Abstract: Medical systems and methods for treating kidney disease alone, heart failure alone, chronic kidney disease with concomitant heart failure, or cardiorenal syndrome are described. The systems and methods are based on delivery of a natriuretic peptide such as Vessel Dilator to a subject. Methods for increasing and maintaining peptide levels at a certain concentration include direct peptide delivery via either an external or implantable programmable pump.

Abstract: The invention relates to use of long-acting GLP-1 peptides in certain dosage regimes for the treatment of type 2 diabetes, obesity, etc.

Abstract: Stabilized pharmaceutical formulations of insulin aspart are disclosed.

Abstract: A therapeutic or bioeffecting film delivery system which includes nanoparticles having actives bound to or associated with the nanoparticles and which when administered allow the active to perform a therapeutic or bioeffecting function.

Abstract: The present disclosure provides for techniques using pro-IGF-I for increasing IGF-I activity. Accordingly, the present disclosure provides for compositions and methods for treating or preventing a disease or disorder mediated by IGF-I. In addition, the present disclosure provides for kits for use in the treatment or prevention of a disease or disorder mediated by IGF-I.

Abstract: A histidine-free composition comprising: a high purity factor VIII (r-factor VIII); arginine and/or sucrose; a surface-active agent to prevent or at least inhibit surface adsorption of factor VIII; an amount of calcium chloride for specific stabilization of factor VIII.

Abstract: Disclosed are compositions and methods for treating conditions characterized by low HDL-CE which can lead to decreased delivery of cholesteryl ester to steroidogenic tissues, reducing the organ's ability to produce steroids especially during periods of demand, stress and or systemic inflammatory response syndrome.

Abstract: The present invention concerns products containing (i) at least one nucleic acid sequence coding for the human somatostatin 2 receptor protein (sst2) having the sequence SEQ ID NO: 1, ortholog or derivative thereof, (ii) at least one nucleic acid sequence coding for the human deoxycytidine kinase protein (dck) having the sequence SEQ ID NO:2, ortholog or derivative thereof, (iii) at least one nucleic acid sequence coding for the human uridine monophosphate kinase protein (umk) having the sequence SEQ ID NO: 3 ortholog or derivative thereof, and (iv) gemcitabine, as a combined preparation for simultaneous, separate, or sequential use for treating cancer in a subject.

Abstract: The invention provides a combination of a source of a CD39 and of a source of a CD73.

Abstract: The invention relates to an anti fibrinolytic composition comprising at least one tPA mutant that carries at least one point mutation substituting Ser481 to Ala on tPA, said mutant inhibits the fibrinolytic activity of at least one of tPA and uPA and therefore may be used for treating disorders associated with fibrinolytic processes, specifically, coagulopathies, thrombocytopenia and bleeding. The invention further provides methods and uses of the mutants of the invention.

Abstract: One aspect of the present invention relates to mutants of chondroitinase ABCI. Such chondroitinase ABCI mutants exhibit altered chondroitin lyase activity or increased resistance to inactivation from stressors including exposure to UV light or heat. Methods of using chondroitinase ABCI mutant enzymes are also provided.

Abstract: A method for reducing cellular senescence in a subject, in particular a subject exposed to or at risk of being exposed to a DNA damaging agents, e.g., radiation, by inhibiting PAI-1 activity in the subject with a truncated PAI-1 agent, rPAI-123.

Abstract: The present invention provides compositions comprising peptide-coupled biodegradable poly(lactide-co-glycolide) (PLG) particles In particular, PLG particles are surface-functionalized to allow for coupling of peptide molecules to the surface of the particles (e.g., for use in eliciting induction of immunological tolerance).

Abstract: The invention relates to recombinant yeasts of the Kluyveromyces lactis species for the production of a humoral immune response against defined antigens, to the production of said yeasts, and to the use thereof for protective vaccination against pathogens and malignant cells containing said antigens.

Abstract: A mutant strain of Neospora spp, in which the function of the NcMIC3 protein and/or the function of the NcMIC1 protein is suppressed, and uses thereof in a pharmaceutical composition or in a vaccine composition.

Abstract: Methods of treating a patient with human immunodeficiency virus are disclosed. The method includes a providing intradermal and intravenous doses of a aTh1 composition that can increase the CD4+ cells in a patient that are resistant to HIV. The description includes a method for viral load reduction and a viral purge method. The regimen leads to a spike in the viral load and a then a return to baseline or lower levels of the virus and can lead to reduction and/or elimination of the latent viral reservoirs. Kits configured to provide intradermal doses and intravenous doses according to the regimen are also included.

Abstract: Isolated KIF20A-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 KIF20A-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: 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: A pharmaceutical composition using natural gonadotropin—releasing hormone (GnRH), and/or some of its mimetic peptides, indistinctly bound by its amino or carboxyl extremes to a carrier molecule; in one case by its carboxyl extreme and in the other case by the amino terminal extreme, thus eliciting a faster and more potent immunological response against the endogenous GnRH hormone. This finally leads to the ablation of the GnRH and consequently of the rest of the involved hormones in the stream GnRH/LH-FSH/Testosterone-(estrogens). An advantage of this formulation consists on facilitating the exposition to the immune system of a greater number of epitopes of the GnRH or its mimetics, minimizing thus the steric hindrance produced by the carriers.

Abstract: The invention is directed to bioconjugate vaccines comprising N-glycosylated proteins. Further, the present invention is directed to a recombinant prokaryotic biosynthetic system comprising nucleic acids encoding an epimerase that synthesizes an oligo- or polysaccharide having N-acetylgalactosamine at the reducing terminus. The invention is further directed to N-glycosylated proteins containing an oligo- or polysaccharide having N-acetylgalactosamine at the reducing terminus and an expression system and methods for producing such N-glycosylated proteins.

Abstract: Serogroup B meningococcus antigens can successfully be combined with diphtheria, tetanus and pertussis toxoids (“DTP”) to provide effective combination vaccines for protecting against multiple pathogens. These combinations are effective with a range of different adjuvants, and with both pediatric-type and booster-type DTP ratios. The adjuvant can improve the immune response which the composition elicits; alternatively, by including an adjuvant it is possible for the compositions to have a relatively lower amount of antigen while nevertheless having immunogenicity which is comparable to unadjuvanted combination vaccines.

Abstract: The invention relates to a modified V2 fHbp having increased stability over a wild type V2 fHbp; a modified V2 fHbp having an amino acid sequence with at least 85% identity to the sequence of Seq ID No: 1, wherein both Ser137 and Gly138 are mutated or both Val112 and Leu114 are mutated; immunogenic, pharmaceutical and vaccine compositions; nucleic acid and a host cell; and methods of use of such compositions.

Abstract: The invention provides the discovery and characterization of a novel arterivirus protein (nsp2TF), whose expression is dependent on ?2 ribosomal frameshifting at a site located in the nsp2 coding region. The coding region for the unique TF domain of nsp2TF overlaps the part of ORF1a that encodes the transmembrane region of nsp2 in arteriviruses, including PRRSV, LDV and SHFV. Mutations affecting the expression of nsp2TF impair PRRSV replication and result in a smaller plaque phenotype. Provided herein are arteriviruses that display reduced translation of nsp2TF and/or altered translation of one or more downstream products, arteriviruses in which nsp2TF function is reduced and/or absent, and vaccines comprising said arteriviruses. Also provided herein are diagnostic methods, methods for identifying compounds that inhibit ?2 frameshifting, and gene expression tools for eukaryotic systems utilizing ?2 frameshifting.

Abstract: Vaccine vectors and methods for enhancing resistance to Campylobacter infection or for enhancing the immune response to Campylobacter are provided herein. The vaccine vectors include a first polynucleotide which encodes an antigenic polypeptide selected from SEQ ID NO: 7-9 or a fragment thereof. The vector may also include an immunostimulatory polypeptide. The methods include administering the vaccine vectors to a subject.

Abstract: An improved method for recovering the protein expressed by open reading frame 2 from porcine circovirus type 2 is provided. The method generally involves the steps of transfecting recombinant virus containing open reading frame 2 coding sequences into cells contained in growth media, causing the virus to express open reading frame 2, and recovering the expressed protein in the supernate. This recovery should take place beginning approximately 5 days after infection of the cells in order to permit sufficient quantities of recombinant protein to be expressed and secreted from the cell into the growth media. Such methods avoid costly and time consuming extraction procedures required to separate and recover the recombinant protein from within the cells.

Abstract: The present invention relates to the use of an immunogenic composition that comprises a porcine circovirus type 2 (PCV2) antigen for treatment of several clinical manifestations (diseases). Preferably, the clinical manifestations are associated with a PCV2 infection. Preferably, they include lymphadenopathy, lymphoid depletion and/or multinucleated/giant histiocytes. Moreover, the clinical symptoms include lymphadenopathy in combination with one or a multiple of the following symptoms in pigs: (1) interstitial pneumonia with interlobular edema, (2) cutaneous pallor or icterus, (3) mottled atrophic livers, (4) gastric ulcers, (5) nephritis and (6) reproductive disorders, e.g. abortion, stillbirths, mummies, etc. Furthermore the clinical symptoms include Pia like lesions, normally known to be associated with Lawsonia intracellularis infections.

Abstract: An influenza C virus has been isolated from a bovine species. Influenza C virus polynucleotides and polypeptides have also been identified. Immunogenic compositions are also described, as well as diagnostic kits and methods of detection.

Abstract: Provided herein are vaccine vectors including an antigenic polypeptide and an HMGB1 polypeptide present on the surface of the vaccine vector. Compositions comprising the vaccine vectors are also provided and include a pharmaceutically acceptable carrier, suitably a carrier for oral or nasal administration. Also provided are methods of enhancing immune responses, in particular antibody immune response and suitably an IgA response, by administering the vaccine vectors or compositions disclosed herein to a subject.

Abstract: A method of raising an immune response in an individual against human immunodeficiency virus (HIV) the method comprising: (a) administering to the individual DNA or SFV encoding an HIV Env protein and optionally nucleic acid encoding one, any two or all three of the HIV Gag, Pol and Nef proteins; (b) subsequently administering to the individual viral vector encoding an HIV Env protein and optionally viral vector encoding one, any two or all three of the HIV Gag, Pol and Nef proteins; and (c) administering to the individual oligomeric HIV Env protein; and an adjuvant.

Abstract: The present invention provides compositions or vaccines that contain a recombinant EHV-1 that elicit an immune response in animals against equine herpesvirus, including compositions comprising said recombinant EHV-1, methods of vaccination against equine herpesvirus, and kits for use with such methods and compositions.

Abstract: Redox-active NPs are disclosed that can potentiate innate immunity and stimulate distinct adaptive responses, producing distinct T cell subset polarization outcomes. Nanomaterials that can alter the cellular redox environment through ROS modulation can impact human immunology. TiO2 nanoparticles potentiate DC maturation, inducing the secretion of IL-12, p70, and IL-1B, while treatment with CeO2 nanoparticles induces IL-10, a hallmark of suppression. When delivered to T cells, the materials direct distinct TH polarization, where TiO2 stimulates largely a TH1 dominated response, whereas CeO2 stimulates a TH2 bias and TReg differentiation.

Abstract: The present invention relates to the use of p38 MAP kinase inhibitors and p38 MAP kinase inhibition to promote wound healing.

Abstract: The invention discloses a novel tumor-specific complete vaccine system generated in-vivo. This vaccine system is developed by the use of separated tumor cells inactivated by irradiation and the in-vivo interaction with an oncolytic viral vector with transgenic expression of GM-CSF, completed with immune checkpoint modulators (“ICM”) such as co-stimulatory signals confirmation with an anti-CTLA4 antibody. Specifically there will be no pre-incubation or interaction of the either two or all three components before administration to the patient. One of such oncolytic viral vector examples is CG0070 (GM-CSF expressing conditionally replication competent adenovirus). Mixing of the tumor-viral-ICM components will take place just prior to administration to preserve the effects of the oncolytic process and subsequent immunotherapeutic responses to be live and in vivo from the very first beginning. This invention is a complete live and in-vivo cancer vaccine system (“CLIVS”).

Abstract: The invention provides compositions and methods for treating cancers. The method comprises administering a PD-1 axis binding antagonist and an OX40 binding agonist.

Abstract: The present invention provides a method of suppressing the formation of a soluble association of an antibody in a solution; a method of suppressing the formation of a chemically degraded product of an antibody in a solution; and a method of stabilizing an antibody in a solution. The present invention also provides a solution-type antibody preparation in which the formation of a soluble association is suppressed; a solution-type antibody preparation in which the formation of a chemically degraded product is suppressed; a solution-type antibody preparation in which the formation of a soluble association, the formation of a chemically degraded product and the formation of an insoluble aggregate are suppressed; an agent for suppressing the formation of a soluble association of an antibody; an agent for suppressing the formation of a chemically degraded product of an antibody; and a stabilizing agent for an antibody.

Abstract: An electromagnetic radiation activated device comprises a property changing material and at least one functionalized fullerene that upon irradiation of the functionalized fullerenes with electromagnetic radiation of one or more frequencies a thermally activated chemical or physical transformation occurs in the property changing material. The thermal activated transformation of the property changing material is triggered by the heating or combustion of the functionalized fullerenes upon their irradiation. The device can include a chemical agent that is embedded in the property changing material and is released when the material is heated by the functionalized fullerenes upon irradiation.

Abstract: The invention relates to a resiniferatoxin solution having an enhanced storage stability, in which the resiniferatoxin is dissolved in a body-compatible solvent which contains a protective gas in solution, wherein the amount of the protective gas is at least 1 wt % of the saturation amount of the protective gas in the solvent at ambient temperature and normal pressure. The resiniferatoxin dissolved in the resiniferatoxin solution remains stable for a relatively long period and exhibits a reduced tendency to cling to polymeric surfaces.

Abstract: The present invention provides a solution formulation for inhalation comprising: a liquid phase; an active ingredient containing a carboxylic ester in which the oxygen atom is covalently bound to a quaternary nitrogen-containing heterocycle, dissolved in the liquid phase; and a magnesium or calcium salt, dissolved in the liquid phase. The formulation is particularly suited to pMDIs and nebulisers.

Abstract: Disclosed is a tigecycline composition for injection, comprising the active component, tigecycline, and a propping agent. Also included is a stabilization agent. Also disclosed is a stable, pharmaceutically acceptable reconstitution liquid having freeze-dried tigecycline. The tigecycline composition for injection of the present invention has good redissolution, and can dissolve without intense shaking, thereby avoiding foams caused by intense shaking. Upon testing, the tigecycline composition and the tigecycline composition-diluted reconstitution liquid prepared in the present invention prove to have substantially lowered oxidation degradation and epimer generation and increased stability of the tigecycline preparation.

Abstract: The invention provides aqueous pharmaceutical adalimumab compositions suitable for long-term storage of adalimumab, methods of manufacture of these compositions, methods of administration, and kits containing same.

Abstract: The invention provides aqueous pharmaceutical adalimumab compositions suitable for long-term storage of adalimumab, methods of manufacture of these compositions, methods of administration, and kits containing same.

Abstract: Methods for stabilizing polypeptides, such as anti-HER2 antibodies, which have been exposed to urea.

Abstract: Disclosed herein are lipid compositions comprising a cationic lipid of formula (I), a neutral lipid, a sterol and a PEG or PEG-modified lipid, wherein formula (I) is Also disclosed are methods of producing the cationic lipid of formula (I).

Abstract: An aqueous dispersion, useful for forming a film, comprises a silicone composition dispersed in an aqueous phase. The silicone composition comprises a product of a reaction of (a) an alkenyl-containing organopolysiloxane having an average per molecule of at least 2 alkenyl groups and (b) an Si H containing siloxane having an average per molecule of at least 2 Si H moieties. The dispersion also comprises a hydrosilylation catalyst and polyvinyl alcohol. The composition is stabilised in dispersion form by the polyvinyl alcohol dissolved in the aqueous phase. The dispersion is an effective method of delivering a pharmaceutically or cosmetically active ingredient by topical application.

Abstract: Systems and methods are disclosed for cosmetic augmentation by forming a biocompatible cross-linked polymer having a multi-phase mixture with a predetermined controlled release of selected pharmaceutical substance to modulate soft tissue response to the polymer; injecting the mixture into a patient and during or after injection, cross-linking the polymer in the patient; and augmenting soft tissue with the biocompatible cross-linked polymer.

Abstract: A drug in a solubility-improved form is combined with a concentration-enhancing polymer in a sufficient amount so that the combination provides substantially enhanced drug concentration in a use environment relative to a control comprising the same amount of the same solubility-improved form of drug without the concentration-enhancing polymer.

Abstract: In accordance with the present invention, there are provided methods for treating hyperplasia in a subject in need thereof. In another aspect of the invention, there are provided methods for reducing neointimal hyperplasia associated with vascular interventional procedures. Formulations contemplated for use herein comprise proteins and at least one pharmaceutically active agent.

Abstract: Provided is an immunogenic composition comprising 15 different polysaccharide-protein conjugates. Each of the conjugates comprises a capsular polysaccharide prepared from different serotype Streptococcus pneumoniae conjugated to a carrier protein, that is, serotypes 1, 2, 3, 4, 5, 6A, 6B, 7F, 9N, 9V, 14, 18C, 19A, 19F and 23F. An immunogenic composition formulated into a vaccine comprising an aluminum-based adjuvant increases application range with respect to pneumococcal diseases in infants and children.

Abstract: The present invention is in the field of pneumococcal capsular saccharide conjugate vaccines. Specifically, an immunogenic composition for infants is provided comprising a multivalent Streptococcus pneumoniae vaccine comprising 2 or more capsular saccharide conjugates from different serotypes, wherein the composition comprises a serotype 22F saccharide conjugate. Such a vaccine may be used in infant populations to reduce the incidence of elderly pneumococcal disease such as exacerbations of COPD and/or IPD.

Abstract: Disclosed are compounds capable of facilitating transport of biologically active agents or substances into cells having the general structure: wherein Q is selected from the group consisting of N, O and S; L is any bivalent organic radical capable of linking each Q, such as C, CH, (CH2)l, or {(CH2)i—Y—(CH2)j}k, wherein Y is selected from the group consisting of CH2, an ether, a polyether, an amide, a polyamide, an ester, a sulfide, a urea, a thiourea, a guanidyl, a carbamoyl, a carbonate, a phosphate, a sulfate, a sulfoxide, an imine, a carbonyl, and a secondary amino group and wherein Y is optionally substituted by —X1-L?-X2—Z or —Z; R1 R6, independently of one another, are selected from the group consisting of H, —(CH2)p-D-Z, an alkyl, an alkenyl, an aryl, and an alkyl or alkyl ether optionally substituted by one or more of an alcohol, an aminoalcohol, an amine, an amide, an ether, a polyether, a polyamide, an ester, a mercaptan, an alkylthio, a urea, a thiourea, a guanidyl, or a carbamoyl group, and wh