Abstract: Pharmaceutical compositions for treating, mitigating or preventing autoimmune diseases and associated conditions are described herein. Methods for fabricating the compositions and using them are also described.

Abstract: Methods for treating diabetes or obesity are provided comprising administering to the subject an amount of an agent that binds a central nervous system FGF receptor homodimer.

Abstract: The present invention relates to a method for preparing encoded hydrogel particles for high sensitive detection of a target biomolecule with high accuracy, and encoded hydrogel particles prepared thereby and, specifically, to a method for preparing encoded hydrogel particles, comprising a step of synthesizing hydrogel particles, and then binding a probe thereto, and encoded hydrogel particles prepared thereby. According to the present invention, probes can be loaded with remarkably improved high efficiency, loaded probes can be uniformly distributed, and the potential problem of biomolecule detection inhibition caused by an unreacted end can be resolved. In addition, the present invention can be applied to the diagnosis of diseases or screening of drugs through high sensitive multiplex detection of target biomolecules such as nucleic acids and proteins, and therefore, can be widely used in the field of medical diagnosis including molecular diagnosis.

Abstract: Pharmaceutical compositions for treating, mitigating or preventing autoimmune diseases and associated conditions are described herein. Methods for fabricating the compositions and using them are also described.

Abstract: New designed ankyrin repeat domains with binding specificity for serum albumin, recombinant binding proteins comprising at least two designed ankyrin repeat domains with binding specificity for serum albumin, as well as recombinant binding proteins comprising at least one designed ankyrin repeat domain with binding specificity for hepatocyte growth factor (HGF), at least one designed ankyrin repeat domain with binding specificity for vascular endothelial growth factor (VEGF-A), and at least two designed ankyrin repeat domain with binding specificity for serum albumin are described, as well as nucleic acids encoding such designed ankyrin repeat domains and recombinant binding proteins, pharmaceutical compositions comprising such designed ankyrin repeat domains, recombinant binding proteins or nucleic acids and the use of such designed ankyrin repeat domains, recombinant binding proteins, nucleic acids or pharmaceutical compositions in the treatment of diseases.

Abstract: The present invention relates to lebecetin, a functional variant or fragment thereof, for use as neovascularization inhibitor, in particular in the treatment of neovascular diseases such as ocular diseases, cancers or inflammatory disorders with a neovascular component.

Abstract: In some aspects, the invention provides methods of treating a subject in need of treatment for a chronic complement-mediated disorder. In some aspects, the invention provides methods of treating a subject in need of treatment for a Th17-associated disorder. In some aspects, the invention provides methods of treating a subject in need of treatment for a chronic respiratory system disorder. In some aspects, the invention provides methods of administering a complement inhibitor to a subject. In some embodiments, a method of treating a subject comprises administering multiple doses of a complement inhibitor to the subject according to a dosing schedule that leverages the prolonged effect of complement inhibition in chronic respiratory disorders. In some embodiments, a subject has chronic obstructive pulmonary disease. In some embodiments, a subject has asthma.

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: The present disclosure relates to the ozone treatment of plants to reduce or eliminate pesticides, mold, yeast, or other pathogens. In an embodiment, the plant is exposed to ozone at a concentration of 150 to 250 ppm for between 15 and 65 minutes. The exposure of the plant to ozone reduces or eliminates pesticides, mold, yeast or other pathogens with little to no negative effects on the plants potency, flavor profile, fragrance, and weight.

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: A method for the avoidance of side effects associated with glucagon-like peptide-1 receptor (GLP-1R) agonists through vitamin B12 conjugation prior to administration. Vitamin B12 may be bound to a GLP-1R agonist, such as exendin-4 (Ex4), to provide enhanced proteolytic stability while retaining GLP-1R agonism. The conjugate (B12-Ex4) also improves glucose tolerance without producing anorexia and malaise. A GLP-1R agonist that is resistant to DPP-IV degradation and does not penetrate readily into the CNS, but retains the enhanced pharmacokinetic and pharmacodynamic profile on pancreatic ?-cells provide a pharmacological tool for glycemic control in type 2 diabetes mellitus (T2DM) patients without eliciting unwanted hypophagia and nausea.

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: Purified therapeutic nanoparticles are provided herein. Such nanoparticles comprise an active pharmaceutical ingredient and human serum albumin, wherein the weight ratio of human serum albumin to the active ingredient in the therapeutic nanoparticles is from 0.01:1 to 1:1, and wherein the nanoparticles are substantially free of free human serum albumin that is not incorporated in the nanoparticles. The present disclosure also provides pharmaceutical compositions that comprise the purified therapeutic nanoparticles and are also substantially free of free human serum albumin. Methods for preparing and using the purified therapeutic nanoparticles and compositions thereof are also provided.

Abstract: This document relates to non-covalently bound complexes including Docetaxel and human serum albumin. This document also relates to compositions comprising non-covalently bound complexes including Docetaxel and human serum albumin. This document also relates to compositions comprising Docetaxel and human serum albumin, wherein the composition is a clear aqueous solution when the composition is dissolved in an aqueous solution, and wherein the composition has a solubility in an aqueous solution of at least 10 mg/ml. This document also relates to compositions comprising Docetaxel and human serum albumin, wherein the Docetaxel and the human serum albumin in the composition have a ratio by weight from about 1:50 to about 1:1000. This document also relates to compositions consisting essentially of Docetaxel and human serum albumin, wherein the Docetaxel and the human serum albumin in the composition have a ratio by weight from about 1:50 to about 1:1000.

Abstract: This disclosure relates to swellable needles that include a proximal end portion and a swellable distal end portion. Upon exposure to a liquid, the needles are configured to undergo a shape change from a first configuration in which the width of the needle is tapered from the proximal end portion to the distal end portion to a second configuration in which the distal end portion is more swollen than the proximal end portion. The swellable needles can be double layer swellable needles or single material swellable needles.

Abstract: The present invention relates to genetically modified host cells, in particular yeast cells, comprising at least one isolated polynucleotide encoding a Killer Expression protease (Kex2p) or a fragment and/or variant thereof which has at least one Kex2p functional activity and at least one isolated polynucleotide encoding a Protein Disulfide-Isomerase (Pdi1) or a fragment and/or variant thereof which has at least one Pdi functional activity.

Abstract: The present invention is directed to treatments for a disease or condition, in a subject in need thereof, that provide alternatives to treatment by injection that give, relative to treatment by injection, improved treatment outcomes, 100% treatment compliance, reduced side effects, and rapid establishment and/or termination of substantial steady-state drug delivery. The method includes providing continuous delivery of a drug from an implanted osmotic delivery device, wherein substantial steady-state delivery of the drug at therapeutic concentrations is achieved within about 7 days after implantation of the osmotic delivery device in the subject and the substantial steady-state delivery of the drug from the osmotic delivery device is continuous over a period of at least about 3 months. In one embodiment, the present invention is directed to treatment of type 2 diabetes mellitus using insulinotrophic peptides. In embodiments, a subject has a baseline HbA1c % of greater than 6.5% or 10.0%.

Abstract: A liquid composition comprising a GLP-1 agonist or/and a pharmacologically tolerable salt thereof and, optionally, at least one pharmaceutically acceptable excipient, wherein the composition comprises methionine, as add-on therapy with metformin and/or with long-acting insulin/insulin derivates where appropriate.

Abstract: A high potency botulinum toxin pharmaceutical composition comprising two excipients (such as albumin and sodium chloride) in a weight to weight ratio of between about 1 and about 100.

Abstract: The invention features a powdered composition including a pharmaceutically active compound and a protein or a hydrolyzed protein. In particular, the powdered composition forms a stable solution or dispersion suitable for oral administration in which the protein or the hydrolyzed protein is bound to the pharmaceutically active compound. The invention also provides a method of administering the composition, such as to a patient with dysphasia; liquid or semi-solid formulations of the composition; methods for preparing the composition; and kits including the composition.

Abstract: Preparations of Clostridium botulinum neurotoxin BoNT/A3 and methods for using such preparations for treating a patient having a symptom in need of botulinum toxin therapy are provided herein.

Abstract: Stabilization of water-containing solutions or lyophilizates of proteins and peptide against non-enzymatic deamidation degradation reactions at asparaginyl or glutaminyl residues is achieved using organic anions, such as saccharin, benzenesulfonic acid, gentisic acid or N-acetyltryptophan which have a pKa within the range of 0.5 to 3.5.

Abstract: An acute pain medication overuse disorder (such as a medication overuse headache disorder) can be treated by administration of a botulinum toxin to a patient. The botulinum toxin can be botulinum toxin type A and the botulinum toxin can be administered to or to the vicinity of where a patient experiences or is predisposed to experience pain or a headache.

Abstract: Botulinum neurotoxin formulated with a hyaluronic acid carrier with increased residency time of the botulinum toxin at a subdermal location and fewer botulinum toxin induced complications or side effects.

Abstract: Botulinum neurotoxin formulated with a hyaluronic acid carrier with increased residency time of the botulinum toxin at a subdermal location and fewer botulinum toxin induced complications or side effects.

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

Abstract: This invention relates to molecules, particularly polypeptides, more particularly fusion proteins that include a serpin polypeptide or an amino acid sequence that is derived from a serpin and second polypeptide comprising of at least one the following: an Fc polypeptide or an amino acid sequence that is derived from an Fc polypeptide; a cytokine targeting polypeptide or a sequence derived from a cytokine targeting polypeptide; a WAP domain containing polypeptide or a sequence derived from a WAP containing polypeptide; and an albumin polypeptide or an amino acid sequence that is derived from a serum albumin polypeptide. This invention also relates to methods of using such molecules in a variety of therapeutic and diagnostic indications, as well as methods of producing such molecules.

Abstract: This invention relates to fusion proteins that include a whey acidic protein (WAP) domain-containing polypeptide and a second polypeptide. Additionally, the invention relates to fusion proteins that include a WAP domain-containing polypeptide a second polypeptide, and a third polypeptide. The second and/or third polypeptides of the fusion proteins of the invention are a Fe polypeptide; an albumin polypeptide; a cytokine targeting polypeptide; or a serpin polypeptide. This invention also relates to methods of using such molecules in a variety of therapeutic and diagnostic indications, as well as methods of producing such molecules.

Abstract: An ophthalmic drug delivery system that contains phospholipid and cholesterol for prolonging drug lifetime in the eyes.

Abstract: The differential expression of select miRNA in plasma and bile among patients with PDAC, chronic pancreatitis (CP), and controls were measured. Patients (n=215) with treatment-naïve PDAC (n=77), CP with bile or pancreatic duct pathology (n=67), and controls (n=71) that had been prospectively enrolled in a Pancreatobiliary Disease Biorepository at the time of endoscopic retrograde cholangiopancreatography (ERCP) or endoscopic ultrasound (EUS) were identified. Controls were patients with choledocholithiasis but normal pancreata. The sample was separated into training (n=95) and validation (n=120) cohorts to establish and then test the performance of PDAC Signature Panels in diagnosing PDAC. The training cohort (n=95) included age-matched patients with CP and controls. Panels were derived from the differential expression of 10-candidate miRNA in plasma or bile.

Abstract: Provided is a separatome-based recombinant peptide, polypeptide, and protein expression and purification platform based on the juxtaposition of the binding properties of host cell genomic peptides, polypeptides, and proteins with the characteristics and location of the corresponding genes on the host cell chromosome, such as that of E. coli, yeast, Bacillus subtilis or other prokaryotes, insect cells, mammalian cells, etc. This platform quantitatively describes and identifies priority deletions, modifications, or inhibitions of certain gene products to increase chromatographic separation efficiency, defined as an increase in column capacity, column selectivity, or both, with emphasis on the former. Moreover, the platform provides a computerized knowledge tool that, given separatome data and a target recombinant peptide, polypeptide, or protein, intuitively suggests strategies leading to efficient product purification.

Abstract: The invention provides methods for predicting or determining the response of a mammalian tumor to a chemotherapeutic agent and for treating a mammalian tumor comprising detecting and quantifying the SPARC protein or RNA in a sample isolated from the mammal. The invention further provides kit for predicting the response of a mammalian tumor to a chemotherapeutic agent, comprising a means for the isolation of protein or RNA from the tumor, a SPARC protein or RNA detection and quantification means, control RNAs, and rules for predicting the response of the tumor based on the level of SPARC protein or RNA in tumor.

Abstract: Bone- and metal-targeted polymeric nanoparticles are provided. Exemplary nanoparticles have three main components: 1) a targeting element that can selectively bind to bone, minerals, or metal ions; 2) a layer of stealth to allow the polymer to evade immune response; and 3) a biodegradable polymeric material, forming an inner core which can carry therapeutics or other diagnostics. Preferred nanoparticles contain a blend of target-element polymer conjugate and polymer that optimizes the ligand density on the surface of the nanoparticle to provide improved targeting of the nanoparticle. The ratio of target-element polymer conjugate to polymer can also be optimized to improve the half-life of the nanoparticles in the blood of the subject. The nanoparticles also exhibit prolonged, sustained release of therapeutic agents loaded into the particles.

Abstract: Described herein are methods for inactivating viruses using caprylate in solutions containing albumin.

Abstract: Otologic materials and methods are provided. For example, a cell-adhesive, biodegradable hydrogel scaffold loaded with time-released drugs for repairing chronic tympanic membrane perforations is disclosed, methods of making same and administering same are provided. This hydrogel may promote vascular in-growth and epithelial cell growth of the tympanic membrane with the purpose of closing the perforation and providing a barrier between the external and middle ear. The hydrogel is initially a liquid polymer that only gels upon exposure to specific conditions, such as exposure to light. This scaffold may simultaneously induce repair of the tympanic membrane while preventing or alleviating middle ear infection, thus filling a void in current tympanic membrane perforation therapies.

Abstract: A wound dressing material for controlled activation of a wound healing therapeutic compound in the presence of a protease enzyme in a wound fluid, the material comprising: a medically acceptable polymer; a wound healing therapeutic agent; an inhibitor of the protease enzyme; and a linker group which is cleavable by the protease enzyme, wherein the activities of both the wound healing therapeutic agent and the inhibitor are increased by contacting the wound dressing material with a would fluid containing the protease enzyme. For example, the enzyme may be a matrix metalloproteinase, the therapeutic agent may be a reactive oxygen scavenger, and the inhibitor may be a tissue inhibitor of metalloproteinase (TIMP).

Abstract: The present invention relates to modified forms of C-peptide, and methods for their use. In one aspect, the modified forms of C-peptide comprise conjugated C-peptide derivatives which exhibit superior pharmacokinetic and biological activity in vivo.

Abstract: The present invention provides methods of treating recurrent cancer (such as recurrent ovarian, peritoneal, or fallopian tube cancer) in an individual, comprising administering to the individual an effective amount of a composition (such as Nab-paclitaxel or Abraxane®) comprising nanoparticles comprising a taxane and a carrier protein.

Abstract: The present invention is directed to a liposomal delivery system comprising defined lipid components, including dimethyldioctadecylammonium and other lipid components and a stabilizing agent, which may be used in the delivery of bioactive agents to a subject in need thereof. The liposomal delivery system of the invention provide improvements in terms of delivery and stability. Ideally, the liposomal delivery system is used as a vaccine or drug/medicament delivery system although other bioactive agents may be delivered.

Abstract: A biocompatible composition which comprises crosslinkable serum albumin, crosslinkable serum protein and/or crosslinkable derivatives derived therefrom, and which is polymerizable to give a hydrogel-forming material, is used in a method for the prevention of pathological adhesions.

Abstract: The apparatus and methods of the present invention are of use for the production of emulsion-based microparticles containing a biological or chemical agent. In particular, the apparatus provides a vessel; packing material situated inside such vessel and may further provide material capable of insertion into both ends of said vessel for enclosure of the packing material. In a particular embodiment, the apparatus is a packed bed apparatus. The methods include production of emulsion based microparticles containing a biological or chemical agent. The usefulness of the present invention is that the apparatus and methods of the present invention provide for a low-shear, non-turbulent, production of emulsion-based microparticles that provides a narrow, reproducible, particle size distribution, capable of use with both large and small volumes that is capable of being conveniently scaled up while providing predictable emulsion properties.

Abstract: Methods of encapsulating cargo in a microgel droplet, microgel droplets prepared according the provided methods, and methods of use thereof are disclosed. The methods of preparing cargo-encapsulated microgels generally include flowing through a flow-focusing nozzle of a microfluidic device a macromer phase, an oil phase, and a crosslinker phase to form microgel droplets by oil-water emulsion. The phases are pumped, injected, or flowed through the microfluidic device such that as the macromer phase approaches the flow focusing nozzle, the co-flowing oil phase shields the macromer from contact with the crosslinker phase until flow instability occurs and macromer phase droplets form. After flow instability occurs, the crosslinker diffuses from the crosslinker phase into the droplets in an effective amount to covalently crosslink the macromer into a microgel network encapsulating the cargo in the crosslinked macromer.

Abstract: An aqueous composition having increased protein stability is obtained by: a. determining a pH at which the protein has stability at the desired temperature; b. adding to the composition at least one displacement buffer wherein the displacement buffer has a pKa that is at least 1 unit greater or less than the pH of step (a); and c. adjusting the pH of the composition to the pH of step (a); wherein the aqueous composition does not comprise a conventional buffer at a concentration greater than about 2 mM and wherein the conventional buffer has a pKa that is within 1 unit of the pH of step (a).

Abstract: The invention provides methods of reducing or decreasing a size of a tumor or eliminating a tumor or inhibiting, decreasing, or reducing neo-vascularization or angiogenesis in a tumor in a patient by administering an adenovirus comprising a nucleic acid construct comprising a FAS-chimera gene operably linked to an endothelial cell-specific promoter. Also provided is a homogeneous population of an adenovirus comprising a FAS-chimera gene operably linked to an endothelial cell-specific promoter and its uses thereof.

Abstract: Process for the manufacturing of a drug delivery system based on a polymer comprising dispersed bioactive agent via the following process steps: (a) dissolving a polymer in an organic solvent (b) mixing the dissolved polymer with the bioactive agent (c) laminating the mixture between two polymer sheets, whereby at least one of the sheets is permeable to the organic solvent, to provide a film whereby the film can be further processed into the drug delivery system. The drug delivery system is suitable for implantation or injection and comprises fibres, rods, discs, coatings, tubes, films or rolled films.

Abstract: The invention is related to water-soluble products and pharmaceutical formulations in solid or liquid form mainly for parenteral use. They consist of or comprise a therapeutically active substance (having low aqueous solubility and a substantial binding affinity to plasma proteins) and a plasma protein fraction in controlled aggregation state, whereby the said active substance and the said protein fraction are bound to each other by way of non-covalent bonds. It also covers processes for the preparation of the product and pharmaceutical formulation by dissolving the water-insoluble active substance in a water-miscible, pharmaceutically acceptable solvent, combining said solution with the aqueous solution of a plasma protein fraction in controlled aggregation state whereby a true solution is obtained containing the said active substance and the said protein fraction bound together by way of non-covalent bonds.

Abstract: Toroidal-spiral shaped particles, their method of manufacture, and uses thereof are disclosed. The toroidal-spiral particles can contain at least one active agent, such as a drug, and provide a controlled, sustained release of the active agent.

Abstract: The invention discloses a polymer micro-needle array chip, comprising a substrate and a micro-needle array standing thereon; the material for preparing the micro-needle array is a polyacrylamides polymer, with the molecular weight of 1.0×104-2.0×105, the Vickers hardness of 150-600 HV, and the impact strength of 5-30 J/m. The polymer micro-needle array chip has a high mechanical strength and a sharp needle tip, and it can easily dissolve or swell on contact with a water-containing environment, which helps the drug to be released slowly in the skin.

Abstract: The invention provides an aqueous formulation comprising water and a protein, and methods of making the same. The aqueous formulation of the invention may be a high protein formulation and/or may have low levels of conductity resulting from the low levels of ionic excipients. Also included in the invention are formulations comprising water and proteins having low osmolality.

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.