Abstract: The present invention provides methods for reducing or eliminating a patient's need for lipoprotein apheresis therapy. The methods of the present invention comprise administering to a patient a pharmaceutical composition comprising a PCSK9 inhibitor. In certain embodiments, the PCSK9 inhibitor is an anti-PCSK9 antibody. The methods of the present invention are useful for treating patients with hyperlipidemia and related conditions who are currently being treated with a therapeutic regimen comprising lipoprotein apheresis (e.g., LDL apheresis or Lp(a) apheresis).

Abstract: Provided herein are compositions, kits and methods related to permitting a human or non-human primate subject to receive multiple doses of recombinant adeno-associate virus (rAAV) vectors. In some aspects, provided herein are methods comprising administering an anti-CD20 antibody, optionally in combination with an mTOR inhibitor, to the subject to permit multiple doses of an rAAV vector to be administered.

Abstract: The present application relates to highly concentrated antibody and protein formulations with reduced viscosity that are stable, relatively isotonic and are of low turbidity. The formulations are particularly suitable for subcutaneous administration. The application further describes articles of manufacture containing such formulations and method for using them to treat disorders treatable by the formulated antibody or protein.

Abstract: The present invention relates to the treatment of infectious diseases, specifically by extracorporeally eradicating the pathogen. This invention comprises methods for the extracorporeal treatment of infectious diseases that will remove infectious pathogens (leukemia cells, bacteria, viruses, or fungi causing a septicemia, metastatic cancer cells, target protein, viruses, parasites, fungi and prions) in humans by targeting such pathogens with a laser or other high-energy source of emissive radiation. More specifically, the method involves removing a bodily fluid from a patient, attaching an antibody to pathogens in the bodily fluid, sensing the antibody-pathogen moiety, using a high-powered, focused laser, or other suitable light source, to destroy the antibody-pathogen moiety, removing the remains of the antibody-pathogen by filtering or other suitable mechanism(s), and returning the bodily fluid to the patient.

Abstract: The subject matter described herein is directed to articles, compositions, systems, and methods of using and preparing bioceramic compositions and to the bioceramic compositions. A bioceramic composition of the disclosure radiates infrared energy or rays and can be used in the treatment of various conditions.

Abstract: A 5-aminolevulinic acid conjugated quantum dot nanoparticle is useful for treating cancer by administering the 5-aminolevulinic acid conjugated quantum dot nanoparticle in photodynamic therapy as a precursor of both a fluorescence label and a photosensitizer.

Abstract: The present invention is directed to a process for producing inorganic particulate material, the material obtainable by such process, a modified release delivery system comprising the material and the use of the material for the administration of a bioactive agent.

Abstract: This invention relates to the incorporation of bioactive cargo molecules into particles with carotenoids, such as lycopene. The incorporation of a cargo molecule into a carotenoid particle may for example increase the bioavailability of the cargo molecule in the bloodstream compared to other delivery systems. Carotenoid particles as described herein may be useful in the formulation of therapeutic and nutritional compounds for oral administration to individuals.

Abstract: The present invention is directed to novel lyophilized pharmaceutical preparations comprising a cytotoxic dipeptides such as melphalan flufenamide and one or more excipient(s) selected from the group comprising a polysorbate; a polyethylene glycol; ?-cyclodextrin; ocyclodextrin; hydroxypropyl-?-cyclodextrin; sulfobutylether-?-cyclodextrin; lactose; benzyl alcohol; disodium succinate; propylene glycol; Cremophor EL; Dimethyl sulfoxide; D-mannitol; Trehalose; Sucrose and an amino acid. This preparation may be further formulated and is useful in cancer therapy.

Abstract: A stable pharmaceutical formulation is provided that comprises a biologically active protein and an excipient selected from carnitine, creatine or creatinine.

Abstract: The present invention relates to a composition comprising hydrogels from functionalized hyaluronic acid derivatives, said hydrogels loaded with exogenous enzymes selected in the group consisting of prolyl endopeptidase (PEP) and endoprotease (EP) intended for the oral treatment of celiac disease. Specifically, this invention concerns a one-pot methodology useful to prepare methacrylic derivatives of hyaluronic acid, through the formation of a specific active group on hydroxyl groups of hyaluronic acid, the subsequent substitution of the inserted active group with ethylenediamine and finally, the reaction with methacrylic anhydride. The obtained methacrylic hyaluronic acid derivatives are used to prepare hydrogels through irradiation and loaded with exogenous enzymes selected in the group consisting of prolyl endopeptidase (PEP) and endoprotease (EP). The ability of prepared hydrogels to allow the enzyme release, as active form in simulated gastrointestinal fluids is proved.

Abstract: Provided are conjugates between p97 (melanotransferrin) and polynucleotides such as small interfering RNA (siRNA) molecules, and related compositions and methods of use thereof, for instance, to facilitate delivery of polynucleotides such as siRNA molecules across the blood-brain barrier (BBB) and/or improve their tissue penetration in CNS and/or peripheral tissues, and thereby treat and/or diagnose various diseases, including those having a central nervous system (CNS) component.

Abstract: The present invention relates to fluorocarbon vectors for the delivery of influenza antigens to immunoresponsive target cells. It further relates to fluorocarbon vector-influenza antigen constructs and the use of such vectors associated with antigens as vaccines and immunotherapeutics in animals, including humans.

Abstract: The present invention provides pharmacological compounds including an effector moiety conjugated to a binding moiety that directs the effector moiety to a biological target of interest. Likewise, the present invention provides compositions, kits, and methods (e.g., therapeutic, diagnostic, and imaging) including the compounds. The compounds can be described as a protein interacting binding moiety-drug conjugate (SDC-TRAP) compounds, which include a protein interacting binding moiety and an effector moiety. For example, in certain embodiments directed to treating cancer, the SDC-TRAP can include an Hsp90 inhibitor conjugated to a cytotoxic agent as the effector moiety.

Abstract: The present invention provides a complex comprising at least one phosphoinositide and at least one positively charged modified polysaccharide, pharmaceutical compositions comprising the complex, methods for treatment of a disease, disorder or condition associated with impaired phosphoinositide-mediated signaling comprising administering the complex to an subject in need, and methods for delivery of a phosphoinositide into cells, comprising contacting the cells with the complex of the invention.

Abstract: The present invention provides bis-polymer lipid-peptide conjugates containing a hydrophobic block and headgroup containing a helical peptide and two polymer blocks. The conjugates can self-assemble to form helix bundle subunits, which in turn assemble to provide micellar nanocarriers for drug cargos and other agents. Particles containing the conjugates and methods for forming the particles are also disclosed.

Abstract: Polythioaminal polymers are made from hexahydrotriazine precursors and dithiol precursors. The precursors are blended together and subjected to mild heating to make the polymers. The polymers have the general structure wherein each R1 is independently an organic or hetero-organic group, each R2 is independently a substituent having molecular weight no more than about 120 Daltons, X and Z are each a sulfur-bonded species, at least one of X and Z is not hydrogen, and n is an integer greater than or equal to 1. X and Z may be hydrogen or a functional group, such as a thiol-reactive group. The reactive thiol groups of the polythioaminal may be used to attach thiol-reactive end capping species. By using water soluble or water degradable dithiols, such as polyether dithiols, water soluble polythioaminals may be made. Some such polymers may be used to deliver therapeutics with non-toxic aqueous degradation products.

Abstract: The invention provides a composition containing particulate composite of a polymer and a therapeutic agent. The composition also contains a complexing agent. The polymer interacts with the complexing agent in a host-guest or a guest-host interaction to form an inclusion complex. A therapeutic composition of the invention may be used to deliver the therapeutic agent and to treat various disorders. Both the polymer of the particulate composite and the complexing agent may be used to introduce functionality into the therapeutic composition. The invention also relates to a method of preparing a composition. The method combines a therapeutic agent, a polymer having host or guest functionality, and a complexing agent having guest or host functionality to form the therapeutic composition. The complexing agent forms an inclusion complex with the polymer. The invention also relates to a method of delivering a therapeutic agent.

Abstract: The invention relates to novel polyalkylene glycol compounds and methods of using them. In particular, compounds comprising a novel polyethylene glycol conjugate are used alone, or in combination with antiviral agents to treat a viral infection, such as chronic hepatitis C.

Abstract: Described herein are methods for maintaining PEGylation and inhibiting dePEGylation of polypeptides, such as fibronectin-based scaffold proteins, during storage.

Abstract: Disclosed is a new approach for delivering compounds and drugs to the cytosol of living cells through the use of engineered protein transporters. The engineered protein transporters include a pore and a pore specific delivery protein, wherein a reagent such as a drug is attached to one or more of the engineered protein transporters.

Abstract: The present disclosure provides conjugate structures and hydrazinyl-pyrrolo compound structures used to produce these conjugates. The disclosure also encompasses methods of production of such conjugates, as well as methods of using the same.

Abstract: Extracellular drug conjugates (EDCs) targeting an extracellular protein or portion thereof (e.g., CD38) and comprising a non-cleavable linker including one or two nitrogen heteroatoms are useful in the treatment of diseases such as cancer and immune disorders, including asthma.

Abstract: Provided herein are recombinant constructs, vectors and expression cassettes including a first promoter which is suitably a tRNA promoter operably connected to a first polynucleotide encoding a first single guide RNA and a second promoter operably connected to a second polynucleotide encoding a Cas9 polypeptide. The first single guide RNA includes a first portion complementary to a strand of a target sequence of a DNA virus and a second portion capable of interacting with the Cas9 polypeptide. Also provided are codon optimized Staphylococcus aureus derived Cas9 polynucleotides and polypeptides with nuclear localization signals and optionally an epitope tag. Also provided are constructs for production of sgRNAs including a tRNA. Methods of inhibiting viral replication, inhibiting expression of a target sequence from a virus or treating a viral infection or viral induced cancer using the compositions are also provided.

Abstract: Described herein are capsid proteins and adeno-associated viruses capable of targeting various types of ocular cells including bipolar and horizontal cells. Also described herein are methods of treating various ocular disorders in a subject in need thereof by administering to the subject an effective concentration of a composition comprising the recombinant adeno-associated virus (AAV) of the invention.

Abstract: The present invention relates to pH-tunable, highly activatable multicolored fluorescent nanoplatforms and methods of using the nanoplatforms in a variety of applications including, but not limited to, investigating fundamental cell physiological processes such as pH regulation in endocytic vesicles, endosome/lysosome maturation, and effect of pH on receptor cycling and trafficking of subcellular organelles.

Abstract: The present invention provides bivalent and multivalent ligands with a view to improving the affinity and pharmacokinetic properties of a urea class of PSMA inhibitors. The compounds and their synthesis can be generalized to multivalent compounds of other target antigens. Because they present multiple copies of the pharmacophore, multivalent ligands can bind to receptors with high avidity and affinity, thereby serving as powerful inhibitors. The modular multivalent scaffolds of the present invention, in one or more embodiments, contains a lysine-based (?, ?-) dialkyne residue for incorporating two or more antigen binding moieties, such as PSMA binding Lys-Glu urea moieties, exploiting click chemistry and one or more additional lysine residues for subsequent modification with an imaging and/or therapeutic nuclides or a cytotoxic ligands for tumor cell killing.

Abstract: A plasma generating apparatus according to embodiments of the inventive concept, which provides plasma to a biological material, includes a housing configured to provide an inner space in which plasma is generated, a ground electrode coupled to one side of the housing, a power electrode coupled to the other side of the housing, and a controller configured to control a generation mode of the plasma. The generation mode includes a first mode in which the plasma is provided to the biological material while generating the plasma and a second mode in which the plasma is generated in the housing, and then the generated plasma is provided to the biological material.

Abstract: Sterilization apparatus for sterilizing packaging containers, the sterilization apparatus comprising a first carousel for supporting a plurality of sterilization devices, the sterilization devices being adapted to sterilize an interior of the packaging containers by electron beam irradiation, and a transport system for transporting the packaging containers, the transport system comprising a second carousel coaxial with the first carousel, wherein the first carousel comprises a first rotatable shaft and the second carousel comprises a separate second rotatable shaft coaxial with the first rotatable shaft.

Abstract: A room decontamination systems, controllers and methods for decontaminating a room. The room decontamination system may be a UV room decontamination system that uses UV radiation to perform a decontamination operation in the room. A controller may determine whether safe conditions for decontamination exist and initiate a decontamination operation on the basis of whether they exist. Determination of safe conditions for decontamination may be based on light actuation detection and/or sensor data, which may include presence detector data and door sensor data. Determination of safe conditions for decontamination may include a determination of whether sensors are functioning properly. The controller may also determine whether decontamination operations are required on the basis of the historical condition data, for example on the basis of whether the room has been occupied since the last decontamination operation.

Abstract: A sterilizer includes: a first sterilization unit configured to house an object to be sterilized; a second sterilization unit configured to house a bag that houses the object to be sterilized; and a sterilizing gas supply system configured to supply a sterilizing gas to both of the first sterilization unit and the second sterilization unit.

Abstract: A system for neutralizing a biological organism is provided. The system includes a first element is made from paraformaldehyde. A second element is configured to generate heat and decompose the paraformaldehyde into formaldehyde gas. In one embodiment, the second element is configured to have an exothermic and self-sustaining alloying reaction in response to being thermally energized by an initiator.

Abstract: Liquid dispensing systems which automatically sanitize the liquid and liquid-contacting parts of a liquid dispensing system, by periodically flushing the system with a sufficiently heated, liquid and/or gas.

Abstract: A freshener device includes a clip, a carrier, and a carrier retainer. The carrier is provided with odor emitting substances, odor eliminating substances and/or incest repellent. The carrier retainer secures the carrier to the clip, and the clip may be used to secure the device to an ancillary object so as to expose the carrier for controlling odor within a region of space near the ancillary object. Some embodiments enable removably securing the device to at least one air-directional controller exhaust vent louver of a vehicle air conditioning unit to control odor within the passenger compartment of the vehicle. Other embodiments enable interchangeable and replaceable components to provide various utilitarian and aesthetic features.

Abstract: A method and system of controlling operation of a diffusion appliance to treat the atmosphere within an enclosed space. The appliance may be programmed to operate according to a control scheme specifying a flow rate of liquid to a diffusion means and a periodic operation of the diffusion means. Control schemes may be associated with different volumes of spaces to be treated by the appliance. Anti-fatigue schemes may provide variation of the flow rate or periodic operation of the appliance. Initiation controls schemes may be used to start treatment of the space before the appliance is programmed to operate according to one of the control schemes.

Abstract: An antimicrobial suture comprising a filament and taurolidine.

Abstract: The present disclosure is directed to a bioresorbable ceramic composition having a plurality of biocompatible ceramic granules, each of the granules having a coating of a plurality of calcium containing particles, where at least a portion of the particles are bound to at least a portion of an outer surface of each of the granules, and further where the composition is flowable in a dry state. The present disclosure is also directed to a three dimensional scaffold for bone repair that includes the bioresorbable composition, which upon implantation to a locus of repair defines an interconnected pore network between outer walls of the coated granules of the composition. Finally, the present disclosure is directed to methods of forming both the bioresorbable ceramic composition and the three-dimensional ceramic scaffold.

Abstract: Disclosed are elastin-like polypeptides (ELPs) that form hydrogels upon heating. Hydrogels comprising the polypeptides have mechanical properties, including elastic modulus and fracture toughness, required for load-bearing applications.

Abstract: One aspect of the present invention generally relates to methods of sealing a wound or tissue plane or filling a void splace. In a preferred embodiment, the wound is an ophthalmic, pleural or dural wound. In certain instances, the compositions used to seal the wound or tissue plane comprises a polyalkyleneimine. In a preferred embodiment, the polyalkyleneimine is polyethyleneimine. Treatment of the polyethyleneimine with a cross-linking reagent causes the polyethyleneimine polymers to polymerize forming a seal. In certain instances, the cross-linking reagent is a polyethylene glycol having reactive terminal groups. In certain instances, the reactive terminal groups are activated esters, such as N-hydroxy succinimide ester. In certain instances, the reactive terminal groups are isocyanates. In certain instances, the polyethyleneimine has a lysine, cysteine, isocysteine or other nucleophilic group attached to the periphery of the polymer.

Abstract: The inventive subject matter provides kits, compositions and methods for treating or covering skin using a polymerizable formulation. The polymerizable formulation can include a first component including a siloxane polymer and a catalyst, and a second component including a siloxane polymer and a cross-linker. The first and second components, when combined, can form a film or seal having an elasticity that at least one of decreases the formation of fibroblasts, presses down blisters, decreases a biochemical cascade that promotes scar formation, compresses skin, and holds skin in a desired configuration.

Abstract: Film forming gel compositions, useful in creating conformable and flexible gel bandages, can be formulate from a film forming polymer, a tackifier, and a volatile solvent. The film forming gels can also include antiseptics, cationic polymer coagulants, fillers, and other additives. The gel compositions form relatively thick films when dried on tissue, and can exhibit enhanced breathability to promote wound healing.

Abstract: A fibre-based surgical implant stabilized against fraying, includes a thermally crimped flat-knitted fabric of a biocompatible, optionally biodegradable, polymer material having a glass transition temperature or other thermally induced secondary conformational mobility threshold in the temperature range of from 20° C. to +170° C. Also disclosed is a corresponding fabric and methods of producing the implant and the fabric.

Abstract: A transplant product derived from human umbilical cord has a collagenous tissue membrane derived from an umbilical cord, configured as a soft tissue barrier or wound covering or other internal or external wound healing attachment. The structural, chemical and biochemical properties are retained, the collagenous tissue membrane is cleaned removing the veins, arteries and Wharton's jelly without exposure to harsh chemicals. The collagenous tissue membrane is soaked in normal saline solution under mild agitation for a predetermined time to structurally increase tear resistance of the membrane. The collagenous tissue membrane is free of meconium. The collagenous tissue membrane has a general transparent or translucent appearance of a clear or slightly pink color. In one embodiment, the transplant product has one or more suture entry sites to facilitate suturing the product to tissue.

Abstract: Tissue fillers derived from decellularized tissues are provided. The tissue fillers can include acellular tissue matrices that have reduced inflammatory responses when implanted in a body. Also provided are methods of making and therapeutic uses for the tissue fillers.

Abstract: Cartilage fibers and implants made therefrom are disclosed, with and without cartilage particles. Methods for making the cartilage fibers and the implants containing them are also disclosed. The implants may be pre-shaped and may be reshapable and provide good shape retention and little swelling when placed into a cartilage defect.

Abstract: A biocompatible tissue repair implant or scaffold device is provided for use in repairing a variety of tissue injuries, particularly injuries to cartilage, ligaments, tendons, and nerves. The repair procedures may be conducted with implants that contain a biological component that assists in healing or tissue repair. The biocompatible tissue repair implants include a biocompatible scaffold and particles of living tissue, such that the tissue and the scaffold become associated. The particles of living tissue contain one or more viable cells that can migrate from the tissue and populate the scaffold.

Abstract: Provided herein are methods of fractionating extracellular matrix (ECM) materials, producing soluble and structural fractions having different immunological activities. Also provided are compositions and devices comprising the fractions. A method of immune modulation also is provided in which an amount of a soluble or structural ECM fraction prepared according to the methods provided herein is administered to a patient in an amount effective to modulate immune function, for example macrophage function.

Abstract: A method for producing a bone regeneration material containing an octacalcium phosphate-gelatin complex, the method including: co-precipitating octacalcium phosphate with gelatin to produce an octacalcium phosphate-gelatin co-precipitate; washing the co-precipitate with a washing liquid to remove gelatin from the co-precipitate, thereby obtaining an octacalcium phosphate slurry; dispersing the octacalcium phosphate slurry or dry granules formed using the slurry in an aqueous gelatin solution; and drying the dispersion of octacalcium phosphate dispersed in the aqueous gelatin solution to produce an octacalcium phosphate-gelatin complex.

Abstract: The present invention relates to methods for making cross-linked oxidation-resistant polymeric materials and preventing or minimizing in vivo elution of antioxidant from the antioxidant-containing polymeric materials. The invention also provides methods of doping polymeric materials with a spatial control of cross-linking and antioxidant distribution, for example, vitamin E (?-Tocopherol), and methods for extraction/elution of antioxidants, for example, vitamin E (?-tocopherol), from surface regions of antioxidant-containing polymeric materials, and materials used therewith also are provided.

Abstract: The present invention relates to methods for recellurization of blood vessels. This method is particularly useful for producing an allogeneic vein, wherein a donor vein is decellularized and then recellularized using whole blood or bone marrow stem cells. The allogeneic veins produced by the methods disclosed herein are particularly advantageous for implantation or transplantation into patients with vascular diseases.