Abstract: Methods of treating disorders in which TNF? activity is detrimental via biweekly, subcutaneous administration of human antibodies, preferably recombinant human antibodies, that specifically bind to human tumor necrosis factor ? (hTNF?) are disclosed. The antibody may be administered with or without methotrexate. These antibodies have high affinity for hTNF? (e.g., Kd=10?8 M or less), a slow off rate for hTNF? dissociation (e.g., Koff=10?3 sec?1 or less) and neutralize hTNF? activity in vitro and in vivo. An antibody of the invention can be a full-length antibody or an antigen-binding portion thereof. Kits containing a pharmaceutical composition and instructions for dosing, and preloaded syringes containing pharmaceutical compositions are also encompassed by the invention.

Abstract: The invention relates to human targets of interest (TOI), anti-TOI ligands, kits compositions and method.

Abstract: The present invention relates, in part, to agents for binding and/or inactivating native ghrelin. These agents include those that specifically bind and/or cleave octanoylated native ghrelin. Such agents include antibodies and enzymes. The agents also include those that can be used to generate antibodies that specifically bind and/or cleave octanoylated native ghrelin. Compositions that include the agents are also provided. Further provided are methods of producing and using the agents and compositions thereof. For instance, the agents and compositions can be used to reduce or eliminate the hunger response activity of octanoylated native ghrelin. Therefore, the agents, compositions and methods provided can be used to suppress appetite and/or treat obesity. In addition, the agents, compositions and methods can be used to treat any disease associated with or caused by ghrelin (e.g., Prader-Willi Syndrome).

Abstract: The present invention relates to the murine monoclonal antibody 4C2 or to chimeric or humanized monoclonal antibodies specific to a major neutralizing epitope of influenza H5 hemagglutinin and active fragments thereof. The present invention also relates to methods and compositions for the prophylaxis and treatment of H5N1 influenza using such murine or chimeric or humanized monoclonal antibodies or fragments thereof.

Abstract: The present invention relates to the inhibition of the circulating extracellular form of the interferon inducible protein 16 (extracellular IFI16) for the treatment of diseases, particularly autoimmune and/or inflammatory disorders or infective disorders.

Abstract: Described herein are compositions and methods of use of radionuclide-antibody conjugates (for RAIT) and drug-antibody conjugates (ADC). The combination of RAIT and ADC was more efficacious than either RAIT alone, ADC alone, or the sum of effects of RAIT and ADC. The unexpected synergy resulted in decreased tumor growth rate and increased survival, with a high incidence of tumor-free survival in Capan-1 human pancreatic cancer xenografts in nude mice.

Abstract: The present application relates to new binder-drug conjugates (ADCs) of N,N-dialkylauristatins that are directed against the target C4.4a, to active metabolites of these ADCs, to processes for preparing these ADCs, to the use of these ADCs for treating and/or preventing illnesses, and also to the use of these ADCs for producing medicaments for treating and/or preventing illnesses, more particularly hyperproliferative and/or angiogenic diseases such as, for example, cancer diseases. Such treatments may be practiced as a monotherapy or else in combination with other medicaments or further therapeutic measures.

Abstract: The present invention is directed to a method for promoting differentiation, activation and proliferation of human T helper lymphocytes such as those that express IL17 and IL22 (Th-IL17+ and Th-IL22+ T cells) and provides methods for decreasing T cell activation or T cell biological activity, inhibiting an immune response and treating autoimmune diseases by increasing the biological activity of or administering a transcription factor such as a Krüppel-like factor or a forkhead box factor, and pharmaceutical compositions effective for these methods. Also, the present invention provides methods for increasing T cell activation or T cell biological activity, stimulating an immune response and treating diseases such as cancers and infections by decreasing the biological activity of or administering an inhibitor of a transcription factor such as a Krüppel-like factor or a forkhead box factor and pharmaceutical compositions effective for these methods.

Abstract: The present specification discloses an immunogenic composition comprising polypeptide, wherein each of the polypeptides has no more than 100 amino acids, which polypeptides comprises one or more sequences having at least 60% homology with any of SEQ ID 1-4, or comprises two or more epitopes having 7 amino acids or more, each epitope having at least 60% homology with a sub-sequence of any of SEQ ID 1-4 that has the same length as the epitope, wherein, the polypeptide is immunogenic in a vertebrate expressing a major histocompatibility complex (MHC) allele, and wherein the polypeptide is not a complete HIV virus protein.

Abstract: The present invention relates to a means of controlling infection persistence of Helicobacter pylori (H. pylori). In particular, the present invention relates to an isolated, genetically modified Helicobacter pylori comprising a functional urease, wherein the contiguous amino acid sequence between amino acid 529 and amino acid 555 of SEQ ID NO:1 is altered to produce said modified Helicobacter pylori which is unable to establish or maintain a persistent infection.

Abstract: Provided herein are OspA polypeptides from Lyme Disease-causing Borrelia having certain alteration(s). In one embodiment, the alteration(s) increase the conformational stability of the OspA polypeptide containing the alteration(s) while maintaining at least some of the antigenicity of the corresponding unaltered OspA polypeptide. In another embodiment, the altered OspA polypeptide has reduced cross-reactivity to hLFA-1, as compared to the corresponding unaltered OspA polypeptide.

Abstract: A disulfide trap, comprising an antigen peptide covalently attached to an MHC class I heavy chain molecule by a disulfide bond extending between two cysteines, is disclosed. In some configurations, a disulfide trap, such as a disulfide trap single chain trimer (dtSCT), can comprise a single contiguous polypeptide chain. Upon synthesis in a cell, a disulfide trap oxidizes properly in the ER, and can be recognized by T cells. In some configurations, a peptide moiety of a disulfide trap is not displaced by high-affinity competitor peptides, even if the peptide binds the heavy chain relatively weakly. In various configurations, a disulfide trap can be used for vaccination, to elicit CD8 T cells, and in multivalent MHC/peptide reagents for the enumeration and tracking of T cells. Also disclosed are nucleic acids comprising a sequence encoding a disulfide trap. Such nucleic acids, which can be DNA vectors, can be used as vaccines.

Abstract: Novel polynucleotide and amino acids of Brachyspira hyodysenteriae are described. These sequences are useful for diagnosis of B. hyodysenteriae disease in animals and as a therapeutic treatment or prophylactic treatment of B. hyodysenteriae disease in animals. These sequences may also be useful for diagnostic and therapeutic and/or prophylactic treatment of diseases in animals caused by other Brachyspira species, including B. intermedia, B. suantatina, B. alvinipulli, B. aalborgi, B. innocens, B. murdochii, and B. pilosicoli.

Abstract: This invention discloses a method of increasing production of virus-like particles comprising expressing an avian influenza matrix protein. The invention also comprises methods of making and using said VLPs.

Abstract: The use of an agent in the manufacture of a medicament to affect an allergic condition and/or a hypersensitivity condition is described. The agent is capable of modulating a ganglioside associated activity. The agent is not coupled to an antigen. The modulation of the ganglioside associated activity affects an allergic condition and/or a hypersensitivity condition.

Abstract: The present invention relates to methods of treating esophageal spasms using botulinum toxins.

Abstract: The present invention is directed to reagents useful for generating immune responses to Mycobacterium tuberculosis and for diagnosing infection and disease in a subject that has been exposed to M. tuberculosis.

Abstract: Compositions and methods for protecting a susceptable host against an infection of Shigella sonnei are disclosed. Such compositions and methods are useful for protecting the host against bacillary dysentery and shigellosis.

Abstract: Disclosed are substantially purified Plasmodium sporozoites and preparations of Plasmodium sporozoites substantially separated from attendant non-sporozoite material, where the preparations of Plasmodium sporozoites have increasing levels of purity. Vaccines and pharmaceutical compositions comprising purified Plasmodium sporozoites are likewise provided. Methods of purifying preparations of Plasmodium sporozoites are also provided.

Abstract: A bio-adhesive supramacromolecular complex of the general formula: wherein R1 is independently selected from the group consisting of an alkane unsubstituted or substituted with alkoxy groups; R2 is independently selected from the group consisting of C1-6 alkyl; R3 and R4 are independently selected from the group consisting of optionally substituted aliphatic or aromatic alkyl; R5 is independently selected from the group consisting of H or C1-6 alkyl; W is a hydrogen-bond accepting functional group-containing entity; Y is a carboxylic acid ester or amide linkage; R is an independently selected peptide linking group; T1, T2, T3 and T4 are independently selected polymer residues; and m1, m2, m3, n1 and n2 are integers selected from at least 25; and wherein P has a molecular weight of about 1×103 to 1×107 and Q has a molecular weight of about 1×103 to 1×107. The complex provides controlled nitric oxide release over a longer period of time than prior art compounds in the locally delivery systems.

Abstract: Tissue regeneration or grafting is promoted utilizing a structure including a multi-layer sheet of collagen membrane material which includes a purified collagen barrier sheet material derived from natural collagen-containing tissue, the barrier sheet material including a barrier layer with an outer smooth barrier face and a fibrous face opposite the smooth barrier face. The structure further includes a matrix layer of collagen sponge material adjacent to the fibrous face. The matrix layer of collagen sponge material is resorbed by a body of a subject at a substantially faster rate than the barrier sheet material.

Abstract: The present invention developed a novel antitumor agent for renal cell carcinoma that cannot be fully treated by the existing therapies. The present invention provides an antitumor agent comprising a combination drug of tegafur/gimeracil/oteracil potassium that ensures an excellent therapeutic effect in renal cell carcinoma patients that is superior to that of the existing therapies, by way of selecting the patients based on thymidylate synthase.

Abstract: The present invention provides a pharmaceutical composition for sublingual or buccal administration of actives with low to poor aqueous solubility, e.g. the indole hormone melatonin, which contains a solution of the active in a pharmaceutically acceptable solvent adsorbed or absorbed onto particles of a pharmaceutically acceptable carrier and methods of preparing and using the pharmaceutical composition.

Abstract: Compositions comprising a polymer-based macroscopically homogeneous polymer alloy comprising a plurality of microcrystalline components dispersed within an amorphous component, which is biocompatible, bioerodable, substantially non-toxic, and excretable, or metabolized when introduced into a mammalian body. In preferred embodiments, malleable molded devices such as implants, films, drug delivery systems and the like, are comprised of the compositions. Methods of making such compositions by controlled cooling of the molten alloy are also described.

Abstract: A solid dosage form designed to facilitate rapid and reliable oral, esophageal and GI transit has a surface area of the contact patch, i.e., the area of contact between the dosage form and the bodily surface reduced. The dosage form can be an asymmetric oral dosage unit containing a bioactive, the dosage unit being asymmetric with respect to a rotational axis perpendicular to a longitudinal axis of the dosage form, the rotational axis being located substantially at a mid point along the longitudinal axis. The dosage unit may have an outer surface ridged or dimpled or have at least one annular ring so as to reduce the contact patch of the dosage unit with a flat surface compared to non-ridged dosage unit of the same size and shape. The oral dosage unit can also have a spherical shape with or without ridges and/or dimples. Dies for forming these oral dosage units have, in a closed state, a cavity having a shape corresponding to the oral dosage unit.

Abstract: Novel formulations and methods for their use in treating neuropathology incident to trauma are provided. Multiple-component formulations of the invention, and especially those having four components, comprise biologically active compounds configured for preventing or reducing the incidence and severity of damage caused by neurotrauma. Formulations and methods of the invention effect both neuroprotective actions to prevent or reduce secondary injuries, and neurotrophic actions to repair and restore cells and tissues affected by the trauma. Formulations and methods of the invention are especially useful in treating neurological trauma, such as those caused by sports injuries and improvised explosive devices in combat.

Abstract: The present invention provides for compositions for administering a therapeutically effective amount of a therapeutic component. The compositions may include an ophthalmically acceptable carrier component; a therapeutically effective amount of a therapeutic component; and a retention component which may be effective to reduce wettability, induce viscosity, increase muco-adhesion, increase meniscus height on a cornea of an eye and/or increase physical apposition to a cornea of an eye of a composition.

Abstract: Cosmetic compositions in the form of an emulsion having at least one aqueous phase and at least one fatty phase, the fatty phase having at least one vegetable oil, and the composition having at least one volatile solvent of C9 to C15 volatile linear alkane(s) type and at least one calcium carbonate.

Abstract: The present invention relates to compositions comprising a derivative of 5-aminolevulinic acid (5-ALA), e.g. an ester of 5-ALA or a skin compatible salt thereof. Further, the invention relates to use of such compositions in methods of cosmetic treatment, particularly in methods of improving or otherwise enhancing the appearance of the skin.

Abstract: Disclosed is an oil-in-water emulsion base which is stable even when ethanol in an amount of 50% by mass or less is blended therein and which exhibits excellent water resistance after being applied to the skin or the like. Specifically disclosed is an oil-in-water emulsified cosmetic composition which is characterized by containing (A) 0.1-10% by mass of a polyether-modified silicone having an HLB(Si) of 5-10, (B) 5-50% by mass of ethanol, (C) 0.01-3% by mass of a hydrophilic thickening agent and (D) 0.1-15% by mass of a polyol. Preferably, the oil-in-water emulsified cosmetic composition additionally contains a UV absorbent, thereby forming a sunscreen cosmetic composition.

Abstract: The present invention relates to a cosmetic composition having a high content of a stable oil phase, and more particularly to a cosmetic composition, which combines advantages of spreadability and softness of an oil-in-water type with emollient effect and water resistance of a water-in-oil type as a resulting of stabilizing, based on the total weight of the composition, 30-56 wt % of an oily component by multiple emulsification of W/O/W, and which provides skin moisturizing and softening effects by a large amount of oil components, and also which allows irritations caused by active ingredients to be relieved by a high content of the oily component.

Abstract: A polylactide hydrosol polymer formulations suitable for thin film articles and methods of making the thin film articles are provided. The formulations and methods can be use to make articles such as gloves, condoms, catheters and the like using dip forming, and various casting processes.

Abstract: There is provided an ultrasonic cancer treatment enhancer and cell killer that can significantly improve the effect of treating cancer by ultrasonic irradiation while ensuring a high level of safety. The ultrasonic cancer treatment enhancer and cell killer comprise metal semiconductor particles and can be activated upon ultrasonic irradiation to kill or destruct cancer cells.

Abstract: According to one embodiment, a coagulant comprising calcium nitrate and an antimicrobial agent is disclosed. The coagulant may be used in the molding process to releasably bond the substrate material to the mold and to bond to the antimicrobial to the substrate material.

Abstract: Briefly described, embodiments of this disclosure, among others, include compositions, gels, methods for synthesizing multifunctional silica based nanoparticle gel, method of treating, preventing, or both treating and preventing, a disease in a plant species, method for simultaneously treating citrus plants for citrus canker and preventing the invasion of an Asian Citrus Psyllid (ACP) vector that carries the pathogen and spreads the citrus greening disease in citrus plants, and the like.

Abstract: This invention relates to stable non-aqueous single phase viscous vehicles and to formulations utilizing such vehicles. The formulations comprise at least one beneficial agent uniformly suspended in the vehicle. The formulation is capable of being stored at temperatures ranging from cold to body temperature for long periods of time. The formulations are capable of being uniformly delivered from drug delivery systems at an exit shear rate of between about 1 to 1×10?7 reciprocal second.

Abstract: An osmotic delivery system flow modulator includes an outer shell constructed and arranged for positioning in an opening, an inner core inserted in the outer shell, and a fluid channel having a spiral shape defined between the outer shell and the inner core. The fluid channel is adapted for delivery of an active agent formulation from the reservoir of the osmotic delivery system.

Abstract: There is described inter alia a medical device having a surface which comprises a coating layer, said coating layer being a biocompatible composition comprising an entity capable of interacting with mammalian blood to prevent coagulation or thrombus formation, which entity is covalently attached to said surface through a link comprising a 1,2,3-triazole.

Abstract: A demineralized bone matrix is produced by a process in which a bone body is placed in a first processing solution comprising an acid to demineralize the bone body. The bone body is periodically removed from the first solution at specific time intervals to perform at least one test, such as a compression test, on a mechanical property of the bone body. When the test yields a desired result, the bone body is exposed to a second processing solution that is less acidic than the first, thus minimizing the exposure of the bone body to the harsh acidic conditions of the demineralization phase of the process.

Abstract: An osteoinductive composition, corresponding osteoimplants, and methods for making the osteoinductive composition are disclosed. The osteoinductive composition comprises osteoinductive factors, such as may be extracted from demineralized bone, and a carrier. The osteoinductive composition is prepared by providing demineralized bone, extracting osteoinductive factors from the demineralized bone, and adding the extracted osteoinductive factors to a carrier. Further additives such as bioactive agents may be added to the osteoinductive composition. The carrier and osteoinductive factors may form an osteogenic osteoimplant. The osteoimplant, when implanted in a mammalian body, can induce at the locus of the implant the full developmental cascade of endochondral bone formation including vascularization, mineralization, and bone marrow differentiation. Also, in some embodiments, the osteoinductive composition can be used as a delivery device to administer bioactive agents.

Abstract: An artificial bone capable of being absorbed and replaced by an autogenous bone, which comprises a cylindrical body comprising at least an apatite/collagen composite layer and a collagen layer.

Abstract: The present invention is directed to a novel poly(diol citrates)-based bioceramic composite materials created using completely biodegradable and a bioceramic material polymers that may be used in implantable devices. More specifically, the specification describes methods and compositions for making and using bioceramic composites comprised of citric acid copolymers and a bioceramic material.

Abstract: A fiber-reinforced composite ring for the controlled release of at least one bioactive agent includes a biocompatible matrix reinforced with absorbable/biodegradable fibers capable of providing the mechanical properties needed for inserting and maintaining the ring in a body cavity for a desired period of time. Such ring system as can be used for the intravaginal, intraperitoneal, and subcutaneous delivery of at least one bioactive agent, including those used as contraceptives, antimicrobial agents, and/or antiviral agents, as well as those for the treatment of cancer.

Abstract: This invention relates to biphasic lipid-vesicle compositions and methods for treating cervical displasia by intravaginal delivery.

Abstract: The present invention provides liposome compositions containing substituted ammonium and/or polyanion, and optionally with a desired therapeutic or imaging entity. The present invention also provides methods of making the liposome compositions provided by the present invention.

Abstract: The present invention relates to a non-animal soft capsule shell composition having improved disintegration stability and shell hardness. More particularly, the present invention relates to a non-animal soft capsule shell composition and to a method for preparing same, in which an antioxidant and a disintegration aid are added to the non-animal soft capsule shell composition that is typically made of starch or a starch derivative, gums, a plasticizer, a buffering agent, and purified water which inhibit starch retrogradation and thus inhibit an increase in disintegration stability and capsule shell hardness, thereby improving disintegration stability and shell hardness.

Abstract: A capsular design is disclosed for self-administered delivery of a pre-determined amount of liquid medication. The capsular design can be constructed as having either a single piece or two piece capsular wall construction where a portion of the liquid medication contained within can be administered sublingually and the remaining portion can be subsequently swallowed for gastro-intestinal absorption.

Abstract: The invention relates to a controlled release composition comprising a combination of isosorbide dinitrate and hydralazine, such as hydralazine hydrochloride, that in operation delivers the drug in a pulsed or multi-modal manner for the treatment of angina, ischaemic heart disease, arterial hypertension and related disease conditions. Preferably, the isosorbide dinitrate and hydralazine hydrochloride can be released from the dosage form in an erodable, diffusion and/or osmotic-controlled release profile.

Abstract: Disclosed are preparations and formulations of high thermodynamic activity lipophilic associations (LA), in which there is pairing between an ionizable pharmaceutical agent and a lipophilic species having ionic characteristics opposite to that of the pharmaceutical agent. Such lipophilic associations manifest high thermodynamic activity, as evidenced by their being predominantly in a liquid phase at room temperature or solvated in a lower-than-water dielectric solvent. Further the pharmaceutical agent being solubilized means that dissolution is not rate limiting to transmucosal absorption. This LA or LA-solvate is formulated into a low dielectric dosage form, from when, upon the dosage form's hydration, the pharmaceutical agent is driven through the mucosal tissue and into systemic circulation. The invention therefore provides an enhanced transmucosal drug delivery system for ionizable pharmaceutical agents at or near physiological pH.

Abstract: The present disclosure provides an extended release pharmaceutical composition comprising oxycodone and acetaminophen that provides a rapid onset of analgesia, and reduced levels of acetaminophen near the end of the dosing interval. Also provided are methods for reducing the risk of acetaminophen-induced hepatic damage in a subject being treated with an acetaminophen containing composition, as well as methods for treating pain in a subject in need thereof.