Abstract: Provided herein are peptide formulations comprising polymers as stabilizing agents. The peptide formulations can be more stable for prolonged periods of time at temperatures higher than room temperature when formulated with the polymers. The polymers used in the present invention can decrease the degradation of the constituent peptides of the peptide formulations.

Abstract: The delivery of biopharmaceutical and other therapeutic agents parenterally to an animal via a minimally invasive, low pain administration is provided. The agents are delivered to the patient via, e.g., the epidermal, dermal, or subcutaneous layer of the skin in a concentrated form of injectable glucagon that is dissolved in a pharmaceutically acceptable carrier.

Abstract: The present disclosure is directed to transdermal and moisturizing compositions.

Abstract: The present invention relates, in general, to methods of controlling coagulation, and in particular, to methods of effecting neutralizable rapid onset anticoagulation, and to compounds and compositions suitable for use in such methods.

Abstract: The present invention relates to methods of treatment of Hypoxia Inducible Factor (HIF)-related conditions, and in particular to methods of treatment of HIF-related conditions comprising the administration of a composition comprising transferrins.

Abstract: Methods to introduce highly phosphorylated mannopyranosyl oligosaccharide derivatives containing mannose-6-phosphate (M6P), or other oligosaccharides bearing other terminal hexoses, to carbonyl groups on oxidized glycans of glycoproteins while retaining their biological activity are described. The methods are useful for modifying glycoproteins, including those produced by recombinant protein expression systems, to increase uptake by cell surface receptor-mediated mechanisms, thus improving their therapeutic efficacy in a variety of applications.

Abstract: The present application relates to sialylated glycoprotein compositions and methods of their use in treating various conditions and disorders.

Abstract: Provided are compositions comprising newly identified protein fragments of aminoacyl-tRNA synthetases, polynucleotides that encode them and complements thereof, related agents, and methods of use thereof in diagnostic, drug discovery, research, and therapeutic applications.

Abstract: A therapeutic agent for the treatment of the symptoms of addiction and the method for preparing the therapeutic agent is disclosed. The therapeutic agent is a stable pharmaceutical preparation containing, but not limited to, digestive/pancreatic enzymes. The therapeutic agent may be manufactured by a variety of encapsulation technologies. Delivery of the therapeutic agent may be made orally, through injection, by adherence of a medicated patch or other method. Further, a method of using of a biomarker, the presence of chymotrypsin in the gastrointestinal tract to determine the presence of symptoms of addiction, and the likelihood of relapsing into addiction is disclosed.

Abstract: A therapeutic composition for the treatment of the symptoms of prion diseases and the method for preparing the therapeutic agents is disclosed. The therapeutic composition is a stable pharmaceutical composition comprising one or more digestive and/or pancreatic enzymes. The therapeutic composition may be manufactured by a variety of encapsulation technologies. Delivery of the therapeutic composition may be made orally, through injection, by adherence of a medicated patch or other method. Further, a method of using fecal chymotrypsin level as a biomarker for the presence of a prion disease, or the likelihood of an individual to develop a prion disease is disclosed.

Abstract: Provided herein are methods for generating dry vaccine powder formulations. Dry vaccine powder formulations can be used for intranasal delivery. Also provided are methods for stimulating local mucosal and systemic immunity by intranasal vaccine delivery.

Abstract: A vaccine containing AAH-loaded mature dendritic cells for treatment of AAH-expressing tumors in mammalian subjects. A method of producing primed dendritic cells is carried out by contacting isolated dendritic cells with an antigen such as AAH. Following the antigen-contacting step, the dendritic cells are contacted with a combination of cytokines such as GM-CSF and IFN-?.

Abstract: Isolated CDCA1-derived epitope peptides having Th1 cell inducibility are disclosed herein. Such peptides can be recognized by MHC class II molecules and induce Th1 cells. In preferred embodiments, such a peptide of the present invention can promiscuously bind to MHC class II molecules and induce CDCA1-specific cytotoxic T lymphocytes (CTLs) in addition to Th1 cells. Such peptides are thus suitable for use in enhancing immune response in a subject, and accordingly find use in cancer immunotherapy, in particular, as cancer vaccines. Also disclosed herein are polynucleotides that encode any of the aforementioned peptides, APCs and Th1 cells induced by such peptides and methods of induction associated therewith. Pharmaceutical compositions that comprise any of the aforementioned components as active ingredients find use in the treatment and/or prevention of cancers or tumors.

Abstract: The present invention concerns CD4+ T survivin epitopes and their vaccines and diagnostic uses.

Abstract: The present invention discloses that Salmonella enterica serogroup C2-3 serovars cross protect against Salmonella enterica serogroup C1 serovars and vice versa. Therefore, the present invention discloses the use of either a Salmonella enterica serogroup C2-3 serovar or a Salmonella enterica serogroup C1 serovar in the manufacture of a vaccine for administration to poultry to protect against a disorder arising from a Salmonella enterica serogroup C2-3 serovar and/or a disorder arising from a Salmonella enterica serogroup C1 serovar.

Abstract: This invention relates to compositions including Clostridium difficile toxins and/or toxoids and corresponding methods. The compositions of the invention include one or more excipients that increase stability and/or decrease aggregation of the toxins.

Abstract: Disclosed herein is a robust system for the reverse genetics generation of a Rift Valley fever (RVF) virus replicon particle (VRPRVF) vaccine candidate. VRPRVF can actively synthesize viral RNA and proteins, but lack structural glycoprotein genes, preventing spread within immunized individuals and reducing the risk of vaccine-induced pathogenicity. Is it disclosed herein that VRPRVF immunization is both safe and efficacious, resulting in a robust immune response that is protective against RVF virus challenge within 24 hours of immunization. Provided herein are VRPRVF, methods of producing VRPRVF, and method of using VRPRVF for immunization against RVF virus infection.

Abstract: Provided herein are embodiments relating to porcine reproductive and respiratory syndrome (PRRS) virus, compositions comprising the virus, and methods of using the virus. The virus may be used to immunize a mammal, including swine. Methods for generating an immune response against PRRS virus in swine by administering a composition comprising the virus are provided.

Abstract: The present invention relates to novel compositions for inducing an immune response in mammals. The composition preferably comprises an antigen and a lipopolysaccharide in an oil-in-water formulation. The invention is particularly suited to vaccinate swine against mycoplasma infections.

Abstract: Disclosed are a nonspecific immunostimulant composition, a preparation method thereof, and uses thereof. The composition includes 150 to 300 wt. parts of sodium silicate, 2˜8 wt. parts of sodium thiosulfate, 0.5˜2 wt. parts of sodium carbonate, 0.5˜2 wt. parts of potassium chloride, 200˜400 wt. parts of white sugar, and 300˜400 wt. parts of water, based on 100 wt. parts of potassium carbonate. The composition exhibits excellent defense against the mortality caused by AIV H5N1, thus improving the survival of infected animals. As a supplement of a formulated feed mixture for farmed aquatic organisms, the composition provides excellent immunostimulation and disease resistance so as to decrease the mass mortality of aquatic organisms and to increase productivity. Particularly, when raised with a food in mixture with the composition, livestock and farmed aquatic organisms are immunologically improved so that they can endure and are protected against epidemic diseases caused by viruses and bacteria.

Abstract: Polyphosphazene polymers having immunomodulating activity, and the biomedical use of such polyphosphazene polymers, in conjunction with an antigen or an immunogen are disclosed.

Abstract: The present invention concerns methods and compositions for treatment of HIV infection using a T20 expression vector, such as that shown in SEQ ID NO:1 or SEQ ID NO:3. The T20 expression vector may be used in a variety of therapeutic applications, such as ex vivo transfection of dendritic cells to induce a host immune response to HIV, localized transfection in vivo in a gene therapy approach to provide longer term delivery of T20, or in vitro production of T20 peptide. The T20 may be secreted into the circulation to act as a fusion inhibitor of HIV infection, or may induce an endogenous immune response to HIV or HIV-infected cells. Alternatively, a DDD peptide may be incorporated in a fusion protein comprising T20 or another antigenic protein or peptide to enhance the immune response to the protein or peptide.

Abstract: Provided herein are compositions containing photoactivatable caged tamoxifen and tamoxifen derivative molecules. Also provided are kits containing one of these compositions and a light source. Also provided are methods of optically inducing nuclear translocation of a fusion protein containing a mammalian estrogen receptor ligand binding domain in a eukaryotic cell and methods of optically inducing recombination in a eukaryotic cell that include contacting a eukaryotic cell with at least one of these compositions. Also provided are methods of treating breast cancer in a subject that include administering a photoactivatable caged tamoxifen or tamoxifen derivative molecule to a subject having breast cancer.

Abstract: A topical pharmaceutical gel compositions of diclofenac sodium, is provided. The topical gel composition contains at least about 10% w/w diclofenac sodium and is suitable for twice daily application.

Abstract: The present invention is based, in part, upon the discovery of charged lipids that provide advantages when used in lipid particles for the in vivo delivery of a therapeutic agent. As such, described herein are compounds useful for delivering a nucleic acid to a cell.

Abstract: A novel pharmaceutical composition is provided by which nonsteroidal anti-inflammatory drugs (NSAIDs) are added directly to phospholipid-containing oil such as lecithin oils or to a bio-compatible oil to which an phospholipid has been added to make a NSAID-containing formulation that possess low gastrointestinal (GI) toxicity and enhanced therapeutic activity to treat or prevent inflammation, pain, fever, platelet aggregation, tissue ulcerations and/or other tissue disorders. The composition of the invention are in the form of a non-aqueous solution, paste, suspension, dispersion, colloidal suspension or in the form of an aqueous emulsion or microemulstion for internal, oral, direct or topical administration.

Abstract: The present invention relates to an association of poly (N-acryloyl glycinamide) with at least one active principle and/or at least one product which is visible in medical imaging, in a physiologically acceptable aqueous medium.

Abstract: Nanocarriers are synthesized with polymers that respond to lower pH and/or ROS by being degraded. The compositions may be utilized to selectively deliver payloads within patients by responding to lower pH and/or ROS at localities within the patient. The present invention also features methods of synthesizing nanocarriers that are degraded by lower pH and/or ROS.

Abstract: The present invention relates to a pharmaceutical composition for topical application for the treatment of alopecia, said composition comprising polymeric nanoparticles, preferably nanocapsules containing two active ingredients, finasteride and minoxidil, additives and a pharmaceutically acceptable carrier. The invention further includes a process for the preparation of polymeric nanoparticles, preferably nanocapsules of finasteride and minoxidil, a composition suitable for topical application for the treatment of alopecia, as well as the use of said nanocapsules for the preparation of a pharmaceutical composition.

Abstract: The present invention relates to the use of a taste masking agent selected from the group of starch; cellulose; xanthan gum; gellan gum; alginate; galactomannans such as fenugreek, guar gum, tara gum, locust bean gum, and cassia gum; gum karaya; gum tragacanth; carrageenan; and mixture thereof, for improving one or more of mouth feel, taste, aftertaste and smell of a liquid aqueous nutritional composition comprising a nucleoside and/or a nucleotide. It also relates to a nutritional composition comprising an unsavory nucleoside and/or nucleotide component, having improved sensory characteristics such as improved mouth feel, taste, aftertaste and smell. In particular, it relates to a composition comprising said unsavory nucleoside and/or nucleotide component, in particular comprising an uridine-containing nucleoside and/or a nucleotide in combination with an unsavory edible oil, such as a fish oil.

Abstract: A novel delivery system for drugs, and especially macromolecules such as proteins or oligonucleotides through biological membranes is provided, and specifically delivery of siRNA The delivery system comprises conjugation of the macromolecule drug to a moiety that enables effective passage through the membranes. Respectively, novel compounds and pharmaceutical compositions are provided, utilizing said delivery system. In one aspect of the invention, the compounds may be utilized in medical practice, for example, in delivery of siRNA or antisense oligonucleotides across biological membranes for the treatment of medical disorders.

Abstract: The present invention relates to an optimized in vivo delivery system with endosomolytic agents for nucleic acid of therapeutic interest conjugated to molecules facilitating endocytosis, in particular for use in the treatment of cancer.

Abstract: The present invention describes a new group of bioconjugates which can be obtained by means of indirect synthesis, via a molecular spacer, between hyaluronic acid and/or its derivatives and drugs with an antitumoral activity belonging to different groups, their preparation process and use in the oncological field. The new derivatives, in relation to the type of bond and Substitution degree, have different physico-chemical properties which improve their tolerability and efficiency and allow a more accurate modulation of the dosage, exploiting an active targeting mechanism.

Abstract: The present invention includes compositions, methods, and systems for the development and use of heparosan, a natural polymer related to heparin, as a new therapeutic modifying agent or vehicle which can modulate drug cargo pharmacokinetics and behavior within a mammalian patient.

Abstract: The present invention relates to a skin-permeating peptide, and more particularly, the present invention relates to an isolated peptide capable of permeating the skin to deliver a drug to the skin, to an isolated polynucleotide coding the peptide, to a composition for transdermal delivery comprising the peptide, and to a peptide/cargo composite comprising the peptide and cargo.

Abstract: The invention relates to dendrimers conjugated to multiple targeting peptides and one or more therapeutic, diagnostic, or imaging agents for delivery of such agents across the blood-brain barrier and into certain cell types including, cells expressing the LRP-1 receptor. Also described are methods of making compounds that comprise dendrimers conjugated to targeting peptides and therapeutic, diagnostic, or imaging agents.

Abstract: Polymeric conjugates of a polymeric backbone formed of a plurality of backbone units and having attached to portions of the backbone units two or more therapeutically active agents, or one or more therapeutically active agents and a NCAM targeting moiety, are disclosed. Uses of such polymeric conjugates in treating and/or monitoring cancer and/or medical conditions associated with angiogenesis are also disclosed.

Abstract: A new nanoscale carrier made by one or more pH-sensitive peptides is provided for delivery of a biologically active substance. The peptides are composed of pH-sensitive hydrophilic and hydrophobic amino acids in the backbone. As the pH environment changes from physiological pH level to a weakly acidic environment such as near a tumor site (pH˜6.5-6.9), the peptides may dissolve, releasing the biological substance. Also provided are the delivery methods and related kits.

Abstract: The present invention is directed to long-lasting erythropoietin therapeutic formulations and their methods of use wherein the formulation comprises a genetically modified micro-organ that comprises a vector which comprises a nucleic acid sequence operably linked to one or more regulatory sequences, wherein the nucleic acid sequence encodes erythropoietin.

Abstract: Compounds and a method for imaging myocardial perfusion, including administering to a patient a compound linked to an imaging moiety, wherein the compound binds MC-1, and scanning the patient using diagnostic imaging. Kits including the compound or precursor compounds linked or not linked to an imaging moiety are also described.

Abstract: Genetically modified non-human animals and methods and compositions for making and using them are provided, wherein the genetic modification comprises a deletion of the endogenous low affinity Fc?R locus, and wherein the mouse is capable of expressing a functional FcR?-chain. Genetically modified mice are described, including mice that express low affinity human Fc?R genes from the endogenous Fc?R locus, and wherein the mice comprise a functional FcR?-chain. Genetically modified mice that express up to five low affinity human Fc?R genes on accessory cells of the host immune system are provided.

Abstract: The present invention relates to compositions for and methods of optically imaging tissues or cells using imaging agents having desirable in vivo properties that result in improved signal-to-background ratio.

Abstract: This invention relates to a composition of a non-labeled monoclonal antibody binding to a tumor antigen and a second monoclonal antibody labeled with a NIR fluorescence label, binding to the same tumor antigen, wherein the first and second antibody exhibit no cross reactivity. The composition can be used for the treatment of patients suffering of solid tumors which are associated with an overexpression of such a tumor antigen. The invention further relates to a the co-administration of said first and second antibody as wells as to a method of acquiring a NIR fluorescence images of such tumors or the patients suffering from such tumors during the treatment of said patient with such composition.

Abstract: Nanoparticle having a poly(beta-amino ester) coating. The poly(beta-amino ester) coating includes one or more therapeutic agents that can be delivered by the particle and one or more anchoring groups that couple the polymer to the nanoparticle's core surface. In certain embodiments, the poly(beta-amino ester) includes one or more polyalkylene oxide groups. The poly(beta-amino ester) can further include a targeting agent to target the nanoparticle to a site of interest and a diagnostic agent that allows for imaging of the particle. Methods for making and using the nanoparticles are also provided.

Abstract: A method of producing lipid-based micro/nano bubbles includes steps of (a) preparing a lipid mixture including one or more first lipids with different phase transition temperature, and a second lipid bonding with a hydrophilic polymer moiety or molecules capable of getting across a lipid membrane and decreasing van der Waals forces between lipid bilayers; (b) emulsifying the lipid mixture with a solvent, to form a transparent lipid carrier solution; (c) placing the transparent lipid carrier solution in a closed vessel with halo-substituted hydrocarbon; (d) manipulating temperature of the transparent lipid carrier solution to be close to a main phase transition temperature thereof; and (e) agitating in a mechanical manner the vessel containing the transparent lipid carrier solution to form micro/nano bubbles within the closed vessel. This method contributes to form micro/nano bubbles with desired diameters in a way of optimal material utilization efficiency.

Abstract: Radiopharmaceutical compositions, and related methods, useful for medical imaging are provided. The radiopharmaceutical compositions include one or more radiopharmaceutical compounds, together with a stabilizer comprising ascorbic acid, wherein the pH of said composition is within the range of about 3.5-5.5.

Abstract: A dendrimer conjugate according to Formula (I), or its pharmaceutically acceptable salt, or solvate thereof: and complexes of Formula I conjugates with metals radionuclides of elements such as rhenium, technetium, yttrium, lutetium and others to provide a complex for imaging tissues or for the radiotherapeutic treatment of cancer tissue. Such complexes are specific to PSMA protein and can therefore be used in imaging or treating cancer of the prostate and other tissue where the protein is expressed.

Abstract: The present disclosure relates to polymeric materials that may be labeled with a radioisotope, to processes for producing the labeled polymeric material, and to methods of using the materials in analytical and therapeutic applications. Specifically, the disclosure relates to injectable and implantable microparticles, such as microspheres, which are associated with radioisotopes such that the microparticles are both therapeutic and detectable. The radioisotope-containing microparticles are useful for embolization and other therapeutic medical applications.

Abstract: This invention concerns a pharmaceutically-acceptable composition of radioactive metals, which are used for treating various diseases in animals or humans, such as cancer and arthritis.

Abstract: Provided herein are ultraviolet (UV) devices, systems, and methods for UV disinfection and sterilization, more specifically, UV devices, systems, and methods for UV disinfection and sterilization of a container, room, space or defined environment. The systems, UV devices, and methods are particularly useful for the UV disinfection and sterilization of a container used in the food and dairy industry and for containers used in the process of fermentation for an alcoholic beverage. Provided are also UV devices, systems, and methods for inhibiting the growth of one or more species of microorganisms present in a container, room, space or defined environment, preferably for inhibiting the growth of one or more species of microorganisms present on an interior surface of a container, room, space or defined environment.