Abstract: Compositions and formulations comprising insulin or insulin analogues comprising a carboxy terminal portion (CTP) peptide comprising amino acids 112-188 to 142 of the beta subunit of human chorionic gonadotropin (hCG?) or a partial variant thereof that includes at least one O-glycosylation site of the CTP peptide, wherein the CTP peptide of the CTP peptide-based insulin or insulin analogue is O-glycosylated are described. In particular embodiments, the O-glycosylated insulin analogues are produced in vivo and in further embodiments, the O-glycosylated CTP-based insulin analogues comprise predominantly mannotriose and mannotetrose O-glycans or predominantly mannose O-glycans.

Abstract: A method for treating cancer using at least one globin, a globin protomer or an extracellular haemoglobin of annelids.

Abstract: A skin sensitivity improving agent which is safe and, when routinely taken or applied to the skin, exerts an effect of improving deterioration in peripheral sensation is provided. The present invention also provides a food, a drink, a feed or a cosmetic for improving sensation which exerts an effect of improving deterioration in peripheral sensation when orally taken or applied to the skin. The skin sensitivity improving agent includes, as the active ingredient, a basic protein fraction derived from milk or a degraded basic protein fraction derived from milk. By orally taking the basic protein fraction derived from milk or the degraded basic protein fraction derived from milk or applying the same directly to the skin, deterioration in sensation, in particular, peripheral sensation can be improved. Thus, a food, a drink, a feed or a cosmetic for improving sensation can be obtained.

Abstract: The invention is directed to a method of treating a spinal cord injury, a neurodegenerative disease or a neuronal injury in an individual in need thereof comprising administering an effective amount of superoxide dismutase (SOD) and catalase to the individual, wherein the superoxide dismutase and the catalase are encapsulated in one or more nanoparticles that release the SOD and catalase upon administration. Another aspect of the invention is directed to compositions comprising superoxide dismutase (SOD) and catalase encapsulated in one or more nanoparticles.

Abstract: A method for stimulating angiogenesis in a tissue of a mammal comprising contacting tissue with a protein substantially similar to pyruvate kinase M2.

Abstract: Described is a compound capable of reducing or inhibiting (a) the biological activity of branched-chain-aminotrans-ferase-1 (BCATI) or (b) the expression of the gene encoding BCATI for use in a method of treating a neoplasia. A preferred compound is 1-(aminomethyl)cyclohexaneacetic acid (gabapentin).

Abstract: In one aspect, the disclosure provides proteins with modified glycosylation and methods of their production. In aspect, the disclosure provides transgenic animals and cells for the production of proteins with modified glycosylation. In some embodiment, the modified glycosylation is increased sialylation.

Abstract: The invention provides compositions and methods for treating inflammatory diseases, such as cardiac or hepatic inflammatory diseases, involving the use of parasite-derived neurotrophic factor (PDNF), or fragment of PDNF. The invention also provides compositions featuring PDNF, or a fragment thereof, and methods for using such compositions for the proliferation and/or mobilization of a stem cell (e.g., cardiac stem cell) or progenitor cell (e.g., hepatic progenitor cell). In one aspect, the invention provides a method of decreasing inflammation in a nonneuronal tissue of a subject. In another aspect, the invention provides a method of decreasing inflammation in a cardiac, liver, pancreas, or gastrointestinal tissue of a subject.

Abstract: The present invention provides AAV vectors and methods of use thereof for delivery of transgenes or therapeutic nucleic acids to subjects.

Abstract: Raising the level of Factor I above physiological levels can be used to treat diseases in which the underlying pathology is linked to overactivity of the C3b-feedback cycle and the generation and pro-inflammatory effects of iC3b. Methods, agents, and compositions for treatment of such diseases are described.

Abstract: The present invention relates to methods for treating neurological-urological conditions. This is accomplished by administration of at least one neurotoxin.

Abstract: A method of inducing specific immune tolerance to myelin in an individual is provided. The method includes introducing directly into a lymph node of the individual an effective amount of a composition that contains a myelin antigen, a biodegradable material and at least one tolerogenic agent. The method is suitable for reducing the severity of symptoms of multiple sclerosis in individuals who suffer from primary-progressive multiple sclerosis (PPMS), and can halt or even reverse PPMS progression.

Abstract: The present invention is related to the fields of molecular biology, virology, immunology and medicine. The invention provides a composition comprising an ordered and repetitive antigen or antigenic determinant array, and in particular an A?1-peptide-VLP-composition. More specifically, the invention provides a composition comprising a virus-like particle and at least one A?1-6 peptide bound thereto. The invention also provides a process for producing the conjugates and the ordered and repetitive arrays, respectively. The compositions of the invention are useful in the production of vaccines for the treatment of Alzheimer's disease and as a pharmaccine to prevent or cure Alzheimer's disease and to efficiently induce immune responses, in particular antibody responses. Furthermore, the compositions of the invention are particularly useful to efficiently induce self-specific immune, responses within the indicated context.

Abstract: The application discloses therapeutic vaccines based upon the “pING” DNA plasmid vector expressing the gene encoding the rat Her2 protein. Vaccines according to the instant disclosure are used as an adjunct treatment for surgery, radiation and/or chemotherapy for dogs and cats with cancers that over express the Her2 antigen, and prolong the post-surgical disease free interval and/or survival time. Also included are therapeutically effective methods of immunization using said vaccines.

Abstract: The present invention provides a therapeutic agent comprising an antibody-recognition epitope (ARE) covalently bound to a tumor cell, wherein the ARE is bound to an antibody that is specific for the ARE, to form a tumor cell:ARE:antibody complex, and kits and methods of using these tumor cell:ARE:antibody complexes.

Abstract: The present invention provides isolated peptides or the fragments derived from SEQ ID NO: 42, which bind to an HLA antigen and induce cytotoxic T lymphocytes (CTL). The peptides may include one of the above mentioned amino acid sequences with substitution, deletion, or addition of one, two, or several amino acids sequences. The present invention also provides pharmaceutical compositions including these peptides. The peptides of this invention can be used for treating cancer.

Abstract: The present application is generally directed to novel pneumococcal polypeptide antigens and nucleic acids encoding such antigens, and immunogenic compositions comprising such antigens for treating and preventing pneumococcal infection. The present invention further provides method of using the antigens to elicits an immune response (e.g., IL-17A response, a T cell-mediated and/or B-cell-mediated immune responses). The present invention also provides methods of prophylaxis and/or treatment of pneumococcal-mediated diseases, such as sepsis, comprising administering an immunogenic composition including one or more of a combination of pneumococcal antigens or functional fragments thereof as disclosed herein. In some embodiments, one or more pneumococcal antigens can be present in a polysaccharide conjugate. The compositions induce an anti-pneumoccocus immune response when administered to a mammal.

Abstract: Provided herein are engineered cell lines. In some embodiments, cells of an engineered cell line have altered expression of a gene and/or altered expression of an miRNA, wherein the altered expression results in increased or decreased production of a virus. The virus is a picomavirus, such as a poliovirus or Enterovirus 71. Also provided herein are methods for using the engineered cells to produce virus, and methods for treating a subject having or at risk of having a viral infection.

Abstract: The present invention discloses and claims virus like particles (VLPs) that express and/or contains seasonal influenza virus proteins, avian influenza virus proteins and/or influenza virus proteins from viruses with pandemic potential. The invention includes vector constructs comprising said proteins, cells comprising said constructs, formulations and vaccines comprising VLPs of the inventions. The invention also includes methods of making and administrating VLPs to vertebrates, including methods of inducing substantial immunity to either seasonal and avian influenza, or at least one symptom thereof.

Abstract: The problem to be solved: absence of safe efficient universal vaccine against influenza. The solution: The vaccine based on the fusion protein consisting of antigenic determinants of haemagglutinins of influenza A and B viruses and flagellin fragments functioning as safe adjuvant (SEQ ID NO:1) joined via flexible hinges is given which can be used for prophylaxis of influenza caused by existing influenza A and B strains as well as by possible reassortants. Safety, efficacy, polyvalence and preventive effect have been demonstrated. Usage of the present vaccine will allow to provide a universal protection against influenza.

Abstract: Disclosed are synthetic nanocarrier compositions and immune checkpoint inhibitor compositions and related methods for administration to a subject.

Abstract: The invention provides a method of treating a microbial infection in a subject and a method of improving an immune system response in a subject against a disease, condition, infection, or virus thereof, by administering an effective amount of a nucleoside, short oligonucleotide compound or an analog thereof, or a pharmaceutically acceptable salt, racemate, enantiomer, diastereomer, geometric isomer, or tautomer thereof. In addition, the invention provides methods for treating or preventing a viral infection, bacterial infection, parasitic infection, or fungal infection in a subject (such as, a human). The compounds of the invention include, for example, di-, and trinucleotide compounds as provided herein. The compounds of the invention are useful for different therapeutic applications including, such as, prophylactics and therapeutics. The invention also provides design and synthesis of a compound that is useful for various therapeutic applications as mentioned herein.

Abstract: The present invention is directed to a pharmaceutical composition or a kit-of-parts and its use in the treatment of burnout syndrome and longevity therapy.

Abstract: The present application relates to activable inorganic nanoparticles which can be used in the health sector, in particular in human health, to disturb, alter or destroy target cancerous cells, tissues or organs. It more particularly relates to nanoparticles which can generate a surprisingly efficient therapeutic effect, when concentrated inside the tumor and exposed to ionizing radiations. The invention also relates to pharmaceutical compositions comprising a population of nanoparticles as defined previously, as well as to their uses.

Abstract: The present invention relates to compositions and methods for destroying target cells in a patient using photodynamic therapy. In particular, the present invention provides a photosensitizing agent based on a small molecular weight (<50 kDa) protein or peptide or a small molecule that is conjugated to a phthalocyanine dye, such as IRDye® 700DX.

Abstract: The present invention relates to an emulsion composition containing difluprednate and zinc. The present invention also relates to a method of stabilizing an emulsion composition containing difluprednate, the method includes preparing an emulsion composition comprising difluprednate and zinc. According to the present invention, a difluprednate-containing emulsion composition having excellent preservative efficacy and excellent stability (photostability and heat stability) can be provided.

Abstract: An abuse deterrent pharmaceutical composition including a pharmaceutically active ingredient; an acid soluble ingredient; and a buffering ingredient; wherein the acid soluble ingredient and the buffering ingredient retard release of the active pharmaceutical ingredient when the composition is ingested in excess of an intended dosage.

Abstract: Apparatus and methods deliver physiologically active agents in the presence of adjuvant gases. The adjuvant gases can enhance the effectiveness of the drug, lower the dosage of drug or concentration of drug necessary to achieve a therapeutic result, or both. Exemplary adjuvant gases include carbon dioxide, nitric oxide, nitrous oxide, and dilute acid gases.

Abstract: The present invention relates to the use of polyalkoxylated alcohols of the formula R—O-(AO)—H, wherein R is a substituted or unsubstituted alkyl, alkenyl, alkynyl, aryl, aralkyl or heterocyclic group having 7 to 25 carbon atoms, (AO) is a polyoxyalkylene moiety of the composition (BO)m(EO)n(DO)r with random or blockwise arrangement of the constituting oxyalkylene units, wherein m, n and r represent the average number of oxybutylene (BO) units, oxyethylene (EO) units and oxyalkylene units derived from at least one epoxide selected from styrene oxide and alkylene oxides having from 5 to 10 carbon atoms (DO) per molecule of the polyalkoxylated alcohol, respectively, m being a number greater than or equal to 1, n being a number greater than or equal to 1 and r being a number in the range from 0 to 50 under the proviso that (m+n+r) is less than or equal to 200 and the ratio n/(m+r) is in the range of 1 to 20, as excipients in pharmaceutical compositions.

Abstract: A stable and lyophilized pharmaceutical agent containing nocathiacin, which is prepared by lyophilizing a liquid formulation of nocathiacin, a stabilizer, an excipient, a pH regulator and injectable water, wherein the stabilizer is selected from polyethylene glycol, polysorbate or a mixture thereof, and the pH value of the liquid formulation is 1.0-6.0 is provided.

Abstract: Stabilized formulations containing a peptide, such as a glucagon, are described herein. The formulations are in the form of a solution or suspension, which exhibit ttle or no chemical degradation and/or aggregation of the peptide over an extended period of time. In some embodiments, the formulations are in the form of a solution containing the peptide, a solvent such as glycerin, and one or more thermal stabilizers. In other embodiments, the formulation is in the form of a suspension containing nano- and/or microparticles containing the peptide suspended in a non- aqueous, non-solvent. The nano- and/or microparticles can be prepared by micronizing the peptide with one or more humectants, such as salts, sugars, water-soluble polymers, and combinations thereof which increase the rate of dissolution of the peptide upon administration.

Abstract: Pharmaceutical compositions and dosage forms for administration of hydrophobic drugs are provided. The pharmaceutical compositions include a therapeutically effective amount of a hydrophobic drug, preferably a steroid; a solubilizer, and a surfactant. The synergistic effect between the hydrophobic drug and the solubilizer results in a pharmaceutical formulation with improved dispersion of both the active agent and the solubilizer. As a result of the improved dispersion, the pharmaceutical composition has improved bioavailability upon administration. Methods of improving the bioavailability of hydrophobic drugs administered to a patient are also provided.

Abstract: Disclosed are compositions including a solid dispersion comprising a dispersion polymer, a basic low-water solubility active, and an anionic counterion, as well as methods of making and using the compositions.

Abstract: Disclosed are glucose-sensitive nanoparticles which includes a phenylboronic acid derivative and a biocompatible polymer, and is prepared as an amphiphilic conjugate having chemical binding between the phenylboronic acid derivative and the biocompatible polymer. The use of the composition can effectively collect glucose in the cancer tissue, thereby simultaneously performing diagnosis and therapy of cancer.

Abstract: The invention relates to the implementation of a method for loading, without a vehicle, a naturally crystalline substance solubilised by a solvent mixture in a lipophilic medium in a mixture of granulated polymers, for forming, without a plasticiser, a polymer support for the long-term controlled distribution of the naturally crystalline substance in the stable solubilised state, without permanent crystallisation on the surface of said support. Said substance according to the invention can be insecticides and pesticides of the group of pyrethroids (e.g. deltamethrin), formamidines (e.g. amitraz) and carbamates (e.g. propoxur), or the mixture thereof, or cosmetics of the group of alkaloids (e.g. caffeine), or medicaments (e.g. ibuprofen).

Abstract: Improved medical devices and methods are provided that are implantable at or near a target tissue site beneath the skin of a patient, the medical device comprises an adhesive sheet having a region configured to receive a drug depot, the drug depot disposed within the region of the adhesive sheet and the drug depot having at least one surface configured to release a therapeutically effective amount of the drug over a period of at least one day, wherein the adhesive sheet limits movement of the medical device at or near the target tissue site. In some embodiments, the medical device provided can include an effective amount of at least one analgesic and/or at least one anti-inflammatory agent at or near a target site, and can reduce, prevent or treat inflammation and/or pain, particularly postoperative pain or orthopedic degenerative pathology pain.

Abstract: Esterified cellulose ethers which comprise (i) aliphatic monovalent acyl groups or (ii) groups of the formula —C(O)—R—COOA, wherein R is a divalent aliphatic or aromatic hydrocarbon group and A is hydrogen or a cation, or (iii) a combination of aliphatic monovalent acyl groups and groups of the formula —C(O)—R—COOA, which have a viscosity of up to 2.33 mPa·s, measured as a 2.0 wt % solution of the esterified cellulose ether in 0.43 wt % aqueous NaOH at 20° C., and which have a viscosity of up to 13 mPao·s, measured as a 10 wt % solution of the esterified cellulose ether in acetone at 20° C. are useful for preparing solid dispersions comprising drugs.

Abstract: The invention relates to compositions of epinephrine formulation in an aqueous solution that enhances the chemical stability of epinephrine and consequently extends the product shelf life. The formulation comprises epinephrine or a salt thereof, a tonicity modifier, and a complexing agent, in an aqueous solution adjusted to a pH of about 2-7. A process for manufacturing and methods of using the formulation for the medicinal products are also provided.

Abstract: A polypeptide hydrogel of the present invention is a hydrogel of a polypeptide derived from spider silk proteins, and has a moisture content of 85.0 to 99.9 mass % based on 100 mass % of the polypeptide hydrogel. A method for producing the hydrogel includes: a solution production step in which a polypeptide derived from spider silk proteins is dissolved in at least one dissolving solvent selected from the group consisting of: (A) dimethyl sulfoxide; (B) dimethyl sulfoxide with an inorganic salt; and (C) N, N-dimethylformamide with an inorganic salt, so as to obtain a solution of the polypeptide; and a substitution step in which the solution produced in the solution production step is substituted with a water-soluble solvent. Thus, the present invention provides a polypeptide hydrogel having excellent water retentivity and a polypeptide hydrogel suitable for application to a living body.

Abstract: The present invention provides novel, serum-stable lipid particles comprising one or more active agents or therapeutic agents, methods of making the lipid particles, and methods of delivering and/or administering the lipid particles. More particularly, the present invention provides serum-stable nucleic acid-lipid particles (SNALP) comprising a nucleic acid (e.g., one or more interfering RNA molecules), methods of making the SNALP, and methods of delivering and/or administering the SNALP (e.g., for the treatment of cancer). In particular embodiments, the present invention provides tumor-directed lipid particles that preferentially target solid tumors. The tumor-directed formulations of the present invention are capable of preferentially delivering a payload such as a nucleic acid to cells of solid tumors compared to non-cancerous cells.

Abstract: Aspects of the present invention are directed to compositions that are useful for delivery of an active ingredient to a subject. Some embodiments are formulated with an active ingredient, including, for example, a non-steroidal anti-inflammatory drug (NSAID), such as aspirin, ibuprofen, ketoprofen, or naproxen, acetaminophen, or a polypeptide or protein, such as insulin, wherein the active ingredient is stabilized and greater than 90% of the particles of the active ingredient have a particle size that is less than or equal to or any number in between 100, 90, 80, 70, 60, 50, 40, 30, 20, 19, 18, 17, 16, 15, 14, 13, 12, 11, 10, 9, 8, 7, 6, 5, or 4 nanometers, or smaller, as determined by Dynamic Light Scattering (DLS), using a volume-weighted particle size distribution calculation method.

Abstract: The invention provides analgesic conjugates having a mu opioid receptor agonist linked to a mGluR5 antagonist, and to methods for producing analgesia using such compounds.

Abstract: The invention relates to medicine, namely to the antimicrobial agent for the treatment of infectious bacterial diseases including hospital infections and drug-resistant TB which represents the ion nanostructured complex (INSC) synthesized from carbohydrates proteins and/or polypeptides (albumins, interleukins, interferons, signaling proteins, etc), which are to enhance the antimicrobial activity in vivo, by activating immune cells that contain at least one terminal amino acid such as Phe, Ala, Val, Ala, Leu, Ile, and others with electron-donor functional groups, iodine and halides of the alkali and alkaline earth elements in the fourth stage at a certain ionic strength; an antibacterial agent increases: the susceptibility of bacteria, including antibiotic-resistant, to antibiotics; activity of monocytes and macrophages; efficiency of antibiotic treatment of hospital infections and drug-resistant TB; it also has antiviral activity, stimulates hematopoietic function of bone marrow; has an antitumor effect and r

Abstract: The present disclosure relates to a polymeric system for release of an active agent, comprising a first polymeric phase containing the active agent, the first polymeric phase forming discrete regions of a set size range and being dispersed within a second polymeric phase comprising a cross-linked polymer-phenol conjugate for release of the active agent therein. The present disclosure further provides an injectable hydrogel comprising the disclosed polymeric system, a carrier for delivering a biologically active substance or a drug comprising the injectable hydrogel, and a method for producing the disclosed polymeric system.

Abstract: The invention provides compositions and methods for treating or preventing cancer with an inventive composition. The invention relates to the fields of biomedicine, pharmacology, and molecular biology.

Abstract: Provided are compounds and methods of making compounds containing two or three groups derived from a peptide, such as enfuvirtide or exenatide, covalently bound to a linker. The compounds may contain polyethylene glycol groups to enhance solubility and pharmacokinetic properties. The compounds are useful for the treatment of diseases or conditions subject to treatment with the parent peptide, such as HIV and AIDS in the case of enfuvirtide, or diabetes in the case of exenatide.

Abstract: Oligonucleotide conjugates, where an oligonucleotide is covalently attached to an aromatic system, are provided. In particular embodiments the oligonucleotide is complementary to the RNA component of human telomerase and is covalently attached to a nucleobase via an optional linker. The conjugates inhibit telomerase enzyme activity.

Abstract: Formulations comprising anionic agents such as nucleic acids within a lipid-containing particle methods of formulating a lipid-containing particle comprising an anionic agent such as a nucleic acid, methods for preparing a lipid-containing particle comprising an anionic agent such as a nucleic acid, methods for therapeutic delivery of an anionic agent to a patient in need thereof, where the anionic agent is formulated in a lipid-containing particle as described herein.

Abstract: The invention provides compositions and methods for therapeutic and diagnostic applications.

Abstract: Disclosed herein is a pH-switchable pore formation (PSPF) peptide comprising one or more amino acids in peptide sequence whose charge state and hydrophobicity are pH-dependent, wherein the peptide can bind to a biological membrane upon contact and form pores on the membrane at pH of less than about 7, and wherein the peptide forms substantially no pores on the biological membrane at pH of greater than about 7. Also disclosed is a modular composition comprising: a) one or more PSPF peptides, which may be the same or different; b) a single stranded or double stranded oligonucleotide; and c) one or more linkers, which may be the same or different.