Abstract: The present disclosure relates to nutritional compositions including a protein equivalent source that includes a peptide component comprising selected peptides. The protein equivalent source may further include intact protein, hydrolyzed protein, including partially hydrolyzed protein, or combinations thereof. The disclosure further relates to methods of promoting healthy body weight in a target subject by stimulating adiponectin levels by providing the nutritional compositions disclosed herein to a target subject, which includes a pediatric subject.

Abstract: The present invention is a method and compound for treating cancer and tumors. The invention treats cancer by encapsulating certain cancer fighting drugs in a liposome. Peptides attached to the compound then guide the compound towards its target. During its journey, DSPE-PEG is used to stabilize the compound, to allow more time in the blood stream before losing effectiveness.

Abstract: A method of detecting the presence or absence of a disease in a patient wherein said disease is accompanied by deficient levels of S-adenosylmethionine comprising: identifying a patient that is suspected of having said disease or is at risk of having said disease; obtaining a biological sample from said patient; determining the level of S-adenosylmethionine in said biological sample using an antibody derived from a hapten analog of S-adenosylmethionine; and correlating the level of S-adenosylmethionine in said biological sample with the presence or absence of said disease. The invention also provides methods for measuring SAH which is used to determine the methylation index (ratio of SAM/SAH) in biological fluids which is indicative of the health status of an individual.

Abstract: Compositions provided by contacting a biotin-containing component and an avidin-containing component are useful as drug delivery devices. Bioactive agents may be covalently bound to the biotin-containing component, the avidin-containing component, or both, mixed therewith, or combinations of the foregoing.

Abstract: Compounds are provided having inter alia good duration of action, high potency and/or convenient dosing regimens including once weekly administration. The compounds are engineered polypeptides which incorporate an albumin binding domain in combination with one or more biologically active polypeptides. Also provided are pharmaceutical compositions and methods of treatment for diseases and disorders including lipodystrophy, dyslipidemia, hyperlipidemia, overweight, obesity, hypothalamic amenorrhea, Alzheimer's disease, leptin deficiency, fatty liver disease or diabetes (including type I and type II). Additional diseases and disorders which can be treated by the compounds and methods described herein include nonalcoholic steatohepatitis (NASH) and nonalcoholic fatty liver disease (NAFLD), metabolic syndrome X and Huntington's Disease.

Abstract: The invention relates to improvements in the field of drug delivery. More particularly, the invention relates to polypeptides derived from aprotinin and from aprotinin analogs as well as conjugates and pharmaceutical compositions comprising these polypeptides or conjugates. The present invention also relates to the use of these polypeptides for transporting a compound or drug across the blood-brain barrier of a mammal and in the treatment and diagnosis of neurological diseases.

Abstract: The present invention is directed to compositions and methods of preparation of phospholipid gels.

Abstract: The present invention relates to amylin peptide-carrying nanoparticles, particularly for use in medicine, and includes methods for treatment of disorders, e.g., of blood glucose regulation. Nanoparticle composition comprise a nanoparticle comprising a core comprising a metal and/or a semiconductor; and a corona comprising a plurality of ligands covalently linked to the core, wherein said ligands comprise glutathione; and at least one amylin peptide that is non-covalently bound to the corona.

Abstract: The invention provides cyclo[{4-(NH2—C2H4—NH—CO—O-)Pro}-Phg-DTrp-Lys-Tyr(4-Benzyl)-Phe], optionally in protected form, or a pharmaceutically acceptable salt or complex thereof, which has interesting pharmaceutical properties.

Abstract: Disclosed are novel methods for making cochleates and cochleate compositions that include introducing a cargo moiety to a liposome in the presence of a solvent. Also disclosed are cochleates and cochleate compositions that include an aggregation inhibitor, and optionally, a cargo moiety. Additionally, anhydrous cochleates that include a protonized cargo moiety, a divalent metal cation and a negatively charge lipid are disclosed. Methods of using the cochleate compositions of the invention, including methods of administration, are also disclosed.

Abstract: The present invention is a method of treating various diseases and conditions through administering a substantial caloric load coupled with administration of hormone to stimulate the body to convert that caloric load and increase metabolism in at least some cells. Body functioning converts intracellular adenosine triphosphate (ATP) as a part of normal cell function. Complex control systems balance caloric inputs by managing internal hormone levels to consume, store, or eliminate various types of caloric inputs. This invention stimulates these systems to increase metabolism of cells within the body and thereby treat various diseases and conditions. Many patients find their metabolism after treatment to be in better balance, and the patient's health improved.

Abstract: A composition for preventing or treating an eye disease includes adiponectin as an active ingredient. Adiponectin as an active ingredient is eventually revealed to show prevention or therapeutic efficacies for eye diseases such as dry eye (syndrome), inflammatory eye disease and side effects due to the use of contact lenses by promoting tear secretion, alleviating ocular surface irregularities, decreasing inflammatory cytokines on the ocular surface and lacrimal gland, and increasing conjunctival goblet cell density. In addition, the composition having eye contact lubrication effects may be used as cleaners or lubricants for preventing non-bacterial inflammation due to wearing contact lenses.

Abstract: The present invention provides heteroaromatic derivatives and pharmaceutical acceptable salts and formulations thereof useful in modulating the protein kinase activity, especially phosphatidylinositol 3-kinases (PI3 kinases) and mTOR, and in modulating inter- and/or intra-cellular signaling activities such as proliferation, differentiation, apoptosis, migration and invasion. The invention also provides pharmaceutically acceptable compositions comprising such compounds and methods of using the compositions in the treatment of hyperproliferative disorders in mammals, especially humans.

Abstract: The invention provides a powdered composition for nasal administration, comprising a physiologically active peptide and cellulose acetate as the base, and having excellent nasal absorption for physiologically active peptides.

Abstract: This invention is a method of killing the stealthy intra-cellular bacteria which are key to the pathogenesis Cancers. These very tiny L-form Cell-Wall-Deficient (CWD) antibiotic-resistant bacteria live within the cytoplasm of cells, including the phagocytic cells (e.g. monocytes, macrophages, lymphocytes, neutrophils and polymorphonuclear cells) of the immune system itself. The cellular proliferation in Cancer is catalysed the action of the same tiny L-form bacteria. They cause the cell nucleus to release mRNA signaling the Th1 cytokine cascade without the need for conventional signaling via, for example, CD4+T -Lymphocytes. Some of these Cytokines and Chemokines, including, without limitation, Cellular Adhesion Molecule (CAM), create the environment which allows the cellular proliferation to start, and then allows the cancerous growth to gain a foothold in the body. Killing these stealthy pathogens removes the environment needed to initiate and feed the cellular proliferation commonly called ‘Cancer’.

Abstract: The invention provides methods and compositions for treating, preventing and/or remedying psoriasis, based on compounds that have a calcitonin-related gene peptide (CGRP) antagonistic effect. Methods are also disclosed for identifying compounds with CGRP antagonist activity which thereby are suitable candidate compounds for treating psoriasis.

Abstract: There are provided polypeptide conjugates having enhanced duration of biological activity, and methods of use thereof. The polypeptide conjugates include duration enhancing moieties, including water soluble polymers, bound to the polypeptide components of defined sequence. Methods of use are provided for treatment of metabolic disorders. Methods of use are provided for treatment of an eating disorder, insulin resistance, obesity, overweight, abnormal postprandial hyperglycemia, Type I diabetes, Type II diabetes, gestational diabetes, metabolic syndrome, dumping syndrome, hypertension, dyslipidemia, cardiovascular disease, hyper lipidemia, sleep apnea, cancer, pulmonary hypertension, cholescystitis, osteoarthritis, or short bowel syndrome.

Abstract: Provided are novel biocompatible copolymers and compositions comprising the copolymers. The copolymers are non-toxic and typically have an LCST below 37° C. Compositions comprising the copolymers can be used for wound treatment, as a cellular growth matrix or niche and for injection into cardiac tissue to repair and mechanically support damaged tissue. The copolymers comprise numerous ester linkages so that the copolymers are erodeable in situ. Degradation products of the copolymers are soluble and non-toxic. The copolymers can be amine-reactive so that they can conjugate with proteins, such as collagen. Active ingredients, such as drugs, can be incorporated into compositions comprising the copolymers.

Abstract: Polyurethane microparticles are derived from structural units comprising poly(alkylene oxide) moieties, caprolactone moieties and urethane moieties. The microparticles may include an active agent and have a particle size from 0.1 to 100 microns. Microparticles for injection have a particle size of 15 to 80 microns; for use as a aerosol 1 to 3 microns; and for intraocular use 0.02 to 2 microns. Dispersivity is in the range 1 to 3.

Abstract: A method of synthesizing PHA nanocapsules as a protein carrier, particularly, the synthesis of PHA nanocapsules synthesized by a modified precipitation/solvent evaporation technique with neutralization. Specifically, the method comprises the steps of sonicating a first solution comprising a triblock PHA copolymer, stirring the first solution into a second solution to give a third solution, the second solution containing a protein, and the second solution being acidic. Further, the method comprises adding the third solution with a neutralizing agent to give a neutralized solution, and sonicating the neutralized solution to form a final solution, wherein the synthesized PHA nanocapsules containing the protein are formed in the final solution. Further, PHA nanocapsules encapsulated with the protein is used by administering the synthesized PHA nanocapsule to an animal in need thereof via the oral cavity.

Abstract: The present invention provides a method for manufacturing a virus-free protein drug, comprising (a) a filtration step of filtering a virus-containing protein solution through a small-pore size virus removal membrane to obtain a virus-free protein solution, the filtration step (a) comprising (q) a low-pressure filtration step of filtering the solution through the small-pore size virus removal membrane at a filtration pressure of 0.30 kgf/cm2 or lower to obtain the virus-free protein solution, wherein the solution prior to filtration in the low-pressure filtration step (q) has a pH (X) and a salt ionic strength (Y (mM)) that satisfy the following equations 1 and 5: 0?Y?150X?590 (Equation 1) and 3.5?X?8.0 (Equation 5) or the following equations 4 and 5: Y=0 (Equation 4) and 3.5?X?8.0 (Equation 5).

Abstract: The specification describes a substance comprising a plurality of microparticles. The microparticles comprise a core comprising a first polymer and a shell surrounding said core and comprising the first polymer and a second polymer, wherein the second polymer is less rapidly degradable than the first polymer. A process for making the microparticles and uses of the microparticles are also described.

Abstract: Disclosed herein are diketopiperazine microparticles having a specific surface area of less than about 67 m2/g. The diketopiperazine microparticle can be fumaryl diketopiperazine and can comprise a drug such as insulin.

Abstract: A pharmaceutically delivery system is described comprising a pharmaceutically active agent and acidified nitrite as an agent to produce local production of nitric oxide at the skin surface. The dosage form may be in any pharmaceutically acceptable carrier means and comprises an acidifying agent adapted to reduce the pH at the environment. In one embodiment, a barrier consisting of a membrane allows diffusions of the anaesthetic and nitrite ions while preventing direct contact of the skin and acidifying agent.

Abstract: The disclosure relates to BAX activators and therapeutic uses relates thereto. In certain embodiments, the disclosure relates to methods of treating or preventing cancer, such as lung cancer, comprising administering a therapeutically effective amount of a pharmaceutical composition comprising a compound disclosed herein or pharmaceutically acceptable salt to a subject in need thereof.

Abstract: Provided are therapeutic and diagnostic somatostatin analogs including radiotherapeutic and radiodiagnostic reagents, and methods of making and use thereof.

Abstract: Methods and compositions for the enteral treatment of autoimmune disease such a multiple sclerosis with polypeptide therapeutics. Enteral therapeutics comprise monomeric alpha-MSH polypeptides such as ACTH. Therapeutic formulations of the invention may be used to reduce the incidence or severity of autoimmune disease. For instance methods for the oral treatment of multiple sclerosis with alpha-MSH and ACTH are described.

Abstract: The present invention provides pharmaceutical formulations for sustained release, and methods for delivering a treatment regimen with a combination of sustained release and long half-life formulations. The invention provides improved pharmacokinetics for peptide and small molecule drugs.

Abstract: Methods and compositions are provided for labeling proteins with radiohalogen-label reagents. Radiohalogen-labeled proteins may be used for imaging studies, as therapeutics and in diagnostic tests. The [125I] HIP-DOTA label reagent 6 is prepared by an efficient and convenient process.

Abstract: Stable formulations for parenteral injection of peptide drugs and methods of using such stable formulations are provided. In particular, the present invention provides stable formulations for parenteral injection of glucagon and methods of using such glucagon formulations to treat hypoglycemia, especially severe hypoglycemia in emergency situations.

Abstract: The present invention relates to a method for preparing by wet spinning a continuous filament based on hyaluronic acid in free acid form, notably soluble in water. The preparation method according to the invention comprises the following steps: a) preparing a spinnable aqueous solution of hyaluronic acid or of a hyaluronic acid salt, preferably a sodium hyaluronate solution; b) extruding said solution to an extrusion die; c) forming the filament by passing the extruded solution into a bath of acetic acid, concentrated to more than 80%, drawing and drying. The invention also relates to a filament based on hyaluronic acid in free acid form, said filament having swelling properties in water and physiological liquids and moreover being solubilizable in water under certain conditions.

Abstract: The present invention provides a storage-stable composition containing a parathyroid hormone-related protein (PTHrP) and methods of using a PTHrP and the PTHrP compositions described herein to treat osteoporosis, to increase bone mass or to increase bone quality. The composition is storage stable, in sterile form, and in general may be stored at room temperature for at least several weeks to allow convenient parenteral administration to human patients.

Abstract: The invention relates to polypeptides comprising an amino acid sequence which is an analogue of pramlintide, pharmaceutical compositions comprising these polypeptides, and these polypeptides for use as medicaments.

Abstract: The present disclosure provides a method, composition and kit for treatment of inflammatory disease and disorder using PKC isoform modulators.

Abstract: The present invention provides a combination of compounds capable of modulating xenin activity and, insulin secretion and weight gain. The invention also provides methods for modulating GIP activity and insulin secretion in a subject, by modulating xenin activity in the subject.

Abstract: Disclosed herein is a skin condition-improving composition for topical application to the skin, comprising human placental lactogen (hPL) as an active ingredient. The disclosed method and composition exhibit various skin-conditioning effects, such as preventing and/or reducing atopic dermatitis, ultraviolet-light-caused skin damage, wrinkles, age spots, skin pigmentation, acne, itching, xerosis, and skin aging; and such as improving skin elasticity and moisturization.

Abstract: Materials and methods for treating a patient to express a therapeutic agent comprising administering a Kupffer cell-suppressing substance in combination with a vehicle for introducing, into the patient, an exogenous nucleic acid comprising a sequence for expression of the agent.

Abstract: Methods are provided for coating crystalline microparticles with an active agent by altering the surface properties of the microparticles in order to facilitate favorable association on the microparticle by the active agent. Type of surface properties that are altered by the disclosed methods include by electrostatic properties, hydrophobic properties and hydrogen bonding properties.

Abstract: Methods and compositions are disclosed to treat metabolic disorders such as obesity, diabetes, and increased cardiovascular risk comprising administering a therapeutically effective amount of a PYY or a PYY agonist.

Abstract: A pharmaceutical composition for preventing fibrosis, treating fibrosis, and/or preventing the progression of fibrosis contains stanniocalcin 1 (STC1) as an active ingredient; or a pharmaceutical composition for preventing pulmonary fibrosis, treating pulmonary fibrosis, and/or preventing the progression of pulmonary fibrosis contains STC1 as an active ingredient. A method for treating, preventing or suppressing progression of fibrosis using the above pharmaceutical composition. The fibrosis may be pulmonary fibrosis.

Abstract: A method for promoting bone formation is provided. More specifically, a method for promoting bone formation by promoting osteoclast formation is provided. In one embodiment, an implant comprising an implantable material and an osteoclast stimulating substance is provided.

Abstract: Compositions, kits, and methods are provided directed to the treatment of prostate cancer using a maintenance dose of degarelix or pharmaceutically acceptable salt thereof, an excipient, and a solvent.

Abstract: The present disclosure provides inter alia conjugates of formula (I): wherein n, R1, R2, Rx, Z, X, Y and Z are as defined herein. A conjugate of formula (I) can also be converted to a conjugate of formulae (II) or (III) as described herein. Without limitation, the conjugates can be used to make controlled release materials and chemical sensors.

Abstract: The present invention relates to novel complex peptidomimetic products comprising multiple homogeneous or heterogeneous pendant groups that are site-specifically positioned along a linear oligomer or polymer scaffold and methods of making thereof. More specifically, the invention relates to N-substituted glycine peptoid oligomers or peptoids and their use as substrates for azide-alkyne [3+2]-cycloaddition conjugation reactions and subsequent additional rounds of oligomerization and cycloaddition. The methods of the invention may also be used to generate peptoid-peptide hybrid or peptide products comprising multiple homogeneous or heterogeneous pendant groups, which are positioned precisely along the linear oligomer or polymer scaffold.

Abstract: The present invention relates to compositions comprising growth hormone linked to extended recombinant polypeptide (XTEN), isolated nucleic acids encoding the compositions and vectors and host cells containing the same, and methods of making and using such compositions in treatment of growth hormone-related diseases, disorders, and conditions.

Abstract: The invention relates to a therapeutic device for the delivery of therapeutic agents, e.g. a peptide such as leuprolide, via the vagina to a female mammal. In some embodiments, the invention also relates to methods for the treatment of obesity and eating disorders, diabetes, multiple sclerosis (MS), endometriosis, uterine fibroids, polycystic ovarian disease, various cancers such as breast cancer, acne, hirsutism, microbial or fungal or viral infections such as bacterial vaginosis or AIDS/HIV, and chronic diseases using a disclosed vaginal device.

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 (HCG), a pharmaceutically active HCG analogue, and a pharmaceutically active metabolite of the HCG or analogue at a dosage selected to provide, or be equivalent 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 kit is also described, which includes a supply of the HCG-related drug, and a label that identifies chronic pain or central sensitization as an indication of the drug.

Abstract: It has been discovered that granulocyte macrophage colony stimulating factor (“GM-CSF”) promotes migration of activated (but not differentiating) keratinocytes to wound sites. It was also discovered that GM-CSF increases the quantity and improves the quality of collagen. This growth factor specifically increases migration of keratinocytes of the “wound” phenotype but does not have significant effects upon differentiated keratinocytes. Examples demonstrate reversal of skin impairment in multiple animal models of diabetic skin imparment when provided in an effective amount over an effective time period. The examples also demonstrate the efficacy of the formulations in cosmetic applications.

Abstract: Nanoparticles, compositions, and methods for the improved uptake of active agents are disclosed herein. The compositions contain a monodisperse population of nanoparticles, preferably including an active agent, where the nanoparticles are formed from a polymeric material possessing specified bioadhesion characteristics. Following enteral administration, preferably oral administration, the nanoparticles exhibit total intestinal uptakes of greater than 20%, preferably greater than 45%, more preferably greater than 65%. When compared to uptake of the same compositon in the absence of the bioadhesive polymeric material, the nanoparticles have significantly increased uptake with intestinal uptake of the increased by more than 100%, preferably even greater than 500%. Further disclosed herein is a method of producing multi-walled nanoparticles, as well as methods of using thereof. Multi-walled particles prepared using the method disclosed herein are useful for controlling the release of active agents.

Abstract: A nasal delivery device for and method of delivering a substance, preferably comprising oxytocin, non-peptide agonists thereof and antagonists thereof, preferably as one of a liquid, as a suspension or solution, or a powder to the nasal airway of a subject, preferably the posterior region of the nasal airway, and preferably the upper posterior region of the nasal airway which includes the olfactory bulb and the trigeminal nerve, and preferably in the treatment of neurological conditions and disorders.