Abstract: A polytherapy of orally available compounds is disclosed that synergistically modulates and induces the expression of the cathelicidin gene (CAMP), which encodes the host defense peptide LL-37. By providing a number of different CAMP-inducing compounds together at the same time, stronger gene induction is achieved than with just one or two compounds, because the mechanism of induction broadens. Induction also may vary in different parts of the body depending on which compounds are used, and at what levels. We show for the first time that the polytherapy can induce cathelicidin expression in the brain, which may help to treat or prevent Alzheimer's Disease. Systemic cathelicidin gene induction may help treat numerous other conditions including Type 2 Diabetes/Metabolic Syndrome, or chronic bacterial, viral, or fungal infections associated with increased cancer risk or neurodegeneration.

Abstract: Methods of treating renal cancer, including renal cell carcinoma, using bezafibrate are disclosed herein. Bezafibrate can be administered as a monotherapy or as part of a comprehensive treatment program, which can also include administration with other anti-cancer drugs, surgical treatments or exposure to ionizing radiation.

Abstract: Disclosed herein are methods for treating cancer comprising administering CAR-modified immune cells and at least one Retinoic Acid Receptor and/or Retinoid X Receptor active agent.

Abstract: The invention provides compositions and methods of treating autism. Specifically, the invention relates to treating the core symptoms of autism by administering ?-methyl-DL-tyrosine.

Abstract: The invention provides compositions and methods of treating autism. Specifically, the invention relates to treating the core symptoms of autism by administering ?-methyl-DL-tyrosine.

Abstract: The present application is directed to compositions comprising microcapsules comprising encapsulated tretinoin, wherein the microcapsule size is less than 50 ?m; and to methods of use thereof.

Abstract: The present invention relates to the field of food products, especially food products specifically designed for providing health benefits beyond the basic function of nutrition for a subject consuming the product on a regular basis, e.g. on a daily basis. According to the present invention eggs are produced, in particular chicken eggs, that are enriched in one or more pharmacologically active nutrients. The egg yolk obtained from the aforementioned eggs can suitably be used in high amounts as a component of a functional food product having all the characteristics that are normally required for such functional food products. A preferred example of a food product in accordance with the invention is a ready to drink shot containing approximately one whole egg yolk in a volume as small as 100 ml.

Abstract: The present disclosure relates to methods of treatment of acne in a patient in need thereof, comprising the concomitant once daily topical administration of from about 2% w/w to about 10% w/w of solid particulate benzoyl peroxide (BPO) and from about 0.01% w/w to about 0.1% w/w of solid particulate all trans retinoic acid (ATRA) for a period of up to 3 months, wherein the side-effects of the two actives are medically acceptable and wherein the therapeutic effect of BPO and ATRA is superior to the effect of each active administered alone. The concomitant administration may be carried out by once daily administration to a patient in need thereof of a single composition or of a first composition comprising BPO and a second composition comprising ATRA from a dual chamber dispenser or from two separate dispensers, mixed before applying on the skin of a patient in need thereof for up to 2 weeks, up to 1 month, preferably up to 2 months and more preferably up to 3 months.

Abstract: The present disclosure relates to methods of treatment of acne in a patient in need thereof, comprising the concomitant once daily topical administration of from about 20 w/w to about 10% w/w of solid particulate benzoyl peroxide (BPO) and from about 0.01% w/w to about 0.1% w/w of solid particulate all trans retinoic acid (ATRA) for a period of up to 3 months, wherein the side-effects of the two actives are medically acceptable and wherein the therapeutic effect of BPO and ATRA is superior to the effect of each active administered alone. The concomitant administration may be carried out by once daily administration to a patient in need thereof of a single composition or of a first composition comprising BPO and a second composition comprising ATRA from a dual chamber dispenser or from two separate dispensers, mixed before applying on the skin of a patient in need thereof for up to 2 weeks, up to 1 month, preferably up to 2 months and more preferably up to 3 months.

Abstract: The present application is directed to regimens, methods of treatment, and compositions for the treatment of acne in a subject suffering therefrom

Abstract: The present invention provides safe and effective methods for the treatment of sialorrhea (excessive drooling) by administering an effective amount of N desethyloxybutynin, or an optical R- or S-isomer thereof or a pharmaceutically acceptable salt thereof.

Abstract: Described herein are pharmaceutical compositions comprising one or more fumarate esters, processes for making the same, and compositions and methods for treating multiple sclerosis subjects with the compositions. In particular, oral pharmaceutical compositions comprising fumarate esters in liquid vehicles are described. One embodiment is an oral delayed release pharmaceutical dosage form comprising a soft capsule encapsulating an immediate releasing liquid comprising one or more fumarate esters.

Abstract: Described herein are pharmaceutical compositions comprising fumarate esters, methods for making the same, and methods for treating subjects in need thereof. In particular, oral controlled release pharmaceutical compositions comprising fumarate esters suspended in liquid matrices are described. One embodiment described herein is a pharmaceutical composition comprising fumarate esters suspended in a lipid or lipophilic liquid with enhanced bioavailability.

Abstract: Described herein are pharmaceutical compositions comprising fumarate esters, methods for making the same, and methods for treating subjects in need thereof. In particular, oral pharmaceutical compositions comprising fumarate esters are described.

Abstract: Provided are: a composition containing 96-99 area % of eicosapentaenoic acid alkyl ester, the composition having an arachidonic acid alkyl ester content of 0.7 area % or less, and an eicosapentaenoic-acid-alkyl-ester mono-trans isomer content of 2.5 area % or less; and a method for producing a composition containing a high concentration of eicosapentaenoic acid alkyl ester, the method including performing precision distillation on a composition containing eicosapentaenoic acid alkyl ester, obtained by alkyl esterification of a raw material oil containing eicosapentaenoic acid, under a vacuum of 0.2 Torr or lower and a temperature of 190° C. or lower in the entire column, and performing a concentration treatment on the precision-distilled composition using chromatography.

Abstract: Compositions and methods for treating parasitic infections are provided. The compositions can include two or more of alpha-pinene, linalyl acetate, para-cymene, and thymol octanoate. The compositions and methods can be effective against, for example, protozoan parasites, helminthic parasites, nematodes, trematodes, flukes, cestodes, and the like. Formulations made from the composition are also provided, including formulations in which the composition is combined with a carrier to form a food product and/or a drink. The formulation can be, for example, a suspension, a solution, or an emulsion in an oily or an aqueous carrier; like-wise, the composition can be provided in an encapsulated or microencapsulated form.

Abstract: The present disclosure provides methods of treating pulmonary arterial hypertension (PAH) in a subject in need thereof. Compositions for use in these methods are also provided.

Abstract: The present teachings relate to compounds and compositions for treatment of cancers. In some embodiments, the composition comprises a platinum (IV) complex having at least one carboxylate or carbamate ligand.

Abstract: The use of dianhydrogalactitol provides a novel therapeutic modality for the treatment of non-small-cell lung carcinoma (NSCLC) and for the treatment of glioblastoma multiforme (GBM). Dianhydrogalactitol acts as an alkylating agent on DNA that creates N7 methylation. Dianhydrogalactitol is effective in suppressing the growth of cancer stem cells and is active against tumors that are refractory to temozolomide; the drug acts independently of the MGMT repair mechanism.

Abstract: Disclosed herein are ?-glucosidase (GCase) chaperones and methods of using GCase chaperones in an individual in need thereof. GBA1 mutations lead to GCase deficiency and substrate accumulation, causing Gaucher disease. Currently, no FDA or EMA-approved therapeutic for neuronopathic Gaucher disease is available. Improved GCase activity in brain cells using a chaperone may reduce substrate accumulation and associated pathology. Disclosed herein are novel non-inhibitory chaperone compounds of GCase that have properties of a central nervous system drug. Those compounds effectively restored mutant GCase activity by stabilizing protein and enhancing lysosomal localization and may be useful for chaperone therapy to treat neuronopathic Gaucher disease and likely to Parkinson's disease.

Abstract: Methods, formulations and products are disclosed to treat and/or alleviate and/or otherwise improve the condition of a patient with certain medical conditions such as neuro-degenerative ailments, including certain cannabinoid formulations as described, e.g., in certain relative proportions to one another.

Abstract: Some embodiments of the invention relate to a system for delivering to a subject at least one pre-determined amount of THC, the system comprising: a memory which stores a scheduled regimen for delivery of THC to the subject, the scheduled regimen defining: a maximal amount of THC to be delivered, the amount being 0.75 mg THC or less, and a time period within which that amount is delivered, the time period being 2 hours or longer; a decision module which decides, according to the scheduled regimen, if a delivery should take place; and an inhaler device for delivering THC to the subject, the inhaler device comprising a controller which carries out delivery of THC based on the decision made by the decision module.

Abstract: Water-soluble cannabinoid compositions are described herein. The composition may include a cannabinoid mixture, e.g., purified from a cannabis extract, and one or more water soluble agents, such as a complex carbohydrate. Methods of preparing such compositions may include blending the cannabinoid mixture with the water soluble agents(s) in water to form an emulsion. Some methods include drying the emulsion to form a film coating or particles, such as spray-dried and/or agglomerated particles, wherein the film coating or particles are at least partially soluble in cold water.

Abstract: The invention encompasses compositions and methods for effectively treating and/or preventing the development and/or progression of osteoarthritis and rheumatoid arthritis and for promoting overall joint health. This is accomplished by totally addressing the key multiple biochemical processes and mechanisms that lead to such disorders. The invention includes compositions comprising a combination of natural agents that safely and effectively suppress, regulate or interfere with the various biochemical processes and mechanisms that increase the risk for or lead to the development and/or progression of OA and RA.

Abstract: The present invention concerns vitamin E selected among vitamin E phosphate, optionally in combination with methylene blue, and/or vitamin E acetate in combination with methylene blue for use in the treatment and prevention of biofilm infections or as an antifungal agent by means of the application of vitamin E as defined above or in combination with a biocompatible vector on inert or living surfaces.

Abstract: Provided herein are compositions including oxotremorine (e.g., oxotremorine methiodide or Oxo-M) and 4-PPBP (e.g., 4-PPBP maleate). Also provided are methods of treating a connective tissue defect in a subject with oxotremorine and 4-PPBP. In addition, provided are scaffolds and methods of making same that include multiple fibers that include Oxo-M, 4-PPBP, and optionally icariin or kartogenin.

Abstract: This invention is directed to pyrrole, pyrazole, imidazole, triazole, and morpholine based selective androgen receptor degrader (SARD) compounds including heterocyclic anilide rings and their synthetic precursors, R-isomers, and non-hydroxylated and/or non-chiral propanamides, and pharmaceutical compositions and uses thereof in treating prostate cancer, advanced prostate cancer, castration resistant prostate cancer, triple negative breast cancer, other cancers expressing the androgen receptor, androgenic alopecia or other hyperandrogenic dermal diseases, Kennedy's disease, amyotrophic lateral sclerosis (ALS), abdominal aortic aneurysm (AAA), and uterine fibroids, and to methods for reducing the levels of androgen receptor-full length (AR-FL) including pathogenic or resistance mutations, AR-splice variants (AR-SV), and pathogenic polyglutamine (polyQ) polymorphisms of AR in a subject.

Abstract: A composition for opththalmic administration comprising a formaldehyde releasing agent, sodium bicarbonate, and an ophthalmically suitable carrier or excipient is provided.

Abstract: An oral clonidine dosage unit providing a twenty-four hour extended release profile following a single dose administration is provided. The dosage unit comprises a pharmaceutically effective amount of a coated complex comprising clonidine bound to a cationic exchange resin, which is characterized by a twenty-four hour release profile with a single peak, wherein said oral clonidine dosage unit provides a therapeutically effective plasma concentration for at least about 70%, or at least 85% of the twenty-four hour period following the single dose administration. Both liquid and solid formulations are provided, as are methods of treating a patient by a single administration of a formulation of the invention so as to achieve a therapeutic effect for 24-hours.

Abstract: Novel solid forms of bendamustine hydrochloride are described, as well as methods of their preparation and use.

Abstract: The present invention relates to IL-8 inhibitor compounds, preferably dual CXCR1/CXCR2 receptor inhibitors, useful in the treatment and/or prevention of chemotherapy-induced neuropathy, preferably in the treatment and/or prevention of chemotherapy-induced peripheral neuropathy (CIPN) or chemotherapy-induced optic neuropathy.

Abstract: Sodium 2-(5-bromo-4-(4-cyclopropylnaphthalen-1-yl)-4H-1,2,4-triazol-3-ylthio)acetate is described. In addition, pharmaceutical compositions and uses of such compositions for the treatment of a variety of diseases and conditions are described.

Abstract: The present invention relates to a temporary inhibitor of p53 for its use for preventing or reducing cancer relapse in cancer patients.

Abstract: Described herein is a new oral method for using MK-0677 for detecting growth hormone (GH) deficiency (GHD). Also described is a method of treating growth hormone (GH) deficiency (GHD) in children with a functional hypothalamic-pituitary GH axis.

Abstract: The present invention provides tacrolimus for use in the treatment in a human subject of a TDP-43 proteinopathy, such as amyotrophic lateral sclerosis (ALS) and frontotemporal dementias (FTDs), wherein the tacrolimus is for administration at a therapeutically-effective dose which does not cause immunosuppression in the subject.

Abstract: Methods are provided herein for treating agitation in a subject who has Alzheimer's disease comprising administering a VMAT2 inhibitor to a subject in need thereof. VMAT2 inhibitors useful in the methods provided herein include tetrabenazine and (S)-2-Amino-3-methyl-butyric acid (2R,3R,11bR)-3-isobutyl-9,10-dimethoxy-1,3,4,6,7,11b-hexahydro-2H-pyrido[2,1-a]isoquinolin-2-yl ester.

Abstract: Some embodiments are directed to a substance that inhibits P2Y12 receptor for use in the preventive treatment of systemic sclerosis in patients with Raynaud's phenomenon and a dysimmunity.

Abstract: Roflumilast crystals have been shown to increase in size during storage. The size of the roflumilast crystals can affect the bioavailability and efficacy of a pharmaceutical composition. The growth of roflumilast crystals can be inhibited during storage by including hexylene glycol in the composition. The resulting composition has improved bioavailability and efficacy and can be used to inhibit phosphodiesterase 4 in a patient in need of such treatment.

Abstract: Disclosed herein are methods and compositions related to use of aminopyridines, such as 4-aminopyridine, to improve the neuro-cognitive impairments and related neuro-psychiatric impairments of patients with a demyelinating condition such as MS, traumatic brain injury, cerebral palsy, post-radiation encephalopathy.

Abstract: Provided herein are antifungal compositions and methods of use thereof. The antifungal compositions include an antifungal agent and an antipsychotic agent or an antihistamine. The methods of use thereof include administering a composition including an antifungal agent and an antipsychotic or an antihistamine to a plant or animal in need thereof.

Abstract: The present invention provides novel deuterated analogs of Pridopidine, i.e. 4-(3-methanesulfonyl-phenyl)-1-propyl-piperidine. Pridopidine is a drug substance currently in clinical development for the treatment of Huntington's disease. In other aspects the invention relates to pharmaceutical compositions comprising a deuterated analog of Pridopidine of the invention, and to therapeutic applications of these analogs.

Abstract: Compounds effective in inhibiting replication of Hepatitis C virus (“HCV”) are described. This invention also relates to processes of making such compounds, compositions comprising such compounds, and methods of using such compounds to treat HCV infection.

Abstract: The present invention provides a composition including an amphiphilic compound capable of self-assembling into a liquid crystalline phase; and a niacin compound.

Abstract: Disclosed are therapeutic compositions including BA-1076 and/or BA-2057, methods of their use in the treatment of ophthalmological disorders. The therapeutic compositions may further include an IOP-lowering prostaglandin. The methods may further include administration of an IOP-lowering prostaglandin.

Abstract: The present invention relates to therapeutic immunoconjugates comprising SN-38 attached to an antibody or antigen-binding antibody fragment. The antibody may bind to EGP-1 (TROP-2), CEACAM5, CEACAM6, CD74, CD19, CD20, CD22, CSAp, HLA-DR, AFP or MUC5ac and the immunoconjugate may be administered at a dosage of between 4 mg/kg and 24 mg/kg, preferably 4, 6, 8, 9, 10, 12, 16 or 18 mg/kg. When administered at specified dosages and schedules, the immunoconjugate can reduce solid tumors in size, reduce or eliminate metastases and is effective to treat cancers resistant to standard therapies, such as radiation therapy, chemotherapy or immunotherapy.

Abstract: Disclosed is a method for reducing or preventing fetal opioid dependence in a drug dependent or opioid tolerant pregnant subject. The method involves administering to the pregnant subject a composition comprising an opioid antagonist in an amount effective to reduce or prevent fetal opioid dependence, wherein the opioid antagonist a) is orally available or delivered systemically and reaches the circulation of the pregnant subject, b) is substantially excluded from the subject's brain by the blood brain barrier, and c) penetrates the placenta and enters the fetal brain. The method also includes administering the opioid antagonist to the neonate in increasing amounts to facilitate weaning the neonate from continued opioid maintenance.

Abstract: Dosage forms, drug delivery systems, and methods related to sustained release of dextromethorphan or improved therapeutic effects are disclosed. Typically, bupropion or a related compound is orally administered to a human being to be treated with, or being treated with, dextromethorphan.

Abstract: Processes for providing depot injections of recrystallized aripiprazole lauroxil in which particles of the aripiprazole lauroxil have a surface area of about 0.50 to about 3.3 m2/g; and crystals of aripiprazole lauroxil produced by such processes.

Abstract: Compositions and methods of using nintedanib for improving the success rate of glaucoma filtration surgery are disclosed herein. Nintedanib can be used alone or in combination with an anti-metabolite drug in a topical or implant eye formulation.

Abstract: Described are methods of use of compounds that inhibit PIF-mediated substrate binding by PDK1, which are useful as inhibitors of cancer growth or proliferation that is RSK2-dependent or AKT-independent. Also described are compositions of such compounds for use in such methods of treating cancer.