Abstract: The present invention relates to the field of anti-mycobacterial therapeutics, in particular the treatment of tuberculosis, especially including pulmonary multidrug-resistant tuberculosis (MDR-TB), with applications in extensively drug-resistant tuberculosis (XDR-TB) and extremely drug-resistant tuberculosis (XXDR-TB), preferably in combination therapy.

Abstract: The present invention relates to use an agent for the prevention and/or treatment of multiple organ dysfunction syndrome (MODS) or multiple organ failure (MOF) comprising interleukin-22 (IL-22) as an effective ingredient. The present invention is applicable to prevention of or therapy for diseases from sepsis, septic shock, liver failure, to multiple organ dysfunction syndromes. More particularly, the present invention is useful for an emergency medical service, for treatment of injury caused by a traffic accident, burns, heat attacks, hypercytokinemia or severe infective diseases.

Abstract: The present invention is directed to fusion proteins having an IL-21 cytokine portion and an anti-CD20 antibody portion, and methods of using such fusion proteins. The invention also provides pharmaceutical compositions and kits utilizing the IL-21-anti-CD20 fusion proteins. In particular, the methods, kits and compositions of the invention are useful in the treatment of cancer and autoimmune diseases.

Abstract: Methods, compositions, and medical device systems relating to treating exercise-induced pulmonary hemorrhage (EIPH) and nasopharyngeal cicatrix (NC) in a mammal. For example, one method comprises administering through inhalation a composition comprising a physiologically acceptable carrier and an effective amount of each of one or more stem cell derived factors. Exemplary stem cell derived factors include, but are not limited to, growth factors, chemokines, and cytokines. The mammal may be a horse, dog, camel, or Homo sapiens.

Abstract: The invention features methods of diagnosis by assessing B7-H1 expression in a tissue from a subject that has, or is suspected of having, cancer, methods of treatment with agents that interfere with B7-H1-receptor interaction, methods of selecting candidate subjects likely to benefit from cancer immunotherapy, and methods of inhibiting expression of B7-H1.

Abstract: Novel methods for treating patients with autoimmune diseases are disclosed. The methods of the invention include first depleting circulating lymphocytes in the mammal, e.g., by administering anti-thymocyte antibody, and then, during the course of repopulation, administering to the mammal a therapeutically effective amount of latent TGF-? and/or another agent that promotes expansion of regulatory T cells. In certain aspects, the disclosed process results in improved kidney function and survival rates.

Abstract: Described herein are methods of reducing Salmonella in the intestines of poultry in need thereof by administering to a poultry bird an effective amount of an interleukin-10 peptide or an isolated antibody that specifically binds an interleukin-10 peptide. Administering may be performed within 1 to 4 weeks of harvest of the poultry in order to reduce Salmonella transmission to human consumers. Also included herein are finishing feeds that include an interleukin-10 peptide or an isolated antibody that specifically binds an interleukin-10 peptide.

Abstract: A sustained release formulation of interleukin-10 for wound treatment and related methods is provided.

Abstract: The invention relates to a method for predicting an improved therapeutic benefit for an individual with a tumor load before initiating an immune therapy which is capable of activating immune cells against said tumor as well as to pharmaceutical compositions for use in this method.

Abstract: A method for promoting bone formation is provided. More specifically, a method for promoting bone formation by promoting osteoclast formation is provided. In one embodiment, an implant comprising an implantable material and an osteoclast stimulating substance is provided.

Abstract: The invention provides compositions, kits, and methods for treatment of neuronal injury. In one embodiment, the composition comprises a biomembrane sealing agent, such as PEG, and a bioactive agent, such as a magnesium compound. The biomembrane sealing agent and/or the bioactive agent an intravenous administration, an intramuscular administration, an intrathecal administration, a subcutaneous administration, an epidural administration, a parenteral administration, a direct application onto or adjacent to a site of the pathological condition, and any combinations thereof. Alternatively, the biomembrane sealing agent and/or the bioactive agent may be delivered from a pump or an implant.

Abstract: This invention relates to a use of IL-22 in the treatment of viral hepatitis. As illustrated in the examples of this invention, IL-22 can significantly reduce liver damage caused by hepatitis virus, and can significantly reduce the increase of transaminase ALT/AST induced by hepatitis virus. In addition, the IL-22 dimer of this invention can effectively treat viral hepatitis.

Abstract: The invention provides a method of treating or preventing viral diseases in a mammal comprising administering to the mammal an interleukin (IL)-21 blocking agent in an amount effective to treat or prevent the viral disease in the mammal. Also provided is a method of reducing the activation or recruitment of immune cells in a mammal comprising administering to the mammal an IL-21 blocking agent in an amount effective to reduce the activation or recruitment of immune cells in the mammal. Methods of decreasing the expression of at least one cytokine or at least one protein in a mammal comprising administering to the mammal an IL-21 blocking agent in an amount effective to decrease the expression of the cytokine or the protein are also provided.

Abstract: The instant invention provides soluble fusion protein complexes and IL-15 variants that have therapeutic and diagnostic use, and methods for making such proteins. The instant invention additionally provides methods of stimulating or suppressing immune responses in a mammal using the fusion protein complexes and IL-15 variants of the invention.

Abstract: The present invention relates to a composition comprising at least two different albumin-based drug delivery systems, as well as to a pharmaceutical composition comprising said composition.

Abstract: The present invention relates to an in vitro or ex vivo method of preparing a cell-free composition, said method comprising or consisting of (a) subjecting cells to stress; and (b) collecting factors produced, preferably secreted by said cells when subjected to said stress, thereby obtaining said cell-free composition; wherein said cells are comprised in or form at least one first carrier and said collecting is effected by means of at least one second carrier which second carrier(s) is/are cell-free and concomitantly present with and spatially distinct from said first carrier; and said collecting is effected using a device comprising or consisting of (i) said first carrier(s) which first carrier(s) comprise(s) said cells or is/are suitable to hold said cells; (ii) said second carrier(s) which is cell-free; and (iii) means of subjecting said cells in said first carrier to stress; wherein first carrier(s) and second carrier(s) are positioned such that factors secreted by said cells when subjected to stress are

Abstract: Provided are nanoparticles comprising heparin, chitosan, and at least one immunomodulatory agent, e.g. a cytokine. The cytokine can be selected from the group consisting of TNF, IL-12, IL-2, IL-23, IL-1?, IL-10, IL-18, and combinations thereof. Further provided are methods of making a nanoparticle comprising mixing a first composition comprising heparin with a second composition comprising chitosan in the presence of at least one cytokine to form a third composition. Further provided are methods of modulating an immune response comprising co-administering to a subject an antigen or vaccine with nanoparticles comprising heparin, chitosan, and at least one cytokine.

Abstract: Methods of stimulating or enhancing an immune response in a host are disclosed. The methods include contacting a monocyte with 15 kD granulysin thereby producing a monocyte-derived dendritic cell. In one example, the method further includes contacting the monocyte or monocyte-derived dendritic cell with a target antigen, such as a tumor antigen or an autoimmune antigen. In another embodiment, the method includes contacting the monocyte with an additional agent that enhances maturation of dendritic cells or induces immunological tolerance. The methods are of use in vivo, in vitro and ex vivo. In another aspect, the disclosure relates to compositions and methods for the treatment of tumors.

Abstract: The present invention relates to skin care compositions, including cosmeceuticals, for topical application, and more particularly, a skin cream, comprising exosomes and cell culture medium conditioned by cells grown in two-dimensional culture. Also included are methods of making and using such compositions and kits comprising the skin cream therein.

Abstract: Disclosed herein are compositions and methods of use comprising hexavalent DNL complexes. Preferably, the complexes comprise anti-CD20 and/or anti-CD22 antibodies or fragments thereof. More preferably, the anti-CD20 antibody is veltuzumab and the anti-CD22 antibody is epratuzumab. Administration of the subject hexavalent DNL complexes induces apoptosis and cell death of target cells in diseases such as B-cell lymphomas or leukemias, autoimmune disease or immune dysfunction disease. In most preferred embodiments, the DNL complexes increase levels of phosphorylated p38 and PTEN, decrease levels of phosphorylated Lyn, Akt, ERK, IKK?/? and I?B?, increase expression of RKIP and Bax and decrease expression of Mcl-1, Bcl-xL, Bcl-2, and phospho-BAD in target cells. The subject DNL complexes show EC50 values for inhibiting tumor cell growth in the low nanomolar or even sub-nanomolar concentration range.

Abstract: The present invention relates to combination therapies for melanoma, and in particular, metastatic melanoma. Drugs for use in such therapies in include MEK inhibitors combination with cardiac glycosides.

Abstract: The present invention provides compositions and methods relating to IL-1Rrp2 requiring proteins.

Abstract: The invention relates to a combination medicament for treatment of malignant neoplastic disease. The combination medicament comprises an IL-12 polypeptide having a biological activity of IL-12 or a nucleic acid expression vector comprising a sequence encoding such IL-12 polypeptide, and a non-agonist CTLA-4 ligand or non-agonist PD-1 ligand, particularly an anti-CTLA-4 or anti-PD-1 immunoglobulin G.

Abstract: The present invention provides a method of enhancing adoptive cell therapy (ACT) by administering an extended-pharmacokinetic (PK) interleukin (IL)-2 to a cancer subject receiving ACT, optionally in combination with a therapeutic antibody. Methods of treating cancer and promoting tumor regression are also provided.

Abstract: It is described a conditioned medium (CM) obtainable by culturing, in a liquid culture medium, placental mesenchymal stem cells isolated from the placental tissue of pregnant women not affected by preeclampsia. The conditioned medium of the invention includes at least IL-6, IL-10 and MCP-1 proteins and it is effective for the therapeutic treatment of preeclampsia.

Abstract: The present invention relates to a method for producing or identifying a MUC1 molecule which is able to generate an immune response in humans. The invention also relates to a method for producing or identifying a cell, cell lines or cell lysates containing a MUC1 molecule that is able to generate an immune response in humans. The invention further relates to methods for producing medicaments and diagnostic agents. Also disclosed is the use of the MUC1 molecules, cells or cell lysates obtained by means of the methods according to the invention for producing a medicament used for treating or preventing tumours. Further disclosed is a purified MUC1 molecule that can be obtained by means of the methods according to the invention and has an immunostimulating effect on humans. The invention additionally relates to the use of a MUC1 antibody for the production of a medicament used for treating or preventing tumours.

Abstract: This invention relates to the treatment of cancer using anti-cancer agents, such as doxorubicin or paclitaxel, in combination with antibody-interleukin 2 (IL2) conjugates which target tenascin-C.

Abstract: Disclosed herein are ?-galactosylceramide (?-GalCer) analogs and compositions thereof, methods of activating invariant Natural Killer T (iNKT) cells using said analogs, methods of treating diseases by activating iNKT cells using said analogs, and combination therapy of said analogs.

Abstract: The present invention provides compositions, methods and devices for treatment of degenerative disc disease or the repair of a disc in need of repair. The composition or the formulation includes freshly isolated or culture expanded ELA cells, which can be cyropreserved. The composition or a formulation also includes in various embodiments an ELA cell population that has been differentiated into cell types having at least one characteristic of human intervertebral disc cells, such as fibroblast cells, chondrocyte cells or notochordal cells. The composition or the formulation includes in certain embodiments either a population of ELA cells provided in conjunction with one or more biocompatible molecules, therapeutic agents, or agents that induce ELA stem cell differentiation. The ELA cells are obtained from fluid or tissue from live or cadaveric (cadaverous) donors.

Abstract: Homogeneous preparations of human and murine IL-31 have been produced by mutating one or more of the cysteine residues in the polynucleotide sequences encoding the mature proteins. The cysteine mutant proteins can be shown to either bind to their cognate receptor or exhibit biological activity.

Abstract: Methods of promoting bone healing or regeneration by locally administering insulin mimetic agents to patients in need thereof and new uses of insulin-mimetic compounds for accelerating bone-healing processes are disclosed. Bone injury treatment and void filler devices, products and kit suitable for local administration of insulin-mimetic agents or compositions thereof to patients in need of such treatment are also disclosed.

Abstract: The present invention refers to a combination of growth factors, cytokines, antibacterial/antiviral factors, stem cell stimulating factors, complement proteins C3a/C4a, and chemotactic factors. The invention also relates to a process for the preparation of said combination from serum, placenta or colostrum and to composition containing said combination for use in the treatment of conditions requiring tissue repair and regeneration and for the substitution of stem cell therapies.

Abstract: The present invention relates to predicting therapeutic response of treating patients suffering from itching and pruritis mediated by cutaneous lymphocyte antigen positive T cells in atopic dermatitis. The invention also includes methods of predicting a therapeutically responsive patient population.

Abstract: The invention provides methods and compositions for reducing symptoms of steatohepatitis and/or liver fibrosis and/or hepatocellular carcinoma (HCC) in a mammalian subject in need thereof, comprising administering to the mammalian subject a therapeutic amount of a compound that reduces the level of interleukin 17 (IL-17) and/or interleukin 23 (IL-23) and/or signal transducer and activator of transcription 3 (Stat3) and/or Janus kinase 2 (Jak2). The invention's methods may comprise administering to the mammalian subject a therapeutic amount of a compound that increase the level of interleukin 22 (IL-22) and/or interleukin 25 (IL-25) and/or interleukin 27 (IL-27). The invention's methods may comprise administering to the mammalian subject a therapeutic amount of interleukin 22 (IL-22) and/or interleukin 25 (IL-25) and/or interleukin 27 (IL-27).

Abstract: A radiation protection device for providing protection of a body part that includes active bone marrow from ionizing radiation may include a radiation protection component configured to be placed adjacent to and externally cover the body part so as to reduce a radiation dose absorbed in that body part.

Abstract: We have developed DNA and viral vectors that can be used, alone or in combination, as a vaccine against one HIV clade, subtype, or recombinant form of HIV or against multiple HIV clades, subtypes, or recombinant forms. Moreover, the vectors can encode a variety of antigens, which may be obtained from one clade or from two or more different clades, and the antigens selected and/or the manner in which the vectors are formulated (e.g., mixed) can be manipulated to generate a protective immune response against a variety of clades (e.g., the clades to which a patient is most likely to be exposed; with the proportions of the components of the vaccine tailored to the extent of the patient's risk to a particular clade or clades).

Abstract: Methods for enhancing or stimulating hematopoiesis including the step of administering Interleukin-12 (IL-12) to yield hematopoietic recovery in a mammal in need. Preferred methods include the step of administering IL-12 as an adjuvant therapy to alleviate the hematopoietic toxicities associated with one or more treatment regimens used to combat a disease state. Other methods include administering IL-12 to ameliorate various hematopoietic deficiencies. Still other methods are directed to uses of IL-12 for in-vivo proliferation of hematopoietic repopulating cells, hematopoietic progenitor cells and hematopoietic stem cells. Other disclosed methods are directed to uses of IL-12 for bone marrow preservation or recovery.

Abstract: The present invention provides fusion proteins including an autoimmune antigen, an allergen antigen or an alloantigen, and an anti-inflammatory cytokine. Compositions and methods including the fusion proteins are also provided.

Abstract: The present invention provides methods for increasing survival in a subject, and/or preserving bone marrow function, and/or promoting hematopoietic recovery or restoration. The methods include administering a dose of IL-12 to the subject following an acute exposure to non-therapeutic whole body ionizing radiation. Formulations and kits are also provided.

Abstract: The present invention relates to use of interleukin-22 (IL-22) for treating fatty liver disease by decreasing the levels of transaminases. The use of IL-22 in decreasing the levels of transaminases is also provided.

Abstract: The invention provides compositions and methods for, inter alia, augmenting cell-based therapies in vivo by repeatedly stimulating target cells of interest over a period of time.

Abstract: Chemical compounds that inhibit retroviruses are presented herein. More particularly, this disclosure provides small molecule compounds that inhibit infection with, or treat infection caused by, human immunodeficiency viruses.

Abstract: The present invention is drawn to methods of assessing and treating cancers such as ERG-related, prostate, breast and leukemia, by examining the expression of combinations of particular genes disregulated in this disease state. The combinations of genes are selected from the following genes: inhibitor of growth family, member 3 (HSTG3); lymphoid enhancer-binding protein factor 1 (LEF1); frizzled-related protein (FRZB); annexin A4 (ANXA4); Meis homeobox 2 (MEIS2); syndecan binding protein (syntenin) (SDCBP); ankyrin 3, node of Ranvier (ankyrin G) (ANK3); chromodomain helicase DNA binding protein 5 (CHD5); phospholipase A2, group VII (platelet-activating factor acetylhydrolase, plasma) (PLA2G7); and wingless-type MMTV integration site family member 2 (WNT2).

Abstract: Disclosed herein are compositions and methods for treating or preventing a cardiac arrhythmia in a subject.

Abstract: The invention disclosed herein describes biomarkers useful for prognosis, selection and monitoring of oncolytic virus therapy for patients with various types of cancer. In particular, the present invention provides identification of proteins whose expression patterns are strongly predictive of the outcome of oncolytic virus therapy in a patient with cancer. The present invention provides a method for identifying and selecting cancer patients who are likely to be non-responsive to onocolytic virus therapy. These patients can be co-administered an agent that stimulates a cell-mediated immune response in the patient with the oncolytic virus or can be administered a therapy other than oncolytic virus therapy.

Abstract: Disclosed is a multi-layered structure for drug reservoir, comprising a first micelle layer for crosslinking and adhesion, comprising a drug, a multi-arm polymer, a phenol derivative, and a dopa derivative and having a one or two-layered structure; a second micelle layer for crosslinking, being stacked on the first micelle layer, comprising a drug, a multi-arm polymer, and a phenol derivative, and having a one or two-layered structure; and a physiologically active material layer, being stacked on the second micelle layer, comprising a physiologically active material, a water-soluble polymer, and a phenol derivative, and having a one or two-layered structure.

Abstract: Described herein are compositions and methods of use of anti-pancreatic cancer antibodies or fragments thereof, such as murine, chimeric, humanized or human PAM4 antibodies. The antibodies show novel and useful diagnostic characteristics, such as binding with high specificity to pancreatic and other cancers, but not to normal or benign pancreatic tissues and binding to a high percentage of early stage pancreatic cancers. Preferably, the antibodies bind to pancreatic cancer mucins such as MUC1 or MUC5ac and are of use for the detection and diagnosis of early stage pancreatic cancer. In more preferred embodiments, the anti-pancreatic cancer antibodies can be used for immunoassay of serum samples, wherein the immunoassay detects a marker for early stage pancreatic cancer in serum. Most preferably, the serum is extracted with an organic phase, such as butanol, before immunoassay. Alternatively, immunoassay with PAM4 and anti-CA19.9 antibodies may be utilized to improve sensitivity for pancreatic cancer.

Abstract: The invention relates to the use of Interleukin-7 (IL-7), for treating hepatitis C in a patient infected with hepatitis C virus, wherein said patient has been treated or is being treated with an antiviral agent or a combination of antiviral agents that reduces viral load.

Abstract: Multifunctional polymers are disclosed having a smart segment and a biodegradable segment. Advantageously, the biodegradable segment includes a hydrophilic segment and a hydrophobic segment. Embodiments include combining the multifunctional polymeric material with a biologically active substance in an aqueous loading environment and administering the composition as a drug delivery vehicle to a human subject.

Abstract: The invention relates to a method of assessing whether a subject includes CD4+,CD25+ T cells that have been activated to a specific antigen. The method includes the steps of obtaining from the subject a sample of lymphocytes including CD4+,CD25+ T cells, incubating at least one portion of the sample of lymphocytes so as to promote, distinction of CD4+,CD25+ T cells that have been activated to the specific antigen from those CD4+,CD25+ T cells that have not been activated to the specific antigen, and thereafter determining whether CD4+,CD25+ T cells activated to the specific antigen are present in the sample. The invention further relates to methods of growing CD4+, CD25+ T cells that have been activated to a specific antigen in vitro and to methods of increasing tolerance in a subject using the CD4+, CD25+ T cells that have been grown in vitro.