Abstract: The present invention relates to a method for a method for predicting the development of renal dysfunction in a subject following physical trauma, hypotension, sepsis and/or septic shock syndrome, wherein the method comprises the steps of: —a. determining the level of an anti-inflammatory cytokine present in a sample taken from the subject after physical trauma, after a hypotensive event, after sepsis, and/or after septic shock syndrome; b. predicting the development in the subject of renal dysfunction on the basis of the level of an anti-inflammatory cytokine determined in step a).

Abstract: The present invention relates to an agent for the treatment and/or prophylaxis of an autoimmune disease, an agent for the formation of regulatory T cells (TReg) in an organism and various methods in which the agents according to the invention are used.

Abstract: A method of treating a TNF Alpha associated medical condition selected from the group consisting of obesity, metabolic syndrome, diabetes and a liver disease or disorder is provided. The method comprising enterally administering to a subject in need thereof a therapeutically effective amount of plant cells expressing a TNF Alpha polypeptide inhibitor, thereby treating the TNF Alpha associated medical condition.

Abstract: The present invention generally provides processes for purification of Inter-alpha inhibitor proteins (I?Ip) and compositions thereof from blood.

Abstract: The invention provides formulations and methods for ameliorating symptoms associated with metabolic disorders, such as cachexia, hypoglycemia, obesity, diabetes, and the like by administering Zn-?2-glycoproteins or a functional fragment thereof, alone or in combination with additional agents, such as ? adrenergin receptor agonists, ? adrenergin receptor antagonists, and/or glycemic control agents.

Abstract: An antibody preparation suitable for intravenous administration in humans includes IgG, IgA and at least 5 % IgM antibodies by weight of the total amount of antibodies. The preparation is prepared from human plasma, has specific complement activating activity, and, in an in vitro assay with human serum suitable to determine the ability of the antibody preparation to activate complement unspecifically, the antibody preparation generates substantially no C5a and/or substantially no C3a. The antibody preparation can have medical uses.

Abstract: An article of manufacture is disclosed which comprises at least two active agents, wherein a first of the two active agents comprises an anti-cancer agent or an antifibrotic agent and a second of the at least two active agents downregulates the activity and/or expression of lysyl-oxidase like protein-2 (LOXL-2) and which is capable of altering the structure of the extracellular matrix.

Abstract: The present invention relates generally to a method of modulating graft functionality. More specifically, the present invention relates to a method of downregulating the onset or progression of graft dysfunction by downregulating the functional level of activin. The method of the present invention is useful, inter alia, in the treatment and/or prophylaxis of conditions characterized by graft dysfunction, such as the primary graft dysfunction associated with organ transplantation.

Abstract: Provided herein are methods and compositions for treating metabolic diseases and conditions associated with metabolic diseases.

Abstract: The present invention relates, in general, to a method of treating patients undergoing enzyme replacement therapy (ERT) or other therapy involving the administration of a proteinaceous therapeutic agent as well gene replacement therapy with non-viral or viral vectors, or other therapeutic modality or modalities, used alone or in combination, which involve the administration of exogenous substances for potential therapeutic benefit, including, but not limited to DNA vaccines, siRNA, splice-site switching oligomers (SSOs) as well as RNA-based nanoparticles (RNPs) and nanovaccines. The invention further relates to compounds and compositions suitable for use in such methods.

Abstract: The present invention provides antibodies and antigen-binding fragments of antibodies that bind to leptin receptor (LEPR), and methods of using the same. According to certain embodiments, the invention includes antibodies and antigen-binding fragments of antibodies that bind LEPR and activate LEPR signaling. In other embodiments, the invention includes antibodies and antigen-binding fragments of antibodies that bind to LEPR and enhance sensitization of LEPR to an antigen. In certain embodiments, the invention includes antibodies and antigen-binding fragments of antibodies that bind LEPR in the presence and absence of leptin. In certain embodiments, the invention includes antibodies and antigen-binding fragments of antibodies that induce signaling in cells expressing LEPR mutants that otherwise exhibit defective or impaired signaling in the presence of leptin.

Abstract: This invention provides monoclonal antibodies that recognize the Toll-like Receptor 4/MD-2 receptor complex, and monoclonal antibodies that recognize the TLR4/MD2 complex as well as TLR4 when not complexed with MD-2. The invention further provides methods of using the monoclonal antibodies as therapeutics. This invention also provides soluble chimeric proteins, methods of expressing and purifying soluble chimeric proteins, and methods of using soluble chimeric proteins as therapeutics, in screening assays and in the production of antibodies.

Abstract: Expression of proteolytically active, high molecular weight ADAM protease is relatively increased in tumor cells that also express the putative tumor stem cell marker CD133. An antibody or antibody fragment such as 8C7 monoclonal antibody may be used to selectively bind to proteolytically active, high molecular weight ADAM10 protease to thereby detect tumor cells and also as a therapeutic agent for treating cancers, tumors and other malignancies inclusive of leukemia, lymphoma, lung cancer, colon cancer, adenoma, neuroblastoma, brain tumor, renal tumor, prostate cancer, sarcoma and/or melanoma.

Abstract: The present invention provides a combination therapy for effectively treating and/or preventing diseases associated with cells expressing CLDN18.2, including cancer diseases such as gastric cancer, esophageal cancer, pancreatic cancer, lung cancer, ovarian cancer, colon cancer, hepatic cancer, head-neck cancer, and cancer of the gallbladder and metastases thereof.

Abstract: Provided herein are polypeptides that are capable of crossing the cellular membrane and entering into the intracellular environment, which polypeptides are suitable for use in prophylactic, therapeutic or diagnostic applications as well as in screening and detection. Nucleic acids encoding such polypeptides; methods for preparing such polypeptides, host cells expressing or capable of expressing such polypeptides, compositions, and in particular pharmaceutical compositions, that comprise such polypeptides, in particular for prophylactic, therapeutic or diagnostic purposes are also provided.

Abstract: The invention provides a system, composition, and methods of using the systems and compositions for the analysis of a sample from a subject to accurately diagnose, prognose, or classify the subject with certain grades of or susceptibility to Barrett's esophagus. In some embodiments, the system of the present invention comprises a means of detecting and/or quantifying morphological features, the expression of protein, or the expression of nucleic acids in a plurality of cells and correlating that data with a subject's medical history to predict clinical outcome, treatment plans, preventive medicine plans, or effective therapies. In some embodiments, the invention relates to a method of classifying and compiling data taken from a cell sample from a subject analyzing the data, and converting the data from the system into a score by which a pathologist may calculate the likelihood that the subject develops cancer.

Abstract: The present invention relates to the identification of certain biomarkers for use in identifying patients who have, or are likely to develop an IL-33 mediated disease or disorder and who are more likely to respond to therapy with an IL-33 antagonist. The invention also relates to methods of treatment of an IL-33-mediated disease or disorder in a patient by administering an IL-33 antagonist to the patient in need thereof and monitoring the effectiveness of therapy using the biomarkers described herein. Also provided are methods for decreasing the level of at least one biomarker in a subject suffering from an IL-33-mediated disease or disorder, and methods for treating such diseases or disorders according to the expression levels of one or more biomarkers. The methods of the present invention comprise administering to a subject in need thereof a pharmaceutical composition comprising an interleukin-33 antagonist.

Abstract: The present invention relates to a vaccine capable to induce the formation of antibodies directed to PCSK9 in vivo.

Abstract: The invention relates to formulations of single domain antigen binding molecules, e.g., nanobody molecules, in particular formulations of TNF-binding nanobody molecules. The single domain antigen binding molecules can include one or more single binding domains that interact with, e.g., bind to, one or more target proteins. The formulations are useful, e.g., as pharmaceutical formulations. Method of preparing, and using the formulations described herein, to treat, e.g., TNF-associated disorders, are also disclosed.

Abstract: Disclosed is a method of treating, reducing, or preventing pruritis in a mammal, the method comprising administering at least one natriuretic polypeptide b (Nppb) blocking agent to a mammal in an amount effective to treat or prevent pruritis in the mammal. An in vitro method of identifying a compound that inhibits Nppb activity is also disclosed.