Abstract: The invention provides methods and dosing regimens for safely and effectively treating androgen-dependent prostate cancer with a gonadotrophin releasing hormone (GnRH) antagonist without causing a testosterone spike and/or other side effect of GnRH agonist therapy such as a urinary tract infection, or an arthralgia-related or cardiovascular side effect. The present disclosure also provides for methods for treating prostate cancer in a patient with a history of at least one cardiovascular event, wherein administration of degarelix to the subject decreases the likelihood of developing or experiencing an additional cardiovascular event compared to treatment with a gonadotrophin releasing hormone (GnRH) agonist.

Abstract: The invention relates to compositions for synchronizing the time of insemination in an animal. More particularly, the invention relates to a process for manufacturing and stabilizing GnRH-containing compositions for use in synchronizing the time of insemination in an animal.

Abstract: The invention provides peptides, including peptides that bind and, optionally, inhibit Protein S, and compositions thereof. The peptides may be used to, e.g., inhibit Protein S activity, enhance thrombin formation in a subject, increase blood clot formation in a subject, treat a blood coagulation disorder in a subject, purify Protein S, and identify a Protein S binding compound.

Abstract: The description provides compositions and methods for treating ETBR-related cancer. In certain aspects, the description provides a delivery system for the controlled, systemic release of at least one of ETBR antagonists, caspase-8 inhibitors, or a combination thereof, optionally including an ETAR antagonist, an anti-PD-1 antibody, a bRAF inhibitor, niacinamide or a combination thereof. The compositions described are useful for the treatment of certain cancers, including, e.g., breast cancer, malignant melanoma, squamous cell carcinoma, glioblastoma, as well as others. In addition, the description provides a delivery system for the controlled release of at least one of ETBR antagonists, caspase-8 inhibitors or a combination thereof, optionally including at least one of an ETAR antagonist, an anti-PD-1 antibody, a bRAF inhibitor, niacinamide, or a combination thereof, to the central nervous system that are useful for treating cancers that have spread to the brain.

Abstract: The invention provides compositions and methods for reducing one or more symptoms of disease by administering compositions comprising SipA. The invention's compositions and methods are particularly advantageous in reducing symptoms of diseases that are associated with overexpression of P-gp and/or p53. The invention's compositions and methods are useful in reducing cancer symptom and/or cancer multidrug resistance (MDR). The invention provides a method for reducing one or more symptoms of cancer in a mammalian subject in need thereof, comprising administering to said subject a composition comprising purified SipA. In one embodiment, said SipA is operably conjugated to a nanoparticle. In another embodiment, said cancer comprises cancer cells resistant to at least one cytotoxin.

Abstract: The present invention provides lyophilized formulations of active agents, particularly of TAT-NR2B9c. TAT-NR2B9c has shown promise for treating stroke, aneurysm, subarachnoid hemorrhage and other neurological or neurotraumatic conditions. Such formulations are stable at room temperature thus facilitating maintenance of supplies of such a formulation in ambulances for administration at the scene of illness or accident or in transit to a hospital.

Abstract: Disclosed herein are compositions comprising non-naturally occurring zinc finger domains, fusion proteins comprising these zinc finger domains, polynucleotides encoding these proteins, cells expressing these proteins and pharmaceutical compositions comprising these proteins or polynucleotides as well as methods of modifying an Htt gene using these compositions for treating or preventing Huntington's Disease.

Abstract: Heat-treated liquid enteral nutritional composition with a low monovalent metal ion content are provided that contain micellar casein and optionally caseinate, and in which the total amount of monovalent metal ions is less than 25 mg/g of protein. Also, heat-treated liquid enteral nutritional compositions are disclosed comprising 10 to 20 g of protein per 100 ml of the composition, in which all or a major part of said protein comprises micellar casein. Also, a method is disclosed for producing the composition according to the invention, comprising a step wherein an aqueous protein solution in which all or a major part of said protein comprises micellar casein, is subjected to an evaporation step.

Abstract: The present invention relates to compositions and methods for treating myotonic dystrophy.

Abstract: The invention relates to a compound for use for inducing apoptosis in a cancerous cell, wherein said compound is selected from the group consisting of ApoO, a variant or a fragment thereof, their mixtures, and a vector encoding for said ApoO, variant or fragment thereof. The invention further relates to a compound for use for treating a pathophysiological situation, wherein said compound is an inhibitor of the ApoO activity or of the ApoO gene expression.

Abstract: The invention in suitable embodiments is directed to purified non-cage clathrin protein compositions. In one aspect, one or more purified non-cage clathrin protein composition, formed in whole or in part from isolated, synthetic and or recombinant amino acid residues, forms a composition to repurpose at least one aspect of a medicament or use thereof when the medicament is formulated with the non-cage clathrin protein.

Abstract: The present disclosure provides methods of diagnosing painful intervertebral discs. The present disclosure also provides methods of treating a painful intervertebral disc.

Abstract: ?-defensins, non-human macrocyclic peptides, have been found to reduce expression of genes encoding for various pro-inflammatory peptides (such as cytokines and chemokines) in a highly selective manner. Methods for treating inflammatory conditions utilizing a ?-defensin and/or a ?-defensin analog, methods for modifying (e.g. down regulating) gene expression for pro-inflammatory peptides in a subject in need thereof using a ?-defensin and/or a ?-defensin analog, methods for selectively modifying expression of such genes and/or reducing pro-inflammatory peptides in a subject without inducing or worsening immunosuppression using a ?-defensin and/or a ?-defensin analog are discussed, as are compositions that include a ?-defensin and/or a ?-defensin analog in an amount and/or form suitable for use in such methods.

Abstract: A pharmaceutical product containing ?2-microglobulin or a functional variant thereof as an active ingredient in the form of liposomes is provided. The product can increase the concentration of ?2-microglobulin in the blood, and can also restore a normal HC/?2-microglobulin molar ratio within membrane MHC-I complexes, or prevent a ?2-microglobulin deficit from occurring in the MHC-I complexes, of patients suffering from autoimmune diseases. Methods of treating patients with the pharmaceutical product are also presented.

Abstract: Compositions and methods for treating inflammatory disorders of the GI tract are provided. The compositions include a therapeutically effective amount of TGF? and ATRA (all-trans retinoic acid), in a pharmaceutically acceptable carrier suitable for oral administration. TGF? and ATRA are preferably encapsulated in microspheres. The compositions are useful in alleviating symptoms in subject with an inflammatory disease of the gastrointestinal tract. Exemplary subjects include subjects with Chrohns disease, ulcerative colitis, gastritis, irritable bowel syndrome, ileitis, etc. The composition is administered to the subject following a therapeutically effective regimen, for length of time resulting in an improvement in one or more symptoms associated with inflammatory disorders of the GI tract.

Abstract: The present invention relates to the treatment of kidney diseases, both acute and chronic. The invention in particular relates to the use of neuregulins for preventing, treating or delaying kidney diseases.

Abstract: The present invention refers to soluble Neuregulin-1 isoforms representing Posttranslational Neuregulin-1 modifications as medication in cognition-related neurological disorders, in particular schizophrenia, Alzheimer's and Parkinson's diseases.

Abstract: The present invention provides compositions comprising as an essential feature granulocyte-macrophage colony-stimulating factor (GM-CSF) together with fosfomycin for the treatment of bacterial lung infections by administration via the airways.

Abstract: Isolated peptides, compositions and methods of use for treating tumors infiltrated with macrophages, such as glioblastomas.

Abstract: Methods and compositions for the use of long-acting hematopoietic factor protein analogs for accelerating hematopoietic recovery in subjects who have been or will be exposed to radiation are disclosed.

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 present invention pertains to methods for controlled ovarian hyperstimulation in a female subject using improved recombinant human follicle-stimulating hormone (rhFSH). The methods result in a high number of fertilizable oocytes even at low amounts of FSH administered to the female subject.

Abstract: A medicinal composition for suppressing or preventing the metastasis of a malignant tumor, the composition comprising, as an active ingredient, at least one kind of vasoprotective agent selected from the following (i) to (iv): (i) angiotensin II receptor antagonist, (ii) HMG-CoA reductase inhibitor, (iii) ghrelin or its derivative, and (iv) adrenomedullin or its derivative; or a pharmacologically acceptable salt thereof.

Abstract: An exenatide-containing composition is in the form of microspheres, which are prepared by using exenatide acetate and polylactic-co-glycolic acid (PLGA) as raw materials, and the content of acetic acid in the prepared composition is lower than 0.01%. A method for preparing the exenatide-containing microspheres includes selecting a cleaning fluid of a proper external water Phase and a proper amount to clean microspheres, and selecting a proper re-drying temperature to cure the after the microspheres are freeze dried.

Abstract: This invention is directed to a general method for the chronic treatment, potential cure, or prevention of various metabolic and related diseases in people, including diabetes, by modulating IRS2 activity in cells and tissues in the body. IRS1 and IRS2 are part of the insulin or insulin-like growth factor signaling pathway. By upregulating the levels or functional activity of IRS2, insulin is used more efficiently by the body to control nutrient levels. By upregulating IRS2 levels or functional activity in pancreatic ?-cells, glucose sensing and insulin secretion are enhanced.

Abstract: A peptide selected from the group consisting of Ala-Hyp-Gly, Hyp-Gly-Pro, Leu-Hyp, Glu-Hyp, Gly-Pro-Hyp, Pro-Ala, Hyp-Gly and Pro-Hyp, or a pharmaceutically acceptable salt thereof has a myoblast differentiation promoting effect superior to conventional arts.

Abstract: Disclosed are compositions and methods for treating nephrogenic diabetes insipidus and for induction of diuretic effect.

Abstract: Medical compositions and methods of treating or preventing neurodegeneration in a human suffering from or that is at risk of or susceptible to neurodegeneration or cellular dysfunction associated with expression or impaired cellular function of a neuronal protein encoded by one or more genes that code for alpha-synuclein (SNCA), Parkin RBR E3 ubiquitin protein ligase, (PARK2), Leucine-rich repeat kinase 2 (LRRK2), PTEN-induced putative kinase/(PINK1), Daisuke-Junko 1, (DJ-1) and ATPase type 13A2 (ATP13A2), are disclosed. Methods of treatment for these disorders is also provided, comprising administering a vector into a cell, wherein the vector facilitates expression of a molecular component that alters one of the aforementioned genes in the cell or expression of the gene in the cell, the gene being implicated in an etiology of the neurological deficit.

Abstract: A flowable hemostatic gel composition is provided for use at a site of a defect within a biological tissue. The flowable hemostatic gel composition includes a flowable gel solution that includes a biopolymer dissolved in a first solvent. The biopolymer is configured to cross-link with red blood cells at the site to facilitate clot formation at the site. The flowable hemostatic gel composition also includes at least one additional active agent.

Abstract: The present application relates to wound repair and wound healing by the application of a therapeutic amount of Activated Protein C-3K3A (‘APC-3K3A’). Specifically, this application is directed to a method of using APC-3K3A for the treatment of dermal or cutaneous wounds, including but not limited to, acute and chronic wounds, burns and ulcers.

Abstract: There is described variegin for use as a medicament in the treatment of disease or condition characterised in that the variegin is administered in an amount of at least about 0.1 mg/kg (mass of drug compared to mass of patient).

Abstract: The invention provides vaccines containing, as its only active ingredient, a VLP having a CpG oligonucleotide attached thereto and a non-toxic pharmaceutically acceptable carrier or diluent and uses thereof. The invention further provides a pharmaceutical composition comprising a vaccine consisting of a VLP having a CpG oligonucleotide, one or more non-toxic pharmaceutically acceptable carrier or diluent, and a therapeutic agent admixture therewith and uses thereof.

Abstract: An immunity-inducing agent comprising as an effective ingredient a specific polypeptide is disclosed. These polypeptides were isolated, by the SEREX method using a cDNA library derived from canine testis and serum from a cancer-bearing dog, as a polypeptide which binds to an antibody existing specifically in serum derived from a cancer-bearing living body. The polypeptides can induce immunity in a living body and cause regression of a tumor in a cancer-bearing living body. Therefore, these polypeptides are especially effective as a therapeutic and/or prophylactic agent for a cancer(s).

Abstract: The present invention pertains to engineered immune cells, method for their preparation and their use as medicament, particularly for immunotherapy. The engineered immune cells of the present invention are characterized in that at least one gene selected from a gene encoding GCN2 and a gene encoding PRDM1 is inactivated or repressed. Such modified Immune cells are resistant to an arginine and/or tryptophan depleted microenvironment caused by, e.g., tumor cells, which makes the immune cells of the invention particularly suitable for immunotherapy. The invention opens the way to standard and affordable adoptive immunotherapy strategies using immune cells for treating different types of malignancies.

Abstract: Disclosed are methods of treating individuals with yeast-based immunotherapy who have been preselected as being sensitive to type I interferons, as well as methods for selecting individuals for treatment with yeast-based immunotherapeutic compositions and methods for enhancing or improving an individual's response to yeast-based immunotherapy, based on the individual's sensitivity to type 1 interferons (T1IFNs).

Abstract: An immunity-inducing agent comprising as an effective ingredient a specific polypeptide is disclosed. These polypeptides were isolated, by the SEREX method using a cDNA library derived from canine testis and serum from a cancer-bearing dog, as a polypeptide which binds to an antibody existing specifically in serum derived from a cancer-bearing living body. The polypeptides can induce immunity in a living body and cause regression of a tumor in a cancer-bearing living body. Therefore, these polypeptides are especially effective as a therapeutic and/or prophylactic agent for a cancer(s).

Abstract: An immunity-inducing agent comprising as an effective ingredient a specific polypeptide is disclosed. These polypeptides were isolated, by the SEREX method using a cDNA library derived from canine testis and serum from a cancer-bearing dog, as a polypeptide which binds to an antibody existing specifically in serum derived from a cancer-bearing living body. The polypeptides can induce immunity in a living body and cause regression of a tumor in a cancer-bearing living body. Therefore, these polypeptides are especially effective as a therapeutic and/or prophylactic agent for a cancer(s).

Abstract: The present invention relates to an in vitro method for priming genetically modified T cells suitable for administration to a patient having a tumor. The invention is also directed to the composition obtained by the method and uses thereof.

Abstract: The present invention provides a particle comprising a polypeptide and at least one malaria antigen, and a composition or vaccine comprising thereof, its use in medicine, particularly in the prevention or treatment of malaria infections.

Abstract: The present invention provides compositions including polypeptides having the characteristics of polypeptides expressed by a reference microbe such E. coli or Salmonella. Examples of Salmonella strains that can be used include, for instance, S. enterica serovar Newport, S. enterica serovar Enteritidis, S. enterica serovar Typhimurium, and S. enterica serovar Dublin. Also provided are compositions including polypeptides having a particular molecular weight and a mass fingerprint that includes polypeptide fragments having a particular set of masses, or polypeptides having an amino acid sequence with at least about 95% identity with an amino acid sequence, wherein the polypeptide has seroreactive activity. The present invention also provides methods of making and methods of using such compositions.

Abstract: This document relates to methods and materials for producing immune responses against polypeptides involved in antibiotic resistance. For example, vaccines against polypeptides involved in antibiotic resistance as well as methods for vaccinating mammals against polypeptides involved in antibiotic resistance are provided.

Abstract: The present invention provides methods of production of a purified enveloped virus antigen. In particular, it provides purified Ross River Virus (RRV) antigens, and vaccines comprising purified, inactivated Ross River Virus (RRV) antigen.

Abstract: The invention relates to a method for preventing, ameliorating or treating disease caused by dengue virus in a subject in need thereof comprising administering to the subject a dengue vaccine formulation in combination with a NS3 helicase polypeptide and/or fragment(s) thereof, wherein said method comprises stimulating humoral as well as cell-mediated immunity to the dengue virus in the subject.

Abstract: The present invention is directed generally to M1 polypeptides that can be utilized as vaccines and/or antigens for generation of anti-M1 polypeptide antibodies for prophylactic treatment of individuals who are susceptible to infection by influenza virus. The anti-M1 polypeptide antibodies of the invention are useful for treatment of individuals infected with influenza virus, or useful for prophylactic treatment of individuals who are susceptible to infection by influenza virus, or for immune-suppressed individuals who cannot generate an effective antibody response.

Abstract: The present application relates to novel HIV-1 envelope glycoproteins which may be utilized as an HIV-1 vaccine immunogens, antigens for crystallization and for the identification of broad neutralizing antibodies. The present invention encompasses the preparation and purification of immunogenic compositions which are formulated into the vaccines of the present invention.

Abstract: An immunogenic fusion protein for use as a mucosal vaccine is provided, which includes: i) one or more FcyRI-binding domains; ii) one or more antigens from one or more infectious disease organisms; and iii) one or more FcRn-binding domains.

Abstract: The present invention provides formulations that support an individuals body during routine vaccination and adaptive immune response. The individuals who can benefit front these formulations are infants, children and adults. The formulations comprise ingredients that can be administered prior to, concurrent with or subsequent to the vaccination. The formulations of the present invention preferably act by targeting enzymatic reactions an individual's various metabolic pathways, maintaining balance between oxidative stress and methylation, maintaining balance between Th1 and Th2 responses, or a combination thereof during vaccination and adaptive immune response.

Abstract: The present invention provides compositions and methods useful for vaccination and generating CD8+ T lymphocyte immune memory against one or more antigens utilizing lipoteichoic acid.

Abstract: Therapeutic combinations of an interleukin-1 receptor-associated kinase 4 (IRAK4) inhibitor and a Bruton's tyrosine kinase (BTK) inhibitor are described. In some embodiments, the invention provides pharmaceutical compositions comprising combinations of an IRAK4 inhibitor and a BTK inhibitor, and methods of using the pharmaceutical compositions for treating a disease, in particular a cancer.

Abstract: Embodiments of the present invention provide methods for the treatment or prevention of infection-related immune conditions using compositions comprising IgM.