Abstract: Disclosed herein are PTHrP or analogues thereof, such as abaloparatide, for preventing or reducing bone fractures in subjects in need thereof, as well as methods of using PTHrP or analogues thereof to prevent or reduce bone fractures. Also disclosed are PTHrP or analogues thereof, such as abaloparatide, for increasing BMD and/or TBS in subjects in need thereof, as well as methods of using PTHrP or analogues thereof to increase BMD and/or TBS.

Abstract: Provided herein are methods for increasing the concentration of insulin-like growth factor (IGF) in the serum of a subject. In one embodiment, the method includes administering active IGF-1 to a subject, wherein the concentration of IGF in the serum of the subject is increased. Also provided are methods for treating a condition in a subject, methods for improving or maintaining the health of a subject, and methods for improving a characteristic of a subject. Examples of conditions include a motor neuron disorder, Alzheimer's disease, myocardial infarction, hypoxic-ischemic brain injury, osteoporosis, skeletal muscle repair, and growth failure. Examples of characteristics include increased milk production, increased fertilization, increased reproduction, increased growth, increased oocyte quality in a ruminant undergoing superovulation, and increased embryo viability.

Abstract: Mucolytic agents for use in treating pulmonary sarcoidosis are described herein. Patients in need of treatment for pulmonary sarcoidosis are administered a therapeutically effective amount of a mucolytic agent such as DNase I, Mesna or DiMesna. In some embodiments, the DNase I is a recombinant human DNase I such as dornase alfa.

Abstract: The invention relates to cyclic polypeptides derived from the C-terminus of acetylcholinesterase for use in treating or preventing cancer or metastatic disease.

Abstract: Disclosed is a formulation of the following enzymes: Beta Glucanase, Chymotrypsin, Phytase, Lactase, and Invertase, which has been found to be effective in treating salicylate intolerant people, and causing a significant improvement in a wide variety of pathologies and symptoms, including, but not limited to: acid reflux disease, stuttering, migraines, ADHD, behavioral deficits, Tourettes disease, seizures, autism (ASD), atrial fibrillation, anxiety, depression, joint pain, cognitive and perceptual disorders, respiratory difficulties and non-diabetic neuropathy. The formulation is also for treating or reducing intolerance of gluten, corn or soy.

Abstract: The present invention relates to an RGD motif-containing peptide or a fragment thereof, which is used to effectively treat burns and glaucoma, obtain an excellent effect of alleviating skin wrinkles, and is effective in the promotion of hair restoration and hair growth as well as the prevention of hair loss. Therefore, the motif-containing peptide or the fragment thereof can be utilized for a cosmetic composition and a pharmaceutical composition.

Abstract: Provided herein is a antimicrobial sorption composition containing pyrogenic silica and serrathiopeptidase useful for the treatment of wounds such as festering wounds, necrotic wounds, exudative wounds, or wounds with inflammatory infiltration.

Abstract: This invention provides, in part, various compositions and methods for protecting the gastrointestinal microbiome from antibiotic disruption.

Abstract: Provided herein are attenuated Salmonella bacteria for expressing autoantigen alone or in combination with an immunomodulatory, as well as methods of using these bacteria to treat various autoimmune disorders.

Abstract: Disclosed herein are compositions comprising use of compositions comprising a live attenuated recombinant Listeria strain comprising a fusion protein of a truncated listeriolysin O (LLO) protein, a truncated ActA protein, or a PEST amino acid sequence fused to a heterologous antigen, including a tumor-associated antigen, wherein the compositions further comprise or are co-administered with an antibody or fragment thereof. Also disclosed are combination therapies comprising use of these compositions comprising live attenuated recombinant Listeria strains, in conjunction with an antibody or fragment thereof for use in treating, protecting against, and/or inducing an immune response against a tumor, especially wherein the treating, protection against and/or inducing an immune response increases percent survival in a subject.

Abstract: The described invention relates to a pharmaceutical composition comprising a therapeutically effect amount of a therapeutic agent, wherein the therapeutic agent is effective (1) to reduce tumor growth, migration, invasion or a combination and (2) improve subject survival relative to a control. The described invention also relates to a method of treating a subject with a tumor, the method comprising: (1) providing a pharmaceutical composition; and (2) administering the pharmaceutical composition, wherein the composition comprises a therapeutically effective amount of a therapeutic agent which is effective to reduce tumor growth, migration, invasion or a combination. The method may further comprise preparing therapeutic agent and preparing the pharmaceutical composition. The therapeutic agents include but are not limited to Wnt5a derivative peptides or Wnt5a antagonists or Wnt5a blocking antibody. The tumor comprises a population of cancer stem cells.

Abstract: There are provided compositions and methods for prevention or treatment of Streptococcus pneumoniae (SP)-associated diseases. More specifically, there are provided recombinant lipidated fusion proteins comprising pneumococcal surface antigen A (PsaA), the recombinant lipidated fusion proteins comprising, from N-terminus to C-terminus, the N-terminal native lipid signal peptide of PsaA and the C-terminal structural gene for PsaA. Methods of inducing broad spectrum mucosal immunity against SP comprising administering a vaccine comprising recombinant lipidated fusion proteins are also described.

Abstract: The present invention relates to toxoid preparations comprising a non-disrupted and/or a non-denatured toxin associated with a particulate vector that minimizes or precludes said toxin from inflicting damage at an action site of said toxin. The present invention also relates to immunogenic compositions or vaccines comprising the toxoid preparations, and the methods of using the toxoid preparations, immunogenic compositions or vaccines.

Abstract: Methods for generating immune responses to Ebola virus antigens using adenovirus vectors that allow multiple vaccinations with the same adenovirus vector and vaccinations in individuals with preexisting immunity to adenovirus are provided.

Abstract: The invention relates to modified HPV particles that can be used therapeutically. Modified HPV particles may be used to deliver therapeutic agents, including siRNA molecules. Modified HPV particles may be used for the treatment of diseases or conditions of mucosal tissue, including HPV (human papilloma virus) infection and HPV-related tumors.

Abstract: Disclosed herein are methods of eliciting an immune response against a polyomavirus (for example, BKV serotype I (BKV-I), BKV serotype II (BKV-II), BKV serotype III (BKV-III) and/or BKV serotype IV (BKV-IV)) and methods of treating or inhibiting polyomavirus-associated pathology (such as polyomavirus-associated nephropathy, BKV-associated hemorrhagic cystitis, or JC virus-associated progressive multifocal leukoencephalopathy; PML). Further disclosed are immunogenic compositions of use in the disclosed methods. Also disclosed are methods of selecting an organ transplant donor and/or recipient including detecting whether the prospective donor and/or recipient has BKV serotype-specific (such as BKV serotype IV-specific) neutralizing antibodies.

Abstract: The present invention provides co-administration (for example, immunogenic cocktail compositions and/or prime-boost regimens) of computationally optimized H1N1 influenza hemagglutinin (HA) polypeptides. Co-administration of the optimized H1N1 influenza hemagglutinin (HA) polypeptides facilitates synergistic neutralization of viral infection and provides for improved protective immunity (e.g., a broad reactive immune response) to diverse and multiple H1N1 influenza virus strains, including both seasonal and pandemic strains.

Abstract: Disclosed are recombinant chimeric influenza virus vaccines and live attenuated influenza virus (LAIV) vaccines expressing foreign (RSV) neutralizing epitopes or conserved M2e epitopes that are capable of providing broader cross-protection against influenza virus and/or protecting against respiratory syncytial virus (RSV) without vaccine-enhanced RSV disease (ERD).

Abstract: The invention provides in part methods of treating cancers of a specific organ or tissue by administering a composition that is antigenically specific for one or more microbes that are pathogenic in the specific organ or tissue in which the cancer is situated.

Abstract: The present technology relates to compositions comprising inulin particles for use in the enhancement of immune responses to neuronal self-antigens for treating or preventing neurodegenerative diseases, in a subject. Also provided are pharmaceutically acceptable compositions comprising: particles of inulin; a substance comprising one or more pathogen-associated molecular patterns (PAMPs); and a neuronal self-antigen fused to carrier, and methods and uses of the composition for inducing or modulating an immune response in a subject, such as modulating an immune response to a neuronal self-antigen as a vaccine. Also provided are vaccine compositions comprising inulin particles, and an antigen-binding carrier material, and methods and uses of the vaccine.

Abstract: The instant disclosure provides antibodies that specifically bind to TIM-3 (e.g., human TIM-3) and antagonize TIM-3 function. Also provided are pharmaceutical compositions comprising these antibodies, nucleic acids encoding these antibodies, expression vectors and host cells for making these antibodies, and methods of treating a subject using these antibodies.

Abstract: Multispecific molecules that include i) a tumor-targeting moiety; and one, two or all of: (ii) an immune cell engager (e.g., chosen from an NK cell engager, a T cell engager, a B cell engager, a dendritic cell engager, or a macrophage cell engager); (iii) a cytokine molecule; and/or (iv) a stromal modifying moiety are disclosed. Additionally disclosed are nucleic acids encoding the same, methods of producing the aforesaid molecules, and methods of treating a cancer using the aforesaid molecules.

Abstract: The invention herein described, provides, among other things, self-buffering protein formulations. Particularly, the invention provides self-buffering pharmaceutical protein formulations that are suitable for veterinary and human medical use. The self-buffering protein formulations are substantially free of other buffering agents, stably maintain pH for the extended time periods involved in the distribution and storage of pharmaceutical proteins for veterinary and human medical use. The invention farther provides methods for designing, making, and using the formulation. In addition to other advantages, the formulations avoid the disadvantages associated with the buffering agents conventionally used in current formulations of proteins for pharmaceutical use.

Abstract: The invention provides human AdipoR2 which is associated with the cardiovascular diseases, dermatological diseases, gastroenterological diseases, cancer, hematological diseases, respiratory diseases, inflammation, neurological diseases, urological diseases. The invention also provides assays for the identification of compounds useful in the treatment or prevention of cardiovascular diseases, dermatological diseases, gastroenterological diseases, cancer, hematological diseases, respiratory diseases, inflammation, neurological diseases, urological diseases. The invention also features compounds which bind to and/or activate or inhibit the activity of AdipoR2 as well as pharmaceutical compositions comprising such compounds.

Abstract: This disclosure provides methods for treating cancer in a subject comprising administering to the subject an anti-PD-1 antibody and an anti-CD27 antibody. In some embodiments, the cancer is colorectal cancer, rectal cancer, colon cancer, lung cancer, melanoma, ovarian cancer, head and neck cancer, or any combination thereof.

Abstract: There are provided, inter alia, compositions and methods for treatment of cancer. The methods include administering to a subject in need a therapeutically effective amount of a Bruton's tyrosine kinase (BTK) antagonist and a ROR-1 antagonist. Further provided are pharmaceutical compositions including a BTK antagonist, ROR-1 antagonist and a pharmaceutically acceptable excipient. In embodiments, the BTK antagonist is ibrutinib and the ROR-1 antagonist is cirmtuzumab.

Abstract: The disclosure is directed to pharmaceutical products and stable liquid compositions of IL-17 antibodies and antigen-binding fragments thereof, e.g., AIN457 (secukinumab), and processes of making these pharmaceutical products and compositions. The disclosure is also directed to the use of these pharmaceutical products and liquid compositions (e.g., as part of a kit having instructions for use) for the treatment of various IL-17-mediated disorders (e.g., autoimmune disorders, such as psoriasis, ankylosing spondylitis, psoriatic arthritis, and rheumatoid arthritis).

Abstract: The present invention provides a pharmaceutical formulation comprising an anti-epidermal growth factor receptor (EGFR) antibody. The pharmaceutical formulation has low turbidity, without showing aggregation or particle formation, even under accelerated conditions, and exhibits good stability. Therefore, the pharmaceutical formulation can be effectively used for the treatment of disorders such as cancer.

Abstract: Compositions and methods for prolonging the local anesthetic effect of site 1 sodium channel blockers and local anesthetics with minimal or reduced toxicity have been developed for ophthalmic use. It has been established that agents such as dexmedetomidine having alpha-2-adrenergic agonist and Hyperpolarization-activated cyclic nucleotide-gated channel antagonist activity can dramatically prolong the duration of nerve blockade when administered to the surface of, a compartment of or tissue adjacent to, the eye. A preferred active agent for prolonging the local anesthetic effect of site 1 sodium channel blockers or local anesthetics is Dexmedetomidine.

Abstract: Provided is a new therapeutic agent for a malignant tumor, which is highly safe, sustains an antitumor effect, and can improve the means for administration and the number of times of administration. Disclosed is a compound of Formula (1), or a salt thereof: C[CH2O(CH2CH2O)nCH2CO—R1—R2]4 ??(1) wherein R1 represents a single bond, —N(R3)(CH2)n1CO—, or —N(R4)(CH2)n2N (R5)CO(CH2)n3CO—; R2 represents a group of Formula (a), (b), (c), (d), (e), or (f): m represents a number of from 10 to 1,000; and an arrow represents a bonding site.

Abstract: A method of delivering or sequestering anesthetic agents by adsorption of such agents by porous partially fluorinated compounds which display high weight adsorption capacities.

Abstract: Silicone acrylate copolymer composition, namely, silicone resin-acrylate copolymers and methods of preparing the same. The silicone acrylate composition may include a silicone resin coupled with an acrylate polymer via a linking group. The silicone acrylate composition may be formed by preparing an acrylate or a (meth)acrylate functional resin and carrying out acrylate polymerization in the presence of a functionalized resin. A silane-functional acrylate polymer may be prepared, followed by a reaction to couple a resin to the silane-functional acrylate polymer. The resulting copolymer may then be used as desired, e.g., added to a silicone and acrylate mixture to create a non-separating blend.

Abstract: The invention includes a composition comprising an astrocyte comprising aligned and elongated astrocyte processes resulting from ex vivo machine-driven, physical stretching of the astrocyte maintained in culture, as well as a method of making it. The invention also includes a composition comprising an astrocyte comprising aligned bi-polar processes resulting from growth within hydrogel micro-columns in culture, as well as a method of making it. The invention also provides methods of treatment of nervous system injury or degeneration by implanting the compositions of the invention.

Abstract: In a first aspect, the invention provides a polymeric nanoparticle comprising at least one polycationic polymer; at least one polyanionic polymer; and a therapeutically effective amount of at least one therapeutic agent. In a second aspect, the invention provides a method for the preparation of a polymeric nanoparticle according to the first aspect; the method comprising the steps of: (i)admixing the at least one polyanionic polymer with the at least one therapeutic agent; and (ii) introducing to the mixture of (i), to the at least one polycationic polymer. In a third aspect, the invention provides a polymeric nanoparticle according to the first aspect of the present invention, or a polymeric nanoparticle prepared according to the second aspect of the present invention; for use in the treatment of an inflammatory and/or arthritic disorder caused by or associated with dysfunctional nuclear receptor signalling.

Abstract: The present disclose generally provides pharmaceutical semi-solid hydrogels with entrapped calcium phosphate Comparison of Fitted Curves with Log Time for nanoparticles that demonstrate enhanced Preparations Demonstrating Statistical Significance drug release, retention, and esthetic properties. The hydrogels are particularly useful for topical applications of drug molecules. The present disclosure also relates to methods of administering a pharmaceutical agent by providing a pharmaceutical semi-solid hydrogel containing at least one pharmaceutical agent and administering it to a subject in need thereof.

Abstract: An implant for promoting accelerated wound healing. The implant comprises a non-flocculating fiber material, admixed with a settable fluid. The fiber component typically will have short fiber lengths, so as to avoid forming entangled masses or clumps when mixed with a fluid. In an embodiment, the fiber material is native collagen fibers and the settable fluid is an isolated blood fraction, such as platelet rich plasma and platelet poor plasma. The native collagen fiber retaining the native crosslinks of the source tissue and providing an architectural and structural scaffolding for advancing cellular infiltration. The wound healing implant will accelerate the bodies healing process, to provide better healing and less scar tissue of the wound site.

Abstract: A self-emulsifying composition contains: 70 to 90% by weight of at least one compound selected from the group consisting of ?3 polyunsaturated fatty acids and their pharmaceutically acceptable salts and esters; 0.5 to 6% by weight of water; 1 to 29% by weight of a polyoxyethylene sorbitan fatty acid ester as an emulsifier (optionally including a polyoxyl castor oil, and not including lecithin); and lecithin in an amount of 3 to 40 parts by weight in relation to 100 parts by weight of ?3 polyunsaturated fatty acids and the like. The self-emulsifying composition is excellent in self-emulsifying property, composition dispersibility, emulsion stability, and absorbability, is free from ethanol and polyhydric alcohols or only has such an alcohol added thereto at a reduced concentration, and is useful for foods and pharmaceuticals.

Abstract: Synthetic design of drug-incorporated novel dendrimer structures for quantitatively controlled drug delivery. The dendritic drugs have better control and thus a quantitative drug release can be obtained. There are no prior art dendritic drugs that control release both sequentially and quantitatively like the dendritic drugs disclosed herein. The dendritic drugs are formed by incorporating multiple same type drug units or more than two different drug types into a dendritic cascade structure to form a dendrimer drug.

Abstract: The disclosure describes jasmonate conjugates and nanocarried and/or microcarried jasmonate conjugates and pharmaceutical compositions thereof, as well as use thereof for treating or preventing angiogenesis-related or NF-?B-related disorders. Also disclosed are methods of making the conjugates.

Abstract: The invention described herein provides a preparation comprising a non-mammalian derived mixture of serine glycerophospholipid conjugates with a specific content and specific conjugation patterns of LA, linolenic acid (alpha-linolenic acid, gamma-linolenic acid) DHA and EPA which depend on utilizing different sources of lipids and uses of such preparations.

Abstract: The invention relates to novel compounds for use in the treatment or prophylaxis of cancers and other proliferative conditions that are for example characterized by cells that express cytochromne P450 1B1 (CYP1B1) and allelic variants thereof. The invention also provides pharmaceutical compositions comprising one or more such compounds for use in medical therapy, for example in the treatment of prophylaxis of cancers or other proliferative conditions, as well as methods for treating cancers or other conditions in human or non-human animal patients. The invention also provides methods for identifying novel compounds for use in the treatment of prophylaxis of cancers and other proliferative conditions that are for example characterized by cells that express CYP1 B1 and allelic variants thereof. The invention also provides a method for determining the efficacy of a compound of the invention in treating cancer.

Abstract: The present invention relates to prodrugs of C-type natriuretic peptide (CNP), pharmaceutical compositions comprising such CNP prodrugs and their uses. In an embodiment, the CNP prodrugs are conjugates of CNP peptides to poly(ethylene glycol) through a reversible linker.

Abstract: The present invention relates, in part, to a biocompatible hydrophobic-core carrier comprising a carrier, and a plurality of hydrophobic groups covalently linked to the polymeric carrier. The hydrophobic groups are capable of dissociably linking load molecules such as therapeutic agents. The hydrophobic-core carrier may also comprise protective side chains, orienting molecules, and targeting molecules.

Abstract: Provided are polyethylene glycol drug conjugates of general formula (I), (II) or (III) and pharmaceutical compositions and a use thereof. The conjugates are formed by combining low molecular weight polyethylene glycol with 2-4 drug molecules. The conjugates can interact with receptor dimers or polymers, thereby improving the in vivo distribution of the drug, changing the oil and water distribution coefficient, enhancing the pharmacological activity, reducing the blood-brain barrier permeability of the drug, and improving the bioavailability of the drug.

Abstract: This disclosure provides a method for improving maturation of an arteriovenous fistula (AVF) in a patient in need of hemodialysis, which method entails applying a solution to the internal wall of a lumen of an AVF; and restoring or initiating blood flow in the AVF, wherein the solution comprises an effective amount of a synthetic proteoglycan comprises a glycan having from about 1 to about 80 collagen-binding peptide(s) bonded to the glycan. Also provided are methods for preparing a vascular graft for a bypass surgery, comprising contacting the internal wall of a section of a blood vessel with a solution comprising an effective amount of the synthetic proteoglycan.

Abstract: The invention relates to materials and methods of conjugating a water soluble polymer to an oxidized carbohydrate moiety of a therapeutic protein comprising contacting the oxidized carbohydrate moiety with an activated water soluble polymer under conditions that allow conjugation. More specifically, the present invention relates to the aforementioned materials and methods wherein the water soluble polymer contains an active aminooxy group and wherein an oxime or hydrazone linkage is formed between the oxidized carbohydrate moiety and the active aminooxy group on the water soluble polymer, and wherein the conjugation is carried out in the presence of a nucleophilic catalyst.

Abstract: Provided are methods relating to the use of CDP-therapeutic agent conjugates for the treatment of a disease or disorder, e.g., autoimmune disease, inflammatory disease, central nervous system disorder, cardiovascular disease, or metabolic disorder. Also provided are CDP-therapeutic agent conjugates, particles comprising CDP-therapeutic agent conjugates, and compositions comprising CDP-therapeutic agent conjugates.

Abstract: Novel modulators, including antibodies and derivatives thereof, and methods of using such modulators to treat proliferative disorders are provided.

Abstract: Disclosed herein, is a bi-functional allosteric protein-drug molecule comprising a targeting moiety, one or more biological binding domains, and one or more therapeutic agents, wherein the therapeutic agent is allosterically bound to the biological binding domain. Also described herein, are methods of incorporating a bi-functional allosteric protein-drug molecule comprising a targeting moiety, one or more biological binding domains that captures the therapeutic agent without the formation of a chemical bond, and one or more therapeutic agents; physiologically acceptable compositions including them; and methods of administering the bi-functional allosteric protein-drug molecule to patients for the treatment of cancer.

Abstract: The present invention relates to a pharmaceutical composition comprising an inclusion complex of amorphous lenalidomide, or a pharmaceutically acceptable salt thereof, in non-substituted ?-cyclodextrin and one or more pharmaceutically acceptable excipients. The invention further relates to the use of said composition as a medicament, particularly in the treatment of in the treatment of multiple myeloma and myelodyplastic syndromes.