Abstract: Long-acting agonistic analogs for CLR/RAMP receptors are provided that have an extended half-live in vivo.

Abstract: Preparations including FSH, for example recombinant FSH, for use in the treatment of infertility.

Abstract: The present invention relates to exendin-4 derivatives and their medical use, for example in the treatment of disorders of the metabolic syndrome, including diabetes and obesity, as well as reduction of excess food intake.

Abstract: The present invention relates to fibrinogen preparations enriched in ?-extended fibrinogen. Compositions comprising such preparations show improved clotting properties compared to preparations based on HMW Fib which typically contain no or only low amounts of ?-extended fibrinogen. In particular, clot formation time and the clot strength of a clot made by ?-extended fibrinogen are improved. In addition, plasmin-mediated degradation of ?-extended fibrinogen is reduced as compared to plasma derived fibrinogen.

Abstract: The invention is directed to methods of inducing cell recruitment and tissue regeneration at a target site in a subject. It is also based, in part, on the discovery that a subject's own biologic resources and environmental conditions can be used for in situ tissue regeneration and thereby reduce or eliminate the need for donor cell procurement and ex vivo manipulation of such donor cells. Methods are disclosed for recruitment of a subject's own stem cells to a target region by inducing a sustained positive pressure at a target site, such as the kidney, thereby increasing the number of pluripotent cells capable of differentiating to regenerate the target tissue.

Abstract: The present application provides for compositions comprising ?-galactosidase A in combination with an active site-specific chaperone for the ?-galactosidase A, and methods for treating Fabry disease in a subject in need thereof, that includes a method of administering to the subject such compositions. The present application also provides methods for increasing the in vitro and in vivo stability of an ?-galactosidase A enzyme formulation.

Abstract: Compositions of proteins having free thiols, and methods of making and using such compositions, are described.

Abstract: The tumor-necrosis factor superfamily member LIGHT (p30; TNFSF-14) is a cytokine for inducing immune responses against tumors. A novel biochemical approach is used to decorate the surface of tumor cells with LIGHT. LIGHT decorated cells can be used to vaccinate and induce effective, sustained immunity against cells expressing neo or pathogen associated antigens. Variants of LIGHT are described that enhance binding to cellular receptors (e.g., LT beta receptor) and decrease regulation by inhibitors (e.g., Decoy Receptor 3) increasing ability to stimulate immunity.

Abstract: The present invention relates to an ex vivo, fast and efficient process to obtain activated antigen-presenting cells that are useful for therapies against cancer and immune system-related diseases. At the same time, it is related to a cellular composition that contributes to stimulate the activated antigen-presenting cells to induce a specific immune response against tumors in patients with cancer or other pathologies involving immune responses.

Abstract: Peptides and vaccine compositions comprising peptides based upon EGFRvIII and lacking a glycine at the splice junction are disclosed. The vaccines can induce immune responses against EGFRvIII. Methods of inhibiting formation or growth of EGFvIII tumors, methods of inducing regression of EGFvIII tumors, methods of immunizing against EGFvIII tumors and methods of treating a subjects who have EGFvIII tumors are disclosed.

Abstract: Disclosed herein are isolated human monoclonal antibodies, and functional fragments thereof, that specifically bind HMW-MAA. Nucleic acids encoding these antibodies, expression vectors including these nucleic acid molecules, and isolated host cells that express the nucleic acid molecules are also disclosed. The antibodies can be used to detect HMW-MAA in a sample. Methods of diagnosing cancer, or confirming a diagnosis of cancer, are disclosed herein that utilize these antibodies. Methods of treating a subject with cancer are also disclosed.

Abstract: The invention provides novel malaria polypeptides expressed at the pre-erythrocytic stage of the malaria life-cycle. The antigens can be utilized to induce an immune response against malaria in a mammal by administering the antigens in vaccine formulations or expressing the antigens in DNA or other nucleic acid expression systems delivered as a vaccine formulation.

Abstract: The present invention relates to recombinant fragments of C. difficile TcdA and TcdB that may be used in the development of vaccines against C. difficile associated disease. More particularly it relates to combinations comprising a ToxB-GT antigen and a TcdA antigen or a ToxA-GT antigen and a TcdB antigen.

Abstract: The present invention relates to immunogenic compositions comprising a Clostridium difficile (C. difficile) polypeptide and an aluminum-free adjuvant.

Abstract: Described herein are i-DNA™ vectors and vaccines and methods for using the same. The i-DNA™ generates live attenuated vaccines in eukaryotic cells in vitro or in vivo for pathogenic RNA viruses, particularly chikungunya virus (CHIKV). When iDNA is injected into the vaccine recipient, RNA of live attenuated virus is generated by in vivo transcription in the recipient's tissues. This initiates production of progeny attenuated viruses in the tissues of the vaccine recipient, as well as elicitation of an effective immune response protecting against wild-type, non-attenuated virus.

Abstract: The present invention discloses and claims virus like particles (VLPs) that express and/or contains seasonal influenza virus proteins, avian influenza virus proteins and/or influenza virus proteins from viruses with pandemic potential. The invention includes vector constructs comprising said proteins, cells comprising said constructs, formulations and vaccines comprising VLPs of the inventions. The invention also includes methods of making and administrating VLPs to vertebrates, including methods of inducing substantial immunity to either seasonal and avian influenza, or at least one symptom thereof.

Abstract: The present invention relates to a monovalent H5N1 vaccine. More specifically, the present invention relates to the development of a monovalent H5 vaccine strain using hemagglutinin (HA) engineering to elicit cross-clade protection. The present invention also relates to an epitope-chimeric H5 and to a reverse genetics (RG) influenza virus expressing the epitope-chimeric H5.

Abstract: Compositions and methods for producing plant-derived immunogenic compositions that confer immunity against smallpox in a subject are provided. Plants engineered to produce antigenic proteins as well as expression cassettes comprising nucleic acids encoding proteins thereof are described. Methods of immunizing subjects with plant-derived compositions are also provided.

Abstract: The present invention relates to novel 6-acetylmorphine analogs, and methods for their synthesis and use. Such analogs are designed to provide a convenient linkage chemistry for coupling under mild conditions to a suitable group on a target protein, polypeptide, solid phase or detectable label.

Abstract: The invention generally relates to soluble beta-glucan compositions and method of using such compositions. In one aspect, an adjuvant for a pharmaceutical composition is described which includes a soluble beta-glucan and a TLR agonist, each in an amount that, in combination with the other, is effective to increase a subject's immune response to an antigen. In another aspect, compositions that generally include an antigen component, a soluble beta-glucan component, and a TLR agonist component and a method that generally includes administering to a subject a composition that comprises a soluble beta-glucan and a TLR agonist, each in an amount that, in combination with the other, is effective to increase a subject's immune response to an antigen, are described.

Abstract: Highly effective combinations of a compound of formula A (a PI3K? selective inhibitor) and anti-CD20 antibodies are provided herein for the treatment and amelioration of PI3K? and/or CD20 mediated diseases and disorders. In particular, the combination can be used to treat cancers and autoimmune diseases. More particularly, the invention provided for a combination of a compound of formula A, or stereoisomers thereof, and ublituximab for the treatment and/or amerioration of hematological malignancies such as leukemia and lymphoma.

Abstract: The present invention relates to a method for diagnosing neuroendocrine cancers via detecting the presence of N-methyl D-asparate-associated (NMDA) glutamate receptors type 1 and/or type 2. Methods for preventing and treating neuroendocrine cancers are also disclosed.

Abstract: The present invention generally relates to use of compounds and compositions as a chemosensitizers and/or radiosensitizers and/or inhibitors of PNKP phosphatase activity. The present invention provides pharmaceutical combinations and/or a pharmaceutically acceptable salt thereof, kits containing such compounds and/composition and methods of using such compounds and/or compositions.

Abstract: Disclosed are nanovectors of formula (I) that can be used simultaneously for the targeting, imaging and treatment, by photodynamic therapy, of cancer cells, and to biodegradable silicon nanoparticles containing a variety of photosensitizing molecules, in particular porphyrins, capable of targeting diseased cells and inducing cell death by excitation in the near-infrared region (>600 nm) in monophotonic and biphotonic modes. In formula (I), (AA) is a porous silicon nanoparticle.

Abstract: Methods and systems for treatment of hypoxic tumors are provided, including the steps of positioning a delivery device in a bodily cavity adjacent to tumor tissue, delivering an oxygenating agent to the tumor tissue via the delivery device and radiating the tumor tissue with radiation. Methods and systems of treatment of tumors are also provided, including the steps of positioning a delivery device in a bodily cavity adjacent to tumor tissue, delivering a photosensitizing agent to the tumor tissue via the delivery device, and radiating the tumor tissue with light.

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: Disclosed herein are lipid compositions comprising a cationic lipid of formula (I), a neutral lipid, a sterol and a PEG or PEG-modified lipid, wherein formula (I) is Also disclosed are methods of producing the cationic lipid of formula (I).

Abstract: The present invention relates to novel tigecycline compositions with improved stability in both solid and solution states and processes for making these compositions. These compositions comprise tigecycline, a suitable carbohydrate, and an acid or buffer.

Abstract: Compositions comprised of a delivery vehicle or delivery system and an active agent dispersed within the delivery vehicle or system, wherein the delivery vehicle or system contains a polyorthoester polymer and a polar aprotic solvent. Also disclosed are low viscosity delivery systems for administration of active agents. The low viscosity delivery systems have a polyorthoester polymer, a polar aprotic solvent and a solvent containing a triglyceride viscosity reducing agent. Compositions described include an amide- or anilide-type local anesthetic of the “caine” classification, and a non-steroidal anti-inflammatory drug (NSAID), along with related methods, e.g., for treatment of post-operative pain or for prophylactic treatment of pain. The compositions are suitable for delivery via, e.g., direct application and instillation, intradermal injection, subcutaneous injection, and nerve block (perineural).

Abstract: A pharmaceutical composition for controlled release of an active substance, the composition being a matrix composition of: (a) a substantially water soluble or crystalline polymer, (b) an active substance, and optionally, (c) one or more pharmaceutically acceptable excipients having a water solubility of at least 1 mg/ml at ambient temperature. The matrix composition does not contain a water dispersible or water soluble surface active agent that has at least one domain, which is compatible with the polymer in the matrix composition, and which substantially eliminates water diffusion between the interface between the polymer crystals.

Abstract: The invention relates to compositions comprising (i) biocompatible hydrogel and (ii) one or more therapeutic agents contained within said hydrogel; wherein the hydrogel is cross-linked utilizing a cross-linker comprising a peptide sequence that is capable of being degraded by an enzyme; the therapeutic agent being effective as a treatment of a condition related to the presence of the enzyme.

Abstract: This invention provides for compositions, methods and devices for rapidly converting silk fibroin solution into a silk fibroin gel using direct application of voltage, in a process called electrogelation. The silk fibroin gel may be reversibly converted back to liquid form by applying reverse voltage or may be converted further to ?-sheet structure by applying shear force or other treatments. The electrogelated silk may be used as an extracted bulk gel, spray or stream of gel for processing into materials or devices, or may be used as silk gel coating to devices. Active agents may be embedded in the silk gel for various medical applications. This invention also provides for methods and compositions for preparing adhesive silk pH-gels. For example, the method comprises reducing pH level of a silk fibroin solution to increase the bulk or local proton concentration of the silk fibroin solution, thereby forming adhesive silk gels.

Abstract: The present invention generally relates to compositions and methods for treatment of subjects having or at risk of cancer or other conditions. In some cases, the composition may include nitric oxide and/or peptides. The nitric oxide and/or peptide may be present within a first phase comprising a lecithin, such as phosphatidylcholine. In certain embodiments, the lecithin is present in liposomes, micelles, or other vesicles containing nitric oxide. The composition can take the form of a gel, a cream, a lotion, an ointment, a solution, a solid “stick,” etc., that can be rubbed or sprayed onto the skin. Other aspects of the present invention are generally directed to methods of making or using such compositions, methods of promoting such compositions, kits including such compositions, or the like.

Abstract: The present application provides bifunctional compounds which act as protein degradation inducing moieties. The present application also relates to methods for the targeted degradation of endogenous proteins through the use of the bifunctional compounds that link a cereblon-binding moiety to a ligand that is capable of binding to the targeted protein which can be utilized in the treatment of proliferative disorders. The present application also provides methods for making compounds of the application and intermediates thereof.

Abstract: Disclosure of methods and compositions related to chemical conjugations to nanoparticles of polysaccharides cross-linked to poloxamers as well as nano-sized colloids comprised of polysaccharides and poloxamers. The nanoparticles may be produced by various methods including inverse miniemulsion polymerization processes which create nanogels of desired size, shape, and stability for controlled therapeutic drug delivery, imaging, and theragnostic applications.

Abstract: The present invention provides compounds, pharmaceutically acceptable compositions thereof, and methods of using the same.

Abstract: The present invention relates to an improved macromolecule transduction domain (MTD), which facilitates permeating the cell membrane of a biologically active molecule, having enhanced cell permeability. Specifically, an improved MTD according to the present invention, compared to an existing MTD, can transmit various types of biologically active molecule from inside the body and inside a test tube more effectively, and thus can be effectively used in a method to genetically alter a biologically active molecule so as to have cell permeability or in a method to transport a biologically active molecule into a cell, or the like. Additionally, the improved MTD can be very useful in development of new drugs and incrementally modified drugs as uses of the improved MTD are possible in drug delivery systems, recombinant protein vaccines or DNA/RNA therapeutic agents, gene or protein therapies, and pharmacologically or medically useful protein production or medical, pharmacological and pharmaceutical compositions.

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 invention provides a family of agents that target integrins, which can be used as imaging agents and/or therapeutic agents. The agents can be used to image angiogenesis, inflammation or other physiological processes in a subject.

Abstract: The present invention generally relates to a process for the preparation of aqueous solutions of hyperpolarized molecules ready for use in in-vivo MR diagnostic imaging, the use thereof as MRI contrast agent in investigation methods for producing diagnostic MR images of a human or non-human animal body organ, region or tissue.

Abstract: The prostate-specific membrane antigen (PSMA) is increasingly recognized as a viable target for imaging and therapy of cancer. Various 99mTc/Re-labeled compounds were prepared by attaching known Tc/Re chelating agents to an amino-functionalized PSMA inhibitor with or without a variable length linker moiety. Ex vivo biodistribution and in vivo imaging demonstrated the degree of specific binding to engineered PSMA+PC3 PIP tumors.

Abstract: The present invention relates to stabilised 99mTc radiopharmaceutical compositions of the ligand tetrofosmin, which include an ascorbic acid or ascorbate radioprotectant, in the absence of an antimicrobial preservative. The invention also provides lyophilised kits suitable for the bulk preparation of multiple unit patient doses of 99mTc-tetrofosmin metal complexes. Also disclosed are unit doses of 99mTc-tetrofosmin, together with processes for preparing such unit doses from the lyophilised bulk vial.

Abstract: An improved mobile apparatus for sterilizing surgical trays serves as a self-contained autoclave, allowing sterilization of the interior of the apparatus and its contents. A method of sterilization using the apparatus is presented as well. By means of a dedicated transfer and storage system, the apparatus, integrable with respect to a transfer cart and a lift device, may be moved easily between a location of sterilization, a storage area, and an operating room, and more than one such apparatus may be stacked vertically for storage to enhance storage efficiency.

Abstract: Method and apparatus for generating UV and for treating a material with UV utilizing gas filled plasma-shells that emit UV during gas discharge. The UV treatment includes UV curing or inducing a chemical reaction.

Abstract: Systems and methods for plasma sterilization are described. The sterilization method includes placing a substance to be sterilized in a rotating chamber (e.g., drum) and exposing the substance to a radio frequency (RF) plasma. The mixing of the substance and plasma is further promoted by generating a magnetic field that produces a force on the substance in a direction opposite to the rotational direction of the chamber. In other aspects, the chamber may have a gas permeable wall. In addition, the substance may be exposed to acoustic shock waves produced by a modulating RF generator.

Abstract: The present invention is directed to methods, compositions and articles comprising olfactory-active compositions. An article of the present invention comprises a structural component and an olfactory-active composition. The article may control the release, release rate or absorption of the olfactory-active composition. The article may be of various shapes and sizes. A method of use of an article comprises providing fragrance to an environment.

Abstract: Described are modulating coatings that are configured to provide an improved release profile of a volatile composition from a base material, wherein the modulating coating includes a barrier substance that is configured to hinder a release of the volatile composition through the modulating coating, and a hygroscopic substance that is configured to facilitate the release of the volatile composition through the modulating coating.

Abstract: A remotely deployable vapor delivery device is described that is conveniently and effectively deployed in a hard-to-reach location. The device is approximately spherical in shape, and includes an integrated reservoir containing the desired vapor producing substance, an evaporative surface and means for continuous flow of the vapor producing substance from the integrated reservoir to the evaporative surface which provides an approximately constant vapor delivery rate. The advantages of the embodiments include a device that can be conveniently tossed or rolled, is compact in size, provides a maximal amount of stored vapor producing substance, has an efficient usage rate of the stored vapor producing substance and provides a long operating lifetime. Other advantages of the embodiments described include hands-free activation, self-righting after deployment, tamper resistance, non-energized operation, a modest number of low cost parts that are readily manufactured and assembled, and easy retrieval.

Abstract: The present invention relates to a lens care solution having 0.001 to about 5 weight percent of a low molecular weight amine of the general formula: where R1, R2, R3 and R4 are —H or low molecular weight radicals, and R5 is a low molecular weight radical, or salt thereof; an effective amount of a tonicity agent; and the balance water.

Abstract: The present invention is directed to topical enzymatic wound debriding compositions with enhanced enzymatic activity. These compositions comprise a dispersed phase comprising at least one proteolytic enzyme and at least one hydrophilic polyol; and a continuous phase comprising a hydrophobic base.