Abstract: The present invention provides methods of inducing differentiation of oligodendrocyte progenitor cells to a mature myelinating cell fate with a neurotransmitter receptor modulating agent. The present invention also provides methods of stimulating increased myelination in a subject in need thereof by administering said neurotransmitter receptor modulating agent. Methods of treating a subject having a demyelinating disease using a neurotransmitter receptor modulating agent are also provided.

Abstract: The present invention is directed to the combination therapy of an afucosylated anti-CD20 antibody with bendamustine for the treatment of cancer, especially to the combination therapy of CD20 expressing cancers with an afucosylated humanized B-Ly1 antibody and bendamustine.

Abstract: The present invention relates to a highly concentrated, stable pharmaceutical formulation of a pharmaceutically active anti-HER2 antibody, such as e.g. Trastuzumab (HERCEPTIN™), Pertuzumab or T-DM1, or a mixture of such antibody molecules for subcutaneous injection. In particular, the present invention relates to formulations comprising, in addition to a suitable amount of the anti-HER2 antibody, an effective amount of at least one hyaluronidase enzyme as a combined formulation or for use in form of a co-formulation. The formulations comprise additionally at least one buffering agent, such as e.g. a histidine buffer, a stabilizer or a mixture of two or more stabilizers (e.g. a saccharide, such as e.g. ?,?-trehalose dihydrate or sucrose, and optionally methionine as a second stabilizer), a nonionic surfactant and an effective amount of at least one hyaluronidase enzyme. Methods for preparing such formulations and their uses thereof are also provided.

Abstract: The present application describes an antibody-coding, non-modified or modified RNA and the use thereof for expression of this antibody, for the preparation of a pharmaceutical composition, in particular a passive vaccine, for treatment of tumours and cancer diseases, cardiovascular diseases, infectious diseases, autoimmune diseases, virus diseases and monogenetic diseases, e.g. also in gene therapy. The present invention furthermore describes an in vitro transcription method, in vitro methods for expression of this antibody using the RNA according to the invention and an in vivo method.

Abstract: The present application describes an antibody-coding, non-modified or modified RNA and the use thereof for expression of this antibody, for the preparation of a pharmaceutical composition, in particular a passive vaccine, for treatment of tumours and cancer diseases, cardiovascular diseases, infectious diseases, autoimmune diseases, virus diseases and monogenetic diseases, e.g. also in gene therapy. The present invention furthermore describes an in vitro transcription method, in vitro methods for expression of this antibody using the RNA according to the invention and an in vivo method.

Abstract: The present application describes an antibody-coding, non-modified or modified RNA and the use thereof for expression of this antibody, for the preparation of a pharmaceutical composition, in particular a passive vaccine, for treatment of tumours and cancer diseases, cardiovascular diseases, infectious diseases, autoimmune diseases, virus diseases and monogenetic diseases, e.g. also in gene therapy. The present invention furthermore describes an in vitro transcription method, in vitro methods for expression of this antibody using the RNA according to the invention and an in vivo method.

Abstract: Described herein are anti-cancer compounds composed of a macromolecule comprising (1) at least one anti-cancer agent directly or indirectly bonded to the macromolecule and (2) at least one high Z element directly or indirectly bonded to the macromolecule that is capable of producing Auger electrons upon exposure to X-ray energy. When the compounds are exposed to low energy X-ray (e.g., kilo electron volts KeV) Auger electrons are produced by the high Z elements present in the compound. Because lower energy is required when compared to typical radiotherapy, which uses therapeutic X-ray energy in the million electron volt range (MeV), the subject experiences lower collateral damage when compared to radiation therapy. Additionally, the presence of the anti-cancer agent provides a second mechanism for killing cancer cells. Methods for making and using the anti-cancer compounds are also described herein.

Abstract: Provided are methods and compositions useful for treating/aches and/or pains. The compositions include ibuprofen in a clear stable aqueous system of water, alcohol and glycerin that is stable at room temperature for at least 6 months without separation or precipitation. The composition is effective for delivering ibuprofen directly through the mucosal or buccal tissue without passing through the GI tract.

Abstract: The invention is a composition of human insulin or insulin analog that includes specific concentrations of citrate, chloride, in some cases including the addition of sodium chloride, zinc and, optionally, magnesium chloride and/or surfactant, and that has faster pharmacokinetic and/or pharmacodynamic action than commercial formulations of existing insulin analog products.

Abstract: The present invention relates to stable liquid formulations of ketoprofen, amitriptyline, and oxymetazoline.

Abstract: The invention provides a method for treating cancer using a coadministration strategy that combines local codelivery of a therapeutic agent and an intracellular penetration enhancing agent, and optionally in further combination with local administration of an immunotherapeutic agent, such as a cancer vaccine or NKT agonist. The invention also provides a method for treating cancer using an intracellular penetration enhancing agent. The methods of the invention aim to substantially kill and/or destroy the target tumor cells, as well as those cancerous cells that have metastasized to other parts of the body.

Abstract: The present invention is to provide a vesicle composition comprising the following components (A), (B) and (C): (A) 0.0001 to 20 mass % of an organic acid represented by general formula (1): wherein R1 represents a natural sterin having a single hydroxy group or a hydrogenated product thereof or a residue which remains after a hydrogen atom is removed from the hydroxy group of bile acid, R2 represents a divalent hydrocarbon group having 1 to 24 carbon atoms, M represents a hydrogen atom, an alkali metal, an alkali earth metal, ammonium, an alkanolammonium having 2 to 9 carbon atoms in total, an alkylammonium or alkenylammonium having 1 to 22 carbon atoms in total, pyridinium substituted with an alkyl group or alkenyl group having 1 to 18 carbon atoms or a basic amino acid, (B) 0.0001 to 10 mass % of a sphingosine, and (C) water, and having a pH of 2 to 11.

Abstract: The present disclosure provides for a composition which may be used for the solublization of an agent or the oral administration of an agent, the composition comprising, a lyosphosphatidyl compound and at least one of a monoglyceride and a free fatty acid. In certain embodiments, the composition comprises a lyosphosphatidyl compound, a monoglyceride and a free fatty acid. In certain embodiments, the composition comprises an agent, a lyosphosphatidyl compound, a monoglyceride and a free fatty acid.

Abstract: The present invention is related to a method for ameliorating liver fibrosis in a subject. The present invention utilizes copolymers of polyethylene glycol and poly (D, L-lactide-co-glycolide) to form nanoparticle composition containing tyrosine kinase inhibitor, such as Sorafenib. The use of nanoparticle composition is non-toxic and can increase the stability and decrease the release of drug in blood circulation. The pharmaceutical composition is in an injectable form. The nanoparticle composition containing tyrosine kinase inhibitor of the present invention can effectively ameliorate liver fibrosis including decreasing extracellular matrix accumulation, suppressing hepatic stellate cell activity, shrinking of abnormal blood vessel, and lowering microvascular density in fibrotic liver; hence is suitable for clinical application for the treatment of liver fibrosis.

Abstract: A drug-delivery composition includes an intermediate composition having a hydrophilic matrix of a cross-linked polymer in form of particles, and a pharmaceutically active composition distributed in the cross-linked polymer of the particles.

Abstract: An extended release aqueous suspension composition of methylphenidate or salts thereof is provided. The extended release aqueous suspension of methylphenidate or salts has pH of more than 5.0 and exhibits excellent storage stability when tested for impurity and potency of methylphenidate. The suspension also comprises immediate release and sustained release components of methylphenidate or salts thereof. Following administration of a single dose of the extended release aqueous suspension of methylphenidate, a therapeutically effective amount of methylphenidate is reached in less than an hour, provides a release profile of at least 12 hours and has an in vivo release characterized by one single main plasma concentration peak.

Abstract: A carrier molecule composition. Specific implementations may include: a carrier molecule including at least one cell penetrating peptide (CPP) where the carrier molecule may include at least one hydrophobic domain and where the carrier is non-covalently associated with a biologically active molecule in one of a micelle and a liposome.

Abstract: This disclosure provides novel saccharide derivatives, conjugates, and methods for making the derivatives and conjugates.

Abstract: A method of treating a human subject having a condition responsive to valproic acid therapy, includes administering to the subject an effective amount of a metal-based ternary complex of valproic acid with nitrogen donor ligands, in particular with diimines or diamines.

Abstract: Polymer/drug conjugates that can selectively target and kill cancer cells are described. Conjugates can include a copolymer formed by the reaction of a biocompatible hydrophilic component and a disulfiram derivative. The copolymer reaction product can include additional functional groups pendant to the backbone via a disulfide linkage, for instance copper chelators. The hydrophilic component can form the polymer backbone and/or can form hydrophilic pendant groups off of the backbone. Copper ions can be associated with the copolymer.

Abstract: The present invention provides for a carrier complex for administration of therapeutic agents. In one aspect, an isolated C. botulinum carrier complex is provided, where the carrier complex lacks a native neurotoxin subunit.

Abstract: Disclosed are methods, compositions and uses of conjugates of prodrug forms of 2-pyrrolinodoxorubicin (P2PDox) with antibodies or antigen-binding fragments thereof (ADCs), with targetable construct peptides or with other targeting molecules that are capable of delivering the P2PDox to a targeted cell, tissue or pathogen. Once delivered to the target cell, the ADC or peptide conjugate is internalized, a highly toxic 2-pyrrolinodoxorubicin (2-PDox) is released intracellularly. The P2PDox-peptide or ADC conjugates are of use to treat a wide variety of diseases, such as cancer, autoimmune disease or infectious disease.

Abstract: The present disclosure provides methods of treating a disease or delivering a therapeutic agent to a mammal comprising administering to the mammal's cisterna magna and/or ventricle an rAAV particle containing a vector comprising a nucleic acid encoding a therapeutic protein inserted between a pair of AAV inverted terminal repeats in a manner such that cells with access to the cerebrospinal fluid (CSF) express the therapeutic agent and in certain embodiments secretes the therapeutic agent into the CSF for distribution to the brain.

Abstract: The invention relates to an RNA comprising at least one open reading frame (ORF) and comprising at least one modification, which increases the expression of the encoded peptide or protein. Furthermore, the invention relates to the medical use of such a modified RNA administered to a subject by jet injection. The invention relates further to a pharmaceutical composition and to a kit of parts comprising said modified RNA for administration by jet injection, preferably for use in the field of gene therapy and/or genetic vaccination. Additionally, the invention relates to a method for enhancing the (localized) expression of RNA-encoded peptides or proteins in the dermis or muscle (of a mammal) comprising administering the modified RNA by jet injection. And finally, the invention relates to a method of treatment comprising administering the modified RNA by jet injection to a subject in need thereof.

Abstract: The present invention relates to an mRNA sequence, comprising a coding region, encoding at least one antigenic peptide or protein of Rabies virus or a fragment, variant or derivative thereof. Additionally the present invention relates to a composition comprising a plurality of mRNA sequences comprising a coding region, encoding at least one antigenic peptide or protein of Rabies virus or a fragment, variant or derivative thereof. Furthermore it also discloses the use of the mRNA sequence or the composition comprising a plurality of mRNA sequences for the preparation of a pharmaceutical composition, especially a vaccine, e.g. for use in the prophylaxis or treatment of Rabies virus infections. The present invention further describes a method of treatment or prophylaxis of rabies using the mRNA sequence.

Abstract: The invention provides a murine model of wound infection and biofilm formation and methods for producing such model. The inventive murine model of wound infection may be used to evaluate pathogen virulence and test efficacy of a pharmaceutical composition and/or a treatment procedures in preventing or treating wound infection, reducing biofilm formation, or reducing symptoms in a subject.

Abstract: Genetically-modified zebrafish lacking one or more immune-related genes, and the use thereof, e.g., in cell or tissue transplantation methods or in stem cell biology. In a first aspect, the invention provides a genetically-modified fish whose genome is homozygous for engineered or induced genetic alteration, e.g., an alteration that changes the sequence of the genomic ONA resulting in insertion and deletion of nucleotides that disrupt protein function or shift the frame of translation leading to premature protein termination, in one or more immune-related genes selected from the group consisting of: foxn1, rag2, jak3, prkdc, and interleukin 2-receptor gamma a and (IL2RGa and IL2RGb),wherein the genetic alteration results in an inactivation (i.e., loss of expression or function) of both alleles of the immune-related gene.

Abstract: Described herein are cyclic peptides, nanoparticles bound with cyclic peptides, and methods for using said cyclic peptides and/or said nanoparticles bound with cyclic peptides for intraoperative nerve tissue imaging.

Abstract: The present invention relates to the use of in vivo contrast agents in medical imaging in order to diagnose and treat disease, and to monitor and assess disease progression following treatment with a nanoparticle therapeutic agent comprising an active pharmaceutical agent. The present invention also relates to modulating nanoparticle tumor concentration by modulating the PEG density of the nanoparticles.

Abstract: The present invention provides a nanobubble comprising a continuous outer shell, the outer shell comprising a cross-linked polymeric material, an inner wall of the continuous outer shell and a hollow core within the continuous outer shell. The nanobubble may be less than 250 nm in diameter. In a further aspect of the invention, the cross-linked polymeric material is a cellulose-based material.

Abstract: The present invention relates to the field of radiopharmaceuticals for in vivo imaging, in particular to a method of labelling a biological targeting molecule with the radioisotope 18F. The invention provides a method of preparation of lyophilised compositions of aminooxy-functionalised biomolecules, as well as radiolabelling methods using the purified materials. Also provided are lyophilised compositions and cassettes comprising such purified compositions. The invention is particularly suitable for use with an automated synthesizer apparatus.

Abstract: Disclosed are agents (e.g., peptides, polypeptides, proteins, small molecules, antibodies, and antibody fragments that target senescent cells) and methods of their use for imaging senescent cells in vivo and for treating or preventing cancer, age-related disease, tobacco-related disease, or other diseases and disorders related to or caused by cellular senescence in a mammal. The methods include administering one or more of the agents of the invention to a mammal, e.g., a human. The agents, which specifically bind to senescent cells, can be labeled with a radioactive label or a therapeutic label, e.g., a cytotoxic agent.

Abstract: Systems, devices and methods for thermal bacterial decolonization are provided. More particularly, in several embodiments, a heated fluid such as air or a liquid is directed to a body cavity or surface of a patient colonized or infected with bacteria in order to thermally decolonize that cavity or surface. In several embodiments, the systems, devices and methods disclosed herein achieve bacterial decolonization without risk of development of antibacterial resistance.

Abstract: A sterilizer including a base and a lid. The base includes a bottom wall and a sidewall. There is an elastomeric covering over at least most of the outside of the sidewall. The lid is sized and shaped to close the base. The lid defines a vent that is adapted to vent the base.

Abstract: A reusable portable decontamination system is provided for a transportation asset. The decontamination system includes a plurality of insulated panels detachably secured together to form an enclosure for the transportation asset and other equipment. The decontamination system also includes a humidifying module in fluid communication with an interior of the enclosure to raise a temperature and a humidity of the interior of the enclosure to a predetermined temperature level and a predetermined humidity level for a timed duration. Additionally, the decontamination system includes a dehumidifying module in fluid communication with the interior of the enclosure to lower the temperature and the humidity of the interior of the enclosure from the predetermined temperature level and the predetermined humidity level to ambient levels. A storage and decontamination module is also presented, to decontaminate one or more components of a transportation asset.

Abstract: The present invention describes an improved scented lenticular air freshener. In a preferred embodiment, a scent cartridge may be inserted in a separate scent sleeve which may be affixed to a lenticular image. Such a scent sleeve may also include a plurality of perforations to facilitate dispersal of a scent into the environment. This scent sleeve may act as a physical barrier to prevent, for example scented oils from penetrating the lenticular image and destroying the corresponding lenticular image and/or lenticular lenses.

Abstract: A device for dispensing a disinfecting agent includes a container made of a non-oxidizing, non-elastic material of a predetermined volume configured to store a predetermined amount of a disinfecting agent and a predetermined propellant at a predetermined pressure. A diffusion device coupled to the container is configured to nebulize a fog of the disinfecting agent into a space having a predetermined volume and pathogens therein. The container and diffusion device and a combination of predetermined volume of the container, the predetermined amount of the disinfecting agent, and the predetermined pressure of the propellant are configured for the space such that the fog of disinfecting agent disinfects the pathogens in the air and surfaces of the space.

Abstract: The present invention provides for a filter system having a catalyst filter configured for placement in a filter housing. The catalyst filter has a first band and a second band of material. Each band has a length of material extending in a longitudinal direction. Each band has a first wall and a second wall, each wall facing in an opposite direction from the other wall. A portion of each first wall is coated with a catalyst material, which receives light emitted by a light source to break down contaminants passing in air through the housing and over the catalyst material. Each of the first and second bands extends continuously along its longitudinal axis traversing the catalyst filter without being intersected by other structure of the catalyst filter. The first and second bands of material diverge relative to each other across the catalyst filter. The first wall of each band is optically exposed to light from the light source.

Abstract: A composition comprising at least one polymer having the structure A-B-A?, wherein A and A? may be the same or different and each is a degradable polyester component and wherein B is the reaction product resulting from the reaction between a diol, having one or more pendant oligomeric or polymeric groups, and A and A?. Additionally, a bioresorbable patch comprising: (a) an adhesion barrier component comprising the composition in the form of a film; and (b) an adhesive component comprising (i) at least one synthetic adhesive polymer and/or (ii) at least one polysaccharide. Also, a method of wound healing, comprising administering the composition or apply the patch to a patient.

Abstract: The present invention relates to a non adherent healing interface including at least one net with open meshes and wherein the net has been coated with a mixture including at least silicone gel and at least a gelling agent. Another object of the present invention is a compress and a dressing which includes at least the interface.

Abstract: Resorbable multifilament yarns and monofilament fibers including poly-4-hydroxybutyrate and copolymers thereof with high tenacity or high tensile strength have been developed. The yarns and fibers are produced by cold drawing the multifilament yarns and monofilament fibers before hot drawing the yarns and fibers under tension at temperatures above the melt temperature of the polymer or copolymer. These yarns and fibers have prolonged strength retention in vivo making them suitable for soft tissue repairs where high strength and strength retention is required. The multifilament yarns have tenacities higher than 8.1 grams per denier, and in vivo, retain at least 65% of their initial strength at 2 weeks. The monofilament fibers retain at least 50% of their initial strength at 4 weeks in vivo. The monofilament fibers have tensile strengths higher than 500 MPa. These yarns and fibers may be used to make various medical devices for various applications.

Abstract: Bioadhesives and crosslinked gels therefrom are disclosed. The bioadhesives can be applied to a vessel for occluding the vessel. The present disclosure also describes kits that comprise the various components for preparing and applying the bioadhesives. Bioadhesives of the present disclosure include: (i) a biopolymer having one or more first chemically reactive amine groups; (ii) a biocompatible crosslinker having at least two second chemically reactive groups that can chemically react with the one or more first chemically reactive amine groups of the biopolymer; and (iii) a biocompatible rheological modifier.

Abstract: Methods for forming implantable compositions are provided. In some embodiments, the methods include (i) providing a gel base, (ii) adding water and a hydrating agent to the gel base to form a mixture, (iii) reducing the water content of the mixture; and (iv) adding a delivered material before, during, and/or after step (ii) or (iii). The water content is reduced to about 5% or less by weight of the implantable composition.

Abstract: Annular prostheses comprising an elongated tubular member formed from an extracellular matrix (ECM) composition comprising ECM from a mammalian tissue source, which, when disposed proximate damaged cardiovascular tissue, induces modulated healing, including modulation of inflammation and bioremodeling. The ECM can also be augmented with a supplemental biologically active agent, such as a growth factor, to enhance modulation of inflammation and bioremodeling.

Abstract: A holey substrate now is used for constructing a graft product, such as building an autograft by 3D printing of living cells. When the autograft built atop the holey substrate is implanted, blood vessels and other patient tissues can grow through the holes.

Abstract: A holey substrate now is used for constructing a graft product, such as building an autograft by 3D printing of living cells. When the autograft built atop the holey substrate is implanted, blood vessels and other patient tissues can grow through the holes.

Abstract: A method for producing an engineered tissue scaffold for neural repair is described. The method includes tethering a hydrogel matrix seeded with tension-generating cells to a frame, and allowing the tension-generating cells to generate tension within the matrix, such that the cells self-align. The matrix may then be at least partially dehydrated to form a sheet. The tension-generating cells are stem cells capable of differentiating into cells having Schwann-cell-like properties, or are derived from such stem cells. In preferred embodiments, the cells are neural stem cells, for example conditionally immortalized neural stem cells of fetal cortex origin.

Abstract: A method according to the present invention for producing a cartilage-damage treatment agent, includes the steps of: (i) proliferating mesenchymal stem cells in a serum-free medium A containing an FGF, a PDGF, a TGF-?, an HGF, an EGF, at least one phospholipid and at least one fatty acid; and (ii) mixing the mesenchymal stem cells thus proliferated in the step (i), an isotonic preserving agent, and a cytoprotective agent. This method provides a cartilage-damage treatment agent which favorably regenerates a cartilage tissue.

Abstract: The invention provides an injectable composition and method for the minimally invasive, in-situ repair and regeneration of an injured ligament or tendon in a mammalian subject. The composition is also useful for the delivery of growth factors, therapeutic agents and cells into the area of tendon or ligament injury.

Abstract: Provided is an osteoinductive material comprising a substrate; and a layer of a hydrocarbyl group comprising 10 to 12 carbon atoms, the hydrocarbyl group having one end attached to the substrate and a presenting amine (—NH2) group at the unattached end. The hydrocarbyl group may be 11 carbons long, and may be provided in the form of 11-aminoundecyltriethoxysilane. The substrate may be a glass; metal; polymer; ceramic; plastic; or hydroxyapatite. The substrate may, for example, be a metal selected from the group consisting of: titanium; titanium alloys; cobalt chrome; and steel. An osteoinductive material may be provided in the form of a medical implant, or part thereof, such as an orthopaedic implant or a dental implant or part thereof. Alternatively the substrate may be in the form of a cell culture vessel. Also provided is a method of producing such osteoinductive materials, the medical use of such materials, and a method of producing bone or a bone precursor utilising the disclosed materials.