Abstract: A pharmaceutical formulation comprising a solid matrix of one or more biodegradable polymers, the solid matrix including a pharmaceutically active substance or a pharmaceutically acceptable salt thereof distributed homogeneously or substantially homogeneously within the matrix; wherein the pharmaceutically active substance is, for example, a gonadotropin releasing hormone (GnRH), a GnRH agonist or a GnRH antagonist.

Abstract: A compound can destabilize an epidermal growth factor receptor (EGFR) protein and a sodium/glucose co-transporter 1 (SGLT 1) protein. In one embodiment, the compound is a peptide derived from the interacting domain of EGFR. In another embodiment, the peptide is administered to a patient to treat cancer.

Abstract: The present invention features therapies for the treatment of HCV comprising direct-acting antiviral agents. Preferably, the treatment is administered to an HCV-infected patient who has been tested to determine methylation status of a CpG island within a promoter region of the IL28B gene. In one aspect, the therapies comprise administering one or more direct acting antiviral agents and, optionally ribavirin, to a subject with HCV infection. For example, the therapies comprise administering to the subject effective amounts of therapeutic agent 1, therapeutic agent 2, therapeutic agent 3, an inhibitor of cytochrome P450 (e.g., ritonavir), and/or ribavirin.

Abstract: The present invention relates to a poly(lactic glycolic) acid (PLGA) nanoparticle associated with therapeutic agents for a variety of therapeutic applications.

Abstract: Provided are compositions and methods for preventing or treating damage to mucosal tissue, for example as a result of radiation and/or chemotherapy. The damage may be, for example, oral or gastrointestinal mucositis.

Abstract: The application provides data from a clinical trial of a PSD-95 inhibitor in subjects undergoing endovascular repair of an aneurysm in or otherwise affecting the CNS. The subjects were stratified by whether the aneurysm ruptured before performing the endovascular surgery. Rupture is associated with higher mortality or increased debilitation if a subject survives. The trial provided evidence of significant benefit in subjects with and without aneurysm rupture before endovascular was surgery performed. Surprisingly, the subjects benefitting most from treatment as judged both by pathology and neurocognitive outcome were those in which the aneurysm had ruptured causing a subarachnoid hemorrhage. These data constitute evidence that a PSD-95 inhibitor is beneficial not only in ischemic and hemorrhagic stroke but in forms of hemorrhage in or affecting the CNS, particularly, subarachnoid hemorrhage.

Abstract: Provided herein are compositions and methods for eliciting an immune response against Streptococcus pneumoniae. More particularly, the compositions and methods relate to immunogenic polypeptides, including fragments of PhtD and variants thereof, and nucleic acids, vectors and transfected cells that encode or express the polypeptides. Methods of making and using the immunogenic polypeptides are also described.

Abstract: Provided is a novel pharmaceutical composition for inhibiting human cytomegalovirus (HCMV) replication by increasing the expression of a target gene of a notch signaling pathway, for example, hairy and enhancer of split-1 (Hes1), hairy and enhancer of split-5 (Hes5), hairy/enhancer-of-split related with YRPW motif protein 1 (Hey1) and hairy/enhancer-of-split related with YRPW motif protein 2 (Hey2), and a method and use for treating an HCMV infectious disease using the same. The novel composition of the present invention has an excellent effect in inhibiting the HCMV replication, and therefore a novel target and a therapeutic agent for preventing or treating various HCMV-related diseases caused by the HCMV infection and a novel use for treating the HCMV infectious disease may be provided.

Abstract: Embodiments of the disclosure concern methods and compositions related to the small Ankyrin 1 (sAnk1) protein and its role as a regulatory protein in at least muscle cells. In particular embodiments, its expression and/or activity are modulated with one or more compositions. In specific embodiments, compositions such as nucleic acids that inhibit expression of sAnk1 are utilized for a variety of methods, whereas in other embodiments compositions such as polypeptides, peptides, or sAnk1-encoding nucleic acids that enhance sAnk1 levels are utilized for certain methods.

Abstract: Nutritive polypeptides are provided herein. Also provided are various other embodiments including nucleic acids encoding the polypeptides, recombinant microorganisms that make the polypeptides, vectors for expressing the polypeptides, methods of making the polypeptides using recombinant microorganisms, compositions and formulations that comprise the polypeptides, and methods of using the polypeptides, compositions and formulations.

Abstract: The present invention relates to S100 protein and nuclei acids encoding S100 protein for enhancing the cardiac power as well as vectors and pharmaceuticals comprising the same and uses thereof.

Abstract: The invention relates to the use of gelsolin to treat inflammatory diseases (e.g., rheumatoid arthritis) and to the use of gelsolin to diagnose, monitor, and evaluate therapies of inflammatory diseases (e.g., rheumatoid arthritis).

Abstract: Nutritive polypeptides are provided herein. Also provided are various other embodiments including nucleic acids encoding the polypeptides, recombinant microorganisms that make the polypeptides, vectors for expressing the polypeptides, methods of making the polypeptides using recombinant microorganisms, compositions and formulations that comprise the polypeptides, and methods of using the polypeptides, compositions and formulations.

Abstract: A method of altering intercellular interactions between a combination of microorganisms includes contacting a combination of different species of microorganisms with at least one mucin. Isolated compositions include a combination of microorganisms and at least one mucin. One microorganism of the combination inhibits cell growth or promotes cell death of at least one other microorganism of a different species in the combination. The combination of microorganisms with the mucin results an increase in cell growth or a reduction in cell death, respectively, of the at least one other microorganism.

Abstract: The present invention relates to a method for preparing a cartilage product comprising a protein hydrolysate with a degree of hydrolysis comprised between 0.5% and 3.0%, at least one glycosaminoglycan and at least one growth factor. The present invention also relates to the cartilage product obtainable through said method. Said cartilage product is useful in the treatment or prevention of wounds, ulcers, burns, psoriasis, osteoarthritis, synovitis, osteoporosis, osteopenia, diseases of the tendons and ligaments, periodontal diseases, signs of skin aging, the harmful effects of ultraviolet radiation exposure or stretch marks.

Abstract: The present invention provides novel methods of inhibiting fibrosis, as well as methods of treating or inhibiting fibrotic disorders, using BMP9 and/or BMP10 antagonists. The present invention also provides methods of assessing whether a subject has or is at risk of developing a fibrotic disorder by detecting levels of BMP9 and/or BMP10. Further provided are methods of assessing the efficacy of a treatment regimen for treating a fibrotic disorder by detecting and comparing pre-treatment levels of BMP9 and BMP10 with post-treatment levels of BMP9 and BMP10.

Abstract: A method of treating or improving neurological function in a human subject includes identifying a human subject diagnosed with at least one of post-CNS trauma, post-concussion syndrome, a chronic refractive epileptic encephalopathic condition, autism spectrum condition, cerebral palsy; or ischemic long term treatment for remote ischemic or traumatic brain injury; and administering to the human subject a composition comprising a pharmaceutically effective dose of filgrastim.

Abstract: The present disclosure includes methods and compositions for the treatment or prevention of diseases and disorders characterized by excessive or misregulated cellular proliferations, including methods for the treatment of tumors. The methods involve the use of pharmaceutical compositions comprising at least one agent selected from the group consisting of a LIF preparation, a BMP preparation, a BMPR signalling activator, and a LIFR signalling activator. The disclosure also includes LIF preparations, BMP preparations, BMPR signalling activator, and LIFR signalling activators, and methods for the identification of LIF preparations, BMP preparations, BMPR signalling activator, and LIFR signalling activators. The disclosure also includes pharmaceutical compositions comprising at least one agent selected from the group consisting of a LIF preparation, a BMP preparation, a BMPR signalling activator, and a LIFR signalling activator.

Abstract: A novel IFN-?/? independent ligand receptor system which upon engagement leads, among other things, to the establishment of an anti-viral state is disclosed. Further disclosed are three closely positioned genes on human chromosome 19 that encode distinct but highly homologous proteins, designated INF-?1, IFN-?2, IFN-?3, based inter alia, in their ability to induce antiviral protection. Expression of these proteins is induced upon viral infection. A receptor complex utilized by all three IFN-? proteins for signaling is also disclosed. The receptor complex is generally composed of two subunits, a novel receptor designated IFN-?R1 or CRF2-12, and a second subunit, IL-10R2 or CRF2-4, which is also a shared receptor component for the IL-10 and IL-22 receptor complexes. The gene encoding IFN-?R1 is generally widely expressed, including many different cell types and tissues. Expression of these proteins is induced by immune events, including, for example, upon viral infection.

Abstract: This description relates to the use of a polymer-conjugated interferon-beta as monotherapy or in combination with other cancer therapies.

Abstract: The present invention relates to methods to treat a neurodegenerative disease or disorder, e.g., a motor neuron disease in a subject, whereby the subject is administered a recombinant human Mullerian Inhibiting Substance (MIS) protein as disclosed herein, wherein the recombinant human MIS protein comprises a modified Kex cleavage site for increased cleavage. The recombinant human MIS protein can be produced from a pre-proprotein comprising a non-MIS leader sequence or a functional fragment thereof in place of the MIS leader sequence.

Abstract: The invention provides methods and compositions for treating dysregulated blood glucose disorders.

Abstract: The application relates to an aqueous pharmaceutical formulation comprising 200-1000 U/mL [equimolar to 200-1000 IU human insulin] of insulin glargine.

Abstract: An improved manufacturing process produces microcrystalline hydroxyapatrte with sustained gradual calcium release that avoids spiking in blood calcium levels. Although the improved material did not cause significant elevation of blood calcium, it was just as effective in promoting bone mineralization as conventional calcium supplements. In addition, the material has much higher levels of bone growth factors as compared to prior hydroxyapatite products.

Abstract: The present invention provides a method of reducing the quantity of mucus in the respiratory tract of a subject with elevated levels of mucus in said respiratory tract. The method includes administering to the subject a compound or composition containing a therapeutically effective amount of a fusion protein comprising a sialidase or an active portion thereof and an anchoring domain. The therapeutically effective amount comprises an amount of the fusion protein that results in a reduction of the quantity of mucus in the respiratory tract after administration of the compound or composition when compared to the quantity of mucus present prior to administration of the compound or composition.

Abstract: A pharmaceutical product containing papain, bromelain or mixtures thereof is intended for the treatment of several pathologies, such as Alzheimer's disease and depression, at a dosage of at least 7000 mg administered in a single dose. This dosage relates to papain powder having a titre of 3 U/mg and bromelain powder having a titre of 2 U/mg, and to a patient with a body weight of 55 kg. In the case of variations of the titre and/or of the body weight of the patient, the dosage must be adjusted in proportion to said variations.

Abstract: The present specification disclose methods and uses for the treatment of a vasculitic syndrome. The disclosed methods comprise administering a composition comprising a Proteinase 3 (PR3) inhibitor to a patient in need thereof. Also disclosed are compositions comprising a PR3 inhibitor disclosed herein for use in the treatment of a vasculitic syndrome as well as use of a composition comprising a PR3 inhibitor disclosed herein in the treatment of a vasculitic syndrome. The present specification also discloses use of a composition comprising a PR3 inhibitor disclosed herein in the manufacture of a medicament for the treatment of a vasculitic syndrome.

Abstract: The present invention provides, among other things, methods of treatment of donor and/or host subjects prior to, during, and/or after transplantation of donor tissue into the host subject with nanoparticle compositions encapsulating tissue components to usefully manage immune responses associated with transplantation. In some embodiments, methods include administering to a recipient organism who has received or will receive a transplant of one or more heterologous tissue components from a donor organism a composition including encapsulated donor organism tissue components. In some embodiments, methods include administering to a donor organism from which one or more donor tissue components are to be transplanted into a recipient organism a composition including one or more encapsulated recipient tissue components.

Abstract: A novel constrained peptide epitope derived from A?, related antibody compositions and methods of use. An isolated antibody that specifically binds to a cyclic peptide comprising the conformational epitope corresponding to a solvent-exposed, antibody accessible knuckle region of oligomeric A? is described. An antigenic peptide comprising an epitope having a constrained cyclic configuration, corresponding to a solvent-exposed, antibody accessible knuckle region of oligomeric A? is also described. Methods of treating, preventing, and diagnosing Alzheimer's disease are also described.

Abstract: Provided herein are compositions comprising substantially non-viable Gram-negative bacterial organisms that have a substantial reduction in endotoxin activity and/or pyrogenicity and methods for treating a cancer using the same. Also provided are methods for treating cancer provided herein, comprising administering to a mammal diagnosed with cancer, substantially non-viable Gram-negative bacteria having a substantial reduction in endotoxin activity and/or pyrogenicity, in an amount sufficient to inhibit growth or metastasis of the cancer. An additional method is provided comprising administering viable or non-viable Gram-negative bacterial organisms that have a genetic defect that results in a substantial loss of lipopolysaccharide within the outer membrane of the bacteria. Further provided are methods for reducing endotoxin activity and/or pyrogenicity in Gram-negative bacteria comprising treatment with polymyxin and glutaraldehyde.

Abstract: An autologous cancer cell vaccine comprises cancer cells that express both MHCI and MHCII on their cell surface. The MHCI presents a cancer antigen and the MHCII presents a non-self antigen.

Abstract: Embodiments are directed to malaria vaccines comprising a bacteriophage VLP displaying a heterologous peptide identified by affinity selection as an anti-malaria mimotope.

Abstract: A vaccine composition for birds comprising as an active ingredient a structure containing O-antigen derived from Gram-negative bacteria, provided that said structure does not contain a whole cell, and a process for preparing the same are provided. By using a structure containing O-antigen (e.g. lipopolysaccharide) derived from Gram-negative bacteria as an active ingredient in accordance with the present invention, alleviation of inoculation reaction and reduction in an amount of injection are attained as compared to the conventional whole-cells vaccine to thereby allow for the increase in the number of other antigens to be mixed therewith.

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: The present invention provides one or more immunogenic polypeptides for use in a preventive or therapeutic vaccine against latent or active infection in a human or animal caused by a Mycobacterium species, e.g. Mycobacterium avium subsp. paratuberculosis. Furthermore a single or multi-phase vaccine comprising the one or more immunogenic polypeptides is provided for administration for the prevention or treatment of infection with a Mycobacterium species, e.g. Mycobacterium avium subsp. paratuberculosis. Additionally, nucleic acid vaccines, capable of in vivo expression of the multi-phase vaccine comprising the one or more immunogenic polypeptides, is provided for prevention or treatment of infection with a Mycobacterium species, e.g. Mycobacterium avium subsp. paratuberculosis.

Abstract: A dual formulation for vaccines against Neisseria meningitidis serogroup B (‘Men-B’) comprises (i) an oil-in-water emulsion adjuvant and (ii) a Men-B immunogenic component in lyophilised form. The lyophilised Men-B antigens can be reconstituted into liquid adjuvanted form at the time of use ready for administration to a patient. This formulation has been found to give excellent result in terms of both stability and immunogenicity. The lyophilised component can also include one or more conjugated saccharides from N. meningitidis in serogroups A, C, W135 and/or Y.

Abstract: The present invention provides methods of treating anal or vaginal tumors and cancers, comprising the step of administering to a subject a combination therapy comprising a chemo-radiation therapy and a recombinant Listeria strain.

Abstract: Several approaches to treat, inhibit, or prevent HDV infections by redirecting T cells to HDV and HDV infected cells are described. In several alternatives, a gene encoding a molecule that specifically binds to human leucocyte antigen (HLA) loaded with a HDV derived peptide are introduced into the T cells of individuals. Upon receiving the modified T cells, the modified T cells, derived from the individual, will then recognise the individual's cells that are infected by HDV and/or the HDV virus, blocking HDV replication and/or killing the HDV infected cells thereby preventing and/or treating or inhibiting the HDV infection in the individual.

Abstract: This present invention relates to compositions and methods for stabilizing a dried vaccine formulations. In particular, the invention provides a method for producing a vaccine composition comprising the steps of providing an aqueous composition comprising a buffer, the vaccine components and between 17.5% w/w and 60% w/w of a non-polymeric sugar, freezing the composition, and applying microwave radiation under a pressure lower than atmospheric pressure in order to sublimate the composition and obtain a dried vaccine formulation. The invention also provides a product obtainable by this method.

Abstract: This disclosure relates to using EGFR pathway inhibitors in combination with compositions comprising an antigen to increase, elicit, or improve an antigen or vaccine-induced immune response. In certain embodiments, the EGFR pathway inhibitor is administered under conditions such that memory cells to the antigen are formed in a subject. In certain embodiments, the composition is a vaccine. In certain embodiments, the EGFR pathway inhibitor and vaccine are administered to the skin epidermis or dermis.

Abstract: Disclosed herein are compositions and methods related to mutant viruses, and in particular, mutant influenza viruses. The mutant viruses disclosed herein include a mutant M2 sequence, and are useful in immunogenic compositions, e.g., as vaccines. Also disclosed herein are methods, compositions and cells for propagating the viral mutants, and methods, devices and compositions related to vaccination.

Abstract: Disclosed herein are compositions and methods related to mutant viruses, and in particular, mutant influenza viruses. The mutant viruses disclosed herein include a mutant M2 sequence, and are useful in immunogenic compositions, e.g., as vaccines. Also disclosed herein are methods, compositions and cells for propagating the viral mutants, and methods, devices and compositions related to vaccination.

Abstract: Described herein is a recombinant respiratory syncytial virus (RSV) having an attenuated phenotype. In one embodiment, recombinant RSV includes an M2-2 protein with a mutation that renders the M2-2 protein inactive or prevents expression of the M2-2 protein. In one embodiment, the amino acid at position 66 in the F subunit has a positively charged side chain. Nucleic acids encoding recombinant RSV are also described, as well as vectors containing the nucleic acids.

Abstract: Disclosed are means of inducing antigen-specific tolerance through genetically modifying MSC to express antigens of interest in an inducible manner or constitutive manner. MSC have been demonstrated to suppress pathological immunity in an antigen-nonspecific manner in vitro and in vivo, including clinical trials of GVHD, Type 1 Diabetes, and Multiple Sclerosis. Administration of autoantigens in non-immunogenic routes, such as orally, intranasally, or delivered using immature dendritic cells has shown some signs of clinical efficacy, although effect has not been robust enough to allow for human therapeutic success. We disclose genetic modification of MSC to induce overexpression of autoantigens in a regulated manner in order to generate a universal donor antigen-specific tolerogenic vaccine as a treatment for autoimmunity.

Abstract: The present invention relates to the technical field of porcine pseudorabies virus, and more particularly to a porcine pseudorabies virus (PRV)-YF strain, with the preservation No. of CCTCC No. V201502. The present invention also provides an application of the porcine pseudorabies virus (PRV)-YF strain in preparing an inactivated vaccine of the porcine pseudorabies virus, the inactivated vaccine of the porcine pseudorabies virus and a preparation method thereof. It is proved through an immune efficacy evaluating test and a safety test that the inactivated vaccine of the porcine pseudorabies virus has good immune protective efficacy and is safe for weaned piglets, replacement gilts, pregnant sows and the like.

Abstract: Pro-toothpaste compositions formulated to receive a volume of allergen solution to provide toothpastes that exhibit efficacy for oral mucosal immunotherapy (OMIT) and acceptable consumer and product stability properties, along with kits of pro-toothpaste, allergen/extracts of allergens, and optionally compounding means and/or specialized toothbrushes are provided. Toothpastes suitable and effective for OMIT and methods for managing allergic symptoms and for reducing risk of allergy in people without symptoms employing the pro-toothpastes, toothpastes and kits of the invention are also disclosed.

Abstract: The present invention provides a nasal mucosal vaccine composition which is safe, useful as a preventive or therapeutic agent for infectious diseases or cancers, and capable of inducing systemic immune responses and mucosal immune responses effectively.

Abstract: Papaya mosaic virus and virus-like particles (VLPs) comprising ssRNA for use to inhibit cancer growth and metastasis. The PapMV and PapMV VLPs may be used alone or in combination with another cancer therapy, such as a chemotherapeutic, immunotherapeutic, or radiotherapy.

Abstract: The present invention relates generally to the field of allergies. More particularly, the present invention provides a method for treating an allergy in a subject by inducing tolerance to an allergen associated with the allergy. Medicinal kits useful in protocols to induce tolerance or reduce intolerance in a subject also form part of the present invention.

Abstract: The present invention comprises compositions, methods, and devices for creating an infection-mimicking environment within a polymer scaffold to stimulate antigen-specific dendritic cell activation. Devices of the present invention are used to provide protective immunity to subjects against infection and cancer.