comprising triglycerides and omega-3 rich phospholipids are described. The compositions are characterized by providing highly bioavailable omega-3, increased tissue incorporation of omega-3 and reduced concentration of pro-inflammatory cytokines.

Abstract: This invention relates to compositions containing combinations of a balanced phosphatidylcholine composition and one or more cannabinoids, a natural or synthetic derivative thereof, or a salt thereof, and kits containing such combinations and methods of using such combinations to treat subjects suffering from an imbalance of fatty acids and related diseases or disorders. This invention also relates to the synergistic effect of such combination therapies in humans.

Abstract: The present invention includes compositions and methods of making and using a dietary supplement manufactured from one or more natural polysaccharides previously incubated with a probiotic bacteria in a bioreactor system, wherein the bacteria process the polysaccharides and the resulting processed polysaccharide are provided in the nutritional supplement.

Abstract: Composition, preferably, in the form of capsules or chewable wafers in quantities suitable for relieving the symptoms of fibromyalgia comprise formulations of phospholipids, specifically identified concentrations of phosphatidylglycerol, phosphatidic acid, phosphatidylethanolamine, phosphatidylcholine, glycolipids and phosphatidylserine along with inulin and other desirable active ingredients are described.

Abstract: A delivery system comprising an organic nanoparticle, a hyaluronidase anchored or conjugated to the organic nanoparticle. The organic nanoparticle may be selected from a polymer-based nanoparticle, a lipid-based nanoparticle and nanoparticle formed by lipid-like molecules. In some embodiments, the hyaluronidase is covalently bound to a linker or spacer which, in turn, is anchored or covalently bound to the organic nanoparticle. The delivery system may also comprise an active pharmaceutical agent, a diagnostic agent, and/or a cellular membrane. The organic nanoparticle may further have a low density poly(ethylene glycol) layer on the surface. Methods for using the delivery system including for treating or diagnosing a disease are also provided. The organic nanoparticle provides enhanced diffusion/penetration through the extracellular matrix found in tumors, as well as increased circulation time in a human or animal body.

Abstract: Disclosed are prodrugs of anthracyclines (such as doxorubicin) and derivatives thereof that are selectively cleaved and activated by fibroblast activating protein (FAP). The prodrugs are useful for targeted delivery of “warhead” anthracycline or anthracycline derivative to FAP-expressing tissues, including cancer (e.g., solid tumors). Also provided are pharmaceutical compositions comprising the prodrugs, as well as methods of using the prodrugs to treat a disorder characterized by FAP upregulation, e.g., cancer, undesirable fibrosis, and undesirable inflammation.

Abstract: This invention relates to pharmaceutical formulations of gemcitabine-[phenyl-benzoxy-L-alaninyl)]-phosphate, a monophosphate derivative of the well-known oncology drug gemcitabine. In particular, the invention relates to formulations which comprise a polar aprotic solvent, preferably dimethyl acetamide (DMA). Formulations comprising these solvent provide therapeutically effective treatments of gemcitabine-[phenyl-benzoxy-L-alaninyl)]-phosphate. The invention also relates to methods of using said formulations and kits comprising said formulations.

Abstract: This disclosure provides LOX1 (LOX1) binding proteins such as anti-LOX1 antibodies, and compositions and methods for making these binding proteins. In certain aspects the LOX1-binding proteins provided herein, inhibit, or antagonize LOX1 activity. In addition, the disclosure provides compositions and methods for diagnosing and treating conditions associated with atherosclerosis, thrombosis, coronary artery disease (CAD), ischemia (e.g., myocardial ischemia), infarction (e.g., myocardial infarction), acute coronary syndrome (ACS), stroke, reperfusion injury, restenosis, peripheral vascular disease, hypertension, heart failure, inflammation (e.g., chronic inflammation), angiogenesis, preeclampsia, cancer and other LOX1-mediated diseases and conditions.

Abstract: Methods for treating pain such as fibromyalgia, comprising administering to a subject in need thereof an effective amount of an adenosine analog, wherein the adenosine analog may be a compound of Formula (I): (I), or a pharmaceutically acceptable salt thereof. Pharmaceutical compositions comprising the adenosine analog for use in treating pain (e.g., fibromyalgia), optionally further comprising Substance P (SP), are also provided.

Abstract: A combination of THC, CBD and Cobalamin (in a ratio of about 63%, 27% and 10%, respectively) is used with a topical carrier such as Shea butter cream to relieve pain. The THC and CBD mixture is extracted from a Cannabis Indica dominant strain using high pressure and carbon dioxide (CO2) as a solvent and comprises: Tetrahydrocannabinol “THC” (9-Tetrahydrocannabinol (delta-9 THC), 8-Tetrahydrocannabinol (Delta-8 THC) and 9-THC Acid), Cannabidiol “CBD”, Cannabinol “CBN”, Cannabichromene (“CBC”), Cannabigerol (“CBG”), terpenoids and flavonoids. The Shea butter is an extract from the Shea nut from the Shea tree (Vitellaria paradoxa).

Abstract: Methods and devices for use in reducing the appearance of dimpled skin or other undesirable appearance of skin in a cellulitic region of a patient are provided. The methods include the steps of disrupting fibrous septae located beneath the skin of a cellulitic region and introducing a composition beneath the skin, the composition being effective to reduce or prevent regrowth of the fibrous septae.

Abstract: The use of gaseous oxygen for the production of a therapeutic gas for inhalation by a patient who has been identified as a person with a mitochondrial disorder or a coenzyme Q10 deficiency, for the treatment of mitochondrial disorders or Q10 deficiencies is disclosed. For the first time a non-invasive method is disclosed, upon what the body's own level of Q10 can be raised significantly without further interventions.

Abstract: A roll-on product, including magnesium hydroxide; propanediol; glycerin and glycine soja (soybean), is advantageously used as a deodorant and/or for transdermal magnesium delivery to the human body. Combinations of a magnesium source (especially magnesium hydroxide), with propanediol, and with glycerin and glycine soja (soybean) are advantageous for transdermal delivery of magnesium to the body via a roll-on product, a stick, a spray, a lotion, etc. Magnesium deficiency is addressed via products easily used by an ordinary consumer for dermal application.

Abstract: Provided is a method of treating a pathology associated with neural damage, the method comprising administering non-antigen specific polyclonal activated T cells and/or genetically modified T cells into the brain in a manner which prevents meningoencephalitis in the subject, thereby treating the pathology associated with neural damage. Also provided are devices for intrabrain and intrathecal administration of T cells, which comprise the brain-specific or non-antigen specific polyclonal activated T cells and/or genetically modified T cells and a catheter for intrabrain administration in a manner which prevents meningoencephalitis in a subject.

Abstract: The present invention provides compositions and methods for inducing a CAR mediated trans-signal in a T cell. The trans-signaling CAR T cells comprise a first CAR having a first signaling module and a second CAR having a distinct second signaling module. The present invention also provides cells comprising a plurality of types of CARs, wherein the plurality of types of CARs participate in trans-signaling to induce T cell activation.

Abstract: The present invention provides immunoresponsive cells, including T cells, cytotoxic T cells, regulatory T cells, and Natural Killer (NK) cells, expressing at least one of an antigen-recognizing receptor and a co-stimulatory ligand and methods of use therefore for the treatment of neoplasia and other pathologies where an increase in an antigen-specific immune response is desired.

Abstract: The invention concerns a pharmaceutical composition comprising a platelet lysate and its use to treat a wound, an anal fissure, vaginal atrophy or a wrinkle.

Abstract: The present disclosure is in the field of genome engineering, particularly targeted modification of the genome of a hematopoietic cell.

Abstract: The invention relates to the treatment of various injuries, disorders, dysfunctions, diseases, and the like of the brain with MAPCs, particularly in some aspects, to the treatment of the same resulting from hypoxia, including that caused by systemic hypoxia and that caused by insufficient blood supply. In some further particulars the invention relates, for example, to the treatment of hypoxic ischemic brain injury with MAPCs, in children for example, and to the treatment of cortical infarcts and stroke with MAPCs in adults, for example.

Abstract: Provided are a prophylactic or therapeutic agent for a peptic ulcer, a food additive for prevention and treatment of a peptic ulcer, an iNOS expression inhibitor, and a COX-2 expression inhibitor, all of which have little side effects. The prophylactic or therapeutic agent contains a Euglena-derived material as an active ingredient. The Euglena-derived material may be Euglena, paramylon, or an acid-treated paramylon. The prophylactic or therapeutic agent is useful for the prevention or treatment of a peptic ulcer induced by psychological stress. The peptic ulcer may be a gastric ulcer. The food additive contains a Euglena-derived material as an active ingredient.

Abstract: The present invention provides nutritional compositions that are employed as oral supplementation to the human diet. The compositions of the present invention provide for supplementation to the diet of the cancer patient, as well as preventative dietary supplementation aimed at supporting the human immune system for those not currently suffering from cancer. The present invention is comprised of specific combinations of selected forms of unique sets of certain vitamins, minerals, protein, carbohydrates and phytochemicals.

Abstract: The present invention relates to a peptide suppressing the phosphorylation of threonine (T120), the 120th residue of TSPYL5 (testis-specific Y-like protein 5), which is specifically as follows. The present inventors constructed T120D, the mutant of the 120th residue threonine (T120) of TSPYL5, and T120A-TSPYL5 gene and then transfected cells with them in order to investigate the effect of phosphorylation on T120 residue. As a result, wild-type TSPYL5 and T120D moved into nucleus and stayed there. But in the case of T120A-TSPYL5, TSPYL5 did not move into nucleus and instead it was expressed only in cytoplasm. The protein could not bind to AKT, either. Instead, ubiquitination of TSPYL5 was increased but SUMOylation was inhibited. Also, the expressions of ALDH1-A1, -A3, CD44 gene and protein were reduced, and thereby the growth and metastasis of lung cancer cells were suppressed and sphere formation was reduced.

Abstract: Disclosed herein are methods of inactivating and/or decolonizing bacteria on a surface. The present invention also discloses methods for treatment of epithelial conditions caused or aggravated by bacteria, such as acne vulgaris, in a subject in need thereof. The present invention additionally discloses inventive compounds and compositions that exhibit anti-bacterial and/or anti-inflammatory effects.

Abstract: The present invention relates to compositions comprising peptides that may be variants, derivatives and structural equivalents of cupredoxins that inhibit the development of premalignant lesions in mammalian cells, tissues and animals. Specifically, these compositions may comprise azurin from Pseudomonas aeruginosa, and/or the 50-77 residue region of azurin (p28). The present invention further relates to compositions that may comprise cupredoxin(s), and/or variants, derivatives or structural equivalents of cupredoxins, that retain the ability to inhibit the development of premalignant lesions in mammalian cells, tissues or animals. These compositions may be peptides or pharmaceutical compositions, among others. The compositions of the invention may be used to prevent the development of premalignant lesions in mammalian cells, tissues and animals, and thus prevent cancer.

Abstract: The invention provides methods and compositions for minimizing, preventing, or treating damage to corneal nerves by administering to a subject with such damage or at risk of exposure to such damage a composition which blocks an activity of an IL-1 cytokine and/or an IL-17 cytokine.

Abstract: A glycosylated pleiotropic peptide pituitary adenylate cyclase-activating polypeptide (PACAP) which can both agonize PAC1 receptors, causing neuroprotective effects, and antagonize VPAC receptors, causing anti-inflammation in several models of acute neuronal damage and neurodegenerative diseases, including ALS, PD, migraines, and certain forms of dementia, is described. Also described is a method of relieving symptoms of ALS, PD, migraines, and certain forms of dementia, comprising administering to a subject in need thereof an effective amount of a glycosylated PACAP.

Abstract: The present disclosure relates to suppression of cellular transformation and dysplasia by topical application of Lefty. In particular, the present disclosure provides compositions and methods for topically applying Lefty to treat and prevent cancers.

Abstract: The invention relates to a drug comprising at least one insulin and at least one GLP-1 receptor agonist.

Abstract: Disclosed is a composition of natural vitamin C and a fish scale collagen peptide, comprising the following components: natural vitamin C and a fish scale collagen peptide. Also disclosed is a method for preparing the above-mentioned composition.

Abstract: Herpes simplex virus (HSV) including herpes simplex virus 1 and 2 (HSV-1 and HSV-2) are a persistent cause of human disease with no known cure. Guided nuclease systems target specific regions of the HSV-1 and HSV-2 genomes, disrupting the virus' nucleic acid and rendering even latent viruses incapacitated.

Abstract: The present invention relates to a new drug delivery strategy based on prodrug conversion, in which a water-soluble prodrug and its converting enzyme are co-delivered and at a point of administration such as the nasal or buccal mucosa. Enzymatic conversion of the prodrug produces drug in concentrations exceeding the drug's thermodynamic solubility, or saturation level. The supersaturated drug crosses the mucosal membrane quickly, as a result of its high thermodynamic activity, prior to crystallization. This strategy is particularly useful when fast action is required, for example in preventing or responding rapidly to Status Epilepticus (SE) or other central nervous system conditions such as migraine.

Abstract: A surface protein of the murine fungal pathogen Pneumocystis murina can be used to generate an immune response in a recipient animal or human that provides prophylactic protection and an anti-fungal activity in subjects already infected with a Pneumocystis species. Further, the disclosure provides novel polypeptides or peptides derived from the P. murina surface protein Surface Peptidase 1 (SPD-1) that are useful, alone or in combination with the SPD-1 polypeptide, in compositions and methods for the generation of an anti-Pneumocystis immune reaction by a recipient subject. The compositions and methods of the disclosure provide advantageous alternatives to available immunogenic determinants for the treatment or prevention of fungal pneumonia.

Abstract: The present invention is based upon the identification of a number of antigens derived from species of the genus Teladorsagia, which can be used to raise immune responses in animals—particularly those animals susceptible or predisposed to infection by (or with) one or more Teladorsagia species. The antigens may be exploited to provide compositions and vaccines for raising protective immune responses in animals—the protective immune responses serving to reduce, prevent, treat or eliminate Teladorsagia infections/infestations.

Abstract: Disclosed are methods to modulate yeast-based immunotherapy products and the immune responses, prophylactic responses, and/or therapeutic responses elicited by such products. Also disclosed are modified yeast-based immunotherapy products, kits and compositions.

Abstract: The present invention relates to peptides, proteins, nucleic acids and cells for use in immunotherapeutic methods. In particular, the present invention relates to the immunotherapy of cancer. The present invention furthermore relates to tumor-associated T-cell peptide epitopes, alone or in combination with other tumor-associated peptides that can for example serve as active pharmaceutical ingredients of vaccine compositions that stimulate anti-tumor immune responses, or to stimulate T cells ex vivo and transfer into patients. Peptides bound to molecules of the major histocompatibility complex (MHC), or peptides as such, can also be targets of antibodies, soluble T-cell receptors, and other binding molecules.

Abstract: The present invention relates to peptides, proteins, nucleic acids and cells for use in immunotherapeutic methods. In particular, the present invention relates to the immunotherapy of cancer. The present invention furthermore relates to tumor-associated T-cell peptide epitopes, alone or in combination with other tumor-associated peptides that can for example serve as active pharmaceutical ingredients of vaccine compositions that stimulate anti-tumor immune responses, or to stimulate T cells ex vivo and transfer into patients. Peptides bound to molecules of the major histocompatibility complex (MHC), or peptides as such, can also be targets of antibodies, soluble T-cell receptors, and other binding molecules.

Abstract: The present invention relates to efficient methods for providing antigen-specific lymphoid cells. These lymphoid cells may be used to provide antigen specific T cell receptors having a defined MHC restriction and to identify immunologically relevant T cell epitopes. Furthermore, the present invention relates to antigen-specific T cell receptors and T cell epitopes and their use in immunotherapy.

Abstract: This document provides methods and materials for generating CD8? T cells having the ability to recognize cancer cells expressing a HER2/neu polypeptide. For example, methods and materials for using a polypeptide consisting of an SLAFLPESFD amino acid sequence in vivo or in vitro to generate CD8+ T cells having the ability to recognize and lyse cancer cells expressing a HER2/neu polypeptide are provided.

Abstract: The present invention relates to a vaccine/inhibitor combination comprising an RNA vaccine comprising at least one RNA comprising at least one open reading frame (ORF) coding for at least one antigen and a composition comprising at least one PD-1 pathway inhibitor, preferably directed against PD-1 receptor or its ligands PD-L1 and PD-L2. The present invention furthermore relates to a pharmaceutical composition and a kit of parts comprising the components of such a vaccine/inhibitor combination. Additionally the present invention relates to medical use of such a vaccine/inhibitor combination, the pharmaceutical composition and the kit of parts comprising such a vaccine/inhibitor combination, particularly for the prevention or treatment of tumor or cancer diseases or infectious diseases. Furthermore, the present invention relates to the use of an RNA vaccine in therapy in combination with a PD-1 pathway inhibitor and to the use of a PD-1 pathway inhibitor in therapy in combination with an RNA vaccine.

Abstract: The instant invention provides various formulations comprising combinations of immunostimulating oligonucleotides, polycationic carriers, sterols, saponins, quaternary amines, TLR-3 agonists, glycolipids, and MPL-A or analogs thereof in oil emulsions, use thereof in preparations of immunogenic compositions and vaccines, and use thereof in the treatment of animals.

Abstract: Dengue Fever (DF) and Dengue Hemorrhagic Fever (DHF) are significant global public health problems and understanding the overall immune response to infection will contribute to appropriate management of the disease and its potentially severe complications. Live attenuated and subunit vaccine candidates, which are under clinical evaluation, induce primarily an antibody response to the virus and minimal cross-reactive T cell responses. Currently, there are no available tools to assess protective T cell responses during infection or post vaccination. Herein, we report novel, naturally processed and presented MHC class I restricted epitopes, a subset of which binds to and activates T cells in both an HLA-A2 and HLA-A24 restricted manner.

Abstract: Provided herein is a recombinant rod-shaped viral particle comprising a fusion protein comprising a coat protein for a rod-shaped plant virus and a epitope from a human and/or human pathogen, where the epitope is disposed on the outer surface of the viral particle. In certain cases, the amino acid sequence of the coat protein is at least 40% identical to the amino acid sequence of the Tobacco Mosaic Virus (TMV) coat protein.

Abstract: The present invention provides compositions and methods of use comprising a chimeric dengue virus E glycoprotein comprising a dengue virus E glycoprotein backbone, which comprises amino acid substitutions that introduce a dengue virus E glycoprotein domain I and domain II hinge region from a dengue virus serotype that is different from the dengue virus serotype of the dengue virus E glycoprotein backbone.

Abstract: Provided herein are multimeric influenza hemagglutinin stem domain polypeptides, methods for providing hemagglutinin stem domain polypeptides, compositions comprising the same, vaccines comprising the same and methods of their use, in particular in the detection, prevention and/or treatment of influenza.

Abstract: Described is a vaccine against Respiratory Syncytial Virus (RSV). More specifically, described is a recombinant subunit vaccine comprising the ectodomain of the RSV-encoded Small Hydrophobic (SH) protein. The ectodomain of SH is referred to as SHe. The ectodomain is typically presented as an oligomer, or pentamer. Further described are antibodies, raised against the ectodomain or specific for the ectodomain, and their use for protecting a subject against RSV infection and/or for treatment of an infected subject.

Abstract: The present invention relates to a medium composition for production of botulinum toxin and, more particularly, to a medium composition for culture of Clostridium sp. capable of producing botulinum toxin. The medium composition of the present invention comprises a casein hydrolysate and at least one plant-derived peptone selected from the group consisting of a garden pea hydrolysate, a cotton seed hydrolysate and a wheat gluten hydrolysate. When the medium according to the present invention, which contains plant-derived peptones, casein hydrolysates and minerals, is used for culture of Clostridium botulinum, the growth rate of the bacterium in the medium is higher than that in each of the medium that is in current use and the medium comprising plant-derived peptones alone. In addition, when the medium of the present invention is used, a high concentration of botulinum toxin can be produced by culturing the bacterium in a safe manner.

Abstract: The present invention provides compositions and methods that involve the 36 kDa annexin II monomer, which has been identified as having immunostimulatory properties. Accordingly, in one aspect, the invention provides compositions that include at least one 36 kDa annexin II monomer or an immunomodulatory fragment thereof. In another aspect, the invention provides methods that include administering to a subject a composition that includes at least one 36 kDa annexin II monomer or an immunomodulatory fragment thereof. In another aspect, the invention provides methods that induce an in situ increase in the 36 kDa annexin II monomer by administering to a subject an amount of composition effective to induce localized hypoxia sufficient to cause a localized increase in annexin II.