Abstract: The invention concerns methods and compositions for treating a neuropsychiatric disorder, wherein the method comprises administering an effective amount of a co-crystal of lithium to a subject in need thereof, wherein the co-crystal comprises lithium, or a pharmaceutically acceptable salt thereof, and an amino acid.

Abstract: In some embodiments, a composition and/or method may include a toxin binding system formulated for safe and effective mixture into various feed rations which are fed to monogastric and ruminant animals such as poultry, swine, cows, cattle, and fish, among others. The toxin binding system includes novel combinations of one or more of an organoclay, an activated hydrated sodium calcium aluminosilicate clay, and a synthetic hectorite clay. In some embodiments, the binding composition may include organoclay, bentonite, hectorite, Leonardite, and/or any combination thereof. The toxin binding complex may effectively bind mycotoxins, endotoxins and some pesticides in the animal's digestive system, preventing their absorption and the consequent damages to the animal. This binding action includes the T-2 toxin, which can start their damaging action in the animal's mouth, hence, offering protection from oral lesions.

Abstract: Lyme disease caused by B. burgdorferi and B. garinii has been traditionally treated with antibiotics. However, to eradicate all three morphological forms of Borrelia species such as spirochetes, rounded bodies and biofilm more effective and safe treatment plan is required. In the instant application, Vitamins and Phytobiologicals have been tested for as a short term and long term treatment in vitro and on biofilm. The combination of tested compounds in form of Mix AO seems to be very beneficial in treating Lyme disease caused by B. burgdorferi and B. garinii.

Abstract: Compositions comprise an amount of cinnamaldehyde that is orally tolerable, thus avoiding an unpleasant mouth feeling, and also tolerable in the gastrointestinal tract. The amount of cinnamaldehyde is supplemented by zinc, and the combination is effective to increase at least one of energy expenditure, sympathetic nervous system activity, or fat oxidation, relative to a composition lacking cinnamaldehyde and zinc but otherwise identical. The composition comprising the combination of cinnamaldehyde and zinc can be used in a method to support weight management or promote weight loss, a method for preventing obesity or overweight, and a method for treating obesity or overweight. In an embodiment, the composition comprising cinnamaldehyde is administered to a human. The composition comprising cinnamaldehyde may be a medicament, a food product or a supplement.

Abstract: A method is disclosed for delivery of stem cells to the central nervous system, particularly the brain, using an intranasal, injectable approach for the treatment of neurological deficits. The injectable approach employs a syringe to inject a stem cell solution or suspension into mucosal tissue of the nose using endoscopy. The approach provides direct endoscopic visual access to mucosal and sub-mucosal tissue selected for injection and the depth of placement of stem cells within the selected mucosal and sub-mucosal tissue. Placement of stem cells solely within the mucosal and sub-mucosal tissue assures survival of the stem cells and improves the likelihood the stem cells will reach specific sites of damage within the brain. This endoscopic intranasal approach is useful as therapy for patients who may benefit from cellular therapy as a result of stroke, brain trauma, and neurodegenerative conditions.

Abstract: The disclosure is directed to a device and method of treating bone formation disorders or conditions by bioengineering a targeted bone tissue and modulating the homeostasis of osteogenesis and bone resorption by a localized delivery of peripheral blood mononuclear cells and/or hematopoietic stem cells, and/or cells, such as osteoclasts, obtained by the ex vivo differentiation of these cells. A therapeutic strategy, as well as a device to deliver the therapeutic strategy, is described herein.

Abstract: Compositions and preparations of fetal support tissue that prevent or reduce the proliferation and epithelial-mesenchymal transition (EMT) of epithelial cells, wherein the epithelial cells may be human epithelial cells and the human epithelial cells may be conjunctival, retinal, corneal, limbal, or renal epithelial cells. Methods of preventing or reducing the proliferation, cell migration, and EMT of epithelial cells in an individual in need thereof, wherein the epithelial cells may be human epithelial cells and the human epithelial cells may be conjunctival, retinal, corneal, limbal, or renal epithelial cells. Methods of preventing or treating proliferative vitreoretinopathy in an individual in need thereof.

Abstract: The invention provides improved processes for extracting and preparing polar lipids (in particular, desirable phospholipids) from krill and other biological sources. The inventors have discovered processes through which it is possible to extract phospholipids to give high phospholipid content and a reduction of undesired components.

Abstract: A biologically active additive composition for preventing and healing bone diseases comprises a pharmacologically active compound of calcium chosen from a series comprising calcium carbonate, calcium citrate, calcium gluconate, calcium aspartate, calcium amino acid chelate, calcium fumarate, calcium succinate, calcium ascorbate, calcium phosphate, or any combination thereof, in the amount of 16.67-93.75 weight %, and drone brood in the amount of 6.25-83.33 weight %. Due to the combination, osteoporosis, bone fractures and cavities, arthritis, arthrosis, paradontosis can be prevented and healed with substantially reduced risk of calcium deposition in soft tissues. Drone brood can be in the form of an adsorbed or lyophilised homogenate. Methods of making the composition are also disclosed.

Abstract: Various embodiments of the present invention are directed to the field of Oncology, and in particular, embodiments directed to a method of ameliorating, treating, or preventing a malignancy in a human subject wherein the steps of the method assist or boost the immune system in eradicating cancerous cells. In certain embodiments, administration of beneficial bacteria to an individual's microbiome that have been modified so as to produce effective amounts of desired compositions, compounds, agents, e.g. tomatidine, p53 protein, etc., is employed to address cancerous conditions. In several embodiments, the administration of such beneficial bacteria and microbes to an individual's microbiome invokes either an active (or a passive) immune response to destroy, weaken or render less invasive certain cancerous cells, and preferably maintains muscle tissue to combat cancer cachexia.

Abstract: The present disclosure relates to compositions and methods for treating autism spectrum disorder (ASD) by restoring an ASD patient's gut microbiota. These methods can be used with ASD patient with or without ongoing gastrointestinal symptoms. Provided here is a method for ASD treatment in a subject in need thereof comprising or consisting essentially of administering a therapeutic composition comprising a fecal microbe or a fecal microbiota preparation to the subject. Also provided here is a method comprises administering an antibiotic to a human subject; subjecting the human subject to a bowel cleanse; and administering purified fecal microbiota to the human subject. Further provided are evaluation and quantitative characterization of patient symptom improvements upon treatment described here.

Abstract: Provided are adjunct therapies for use in combinations and compositions with an oncolytic virus, such as a vaccinia virus. The adjunct therapies include co-administration and co-formulation of a complement inhibitor and/or a lipid emulsion composition with the oncolytic virus. Also provided herein are therapeutic methods using the adjunct therapies for treatment of disease and conditions employing an oncolytic therapeutic virus, such as for the treatment of hyperproliferative diseases or conditions including tumors or cancers.

Abstract: The present invention relates to a method of reducing total gas production and/or methane production in a ruminant animal.

Abstract: A method of inhibiting COX-2, inhibiting NF-Kappa B activation, treating inflammation, or treating cancer may comprise administering a therapeutically effective amount of an extract of Combretum laurifolium Mart. to a patient. A medicament as described herein may comprise a pharmaceutically acceptable vehicle and a therapeutically effective amount of an extract of Combretum laurifolium Mart. suspended in the vehicle. A method of making an extract of Combretum laurifolium Mart. may comprise creating a component solution by treating Combretum laurifolium Mart. material with an extractor and a solvent and producing an extract by at least partially removing liquid from the component solution. An extract of Combretum laurifolium Mart. may comprise components extracted using various solvents.

Abstract: Disclosed is a method for preparing an herbal composition having atopic immune system strengthening and anticancer effects, wherein the herbal composition contains Siberian ginseng, fish mint, Manchurian wild rice, dried ginger, cinnamon bark, jujube, and citrus peel. The herbal composition, obtained by the method provided, is effective at scavenging reactive oxygen species (ROS), promoting the proliferation of normal cells without toxicity, and inhibiting the proliferation of colon cancer cells without serious toxicity, based on the results of tests conducted at the Blue-Bio Industry Regional Innovation Center, Dong-Eui University, Busan.

Abstract: The present invention relates to the use of a compound comprising plant based saponins for regulating and balancing gut microflora in a subject. The present invention also relates to the use of a compound comprising plant based saponins for exerting anti-cancer and anti-inflammatory effects by regulating and balancing the gut microbial ecosystem and providing a healthy epithelial microenvironment in the gut for a subject.

Abstract: It is provided an anti-microbial composition comprising a phenolic-rich extract such as a phenolic-rich maple syrup extract (PRMSE) and at least one antibiotic and a method of treating a bacterial infection comprising administering to a subject in need thereof a phenolic-rich extract and at least one antibiotic.

Abstract: An herbal composition, comprising a therapeutically effective amount of an extract of Terminalia chebula; a therapeutically effective amount of an extract of Curcuma longa; and a therapeutically effective amount of a non-acidic, water-immiscible organic solvent extract of a Boswellia serrata resin.

Abstract: Disclosed herein are methods of purifying growth cones from specific projections in the brain comprising a combination of in vivo labeling, subcellular fractionation, and fluorescent small particle sorting. The methods disclosed herein enable the quantitative profiling of the proteomes and transcriptomes of growth cones and their parent cell bodies from callosal projection neurons. Also disclosed herein are specific RNA and protein networks involved in callosal circuit formation and core growth cone proteomic machinery. The inventions disclosed herein are adaptable to any projection in the brain, providing insight into the molecular networks that control the wiring of specific neural circuits in vivo.

Abstract: The present invention is directed to compositions comprising the HCV NS3/4A inhibitor, (1aR,5S,8S,10R,22aR)-5-tert-butyl-N-{(1R,2S)-1-[(cyclopropylsulfonyl)carbamoyl]-2-ethenylcyclopro-pyl}-14-methoxy-3,6-dioxo-1,1a,3,4,5,6,9,10,18,19,20,21,22,22a-tetradecahydro-8H-7,10-methanocyclopropa[18,19][1,10,3,6]dioxa-diazacyclononadecino[11,12-b]quinoxaline-8-carboxamide, or a pharmaceutically acceptable salt thererof, an oral absorption enhancing polymer, and, optionally, a surfactant. The present invention is also directed to solid dispersions and pharmaceutical compositions containing or made from these compositions, and the methods for making these solid dispersions and pharmaceutical compositions.

Abstract: A process for the preparation of injectable pharmaceutical compositions for the sustained release of somatostatin analogues and compositions prepared according to the process. The process may comprise lyophilizing a mixture of lanreotide acetate and acetic acid to form a lyophilizate and hydrating the lyophilizate, wherein the lyophilization is performed only once.

Abstract: Disclosed are compositions for inhibiting transmission of a sexually transmitted infection that contain one or more polyanionic microbicides, such as carrageenans, including lambda carrageenan, as well as water-soluble metal salts and specified lectins. Also disclosed are methods for making and using the compositions.

Abstract: This invention concerns compositions and methods of treating or diagnosing inflammatory disorders and other disorders, as well as compositions and methods of treating HIV.

Abstract: Nutritive polypeptides are provided herein. Also provided are various other embodiments including nucleic acids encoding the polypeptides, recombinant microorganisms that make the polypeptides, vectors for expressing the polypeptides, methods of making the polypeptides using recombinant microorganisms, compositions and formulations that comprise the polypeptides, and methods of using the polypeptides, compositions and formulations.

Abstract: Described herein is a transmembrane delivery system comprising: a pharmaceutically active moiety; and a polypeptide of up to 20 amino acids in length comprising a continuous region of at least 2, more typically at least 4 basic amino acids. Typically the system comprises a polypeptide which has the formula: (B)n(A)m where B is a basic amino acid A is an acidic amino acid, m and n are integers, and n is at least 4, and m is less than n.

Abstract: The present invention relates to methods and pharmaceutical compositions for the treatment of hepatocellular carcinomas. In particular, the present invention relates to an OX1R agonist for use in the treatment of hepatocellular carcinomain a subject in need thereof.

Abstract: Acid-containing oral pharmaceutical compositions are provided wherein the pharmaceutical active agents are peptide compounds (i.e., those that include a plurality of amino acids and at least one peptide bond in their molecular structures). Certain barrier layers and/or particulate coated acid are used to reduce any adverse interactions that might otherwise occur between the acid of the compositions and other components of the composition. Use of these barrier layers and/or use of particulate coated acid is believed to promote a more simultaneous release of the components of the composition than is achieved by prior art acid-protection techniques, thus enhancing, and making more consistent, the bioavailability of the active peptide compounds.

Abstract: Calcitonin products and therapies for treating inflammatory or degenerative diseases are disclosed herein. The pharmaceutical compositions disclosed herein include a first therapeutic agent that is calcitonin, in free or salt form; a second therapeutic agent selected from the group consisting of a protease inhibitor, an antibiotic, a non-steroidal anti-inflammatory agent, a COX-2 inhibitor and a steroidal anti-inflammatory agent other than glucocorticoid; and a pharmaceutically acceptable excipient, carrier or diluent.

Abstract: A gonadotropin is administered within a surprisingly effective narrow range for the purpose of treating chronic pain or other central sensitization sequelae. In one aspect, a recipient is provided with at least one of human chorionic gonadotropin (uHCG and/or rHCG), a pharmaceutically active HCG analogue, and a pharmaceutically active metabolite of the HCG or analogue at a dosage selected to provide an amount therapeutically bioequivalent to, a human subcutaneous dosage of between 120 IU/day and 170 IU/day of HCG, and more preferably between 140 IU/day and 160 IU/day of HCG. A combination product is also described, which includes a supply of the HCG-related drug, a delivery device, and a conversion scale for therapeutic bioequivalence that identifies the specific amount and route of administration for chronic pain or central sensitization as an indication of the drug.

Abstract: The application relates to an aqueous pharmaceutical formulation comprising 200-1000 U/mL [equimolar to 200-1000 IU human insulin] of insulin glargine.

Abstract: Pharmaceutical composition containing a mixture of proenzymes and enzymes, containing proenzymes trypsinogen and chymotrypsinogen and enzymes ct-amylase and lipase as active substances, and one or more pharmaceutically acceptable excipients, for simultaneous, separate and subsequent administration of the composition in parenteral or transmucosal way, the composition has anti-proliferative and anti-metastatic effects to cancer tumours and is intended for therapeutic, prophylactic and anti-metastatic use in mammals.

Abstract: The present disclosure relates to a compound and method of using such compound preferably in the form of a dietary supplement that, when administered, is capable of treating thyroid disease and various thyroid-related disorders. The unique combination of the composition is preferably administered orally. The composition is preferably comprised of at least selenium, zinc, iodine, manganese, molybdenum, ashwaganda root powder, polygonum root extract, a digestive enzyme such as DPP-IV, L-tyrosine and mullein leaf, in pre-determined amounts. The composition can further comprise a palliative agent, and can be provided in the form of a capsule or tablet.

Abstract: The present invention provides polypeptides having protease activity for use in the treatment or prevention of microbial infections in a subject with or susceptible to immunodeficiency. For example, the polypeptide may be administered as a mouth spray, nasal spray, lozenge, pastille, chewing gum or liquid to treat or prevent microbial infections in a patient with primary immunodeficiency. In particular, the polypeptides are useful in the treatment or prevention of rhinorrhea and/or fungal infection of the oral cavity and/or gum sores. In one embodiment, the polypeptide is a trypsin enzyme from Atlantic cod, or a fragment or variant thereof.

Abstract: The amount of adipose tissue, including lipomas, at selected locations in the body is reduced by introducing collagenase or collagenase plus another proteinase into the tissue.

Abstract: The present disclosure encompasses immunogenic/therapeutic compositions including Globo H-KLH glycoconjugates (OBI-822) and/or therapeutic adjuvants (OBI-821/OBI-834) as well as methods of making and using the same to treat proliferative diseases such as cancer. The therapeutic conjugates include an antigen linked to a carrier. In particular the therapeutic conjugates include a Globo H moiety and a KLH moiety and/or a derivatized KLH moiety subunit optionally linked via a linker. The therapeutic compositions are in part envisaged to act as cancer vaccines for boosting the body's natural ability to protect itself, through the immune system from dangers posed by damaged or abnormal cells such as cancer cells. Exemplary immune response can be characterized by reduction of the severity of disease, including but not limited to, prevention of disease, delay in onset of disease, decreased severity of symptoms, decreased morbidity and delayed mortality.

Abstract: The present invention relates to neoplasia vaccine or immunogenic composition administered in combination with other agents, such as checkpoint blockade inhibitors for the treatment or prevention of neoplasia in a subject.

Abstract: The presently disclosed subject matter provides methods and compositions for activation of clustered receptors on a target cell using nanocarrier-associated ligands, particularly methods and compositions for targeted activation of clustered receptors on antigen-experienced T cells using nanocarrier-associated antibodies.

Abstract: The present invention relates to peptides, proteins, nucleic acids and cells for use in immunotherapeutic methods. In particular, the present invention relates to the immunotherapy of cancer. The present invention furthermore relates to tumor-associated T-cell peptide epitopes, alone or in combination with other tumor-associated peptides that can for example serve as active pharmaceutical ingredients of vaccine compositions that stimulate anti-tumor immune responses, or to stimulate T-cells ex vivo and transfer into patients. Peptides bound to molecules of the major histocompatibility complex (MHC), or peptides as such, can also be targets of antibodies, soluble T-cell receptors, and other binding molecules.

Abstract: Live attenuated bacteria vaccines against enteric septicemia of fish, especially catfish, and methods related to the same. Mutant strains of the bacteria Edwardsiella ictaluri (a pathogenic bacterial strain of Enterobacteriaceae) are provided. The mutant Edwardsiella ictaluri bacteria (or other pathogenic bacterial strain of Enterobacteriaceae) contain one or more gene deletions or disruptions that result in less virulent bacterial strains as live attenuated vaccine compositions against virulent wild-type Edwardsiella ictaluri bacteria (or other pathogenic bacterial strain of Enterobacteriaceae). The mutant strains showing the best immunological protection and safety as a vaccine are the triple mutants ESC-NDKL1 (?gcvP?sdhC?frdA) strain and ESC-NDKL2 (?gcvP?sdhC?mdh) strain, with the ESC-NDKL1 strain providing the greatest safety and efficacy of these two triple mutants.

Abstract: The present invention relates to bacterial Clp B protein and Clp B expressing bacteria and their impact on diseases or disorders related to reduced appetite, increased appetite and/or anxiety. The invention further relates to compositions related to bacterial ClpB protein and to its use in the immunization against a disorder related to reduced appetite and/or anxiety.

Abstract: Bacterial live vector vaccines represent a vaccine development strategy that offers exceptional flexibility. In the present invention, genes encoding protective antigens of unrelated bacterial, viral, parasitic, or fungal pathogens are expressed in an attenuated bacterial vaccine strain that delivers these foreign antigens to the immune system, thereby eliciting relevant immune responses. Rather than expressing these antigens using only low copy expression plasmids, expression of foreign proteins is accomplished using both low copy expression plasmids in conjunction with chromosomal integrations within the same live vector. This strategy compensates for the inherent disadvantage of loss of gene dosage (versus exclusive plasmid-based expression) by integrating antigen expression cassettes into multiple chromosomal sites already inactivated in an attenuated vector.

Abstract: The present disclosure teaches generally in the field of vaccination and disease control in cattle and bovine animals. A recombinant bovine herpesvirus 1 (BoHV-1) vaccine vector is provided for efficient control of one or more bovine pathogens such as those associated with bovine respiratory disease complex, such as bovine viral diarrhea virus (BVDV), and which ameliorates disease conditions caused thereby. Protocols for the management of confined or herded bovine animals are also enabled herein.

Abstract: Disclosed herein are embodiments of a method for collecting, extracting or eluting proteins and antigens from cells infected with coronavirus. The coronavirus may be a porcine coronavirus, such as porcine epidemic diarrhea virus (PEDV) or porcine delta coronavirus (PDCoV). Also disclosed are embodiments of a composition comprising the coronavirus proteins and antigens, and embodiments of a method of using such a composition. Applications for the composition include, but are not limited to, use in the preparation of antibodies against the proteins and antigens, use as reference markers for coronavirus proteins, and/or use in an immunogenic composition, such as in a vaccine composition.

Abstract: Small molecule integrin ligand mimetics facilitate integrin-ligand interactions, which may be used to prepare vaccines, adoptive cell therapies, immunotherapies for cancer, and a variety of other conditions. As integrin mediated cell-cell interactions are critical to antigen presentation and effector cell killing, increasing the efficiency of integrin receptor-ligand interactions will stabilize the immune synapse and improve effector functions. Compositions and methods including the mimetics enhance: (1) the priming of vaccines (including, but not limited to, cancer vaccines); (2) cytolytic activity of adoptive cell therapies (including, but not limited to ??T-cells, CTLs, NK, iNKT); (3) immunotherapies (including, but not limited to, negative checkpoint blockage strategies such as anti-CTLA-4 and anti-PD-1); and (4) biologic therapies (including, but not limited, to trastuzumab and rituxamab), whereby the mechanism-of-action includes antibody dependent cellular cytotoxicity (ADCC).

Abstract: The present invention relates a pharmaceutical composition comprising (a) an opioid analgesic drug and/or an enkephalinase inhibitor, and (b) a selective Nav1.7 inhibitor.

Abstract: The present invention provides antibodies that bind FGFR2IIIb, wherein the antibodies are afucosylated. The present invention provides compositions comprising antibodies that bind FGFR2IIIb, wherein at least 95% of the antibodies in the composition are afucosylated. In some embodiments, methods of treating cancer comprising administering afucosylated anti-FGFR2IIIb antibodies are provided.

Abstract: The present invention provides a combination therapy for effectively treating and/or preventing diseases associated with cells expressing CLDN18.2, including cancer diseases such as gastric cancer, esophageal cancer, pancreatic cancer, lung cancer, ovarian cancer, colon cancer, hepatic cancer, head-neck cancer, and cancer of the gallbladder and metastases thereof.

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 further 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: Compositions and methods for targeting agents to hard tissue are provided.

Abstract: Provided herein are ready-to-use premixed pharmaceutical compositions of nicardipine or a pharmaceutically acceptable salt and methods for use in treating cardiovascular and cerebrovascular conditions.