Abstract: Methods of treating individuals with a glucose metabolism disorder and/or a body weight disorder, and compositions associated therewith, are provided.

Abstract: Provided herein are methods, assays and kits for evaluating a sample, e.g., a sample obtained from a cancer patient, to detect one or more hedgehog biomarkers and/or one or more cilium markers. Thus, the invention can be used, inter alia, as a means to identify patients likely to benefit from administration of one or more hedgehog inhibitors, alone or in combination with therapeutic agents; to predict a time course of disease or a probability of a significant event in the disease of a cancer patient; to stratify patient populations; and/or to more effectively treat or prevent a cancer or a tumor associated with hedgehog signaling.

Abstract: An injectable, nonaqueous suspension including at least one therapeutic agent suspended in a single component vehicle. The single component vehicle is a single amphiphilic material, such as a polyethoxylated castor oil or derivative thereof, a polyoxyethylene alkyl ether, a polyoxyethylene sorbitan fatty acid ester, a polyoxyethylene stearate, a block copolymer of polyethylene oxide-polypropylene oxide-polyethylene oxide, a block copolymer of polypropylene oxide-polyethylene oxide-polypropylene oxide, a tetra-functional block copolymer of polyethylene oxide-polypropylene oxide, or a tetra-functional block copolymer of polypropylene oxide-polyethylene oxide. A dosage kit that includes the injectable, nonaqueous suspension and a method of administering the injectable, nonaqueous suspension are also disclosed.

Abstract: A method of improving the efficacy of a blood transfusion into a subject is provided comprising administering a composition comprising an EAF PEGylated-blood protein into the subject, prior to, during, or subsequent to the blood transfusion.

Abstract: The present invention provides a method for screening an agent being useful for the treatment of dry eye and/or corneal and conjunctival lesion of dry eye severity level 3 or more according to the report of the International Dry Eye WorkShop (DEWS Report) (2007) and a pharmaceutical composition comprising the agent. The present invention further provides a method for the treatment of dry eye and/or corneal and conjunctival lesion of dry eye severity level 3 or more according to DEWS Report (2007) using the agent.

Abstract: The present invention relates to nanoparticles for encapsulating compounds, the preparation and uses thereof, said nanoparticles being based on a vegetable hydrophobic protein, particularly zein, and a water miscible non-volatile organic solvent, particularly propylene glycol. Said nanoparticles can encapsulate or incorporate a product of interest for use in the agricultural, cosmetic, food or pharmaceutical fields.

Abstract: Dermal delivery compositions are provided. Aspects of the dermal delivery compositions include the presence of active agent-calcium phosphate particle complexes, where these complexes include uniform, rigid, spherical nanoporous calcium phosphate particles associated with one or more active agents. Also provided are methods of using the compositions in active agent delivery applications.

Abstract: The invention provides novel compositions of bioactive polypeptides and proteins with improved stability and shelf-life. The compositions are based on liquid vehicles selected from semifluorinated alkanes. These vehicles are remarkably effective in protecting polypeptides and proteins from degradation and/or aggregation. The compositions are useful for topical administration, e.g. into an eye, or by parenteral injection, e.g. via the subcutaneous or intramuscular route.

Abstract: The present invention relates to sustained release drug delivery systems, medical devices incorporating said systems, and methods of use and manufacture thereof. The inventive systems feature bioerodible drug delivery devices that include biocompatible solid and biocompatible fluid compositions to achieve desired sustained release drug delivery.

Abstract: A pharmaceutical composition comprising an amphiphilic emulsifier, a polar liquid carrier and, optionally, a lipid component. The amphiphilic emulsifier form free-moving, optionally lipid-carrying, micelles (LMs) in the polar liquid carrier. The pharmaceutical composition is free of hemoglobin and fluorocarbon and can be used for treating conditions related to lack of blood supply and to raise the blood pressure and correct hypovolemia.

Abstract: Lipidated micro- or macroparticles are prepared by covalently linking a glycoprotein, typically collagen, with at least one lipid. An amino group in the glycoprotein is joined with a primary amine in the lipid. These particles can be used to encapsulate active ingredients, such as drugs.

Abstract: Provided herein are methods for treating subjects having a cancer, such as a relapsed or refractory solid tumor, wherein the method comprises administering to the subject a cytidine analog. In certain of the methods, the cytidine analog is administered alone or in combination with one or more anti-cancer agents. Also provided are methods for using a cytidine analog, to treat diseases and disorders including disorders related to abnormal cell proliferation, hematologic disorders, and immune disorders, among others. In certain of the methods, the cytidine analog is formulated in an oral dosage form and administered orally.

Abstract: The invention relates to a composition comprising albumin and a therapeutic agent, particularly a gene therapy vector. The composition is useful in the treatment of glioma.

Abstract: Microencapsulation of bioactive and chemical cargo in a stable, cross-linked polymer matrix is presented that results in small particle sizes and is easily scaled-up for industrial applications. A formulation of a salt of an acid soluble multivalent ion, an acid neutralized with a volatile base and one or more monomers that cross-link in the presence of multivalent ions is atomized into droplets. Cross-linking is achieved upon atomization where the volatile base is vaporized resulting in a reduction of the pH of the formulation and the temporal release of multivalent ions from the salt that cross-link the monomers forming a capsule. The incorporation of additional polymers or hydrophobic compounds in the formulation allows control of hydration properties of the particles to control the release of the encapsulated compounds. The operational parameters can also be controlled to affect capsule properties such as particle-size and particle-size distribution.

Abstract: The present invention relates to LRP6 constructs that bind to LRP6 receptor. The LRP6 constructs comprise at least one LRP6 binding moiety and a half-life extender molecule such that the LRP6 construct inhibit the Wnt signaling pathway without potentiation of the Wnt signal. The LRP6 constructs also have an increased half-life to provide more time for the therapeutic benefit.

Abstract: The present invention encompasses albumin fusion proteins. Nucleic acid molecules encoding the albumin fusion proteins of the invention are also encompassed by the invention, as are vectors containing these nucleic acids, host cells transformed with these nucleic acids vectors, and methods of making the albumin fusion proteins of the invention and using these nucleic acids, vectors, and/or host cells. Additionally the present invention encompasses pharmaceutical compositions comprising albumin fusion proteins and methods of treating or preventing diseases, disorders or conditions related to diabetes mellitus using albumin fusion proteins of the invention.

Abstract: A method is described that improves the transport properties of albumin produced on an industrial scale, wherein the albumin is mixed, during the production process, with substances that saturate the binding points on the albumin. Furthermore, pasteurized and then octanoate-reduced human albumin and therapeutic uses of such albumin is described. Such albumin may be useful in detoxifying human plasma, e.g. for the intravenous treatment of acute or chronic liver diseases, and as a dialysate in extracorporeal liver dialysis.

Abstract: In some aspects, the present invention provides cell-reactive compstatin analogs and compositions comprising cell-reactive compstatin analogs. In some aspects, the invention further provides methods of using cell-reactive compstatin analogs, e.g., to inhibit complement-mediated damage to a cell, tissue, or organ. In some aspects, the invention provides long-acting compstatin analogs and compositions comprising long-acting compstatin analogs. In some aspects, the invention further provides methods of using long-acting compstatin analogs, e.g., to inhibit complement-mediated damage to a cell, tissue, or organ. In some aspects, the invention provides targeted compstatin analogs and compositions comprising targeted compstatin analogs. In some aspects, the invention further provides methods of using targeted compstatin analogs, e.g., to inhibit complement-mediated damage to a cell, tissue, or organ.

Abstract: The invention relates to variants of a parent albumin having altered plasma half-life compared with the parent albumin. The invention also relates to fusion polypeptides and conjugates comprising said variant albumin.

Abstract: The invention provides methods and materials for making and using variant serum albumin amino acid sequences which exhibit improved properties compared to wild type serum albumin sequences. The invention further provides methods and materials for making and using fusion proteins in which the variant serum albumin amino acid sequences are fused to a therapeutic or diagnostic agent, such as a therapeutic protein, or a functional fragment or variant thereof that maintains activity, and exhibits improved properties.

Abstract: If albumin is added to a pharmaceutical formulation containing acylated insulin described in WO 2009/022005 and WO 2009/022013, the acylated insulin can be kept in solution after subcutaneous injection.

Abstract: The present invention relates to the provision of a novel method for the reconstitution of dry formulations comprising biomolecules, and in particular, to dry protein formulations, and to pharmaceutical or veterinary products suitable for parenteral administration containing reconstituted formulations prepared according to the novel method of the invention.

Abstract: A method of improving the efficacy of a blood transfusion into a subject is provided comprising administering a composition comprising an EAF PEGylated-blood protein into the subject, prior to, during, or subsequent to the blood transfusion.

Abstract: A principal object of the present invention is to provide a pharmaceutical composition that can produce a high antitumor effect by efficiently delivering a drug with antitumor activity to tumor tissues with the aid of carbonate apatite nanoparticles. The present invention provides a pharmaceutical composition including carbonate apatite nanoparticles with an average particle size of at most 50 nm containing a drug with antitumor activity and a pharmacologically acceptable solvent in which the carbonate apatite nanoparticles containing the drug are dispersed.

Abstract: An equipment assembly for preparing, harvesting and collecting particles is disclosed. The assembly comprises a tandem filter system with one or more high pressure filters, one or more low pressure filters and one or more collection vessel. Particles can be prepared, harvested and collected continuously, semi-continuously or in a batch-type operation. A tandem filter system and its method of use are also disclosed. Particles made with the assembly and according the instant methods are also disclosed. The assembly provides improved particle harvesting and collection over other systems and permits continuous particle formation, in particular by dispersion of a solute-containing process fluid within a supercritical anti-solvent.

Abstract: Base-labile crosslinkers, base-labile conjugates comprising such crosslinkers, methods of their synthesis and use are disclosed.

Abstract: An improved method for the detection of parvovirus B19 in a sample is provided, the improvement consisting of detecting a parvovirus B19 non-structural protein in said sample.

Abstract: Variants of a parent albumin having altered plasma half-life compared with a parent albumin are described. Fusion polypeptides and conjugates including the variant albumin are also described. Embodiments include, but are not limited to, a polypeptide which is a variant of albumin, including one or more alterations at one or more positions corresponding to 104, 105, 106, 107, 108, 109, 110, 111, 112, 113, 114, 115, 116, 117, 118, 119 and 120 in SEQ ID NO: 2.

Abstract: The present disclosure relates to a hydrogel composition and methods of using the same. The hydrogel composition may include precursors that react with each other upon contact as well as precursors that react upon contact with an initiator. In embodiments, the resulting hydrogels may have varying levels of crosslinking with both denser and less dense regions.

Abstract: A chitosan nanofiber for delivering an anionic protein drug, a method of preparing the same, and a pharmaceutical preparation for transmucosal administration including the chitosan nanofiber are provided. The chitosan nanofiber including an anionic protein drug in a core and chitosan in a shell is prepared by coaxial electrospinning an aqueous solution of the anionic protein drug through an inner nozzle and a solution of the chitosan or a chitosan derivative through an outer nozzle.

Abstract: The present invention relates to variants of a parent albumin having altered plasma half-life compared with the parent albumin. The present invention also relates to fusion polypeptides and conjugates comprising said variant albumin.

Abstract: Provided is a hydrogel which comprises water as the main component at a high water content and has mechanical strength suitable for practical use and which exhibits high transparency and self-healing and shape-retaining properties. Also provided are both a material for the hydrogel and a novel polyionic dendrimer. A polyionic dendrimer which comprises a hydrophilic linear polymer as the core and polyester dendrons attached to both terminals of the linear polymer and in which cationic groups are bonded to the surfaces of the dendrons, said cationic groups being selected from the group consisting of guanidine group, thiourea group, and isothiourea group; a material for a hydrogel, which comprises the polyionic dendrimer and clay; and a hydrogel prepared using the material.

Abstract: A special class of drug-depot forming triblock copolymers which are very suitable for the loading, containment and releasing of sensitive drugs such as proteins from biodegradable, injectable drug depots. How to visualize these depots for various imaging related purposes is described. A composition comprising a tri-block copolymer according to formula 1 B-A-B (1), wherein A stands for a linear poly-(ethylene glycol) block and wherein B stands for wherein B stands for a poly(lactide-co-?-caprolactone) block, wherein the hydroxyl end-groups of the tri-block copolymer are at least partially acylated with an optionally substituted acyl having 2 to 12 C-atoms, C-atoms of the substituents included; an active ingredient, preferably a pharmaceutically active ingredient and a solvent, wherein the block ratio of the tri-block copolymer, which ratio is defined as the ratio between the sum of the average molecular weight of the B-blocks and the sum of the average molecular weight of the A-block ranges from 1.4 to 3.5.

Abstract: An object of the present invention is to provide a pharmaceutical composition comprising an enzyme-treated human serum which is useful for treatment and prevention of diseases such as a cancer and an infectious disease, and a method of preparing the same. The present invention relates to a method of preparing a pharmaceutical composition comprising an enzyme-treated human serum, comprising a step of bringing the human serum into contact with ?-galactosidase and, to a pharmaceutical composition comprising an enzyme-treated human serum obtained by the preparation method.

Abstract: The disclosure provides a pharmaceutical composition. The pharmaceutical composition includes a chitosan with palmitoyl groups and an active agent. According to another embodiment, the pharmaceutical composition can further include a gelling accelerating agent. According to an embodiment of the disclosure, the active agent of the disclosure can be administered in the form of a nano-drug, liposome, micelle, or microparticle.

Abstract: This invention is directed to a biodegradable, semi-crystalline, phase separated thermoplastic multi-block copolymer, a process for preparing said multi-block copolymer, a composition for the delivery of at least one biological active compound, and to a method for delivering a biologically active compound to a subject in need thereof. A multi-block copolymer of the invention is characterised in that: a) it comprises at least one hydrolysable pre-polymer (A) segment and at least one hydrolysable pre-polymer (B) segment, b) said multi-block copolymer having a Tg of 37° C. or less and a Tm of 110-250° C. under physiological conditions; c) the segments are linked by a multifunctional chain-extender; d) the segments are randomly distributed over the polymer chain; e) at least part of the pre-polymer (A) segment is derived from a water-soluble polymer.

Abstract: The present disclosure provides a method for treating and/or preventing nephrotic syndrome, such as but not limited to minimal change disease and membranous nephropathy, and conditions related to nephrotic syndrome, such as but not limited to, proteinuria and edema, as well as diabetic nephropathy, diabetes mellitus, lupus nephritis or primary glomerular disease. The present disclosure further provides methods for reducing proteinuria and other disease states as discussed herein. Such methods comprise the therapeutic delivery of an Angptl4 polypeptide or Angptl4 polypeptide derivative to a subject.

Abstract: The present invention relates to compositions and methods for reducing cell proliferation and/or promoting cell death by inhibiting Drp1. It is based, at least in part, on the discoveries that (i) Drp1 disruption-induced mitochondrial hyperfusion is functionally linked to the cell cycle regulation apparatus, so that Drp1 inhibition results in a disruption of the cell cycle and DNA aberrancies; (ii) inhibition of both Drp1 and ATR are synthetic lethal causing increased DNA damage and apoptotic cell death; and (iii) even in resistant cell lines, Drp1 inhibitor (e.g., mdivi-1) together with a second antiproliferative agent (e.g., cisplatin or carboplatin) act synergistically to promote apoptosis. Accordingly, the present invention provides for novel anticancer strategies.

Abstract: The present invention relates to nucleic acid sequences coding for modified coagulation factors, preferably coagulation factor VIII, and their derivatives; recombinant expression vectors containing such nucleic acid sequences; host cells transformed with such recombinant expression vectors; and recombinant polypeptides and derivatives coded for by said nucleic acid sequences, whereby said recombinant polypeptides and derivatives have biological activities and prolonged in vivo half-lives compared to the unmodified wild-type proteins. The invention also relates to corresponding sequences that result in improved in vitro stability. The present invention further relates to processes for the manufacture of such recombinant proteins and their derivatives. The invention also relates to a transfer vector for use in human gene therapy, which comprises such nucleic acid sequences.

Abstract: The present disclosure relates to a class of engineered polypeptides having a binding affinity for albumin. It also relates to new methods and uses that exploit binding by these and other compounds to albumin in different contexts, some of which have significance for treatment or diagnosis of disease in mammals including humans.

Abstract: The invention discloses a pharmaceutical hemostatic liquid foam base preparation comprising albumin as foaming agent and a fibrinogen precipitating substance and optionally a coagulation inducing agent, wherein albumin as foaming agent is present in native form; a method for the production of a transient hemostatic liquid foam; the transient hemostatic liquid foam; and a kit for making the foam.

Abstract: The present invention generally relates to therapeutic compositions for the treatment of mammalian disease and related methods. It more specifically relates to compositions comprising peptides for the treatment of inflammation and methods for delivering the peptides. In one composition aspect, the composition comprises a peptide, and the peptide comprises one or more hexapeptides that are capable of forming fibrils.

Abstract: The present invention relates to variants of a parent albumin having altered plasma half-life compared with the parent albumin. The present invention also relates to fusion polypeptides and conjugates comprising said variant albumin.

Abstract: Provided are human serum albumin (HSA) compositions with improved properties over native HSA.

Abstract: An aligned polymer article including substrates, wherein the substrates are not covalently bonded to the aligned collagen and a method of forming such articles wherein substrates are mixed with a polymer in solution to form a polymer-substrate mixture. The mixture is placed in an electrochemical cell and a voltage is applied to the cell generating a pH gradient, wherein the polymer aligns in the cell and migrates to the isoelectric plane of the polymer solution.

Abstract: The present invention relates to variants of a parent albumin, the variants having altered plasma half-life compared with the parent albumin. The present invention also relates to polynucleotides encoding the variants; nucleic acid constructs, vectors, and host cells comprising the polynucleotides; and methods of using the variants.

Abstract: Compositions, methods, and kits for repair and production of extracellular matrix are provided. In the broad aspect, the composition comprises a ligand of ?5?1 integrin attached to a surface of a nanoparticle composed of a protein, with a proviso that the protein is not fibronectin.

Abstract: Provided are human serum albumin (HSA) compositions with improved properties over native HSA.

Abstract: The present invention provides methods for treating, preventing and/or ameliorating at least one cardiovascular disorder in a human in need thereof comprising administering to said human a pharmaceutical composition comprising at least one polypeptide having at least one GLP-1 activity and/or at least one GLP-1 agonist.

Abstract: A method for inhibiting survival of cancer cells in a subject is disclosed. The method comprises administering to a subject in need thereof a therapeutically effective amount of fibrillar albumin. The preparation of the fibrillar albumin comprises: (i) forming a solution comprising an isolated and/or purified globular albumin; (ii) adding a detergent to the solution containing the isolated and/or purified globular albumin, wherein the detergent is one selected from the group consisting of sodium dodecyl sulfate (SDS) and n-tetradecyl-N,N-dimethyl-3-ammonio-1-propanesulfonate; (iii) applying the solution to a molecular sizing column with a pore size that permits separation of a protein with a molecular weight of at least about 70 kDa so as to promote column-induced formation of the fibrillar albumin from the isolated and/or purified globular albumin; and (iv) eluting the fibrillar albumin from the column, wherein the eluted albumin has a fibrillar structure.