Abstract: The present invention provides 1,2-benzothiazole compounds particularly useful in the treatment of diabetic nephropathy and other chronic kidney disorders and other diabetic complications.

Abstract: The present invention provides 2,4-pyrimidinediamine compounds that inhibit the IgE and/or IgG receptor signaling cascades that lead to the release of chemical mediators, intermediates and methods of synthesizing the compounds and methods of using the compounds in a variety of contexts, including in the treatment and prevention of diseases characterized by, caused by or associated with the release of chemical mediators via degranulation and other processes effected by activation of the IgE and/or IgG receptor signaling cascades.

Abstract: This invention generally relates to compositions and methods for cancer treatment and, in particular, to compositions able to interact (e.g., bind to) with MUC1 growth factor receptor or its ligands, and methods for treating the same. The invention also relates to assays or use of such compositions for the treatment of patients susceptible to or exhibiting symptoms characteristic of cancer or tumorigenesis. Other compositions of the present invention useful for the treatment or prevention of cancer or tumorigenesis include homologs, analogs, derivatives, enantiomers or functional equivalents. The present compositions can also be packaged in kits in some cases.

Abstract: Described herein are irreversible Btk inhibitor compounds, and methods for using such irreversible inhibitors in the treatment of diseases and disorders characterized by the presence or development of solid tumors.

Abstract: The present invention provides tricyclic compounds, pharmaceutically acceptable salts, solvates, or hydrates thereof, having antimitotic activity, anti-multidrug resistance activity, for example P-glycoprotein inhibition, and antitumor activity, and which inhibit paclitaxel sensitive and resistant tumor cells. Also provided are methods of utilizing these compounds for treating tumor cells and inhibiting mitosis of cancerous cells.

Abstract: This invention is in the area of improved therapeutic combinations for and methods of treating selected retinoblastoma (Rb)-negative cancers and Rb-negative abnormal cellular proliferative disorders using particular topoisomerase inhibitors and specific cyclin-dependent kinase 4/6 (CDK4/6) inhibitors. In one aspect, the improved treatment of select Rb-negative cancers is disclosed using specific compounds disclosed herein in combination with a topoisomerase I inhibitor.

Abstract: Concentrated methotrexate solutions are described which are suitable for the use of an active substance in the production of a parenterally administered medicament for the treatment of inflammatory autoimmune diseases. The methotrexate is added to a pharmaceutically acceptable solvent at a concentration of more than 25 mg/ml.

Abstract: The present invention provides, inter alia, methods for treating, preventing, or ameliorating the effects of a lymphoid malignancy, such as those associated with a mutated phosphatase and tensin homolog (PTEN) gene, or T-cell acute lymphoblastic leukemia (T-ALL). These methods include administering to a subject an effective amount of a phosphoinositide 3-kinase-delta (PI3K?) inhibitor and a phosphoinositide 3-kinase-gamma (PI3K?) inhibitor. The present invention also provides pharmaceutical compositions for treating the effects of a lymphoid malignancy. This invention further provides a method for identifying a subject who may benefit from co-treatment with a PI3K? inhibitor and a PI3K? inhibitor. This method includes determining from a sample of the subject whether the subject has a mutated PTEN gene. Additionally, this invention provides methods for identifying a compound that has both PI3K? and PI3K? inhibitory activity.

Abstract: Provided are methods and compositions for treating cancers in patients carrying an IDH1 mutation or IDH2 mutation.

Abstract: Various embodiments relate to the field of liposomal formulations for drug delivery, in particular, liposomal formulations for ocular drug delivery. More specifically, various embodiments relate to sustained timolol maleate delivery from liposomes for glaucoma therapy and ocular hypertension.

Abstract: The present invention provides a crystalline lens hardening inhibitor, containing a compound represented by the formula (I): wherein R1-R4 are the same or different and each is a hydrogen atom, a halogen atom, a hydroxy group, a sulfanyl group, a lower alkyl group, a lower acyl group, a lower alkoxy group, a carboxyl group, a carbamoyl group or a carbonylamino acid group, or a salt thereof, and/or a compound represented by the formula (II): wherein R is a hydrogen atom, or a lower alkyl group optionally substituted by an amino group, a hydroxy group, a sulfanyl group or a carboxyl group, and A is a lower alkylene group, or a salt thereof.

Abstract: A method of alleviating age-related symptoms in a mammal, which comprises a step of administering to a mammal in need thereof, an effective amount of a composition containing an effective amount of at least methylene blue.

Abstract: Unit dosage forms of meloxicam containing either 5 mg or 10 mg of meloxicam that provide effective pain relief and have desirable pharmacokinetic properties are described. The unit dosage forms can provide pain relief when a single unit dose is administered to a patient and useful for treating pain such as osteoarthritis pain at a relatively low systemic exposure to meloxicam.

Abstract: The present invention relates to methods for weight management that utilize modified-release dosage forms comprising (R)-8-chloro-1-methyl-2,3,4,5-tetrahydro-1H-3-benzazepine salts and crystalline forms thereof. The present invention further relates to (R)-8-chloro-1-methyl-2,3,4,5-tetrahydro-1H-3-benzazepine salts, crystalline forms thereof and modified-release dosage forms comprising them.

Abstract: Provided are methods for reversing the effects of drugs of abuse. The method involves administering acyclic CB[n]-type compounds to a mammal in need of the reversal of the effects from a drug of abuse.

Abstract: Provided are methods of treating a cerebral cavernous malformation (CCM) and methods of treating cerebral aneurysm in a mammal with certain rho kinase inhibitors.

Abstract: The present disclosure relates platinum(IV) and texaphyrin linked conjugates and compositions comprising a texaphyrin and a platinum(IV) agent. The present disclosure also provides pharmaceutical compositions of the conjugates and compositions. Also, provided herein are methods of using the instant compounds in the treatment of cancer such as a platinum resistant cancer.

Abstract: A method of contraception in a female is provided. The method includes administering to the female daily for a first number of successive days an oral combination drug formulation of a progestin and an estrogen. The oral combination drug formulation is administered in a multiphasic dosing regimen comprising a second number of phases with duration of each phase is a third number of days. The doses of each of the progestin and estrogen in each subsequent phase of the regimen increase by a predefined dose increment as compared to the corresponding doses of the progestin and estrogen administered during immediately preceding phase of the regimen. The ratio of a daily dose of progestin to a daily dose of estrogen is maintained at a constant level during the entire dosing period. The first number of successive days period is followed by a fourth number of days without progestin and estrogen administration.

Abstract: Methods of treating a testosterone deficiency or its symptoms with a pharmaceutical formulation of testosterone esters are provided. The methods are designed to provide optimum serum testosterone levels over an extended period.

Abstract: The present disclosure is directed to generally methods for treating mammographic breast density and/or breast stiffness in a patient in need thereof, such as a premenopausal or perimenopausal patient, comprising the administration of an effective amount of androgenic agent and an effective amount of an aromatase inhibitor. These methods may also be useful in post-menopausal woman.

Abstract: The present disclosure is drawn to pharmaceutical compositions and oral dosage capsules containing testosterone undecanoate, as well as related methods. The capsule includes a capsule shell and a capsule fill. The capsule fill can include a solubilizer and about 14 wt % to about 35 wt % testosterone undecanoate based on the total capsule fill. The oral dosage capsule is such that when a single oral administration to a male subject of one or more capsules with a total testosterone undecanoate daily dose of about 350 mg to about 650 mg it provides a ratio of serum testosterone Cmax to serum testosterone Cave of about 2.7 or less. In yet another embodiment, a method for providing a serum concentration of testosterone within a target serum testosterone concentration Cave range for a male subject is provided.

Abstract: Described here are substantially pure (17-?)-3-Oxoandrost-4-en-17-yl tridecanoate compositions, methods of their preparation and uses thereof.

Abstract: The present invention provides new compositions and methods for treating and/or reversing organophosphate intoxication, manifested by both cholinergic and non-cholinergic crisis, in a mammal resulting from exposure to organophosphate compounds. The neurosteroidal compounds of this invention are those having the general structural formula of pregnane, androstane, 19-norandrostanes, and norpregnane with further moieties as defined herein. These compounds include, but are not limited to, ganaxolone, pregnanolone, and androstanediol and their analogs, salts and prodrugs. The present invention further relates to combining a therapeutically effective amount of a neurosteroidal compound with a standard organophosphate antidote (e.g. atropine, pralidoxime). The data suggests that neurosteroids are effective or more effective than benzodiazepines, whether given earlier or later than 40-min (up to several hours) after organophosphate compound exposure.

Abstract: The invention relates to a method for treating uterine fibroids, which method comprises administering to a patient in need thereof, an effective amount of 17?-acetoxy-11?-[4-N,N-dimethylamino-phenyl) -19-norpregna-4,9-diene-3,20-dione (ulipristal) or any metabolite thereof. More particularly, the method is useful for reducing or stopping bleeding in a patient afflicted with uterine fibroids, and/or for reducing the size of uterine fibroids.

Abstract: Disclosed herein are methods and formulation for enhancing oral availability of CPT-11 during cancer therapy while at the same time, reducing its gastrointestinal (GI) toxicity, thus the methods and formulations as disclosed herein may augment the efficacy of cancer therapy.

Abstract: Provided herein are 19-nor C3,3-disubstituted C21-pyrazolyl steroids of Formula (I): and pharmaceutically acceptable salts thereof; wherein , R1, R2, R3a, R3b, R4a, R4b, R5, R6, and R7 are as defined herein. Such compounds are contemplated useful for the prevention and treatment of a variety of CNS-related conditions, for example, treatment of sleep disorders, mood disorders, schizophrenia spectrum disorders, convulsive disorders, disorders of memory and/or cognition, movement disorders, personality disorders, autism spectrum disorders, pain, traumatic brain injury, vascular diseases, substance abuse disorders and/or withdrawal syndromes, and tinnitus.

Abstract: By lowering the amount of Sexual Hormone Binding Globulin (SHBG) and, thereafter, raising the serum testosterone level in a person's body, an effective method for treating gastrointestinal disorders such as irritable bowel syndrome and inflammatory bowel disease, including Crohn's Disease and ulcerative colitis, is achieved. First and second androgens, namely, anabolic steroids, are used to lower the SHBG and, thereafter, raise the serum testosterone level in the body, respectively. The SHBG is lowered and the testosterone level is increased until an equilibrium between the SHBG and the second androgen is reached which normalizes the Free Androgen Index (FAI) in the person's body. Preferably, the first androgen used herein to lower the SHBG is stanozolol and the second androgen used herein to normalize the FAI is testosterone.

Abstract: The invention relates to Fatty Acid Acetylated Salicylate Derivatives; compositions comprising an effective amount of a Fatty Acid Acetylated Salicylate Derivative; and methods for treating or preventing an inflammatory disorder comprising the administration of an effective amount of a Fatty Acid Acetylated Salicylate Derivative.

Abstract: An analgesic composition is provided which is safe and effective to patients requiring pain modulation. The analgesic composition contains (a) acetaminophen and (b) at least three components chosen from (i) a bioavailable oral opioid; (ii) a non-steroidal anti-inflammatory drug; (iii) a sulfur-containing, N-acetyl-p-benzoquinone imine scavenging agent or prodrug thereof; or (iv) an agent which lowers acetaminophen toxicity. These analgesic compositions inhibit the formation or reduce the presence of NAPQI, the toxic acetaminophen by-product responsible for liver toxicity in patients. These analgesic compositions are also safely tolerated by patients administering more than the maximum dosage of acetaminophen.

Abstract: This invention relates to pharmaceutically acceptable amphiphilic antioxidant compounds, compositions and dosage forms comprising said compounds and methods and uses reliant on said compounds. The exemplified compounds are all mitoquinone derivatives, being methoxyphenyl alkyl triphenylphosphonium or methoxy dioxocyclohexadiene alkyl triphenylphosphonium derivatives. The compounds, compositions, dosage forms, uses and methods are useful in, for example, the treatment of diseases or conditions associated with oxidative stress.

Abstract: This invention is related to the field of PCSK9 biology and the composition and methods of use of small molecule ligands for modulation of PCSK9 biological activity. In particular, the invention provides compositions of small molecule compounds that modulate circulating levels of low density lipoproteins by altering the conformation of the protein PCSK9. Binding these small molecule ligands to PCSK9 alters the conformation of the protein, modifying the interaction between PCSK9 and an endogenous low density lipoprotein receptor, and can lead to reduced or increased levels of circulating LDL-cholesterol. High LDL-cholesterol levels are associated with increased risk for heart disease. Low LDL-cholesterol levels may be problematic in other conditions, such as liver dysfunction; thus, there is also utility for small molecule ligands that can raise LDL levels.

Abstract: Novel synthetic routes, which are highly applicable for industrial preparation of therapeutically beneficial oxidized phospholipids, are disclosed. Particularly, novel methods for efficiently preparing compounds having a glycerolic backbone and one or more oxidized moieties attached to the glycerolic backbone, which are devoid of column chromatography are disclosed. Further disclosed are novel methods of introducing phosphorus-containing moieties such as phosphate moieties to compounds having glycerolic backbone and intermediates formed thereby. Further disclosed is substantially pure 1-hexadecyl-2-(4?-carboxy)butyl-sn-glycero-3-phosphocholine (CI-201).

Abstract: The present invention is directed to a process for making Nucleoside Phosphoramidate Compounds of formula (I): which are useful for the treatment and prophylaxis of HCV infection. The present invention is also directed to compounds that are useful as synthetic intermediates for making the compounds of formula (I).

Abstract: The present invention describes a method for preparing a polymannan extract from freeze-dried aloe powder. The polymannan extract of the present invention is further used to formulate a sterile injectable formulation for the treatment of one or more cancers, leukemias and lymphomas, prostate cancer, breast cancer, and colon cancer, immune diseases, particularly immune related neoplasms, acquired immune deficiency syndrome, and hepatitis C.

Abstract: The present relates to the use of miRNA-132/212 mimics or activators comprising a doubled stranded ribonucleic acid molecule comprising a seed region sequence of miRNA-132 or miRNA-212, a spacer, a stabilizing sequence, and a carrier for the treatment of neurodegenerative disorders, including Alzheimer's disease, Tauopathies, Amyotrophic lateral sclerosis, Parkinson's disease, frontotemporal dementia, prion's disease, mild cognitive impairment and Huntington's disease.

Abstract: Preparations of glycan therapeutics, pharmaceutical compositions and medical foods thereof, optionally comprising micronutrients, polyphenols, prebiotics, probiotics, or other agents are provided and methods of making same. Also provided are methods of using said glycan therapeutics, e.g. for the modulation of human gastrointestinal microbiota and to treat dysbioses.

Abstract: Compositions and methods involving administration of agents useful for the treatment, prevention, inhibition, etc., of inflammatory disease or fibrous adhesions using low sulphate fucans and, if desired, one or more other anti-inflammatory disease or anti-fibrous adhesion agent.

Abstract: An apparatus for portable delivery of nitric oxide without the need for pressurized tanks, power supplies, or other devices provides a single therapy session by triggering a heater to heat a reaction chamber. A piercing assembly may trigger to open sealed containers, such as bags, of liquid water or salt water in order to activate the heaters. Upon addition of liquid such as water or salt water to a chemically reactive heating element, heat is generated to activate the chemicals generating nitric oxide within a sealed reactor. Upon triggering, liquid containers are unsealed, the liquid drains down to initiate reaction of the heating chemicals, and the heat begins to penetrate the reactor. The reactor, in turn, heats its contents, which react to form nitric oxide expelled by the reactor to a line feeding a cannula for therapy.

Abstract: The invention relates to a drug combination comprising gaseous xenon and at least one antagonist of the NMDA receptors in a liquid or solid form for treating a disease caused by a dysfunction of the dopaminergic synaptic transmission in a human patient. The antagonist of the NMDA receptors is preferably selected from memantine, nitromemantine, amantadine and ifenprodil. The invention allows the normal function of the dopaminergic synaptic transmission of diseased neurons with an altered function to be reestablished.

Abstract: The present invention relates to bath compositions that may release nitric oxide when combined with an aqueous solution, thereby producing a nitric oxide releasing soak and/or bath. The present invention also relates to methods of using nitric oxide releasing bath compositions.

Abstract: A calcium formate composition for oral administration to an individual for the purpose of supplementary dietary calcium is disclosed.

Abstract: Disclosed are antigen specific cancer vaccines in which immunogenic epitopes are produced intracellularly by administration of modified mRNA encoding said immunogenic epitopes. In one embodiment of the invention, said modified mRNA encodes peptides derived from the protein survivin. By directly inducing gene expression of the antigens to which an immune response is desired, immunogenic peptides are generated intracellularly, thus allowing for a wider repertoire of epitopes to be presented to the adaptive immune system, which augments likelihood of successful induction of immunity.

Abstract: The present invention relates to systems and devices to treat and/or prevent inflammatory conditions within a subject and to related methods. More particularly, the invention relates to systems, devices, and related methods that sequester leukocytes and/or platelets and then inhibit their inflammatory action.

Abstract: This disclosure is directed to treatment of a patient having or suspected of having viral hemorrhagic fever, comprising administering to the patient NK-92 cells.

Abstract: A composition comprising TGF?, an inflammatory agent and a tryptophan indoleamine-2,3 dioxygenase (IDO) metabolite, in particular, TGF?, IFN? and kynurenine, is provided, as well as regulatory mesenchymal stem cell lines or myeloid-derived suppressor cell lines obtained by contacting mesenchymal stem cell lines or myeloid-derived suppressor cell lines, respectively, with the composition. Methods for inhibiting proliferation of T cells, reducing Th17 and Tc17 differentiation of activated T cells and inflammation or for treating inter alia graft-versus-host disease (GVHD), comprising administering the cell lines, are further provided.

Abstract: The present invention relates to a method for evaluating the activity level of mesenchymal stem cells, and a method for culturing mesenchymal stem cells using the evaluation method in the field of culturing mesenchymal stem cells for regenerative medicine, and further, a method for producing a therapeutic agent for liver dysfunction and a therapeutic agent for liver dysfunction. This method for evaluating mesenchymal stem cell activity according to the present invention comprises an assay step for assaying the amount of adenylate kinase 4 (AK4) in the mesenchymal stem cells; and a determination step for determining the activity level of the mesenchymal stem cells from the assayed amount of adenylate kinase 4.

Abstract: The present application provides a method of upregulating an expression of immumodulatory cells in vitro comprising treating the immumodulatory cells with IL-25 to increase an expression of PD-L1. The present application also provides a method for treatment of immune disorders by the aforementioned methods. The present application also provides a method to suppress an expression of immumodulatory cells comprising suppressing an expression of PD-L1. The immumodulatory cells can be human monocytes or hMSCs. The present application further provides a method for treatment of immune-evasive diseases by using the aforementioned method to suppress an expression of immumodulatory cells.

Abstract: Compositions and methods for producing reconstituted human skin and/or hair follicles in situ are provided. The method for producing the skin is unique in that tissue culture expanded cells including multipotent cells such as neonatal cells as well as cultured epidermal and dermal cells are immediately placed on a substrate such as a membrane and then the membrane with adherent cells is placed on a skin wound. Examples demonstrate formation of hair follicles in situ.

Abstract: The present invention provides compositions that include an extract of human feces, and methods for using such compositions, including methods for replacing or supplementing or modifying a subject's colon microbiota, and methods for treating a disease, pathological condition, and/or iatrogenic condition of the colon.

Abstract: Provided herein are methods for the repopulation of organs and tissues, such as the liver, using modified cells that express a transcription coactivation factor-ligand binding domain fusion protein, such as a YAP-ERT2 fusion protein. Also provided are compositions, including nucleic acid molecules that encode a YAP-ERT2 fusion protein, YAP-ERT2 fusion polypeptides, and cells containing nucleic acid molecules that encode a YAP-ERT2 fusion protein.