Abstract: The present invention provides muscle-derived cells, preferably myoblasts and muscle-derived stem cells, genetically engineered to contain and express one or more heterologous genes or functional segments of such genes, for delivery of the encoded gene products at or near sites of musculoskeletal, bone, ligament, meniscus, cartilage or genitourinary disease, injury, defect, or dysfunction. Ex vivo myoblast mediated gene delivery of human inducible nitric oxide synthase, and the resulting production of nitric oxide at and around the site of injury, are particularly provided by the invention as a treatment for lower genitourinary tract dysfunctions.

Abstract: The present invention relates to an isolated Bacillus sp. strain having probiotic activity. More particularly, the present invention relates to an isolated Bacillus sp. 2-4 (KCCM11107P) strain having probiotic activity. Since the strain of the present invention functions as probiotics by having an antibacterial activity against various fish pathogenic bacteria, as well as secreting helpful enzymes such as protease, amylase, cellulose, and lipase to help the digestion and absorption of the feed, the strain of the present invention can be helpfully used as a feed additive for fish and crustaceans.

Abstract: Compositions and methods for diagnosing and treating tumors using myeloid derived suppressor cells (MDSCs) are provided. More particularly, the compositions contain labeled MDSCs or MDSCs in combination with oncolytic viruses, nano-particles or other anti-tumor agents.

Abstract: Processes for producing an extract containing phytochemicals from pomegranates are disclosed. The processes generally comprise providing pomegranate solids, such as the pericarp, inner membrane and seeds; creating a mixture comprising the pomegranate solids in an aqueous solution; adding enzymes to the mixture in an amount sufficient to at least partially degrade the pomegranate solids; heating the mixture to a temperature that permits the maximum rate of catalysis of the enzyme; maintaining the temperature of the heated mixture for a time sufficient to allow at least partial degradation of the pomegranate solids; and removing residual insoluble solid materials from the mixture. Compositions containing the extract may be used as a food product, beverage, pharmaceutical preparations, nutritional supplements, vitamin supplements, food additives, and food supplements.

Abstract: The document provides compositions such as dietary supplements. Such compositions can be used to reduce pain, inflammation, stiffness, and/or discomfort associated with inflammatory conditions such as arthritis. The document also provides methods for reducing pain, inflammation, stiffness, and/or discomfort associated with inflammatory conditions such as arthritis.

Abstract: The present invention relates to stable, palatable, freeze-dried, fruit-based compositions. Specifically, the inventions relates to compositions of Açai fruit and Jucara fruit with high antioxidant capability and cyclooxygenase-inhibitory activity, and their uses. The invention further provides for methods of making stable, palatable, freeze-dried, fruit-based compositions from Açai fruit and Jucara fruit.

Abstract: Provided herein are compositions and methods for the treatment of a patient having an HIV-1 infection and/or AIDS. More specifically this invention provides treatment of an HIV-1 infection and/or AIDS using small molecule compounds, such as inhibitors for the activation and/or activity of caspase-1. Inhibitors for the activation and/or activity of caspase-1 also prevent the cell death of CD4 T-cells in a population of CD4 T-cells comprising HIV-1 infected CD4 T-cells and uninfected CD4 T-cells. In addition, caspase-1 inhibitors inhibit inflammation, and pyroptosis.

Abstract: Methods and compositions for synchronizing the time of insemination in swine are described. More particularly, methods are described for synchronizing the time of insemination by administration of a composition comprising a hormone, wherein the swine is inseminated only one time after administration of the hormone, and wherein there is no heat detection.

Abstract: The invention relates to a process for the preparation of injectable pharmaceutical compositions for the sustained release of somatostatin analogues and to pharmaceutical compositions prepared according to the process. In a preferred aspect the process comprises the steps of combining lanreotide acetate and acetic acid, lyophilizing the resulting mixture only once, and hydrating the lyophilizate. Acetic acid may be added to a desired pH during the final step of the process.

Abstract: Use of a subcutaneously administered dose of between about 1.0 mg and 1.75 mg of bremelanotide or a pharmaceutically acceptable salt of bremelanotide for the treatment of female sexual dysfunction in women while reducing or minimizing undesirable side effects.

Abstract: Disclosed herein are methods of making cyclosporin A Form 2.

Abstract: Disclosed are antimicrobial peptides with useful or superior properties such as antimicrobial activity, desirable levels of hemolysis, and advantageous therapeutic index against various microorganisms, especially Pseudomonas aeruginosa, Acinetobacter baumannii and Staphylococcus aureus. Also provided are methods of to control microbial growth and pharmaceutical compositions to treat or prevent microbial infections. Certain peptides are disclosed utilizing a structure-based rational modification of antimicrobial peptide D1, with single D-/L-amino acid substitutions or charged residue substitutions in or near the center of the peptide on the nonpolar or polar face, or peptides with one or more amino acids in the D configuration, and peptides with all amino acids in the D configuration. Modified peptide analogs herein can demonstrate one or more properties such as improved antimicrobial activity, specificity, and resistance to degradation.

Abstract: An inhibitor of FXII/FXIIa for the prevention of the formation and/or stabilization of thrombi during and/or after a medical procedure performed on a human or animal subject comprising contacting blood of said human or animal subject with artificial surfaces, wherein said inhibitor of FXII/FXIIa is administered before and/or during and/or after said medical procedure.

Abstract: The invention relates to pharmaceutical compositions comprising leukotoxin, a chemotherapeutic agent and a pharmaceutically acceptable carrier, including methods to treat cancer, and methods to induce apoptosis.

Abstract: The present invention relates to a composition for preventing and treating neurological diseases, and more particularly to a composition for preventing and treating neurological diseases comprising osmotin, a health functional food composition for preventing and ameliorating neurological diseases comprising osmotin, and a method of preventing or treating neurological diseases by administering the composition.

Abstract: The present invention relates to methods of improving a treatment outcome comprising administering a heat shock protein (HSP) preparation or an ?-2-macroglobulin (?2M) preparation with a non-vaccine treatment modality. In particular, an HSP preparation or an ?2M preparation is administered in conjunction with a non-vaccine treatment modality for the treatment of cancer or infectious diseases. In the practice of the invention, a preparation comprising HSPs such as but not limited to, hsp70, hsp90 and gp96 alone or in combination with each other, noncovalently or covalently bound to antigenic molecules or ?2M, noncovalently or covalently bound to antigenic molecules is administered in conjunction with a non-vaccine treatment modality.

Abstract: The present disclosure provides a method for suppressing a proinflammatory response by administering a composition comprising peptides selected from a casein hydrolysate. Such a composition may reduce the levels of proinflammatory cytokines and may be a treatment for inflammatory disease, especially type 1 diabetes. Preferably, the hydrolysate consists of peptides with a molecular weight of more than 500 Da.

Abstract: Systems and methods for purification and concentration of autologous alpha-2 macroglobulin (A2M) from whole blood and or recombinant A2M are provided. Also provided are methods of treating wounds with A2M. Methods for utilizing A2M in combination with other treatments (e.g., platelets and other growth factors) are provided in addition to combinations with exogenous drugs or carriers. Also provided is a method of producing recombinant A2M wild type or variants thereof where the bait region was modified to enhance the inhibition characteristics of A2M and/or to prolong the half-life of the protein for treating wounds.

Abstract: Procedures are described which use solvents to increase the topical insecticidal activity of toxic insect peptides. These procedures comprise drying the peptides, if needed, followed by the addition of either: 1) a polar organic solvent, with or without water, to a dried peptide, or 2) the addition of polar aprotic solvent or other adjuvant to the dried peptide, followed by the addition of either: 1) a polar organic solvent, with or without water, (where a polar aprotic solvent is added first) or 2) a polar aprotic solvent or other adjuvant to the peptide polar organic solvent (where the polar organic solvent is added first), to the peptide formulation.

Abstract: The invention provides methods, pharmaceutical compositions and kits for treating, inhibiting and/or reducing the severity of inflammatory bowel disease and necrotizing enterocolitis in a subject in need thereof by administering an effective amount of a composition comprising an activator of ErbB4.

Abstract: This invention discloses the uses of IL-22 in the treatment and prevention of a nerve damage disease or a neurodegenerative disease. In particular, the invention discloses the uses of IL-22 or IL-22 dimers as follows: (i) can protect neurons to recover the functions of injured neurons after ischemic nerve damage in animals in vivo, thus enabling effective treatment of nerve damage diseases, (ii) can significantly inhibit the loss of dopaminergic neurons in substantia nigra in PD model animal, enhance the functions of dopaminergic neurons, significantly reduce neuronal apoptosis in hippocampus, improve learning and memory capacity of AD model rats, and effectively prevent neuronal loss, thereby enabling more effective treatment of neurodegenerative diseases.

Abstract: The present invention is directed to a method of treating a metabolic disorder or key elements of a metabolic disorder such method comprising the use of an agent(s) that increases central dopaminergic activity plus a first-phase insulin secretagouge.

Abstract: The present invention relates to insulin- and insulin analog-carrying nanoparticles formulated together with or for use with free insulin or with an insulin analog, such as a rapidly-acting insulin analog. The compositions of the present invention find use in medicine, particularly in glycemic control, e.g. for controlling blood glucose levels in diabetic subjects. Nanoparticle compositions of the invention, formulated together with or for use with free insulin or with an insulin analog, comprise a nanoparticle comprising a core comprising a metal and/or a semiconductor; and a corona comprising a plurality of ligands covalently linked to the core, wherein said plurality of ligands comprise at least one carbohydrate moiety; and at least one insulin peptide and/or insulin analog peptide that is non-covalently bound to the corona.

Abstract: A Factor VIII composition formulated without albumin, comprising the following formulation excipients in addition to Factor VIII: 4% to 10% of a bulking agent selected from the group consisting of mannitol, glycine and alanine; 1% to 4% of a stabilizing agent selected from the group consisting of sucrose, trehalose, raffinose, and arginine; 1 mM to 5 mM calcium salt; 100 mM to 300 mM NaCl; and a buffering agent for maintaining a pH of approximately between 6 and 8. Alternatively, the formulation can comprise 2% to 6% hydroxyethyl starch; 1% to 4% of a stabilizing agent selected from the group consisting of sucrose, trehalose, raffinose, and arginine; 1 mM to 5 mM calcium salt; 100 mM to 300 mM NaCl; and a buffering agent for maintaining a pH of approximately between 6 and 8.

Abstract: The present invention relates to an active (immunostimulatory) composition comprising at least one RNA, preferably a mRNA, encoding at least two (preferably different) antigens capable of eliciting an (adaptive) immune response in a mammal. The invention furthermore relates to a vaccine comprising the active (immunostimulatory) composition, and to the use of the active (immunostimulatory) composition (for the preparation of a vaccine) and/or of the vaccine for eliciting an (adaptive) immune response for the treatment of lung cancer, particularly of non-small cell lung cancers (NSCLC), preferably selected from the three main sub-types squamous cell lung carcinoma, adenocarcinoma and large cell lung carcinoma, or of disorders related thereto. Finally, the invention relates to kits, particularly to kits of parts, containing the active (immunostimulatory) composition and/or the vaccine.

Abstract: The present invention provides isolated polypeptides isolatable from a Yersinia spp. Also provided by the present invention are compositions that include one or more of the polypeptides, and methods for making and methods for using the polypeptides.

Abstract: Immunogenic compositions comprising an Rv1196 related antigen, wherein the conductivity of the composition is 13 mS/cm or lower, or the concentration of salts of the composition is 130 mM or lower, and their use in medicine, are provided.

Abstract: Described herein are influenza virus-like particles (VLPs) that display on truncated, re-engineered or remodeled HA molecules on their surface. Also described are methods of making and using these VLPs.

Abstract: Controlling Classical Swine Fever Virus (CSFV) involves either prophylactic vaccination or non-vaccination and elimination of infected herds depending on the epidemiological situation. Marker vaccines allowing distinction between naturally infected from vaccinated swine could complement “stamping out” measures. Previously, we reported the development of FlagT4v, a double antigenic marker live attenuated CSFV strain. FlagT4v was later shown as not to be completely stable in terms of its attenuation when assessed in a reversion to virulence protocol. We have developed a modified version of the FlagT4v where changes in the codon usage of genomic areas encoding for Flag and T4 were introduced to rectify the reversion to the virulent genotype. The new virus, FlagT4-mFT-Gv, possesses the same amino acid sequence as FlagT4v except for one substitution, Asparagine is replaced by Glycine at position 852 of the CSFV polypeptide.

Abstract: The present invention relates, to novel methods and substrates for the propagation of viruses. The invention relates to IFN-deficient substrates and methods for propagating viruses in these unconventional substrates. In particular, the invention relates to methods of propagating viruses in immature embryonated eggs, preferably six- to nine-day-old chicken eggs. The methods of the invention are particularly attractive for growing viruses suitable for use in vaccine and pharmaceutical formulations.

Abstract: The present invention relates generally to a method for the treatment and prophylaxis of pain. In accordance with the present invention, it is proposed that antagonists of GM-CSF are effective in the treatment of pain. Antagonists of GM-CSF include, but are not limited to, antibodies which are specific for GM-CSF or the GM-CSF receptor. The present invention further provides transgenic animals, such as a GM-CSF knock-out mouse, useful for testing antagonists in certain disease models.

Abstract: The present disclosure relates to, inter alia, stable aqueous solutions comprising a high concentration of an antibody that binds to human complement component C5 and methods for preparing the solutions. The disclosure also provides methods for treating or preventing complement-associated disorders (for example, age-related macular degeneration or rheumatoid arthritis) using the solutions. Also featured are therapeutic kits containing one or more of the solutions and a means for administering the solutions to a patient in need such a treatment.

Abstract: The present invention relates to methods and compositions for pretargeting delivery of therapeutic agents. In preferred embodiments, the pretargeting method comprises: a) administering a bispecific antibody with a first binding site for a disease-associated antigen and a hapten on a targetable construct; b) administering a targetable construct comprising at least one therapeutic agent. In preferred embodiments, the bispecific antibody is made by the dock-and-lock (DNL) technique. In a more preferred embodiment, the targetable construct comprises one or more SN-38 moieties.

Abstract: The invention relates to the field of molecular medicine. In particular, it relates to compositions and methods to enhance the clearance of aberrant cells, e.g. cancer cells or virus-infected cells, by the host's immune system. Provided is a composition comprising (i) a therapeutic compound that can trigger a host's immune effector cells against an aberrant cell, such as a therapeutic antibody, and (ii) at least one agent capable of reducing or preventing inhibitory signal transduction initiated via SIRPalpha.

Abstract: The present invention is directed to a method for treating an inflammatory neurodegenerative condition of the CNS in a subject comprising administering to said subject a G-CSF or G-CSFR inhibiting agent selected from the group consisting of an antibody specific for G-CSF, a soluble G-CSFR or a G-CSF-binding portion thereof and a 20 to 30 nucleotide sense or antisense molecule targeted to a nucleic acid molecule encoding G-CSF.

Abstract: Compositions, kits, and methods for therapeutic screening, diagnostics, and cancer treatment based on the identification or use of the different states of cancer stem cells, including cancer stem cells in the EMT (epithelial to mesenchymal transition) MET (mesenchymal to epithelial transition), and EMT-MET states are disclosed. In some methods, a subject is treated with one therapeutic that targets EMT cancer stem cells and a second therapeutic that targets MET cancers stem cells. In certain methods, the different states of cancer stem cells are distinguished based on markers CD44+CD24?, EpCam?CD49P+ (for EMT cancers stem cells), ALDH+ and EPCam+CD49r? (for MET cancers stem cells), and CD44+CD24?ALDH+ (for EMT-MET cancer stem cells). In particular methods, micro RNAs are used to transition to one particular cancer stem cell type (e.g., mir-100 for EMT and mir-93 for MET).

Abstract: Methods for the treatment of a cell proliferation disorder in a subject, involving: (1) administering to the subject at least one activatable pharmaceutical agent that is capable of effecting a predetermined cellular change when activated, either alone or in combination with at least one energy modulation agent; and (2) applying an initiation energy from an initiation energy source to the subject, wherein the applying activates the activatable agent in situ, thus causing the predetermined cellular change to occur, wherein the predetermined cellular change treats the cell proliferation disorder, preferably by causing an increase or decrease in rate of cell proliferation, and a kit for performing the method, a computer implemented system for performing the method, a pharmaceutical composition useful in the method and a method for causing an autovaccine effect in a subject using the method.

Abstract: An oleogel comprising a non-polar liquid and a powder containing triterpene is provided as an oleogel that may be used for healing wounds.

Abstract: The present invention provides compositions and methods for the delivery of therapeutic agents to cells. In particular, these include novel, trialkyl, cationic lipids and nucleic acid-lipid particles that provide efficient encapsulation of nucleic acids and efficient delivery of the encapsulated nucleic acid to cells in vivo. The compositions of the present invention are highly potent, thereby allowing effective knock-down of a specific target protein at relatively low doses.

Abstract: Discloses herein are high concentration antibody formulations comprising an anti-sclerostin immunoglobulin and an acetate salt and/or an acetate buffer and methods of use.

Abstract: The present invention provides methods for facilitating cleansing of the gastrointestinal tract of a patient prior to a diagnostic, surgical or therapeutic procedure. The methods can improve patient compliance, and thus, efficacy of the preparation. Specifically, the present methods make the gastrointestinal tract preparation composition palatable for the patient to consume. For example, for a patient preparing to undergo colonoscopy, the present methods make the bowel preparation solution taste significantly less salty.

Abstract: Methods for preparing a supramolecular therapeutic agent delivery assembly are provided. A hydrophilic precursor, a hydrophibic precursor, and an aromatic diamine precursor may be combined to form an amphiphilic block co-polymer. The block co-polymer may undergo a cross-linking polymerization process and a therapeutic agent may be incorporated into the resulting supramolecular assembly. The supramolecular assembly may comprise HT, PHT, HA, and/or PHA materials.

Abstract: A composition of matter and method for preparation of a tissue augmentation material. A polysaccharide gel composition is prepared with rheological properties selected for a particular selected application. The method includes preparing a polymeric polysaccharide in a buffer to create a polymer solution or gel suspending properties in the gel and selecting a rheology profile for the desired tissue region.

Abstract: This invention relates to dosage forms for the delivery of drugs across the oral mucosa having improved transmucosal permeability. More specifically, the invention relates to an oral transmucosal dosage form comprising a primary vehicle comprising a crystallization inhibition agent (CIA) system and a drug, and a secondary vehicle. It also relates to methods of designing and making this dosage form, methods of administering this dosage form and methods of packaging the dosage forms.

Abstract: The present invention provides iRNA agents comprising at least one subunit of the formula (I): wherein: A and B are each independently for each occurrence O, N(RN) or S; X and Y are each independently for each occurrence H, OH, a hydroxyl protecting group, a phosphate group, a phosphodiester group, an activated phosphate group, an activated phosphite group, a phosphoramidite, a solid support, —P(Z?)(Z?)O-nucleoside, —P(Z?)(Z?)O-oligonucleotide, a lipid, a PEG, a steroid, a lipophile, a polymer, —P(Z?)(Z?)O-Linker-OP(Z??)(Z?)O-oligonucleotide, a nucleotide, an oligonucleotide, —P(Z?)(Z?)-formula (I), —P(Z?)(Z?)- or -Linker-R; R is LG, -Linker-LG, or has the structure shown below: LG is independently for each occurrence a carbohydrate, e.g.

Abstract: The present invention relates to ligand-therapeutic agent conjugate compounds, silicon linkers for the conjugate compounds, compositions, methods for making them, and methods for the treatment of cancer using the conjugate compounds. The silicon-based linkers described herein can be used to deliver desired therapeutic agents to particular cells or tissue types targeted by the ligand.

Abstract: The present invention provides a process for preparing a compound of Formula 5b, as well as intermediates thereof, and novel classes of compounds useful in process for preparing these and similar compounds.

Abstract: Novel modulators, including antibodies and derivatives thereof, and methods of using such modulators to treat proliferative disorders are provided.

Abstract: Provided is a lentiviral vector system which sustains a high-frequency retrograde transportation ability in animal brain and has a higher titer. A kit for preparing a retrograde transport viral vector, which comprises: (1) a packaging plasmid containing the gag gene and pol gene of HIV-1; (2) a packaging plasmid containing an accessory gene of HIV-1; (3) a transfer plasmid containing a target gene; and (4) an envelope plasmid containing, as an envelope gene, a gene encoding a fused polypeptide comprising the extracellular domain of rabies virus glycoprotein (RV-G), the transmembrane domain of rabies virus glycoprotein (RV-G) or vesicular stomatitis virus glycoprotein (VSV-G) and the intracellular domain of vesicular stomatitis virus glycoprotein (VSV-G).

Abstract: An iron oxide particle constituting a Resovist (trademark) absorbs a small quantity of light in a near infrared region and emits a weak photoacoustic signal. According to a particle having a catechol-like compound and iron atoms, the particle having a ratio of the number of moles of the catechol-like compound to the number of moles of the iron atoms of 270/10,000 or more, light absorption in the near infrared region increases and a strong photoacoustic signal can be transmitted.