Abstract: A method for preparing polymer microparticles with a reduced initial burst, and the polymer microparticles prepared thereby, the method including: contacting polymer microparticles with an alcohol aqueous solution, the polymer microparticles prepared thereby, and use for drug delivery of the polymer microparticles.

Abstract: The present invention provides combinations of (a) an immunoconjugate comprising at least one antigen-binding moiety and an effector moiety, and (b) an antibody engineered to have increased effector function, for use in treating a disease in an individual in need thereof. Further provided are pharmaceutical compositions comprising the combinations, and methods of using them.

Abstract: The invention relates to immunotherapeutic compounds and to methods for stimulating an immune response in a subject individual at risk for developing cancer, diagnosed with a cancer, in treatment for cancer, or in post-therapy recovery from cancer or the compounds of the invention can be administered as a prophylactic to a subject individual to prevent or delay the development of cancer.

Abstract: The present invention relates to novel polymer conjugates of polypeptide variants of the HMGB1 high affinity binding domain Box-A (HMGB1 Box-A) or of a biologically active fragment of HMGB1 Box-A. Further, the invention relates to novel polymer conjugates of polypeptide variants of the HMGB1 high affinity binding domain Box-A (HMGB1 Box-A). Moreover, the present invention concerns the use of said polymer conjugates of polypeptide molecules of HMGB1 Box-A to diagnose, prevent, alleviate and/or treat pathologies associated with extracellular HMGB1 and/or associated with an increased expression of RAGE.

Abstract: Monoclonal antibodies (MoAbs or mAbs) specific for ALPHA-ACTININ-4 antigens, hybridoma lines that secrete these ALPHA-ACTININ-4 mAbs, and the use of such mAbs to detect ALPHA-ACTININ-4 antigens, particularly those expressed by cancer cells are disclosed. Chimeric and humanized antibodies based upon these anti-ALPHA-ACTININ-4 mAbs, processes for producing monoclonal, chimeric, and humanized antibodies using recombinant DNA technology, and their therapeutic uses, particularly in the treatment of cancer are also disclosed. Methods and kits for the immunodetection and immunotherapy of cells for samples which express ALPHA-ACTININ-4 antigens are additionally disclosed.

Abstract: The described invention provides cellular therapeutic approaches for treating a vascular insufficiency following a traumatic injury to head or spine that results in an injury to brain, spinal cord, or both by administering a therapeutic amount of an isolated, nonexpanded population of autologous mononuclear cells comprising a subpopulation of CD34+ cells, which further contains a subpopulation of potent SDF-1 mobile CD34+/CXCR-4 cells that have CXCR-4-mediated chemotactic activity.

Abstract: The present invention refers to single-chain fusion proteins comprising three soluble TNF superfamily (TNFSF) cytokine domains and nucleic acid molecules encoding these fusion proteins. The fusion proteins are substantially non-aggregating and suitable for therapeutic, diagnostic and/or research applications.

Abstract: The invention provides a method of promoting bone formation in a patient at a site in need thereof, the method comprising the step of locally administering a pro-inflammatory compound to the site, wherein the pro-inflammatory compound is selected from one or more of TNF-? at optimal osteogenic dose of 0.5 to 50 ng/kg of patient body weight, or 0.01 to 3.5 ?g, or 1 ng/ml or similar; IL-1? at optimal osteogenic dose of 0.1 ng/ml or similar; alarmins eg HMGB1, HMGN1, S100A8, S100A9, S100A8/9, S100A12, heat shock proteins, lactoferrin, cathelicidins, a-defensins, matrix components including versican, biglycan, fragments of hyaluronic acid and heparan sulphate; and TLR-2 or TLR-4 ligands. The invention also provides the above pro-inflammatory compounds for use in promoting bone formation in a patient at a site in need thereof. Kits comprising the compounds of the invention and a surgical implant are also provided.

Abstract: Increased in vivo and/or in vitro stability is imparted to a biologically active protein by fusing to an amino acid sequence consisting of at least about 100 amino acid residues, which consist essentially of Alanine, Serine and Proline, which form a random coil conformation. Specific examples are described. Also described are related nucleic acids, vectors and cells encoding such amino acids; compositions of biologically active proteins fused to a random coil domain, and methods of making and using the compounds and compositions of the invention.

Abstract: The present disclosure is directed to interleukin-10 (IL-10) peptides and isolated antibodies that specifically bind to the IL-10 peptides. The IL-10 peptides and the isolated antibodies may be administered alone or as an animal feed additive to treat gastrointestinal protozoan infection in animals.

Abstract: Conjugates of a GM-CSF moiety and one or more water-soluble polymers are provided. Typically, the water-soluble polymer is poly(ethylene glycol) or a derivative thereof. Also provided are compositions comprising conjugates, methods of making conjugates, and methods of administering compositions comprising conjugates to a patient.

Abstract: The present invention provides a composition comprising naked humanized, chimeric, and human anti-CEA antibodies and a therapeutic agent, which is useful for treatment of CEA expressing cancers and other diseases, and methods of use in treatment using this composition.

Abstract: An improved thrombopoietin mimetic, the bis-(monoethanolamine) salt of 3?-[(2Z)-[1-(3,4-dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4H-pyrazol-4-ylidene]hydrazino]-2?-hydroxy-[1,1?-biphenyl]-3-carboxylic acid.

Abstract: The present invention includes methods and compositions for the treatment and prevention of protozoal parasitic infections utilizing Diindolylmethane-related indoles. Additive and synergistic interaction of Diindolylmethane-related indoles with other known anti-parasitic and pro-apoptotic agents is believed to permit more effective therapy and prevention of protozoal parasitic infections. The methods and compositions described provide new treatment of protozoal parasitic diseases of mammals and birds including malaria, leishmaniasis, trypanosomiasis, trichomoniasis, neosporosis and coccidiosis.

Abstract: The present invention demonstrates that P2X7 receptor induced apoptosis may be specific for cancerous cells. Treatment with the P2X7 ligand BzATP, increased cellular apoptosis with no associated inflammatory changes or abnormal skin or systemic effects. In mice treated with DMBA/TPA, BzATP decreased papilloma skin formation. BzATP also induced involution of developed papillomas and stimulated apoptosis in keratinocytes outgrowing at the base of developed papillomas. These data show that (a) P2X7 regulates apoptosis of epidermal cells; (b) in vivo, local administration of a drug that activates the P2X7 receptor can inhibit development and progression of epidermal premalignant lesions.

Abstract: The present invention relates to immunogenic compositions for modulating the immune system, comprising a therapeutically effective quantity of two or more immuno-active antigenic agents with pathogen-associated molecular patterns (PAMPs) and/or danger-associated molecular patterns (DAMPs) and one or more physiologically acceptable carriers, excipients, diluents or solvents. The immunogenic compositions according to the present invention are used for producing medicaments for preventing and/or treating, and for preventing and/or treating infectious diseases, auto-immune diseases, allergic diseases, inflammation, arthritis, inflammatory diseases, transplant rejection, affections caused by vascular disorders, diseases caused by haemorrhagic or ischaemic cardiovascular accidents, ischaemia, heart attack and haemorrhagia leading to tissue destruction, heart, kidney, respiratory or liver insufficiency, cancer, malign and benign tumours and neoplasia.

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 subject antibodies show a number of novel and useful therapeutic 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. In preferred embodiments, the antibodies bind to pancreatic cancer mucins. The antibodies and fragments are of use for the detection, diagnosis and/or treatment of cancer, such as pancreatic cancer. The antibodies, such as PAM4 antibodies, bind to a PAM4 antigen that shows unique cell and tissue distributions compared with other known antibodies such as CA19.9, DUPAN2, SPAN1, Nd2, B72.3, and Lea and Le(y) antibodies that bind to the Lewis antigens.

Abstract: Pharmaceutical compositions including macrophage activating factor (MAF) and method of producing same, particularly to MAF compositions essentially devoid of glycosidase enzymes. The compositions of the present invention and pharmaceutical compositions including same are particularly suitable for intravenous administration.

Abstract: Provided are pharmaceutical liquid formulations of G-CSF, which are stable over a long time period and substantially free of excipients, as well as ready-to-use syringes containing such formulations and corresponding kits.

Abstract: The invention provides a method, system, process, vaccine, or device for activating an immune response against a tumor. In particular, in one embodiment, the invention for activating an immune response in situ against a tumor comprises introducing one or more delivery devices having a morphology that prioritizes one or more prioritized cell types which interface with the one or more delivery devices. In another embodiment, the invention provides a method of vaccinating to activate the innate immune system of a subject which comprises administering a vaccine comprising a composition selected from a group consisting of: a selection factor, an antigenic target, an immunogenic enchancing factor, and combinations thereof.

Abstract: The present invention is directed to novel therapeutic uses of T-140 analog peptides and compositions comprising same. Specifically, the invention provides compositions and methods useful for providing improved bone marrow transplantation and in the treatment of other conditions wherein bone marrow depletion or suppression is involved.

Abstract: A biologically engineered stent for treating patients suffering from acute myocardial infarction/ischemia. The stent is inserted in a vessel upstream to and proximal the damaged muscle/ischemic area. The stent elutes Stromal Derived Factor (SDF1)/CXCR4 complex and/or Vascular Endothelial Growth Factor (VEGF) to attract autologous stem cell for the repair of damaged myocardium or tissues and inducing vascularization (creation of collateral vessels) to the ischemic area. The SDF1/CXCR4 acts as a homing mechanism for stem cells. Stem cell mobilizing agents such as Gm-CSF, GCSF and Plerixafor, as a CXCR4 blocker, may be added systemically to assist in stem mobilization. A protocol consisting of multiple doses of Gm-CSF or GCSF may be given in order to mobilize stem cells from the patient. Optionally, stem cells may be injected into the patient. The treatment stimulates repair and improves survival of damaged myocardium and prevents ventricular remodeling.

Abstract: The present invention relates to methods for purification of recombinant human granulocyte colony stimulating factor (rHu GCSF). The present invention particularly relates to methods for purification of rHu GCSF involving techniques such as aqueous two phase extraction and multimodal chromatographic purification to obtain highly purified rHu GCSF. The present invention also provides a pharmaceutical composition comprising the rHu GCSF, purified using the methods described herein.

Abstract: A method of treating a patient having an autoimmune disease or a Th1 polarising infection or a condition associated with inflammation other than asthma or allergy, the method comprising administering to the patient a therapeutically effective amount of an inhibitor of Interferon Regulatory Factor 5 (IRF5).

Abstract: A device for altering the expression or activation of adhesion molecules on cells including endothelial cells, as well as methods for altering the expression or activation of adhesion molecules on cells including endothelial cells, are provided.

Abstract: The present invention relates to crystalline polymorphic forms of monosodium N-[8-(2-hydroxybenzoyl)amino]caprylate (“SNAC”), including two hydrates, a methanol solvate, and an ethanol solvate, of SNAC. More specifically, the present invention provide six polymorphic forms of SNAC (hereafter referred to as Forms I-VI). The present invention also provides an amorphous form of SNAC.

Abstract: Methods and compositions for treating and alleviating symptoms of irradiation injuries, therapeutic radiation intervention and/or anti-cancer therapies in a subject via pulmonary airway administration of granulocyte macrophage colony stimulating factor (GM-CSF) or a compound with similar affinity to the specific alveolar GM-CSF receptor to enhance pulmonary host defense are provided.

Abstract: Methods for preparing polymer-drug conjugates are provided. The disclosed methods involve polymeric reagents comprising a moiety of atoms arranged in a specific order, wherein the moiety is positioned between a water-soluble polymer and a reactive group. Related methods, compositions, preparations, and so forth are also provided.

Abstract: The invention is directed to methods for treating nervous system injury and disease, in particular traumatic brain injury and degenerative nervous system disease. Such methods utilize novel compositions, including but not limited to trophic factor-secreting extraembryonic cells (herein referred to as TSE cells), including, but not limited to, amnion-derived multipotent progenitor cells (herein referred to as AMP cells) and conditioned media derived therefrom (herein referred to as amnion-derived cellular cytokine solution or ACCS), each alone or in combination with each other and/or other agents.

Abstract: The present invention provides humanized, chimeric and human anti-CD19 antibodies, anti-CD19 antibody fusion proteins, and fragments thereof that bind to a human B cell marker. Such antibodies, fusion proteins and fragments thereof are useful for the treatment and diagnosis of various B-cell disorders, including B-cell malignancies and autoimmune diseases. In more particular embodiments, the humanized anti-CD19 antibodies may comprise one or more framework region amino acid substitutions designed to improve protein stability, antibody binding and/or expression levels. In a particularly preferred embodiment, the substitutions comprise a Ser91Phe substitution in the hA19 VH sequence.

Abstract: A composition of matter for use in encapsulating a drug is expressed by formula (1) or formula (2): wherein R1 and R2 are each independently a hydrogen atom or a substituted or unsubstituted, linear or branched alkyl group having 1 to 12 carbon atoms; A is a hydrophilic polymer chain; L1 and L3 are each a linking group; B is a cation-containing group; R3 is a side chain of an amino acid; z is an integer of 5 to 500; x is an integer of 40% or more of z; y is 0 or a positive integer; z-x-y is 0 or a positive integer; p is an integer of 1 to 10; and q is an integer of 1 to 10.

Abstract: Provided are a G-CSF and water-soluble polymer conjugate, or a pharmaceutically acceptable salt thereof, comprising a water-soluble polymer, a protein, and a linking group; a method for preparing thereof; and a pharmaceutical composition comprising the same.

Abstract: Modular aAPCs and methods of their manufacture and use are provided. The modular aAPCs are constructed from polymeric microparticles. The aAPCs include encapsulated cytokines and coupling agents which modularly couple functional elements including T cell receptor activators, co-stimulatory molecules and adhesion molecules to the particle. The ability of these aAPCs to release cytokines in a controlled manner, coupled with their modular nature and ease of ligand attachment, results in an ideal, tunable APC capable of stimulating and expanding primary T cells.

Abstract: The present disclosure provides methods for selecting a treatment composition, or therapy, for the treatment of a cancer, such as prostate or breast cancer, in a patient wherein the treatment composition includes administering a combination of at least two components selected from two different classes of compounds. Methods for treating a patient using the selected treatment composition are also provided, together with methods for monitoring the efficacy of the treatment composition during a treatment period.

Abstract: The present invention relates to host immune factors and antibiotics and, more particularly, to a system and method for controlling and reducing the antibiotic tolerance of bacterial persister cells with host immune factors.

Abstract: The present invention relates generally to composition and methods for topical application to skin. More particularly, it relates to treatment of scars and rosacea, and other aspects of skin care. A composition is disclosed having a skin toner for cleansing a skin surface, removing dead skin cells, restoring alkali balance, and shrinking skin pores; and a skin moisturizer for increasing water content in the external layers of the skin.

Abstract: The invention relates to therapeutic conjugates with improved ability to target various cancer cells containing a targeting moiety and a therapeutic moiety. The targeting and therapeutic moieties are linked via an acid cleavable linkage that increases therapeutic efficacy of the immunoconjugate.

Abstract: Disclosed is a method of eliciting an immune response to an antigen present endogenously in a mammal. The method may comprise administering to the mammal a composition comprising at least one immunomodulator for inducing cell differentiation and or antigen-presenting function of antigen-presenting cell precursor. The antigen-presenting cell precursor may have taken up the antigen. Also disclosed are a composition for use in the method, an adjuvant comprising the composition, the use of the composition and the immunomodulator as described herein.

Abstract: This invention relates to a recombinant human G-CSF (rhG-CSF) dimer and its use in the treatment of neurological disorder. In particular, upon ischemic neural injury in animal, this invention can be used to protect neurons with the use of rhG-CSF dimer such that function of injured nerves can be restored. Serum half-life of G-CSF dimer of this invention is prolonged and the biological activity thereof is increased.

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 present invention concerns the use of a multimerized form of ligands of the TNF family for the preparation of a medicament for injection into an appropriate cavity of the body, for the treatment of diseases wherein cell proliferation has to be controlled wherein the ligand of the TNF family is selected among Fas ligand, CD40L, TRAIL and APRIL.

Abstract: The invention provides small molecule mimics of the Smac peptide that are dimers or dimer-like compounds having two binding domains connected by a linker. These compounds are useful to promote apoptosis. The invention includes pharmaceutical compositions comprising such compounds and methods to use them to treat conditions including cancer and autoimmune disorders.

Abstract: Methods and compositions for immunotherapeutic treatment of prostate cancer are disclosed. More specifically methods of treating patients with prostate cancer comprising administering compositions comprising HLA-binding peptides derived from prostate-associated antigenic molecules, either with or without immunological adjuvants, are disclosed.

Abstract: The present invention concerns particles containing at least one covalently cross-linked polysaccharide and at least one growth factor, a method of preparation, and uses thereof.

Abstract: This disclosure provides modified antimicrobial agents, for example modified defensin polypeptides. Compositions including a modified arginine residue, such as an ADP-ribosylated and/or ribosylated alpha defensin polypeptide, are provided. Also provided are methods of modulating an immune response using the modified defensin polypeptides. Methods are provided for modulating an antimicrobial activity and for inhibiting a cytotoxic activity. Also disclosed are methods for treating diseases in a subject that are associated with an immune response, such as inflammatory and pulmonary diseases, using the disclosed modified defensin polypeptides.

Abstract: The disclosure relates to antigenic polypeptides that induce the production of opsonins, in particular opsonic antibodies, and the use of said antigenic polypeptides in vaccines that are protective against human bacterial pathogens.

Abstract: The present invention is to provide a removal promoter for apoptotic cells which is capable of immediately removing apoptotic cells in vivo by macrophages, or a removal inhibitor which inhibits the removal of apoptotic cells in vivo by macrophages. A removal promoter for apoptotic cells in vivo containing the milk fat globule-EGF factor 8-L (MFG-E8-L), MFG-E8-L mutant having removal promotion action for apoptotic cells in vivo by macrophages, or preferably a recombinant human or mouse MFG-E8-L, or a recombinant human or mouse MFG-E8-L mutant as an active ingredient is prepared. Such removal promoters specifically bind to apoptotic cells and promote the phagocytosis of apoptotic cells by macrophages by recognizing aminophospholipids such as phosphatidylserine exposed on apoptotic cell surface. On the other hand, a point mutation (D89E) MFG-E8-L mutant is used as a removal inhibitor.

Abstract: The present invention relates to methods of using AMG 900, a small molecule pan aurora kinase inhibitor, for the treatment of cancer, including solid tumors, hematologically derived tumors and the like. The invention further provides pharmaceutical compositions, dosage ranges and treatment regimens for administering AMG 900 to treat cancer.

Abstract: A collagen material is characterized in being constituted of collagen gel fragments. Furthermore, the collagen gel fragments may have an orientation. A method for producing a collagen material is characterized in comprising a step for preparing collagen gel fragments, a step for arranging the collagen gel fragments in a desired shape, and a step for drying the collagen gel fragments arranged in the desired shape. Moreover, in one embodiment of the method for producing a collagen material a step may include imparting an orientation to the collagen gel fragments.

Abstract: The present disclosure relates to methods for mobilizing stem and/or progenitor cells which are VLA-4 positive to the peripheral blood of a subject or from a tissue. The method comprises administering to the subject or tissue an effective amount of an antisense compound to VLA-4.