Abstract: A proteomic expression platform to identify age-related sepsis risk is disclosed using patients with community-acquired pneumonia. A semi-quantitative plasma proteomics workflow was applied which incorporated tandem immuno affinity depletion, iTRAQ labeling, strong cation exchange fractionation, and nanoflow-liquid chromatography coupled to high resolution mass spectrometry. A protein profile was determined that exhibit statistically significant differences in expression levels amongst patients with severe sepsis as a function of age. Representative pathways that are differentially-expressed include, but are not limited to, acute phase response, coagulation signaling, atherosclerosis signaling, lipid metabolism, and production of nitric oxide/reactive oxygen species.

Abstract: Disclosed are formulations comprising multivesicular liposomes and one or more non-steroidal anti-inflammatory drugs which minimize the side effects of unencapsulated non-steroidal anti-inflammatory drugs while maintaining or improving efficacy. Methods of making and administering the formulations comprising multivesicular liposomes and one or more non-steroidal anti-inflammatory drugs and their use as medicaments are also provided.

Abstract: Composition, preferably, in the form of capsules or chewable wafers in quantities suitable for relieving the symptoms of fibromyalgia comprise formulations of phospholipids, specifically identified concentrations of phosphatidylglycerol, phosphatidic acid, phosphatidylethanolamine, phosphatidylcholine, glycolipids and phosphatidylserine along with inulin and other desirable active ingredients are described.

Abstract: The present invention includes compositions and methods for preventing one or more cardiac channelopathies or conditions resulting from irregularities or alterations in cardiac patterns caused by an active agent or a drug in a human or animal subject comprising: an amount of a lysophosphatidylglycerol adapted for oral administration effective to reduce or prevent one or more cardiac channelopathies or conditions resulting from irregularities or alterations in cardiac patterns caused by the active agent or drug.

Abstract: The present invention provides a method for removing a tattoo in a region of skin the method comprises administering to a least a portion of the tattoo, and a composition comprising an effective amount of a bisphosphonate and at least one pharmaceutically acceptable excipient to at least cause fading of the tattoo in said region.

Abstract: This invention relates to coated digestive enzyme preparations and enzyme delivery systems and pharmaceutical compositions comprising the preparations. This invention further relates to methods of preparation and use of the systems, pharmaceutical compositions and preparations to treat persons having ADD, ADHD, autism, cystic fibrosis and other behavioral and neurological disorders.

Abstract: This invention relates to a suppository composition comprising cannabinoids. The suppository composition is formulated for easy absorption through mucosal membrane. The suppository as provided herein is useful for administration of cannabinoids in patients with nausea, vomiting, other conditions preventing swallowing, or conditions wherein suppository administration is required. Methods to manufacture the suppository composition are provided. Methods to treat pain, nausea, post-operative ileus and/or inflammatory bowel diseases using the suppository according to this invention are also provided.

Abstract: Provided are compositions comprising porphyrin-phospholipid nanovesicles (PoP-NVs) which can be loaded with cargo. Methods for release of cargo from the PoP-NVs triggered by near infrared (NIR) light are also disclosed.

Abstract: The present invention provides, among other things, methods and compositions for delivering an antibody in vivo by administering to a subject in need thereof one or more mRNAs encoding a heavy chain and a light chain of an antibody, and wherein the antibody is expressed systemically in the subject. In some embodiments, the one or more mRNAs comprise a first mRNA encoding the heavy chain and a second mRNA encoding the light chain of the antibody.

Abstract: The present invention includes compositions and methods for the expression, secretion and use of novel compositions for use as, e.g., vaccine and antigen delivery vectors, to delivery antigens to antigen presenting cells. In one embodiment, the vector is an anti-CD40 antibody, or fragments thereof, and one or more antigenic peptides linked to the anti-CD40 antibody or fragments thereof, including humanized antibodies.

Abstract: The invention provides compositions that may be used for imaging intracellular structures. The invention further provides methods of imaging intracellular structures. In certain embodiments, the compositions of the invention include trans-cyclooctene-containing ceramide lipids and tetrazine-containing rhodamine-related dyes.

Abstract: The present invention provides compositions useful in reducing or preventing pain in a subject in need thereof. In one embodiment, the compositions comprise a halogenated volatile compound. The present invention further includes a method of reducing or preventing pain in a subject in need thereof, the method comprising administering to the subject a therapeutically effective amount of a composition of the invention. Dosing regimens contemplated within the invention include one-time administration, continuous administration or periodic administration.

Abstract: Provided herein are materials and methods for delivering immunoglobulins (e.g. therapeutic immunoglobulins) across the blood-brain barrier.

Abstract: In certain aspects, provided herein are RNA complexes (e.g., asymmetric RNA complexes, such as asiRNAs and lasiRNAs) that inhibit tyrosinase expression and are therefore useful for reducing melanin production and for treating pigmentation-related disorders associated with excessive melanin production, such as melasma and age spots.

Abstract: Methods and compositions to reduce immunogenicity of proteins are disclosed. Compositions comprising therapeutic proteins (such as Factor VIII or any other protein or peptide) complexed with liposomes comprising PS and PC (PS liposomes), or comprising PS, PI and PC and, optionally, cholesterol (PS/PI liposomes) may be used.

Abstract: The present invention relates to chimeric chemical compounds which are used to recruit antibodies to cancer cells, in particular, prostate cancer cells or metastasized prostate cancer cells. The compounds according to the present invention comprise an antibody binding terminus (ABT) moiety covalently bonded to a cell binding terminus (CBT) through a linker and optionally, a connector molecule.

Abstract: Provided are internalizing nucleic acid molecules (“iNA”) that can bind and internalize into target cells containing a cell surface molecule to which the iNA can bind; an iNA further modified to include at least one chemical modification, wherein the at least one modification is selected from the group consisting of a chemical substitution in the nucleic acid sequence of the iNA, incorporation of a modified nucleotide into the iNA, conjugation to a linker, and conjugation to at least one effector moiety comprising one or more of a drug or a detectable moiety or a combination thereof; and methods of using modified iNA to deliver at least one effector moiety into the target cells.

Abstract: This invention provides for a compound of formula (I): or a pharmaceutically acceptable salt thereof, wherein R1-R4, n and p are defined herein. The compounds of formula (I) and pharmaceutically acceptable salts thereof are cationic lipids useful in the delivery of biologically active agents to cells and tissues.

Abstract: The present invention relates to agrochemical compositions comprising certain benzamide compounds and to the use of those benzamide compounds as adjuvants, especially in formulations, in particular in agrochemical formulations and in environmentally friendly formulations. The invention further extends to certain novel benzamide compounds and a process to prepare such novel compounds.

Abstract: This invention relates to compositions containing combinations of a balanced phosphatidylcholine composition and one or more cannabinoids, a natural or synthetic derivative thereof, or a salt thereof, and kits containing such combinations and methods of using such combinations to treat subjects suffering from an imbalance of fatty acids and related diseases or disorders. This invention also relates to the synergistic effect of such combination therapies in humans.

Abstract: The compound N-(4-{[4-amino-2-butyl-1H-imidazo[4,5-c]quinolin-1-yl]oxy}butyl)octadecanamide is a useful drug compound for enhancing immune response and can be used, for example, as a vaccine adjuvant and a cancer treatment.

Abstract: Disclosed is an apparatus and methods for its use that is configured to be used to treat various skin conditions. The apparatus includes a water-permeable absorbent material and a plant material comprising a water-soluble skin-active ingredient. The plant material is enclosed within the water-permeable absorbent material, and the water-permeable absorbent material is configured to absorb water and allow the absorbed water to contact the plant material so as to release the active ingredient from the plant material. The active ingredient is then absorbed by the absorbent material, which is then topically applied to skin in need of skin treatment.

Abstract: The present invention relates to hydroxy-triglycerides, their synthesis, a pharmaceutical and/or nutraceutical composition which comprises at least one of said hydroxy-triglycerides, and a method which comprises the administration to a patient of a therapeutically effective quantity of at least one of said hydroxy-triglycerides or at least one of said pharmaceutical and/or nutraceutical compositions, for the prevention and/or treatment of at least one disease selected from cancer, metabolic/cardiovascular diseases, and/or neurological/inflammatory diseases.

Abstract: The present invention provides a composition for the treatment of cancer including zwitterionic liposomes consisting essentially of: 50-65 mol % of a phosphatidylcholine lipid, 30-45 mol % of cholesterol, and 2-8 mol % of a PEG-lipid; and cisplatin. Cisplatin is encapsulated in the liposomes in an amount such that the ratio of the total lipid weight to the cisplatin weight is from about 65:1 to about 95:1. Methods for the preparation of liposomal cisplatin and the treatment of cancer are also disclosed.

Abstract: Disclosed are synthetic nanocarrier compositions that provide controlled release of immunosuppressants as well as related methods. The synthetic nanocarrier compositions may also include antigen in some embodiments.

Abstract: The present invention refers to the use of N-acetyl-5-methoxytryptamine (melatonin) and/or an analog thereof, for use in the medical or veterinary field in the assisted reproduction for promoting the mechanism of implantation of the embryo, and in particular for the prevention of implantation failure into the uterus, by topical administration of an effective amount in a mammalian subject female in need of such treatment, and related compositions, culture media and medical devices.

Abstract: Compositions for delivery of growth factors needed for stable Tregs and methods of use thereof are provided. In preferred embodiments, the compositions can induce, increase, or enhance a functionally robust induced CD4 Treg population (e.g., Foxp3+ Treg) in vivo or ex vivo. The compositions generally include delivery vehicles including TGF-? and IL-2. Delivery vehicles include, for example, polymeric particles, silica particles, liposomes, or multilamellar vesicles. The TGF-? and IL-2 are typically co-loaded into, attached to the surface of, and/or enclosed within the delivery vehicle into the same particle for simultaneous co-delivery to cells such as T cells. Preferably the delivery vehicles are targeted to CD4. The compositions and cells treated therewith can be used in various methods of treating, for example, inflammation, inflammatory and autoimmune diseases and disorders, and inducing or maintaining tolerance including graft and transplant tolerance.

Abstract: The present invention provides a method for inducing glucose uptake in a muscle cell by inhibiting Trim32 protein in the cell and to a method for inducing glucose uptake in a muscle cell, by increasing the abundance of plakoglobin protein in the cell.

Abstract: The present invention relates to compositions comprising therapeutic and/or diagnostic anionic agents together with cationic peptides and their use in methods for delivering the anionic agents to bladder cells.

Abstract: The present invention provides cell lines for producing single chain FVIII polypeptides, e.g., chimeric single chain FVIII polypeptides, methods of producing single chain FVIII polypeptides, single chain FVIII polypeptides, and methods of treating Hemophilia A with a single chain Factor VIII polypeptide.

Abstract: A method of preparing liposomes, liposome compositions formed by the process, and methods of using the liposome composition are provided herein.

Abstract: Disclosed herein are embodiments of a composition comprising a drug in a polymer nanoparticle. The nanoparticles may have a size and/or a surface potential selected to facilitate lymph node uptake and/or dissemination throughout the lymphatic system. The nanoparticle may be a polyethyleneglycol-block-poly(?-caprolactone) (PEG-PCL) nanoparticle. Also disclosed are embodiments of a method of using the composition. The composition may be administered subcutaneously. The drug-loaded nanoparticles are useful for treating certain cancers and/or decreasing the number of melanocytes in lymph nodes that are proximal to, distal to or both proximal and distal to a site of administration.

Abstract: The present invention is directed to a method for treating cancer intraperitoneally in a subject. The method comprises administering to said subject in need thereof an anti-cancer agent encapsulated in nanoparticles wherein nanoparticles are characterized to slowly release anti-cancer agent in a timely fashion that allows efficient killing of tumor cells. The nanoparticles described herein are characterized to slowly release anti-cancer agent at a rate of 30% or less per 24 hours based on in vitro drug dissolution study.

Abstract: The present application describes amphiphatic compounds like compound IIa below, compositions and methods for incorporating chemoselective and bio-orthogonal complementary functional groups into liposomes. Such compounds are incorporated in greater numbers in liposome and fused cell surfaces, leading to greater adhesion and conjugation efficiency. The present application also describes various uses of these modified liposomes including for tethering the chemoselective and bioorthogonal complementary functional groups from cell surfaces by liposome delivery toward the goal of rewiring the cell surface.

Abstract: The present invention provides nanoparticle compositions including one or more nucleic acids. The present invention achieves delivery (particularly transdermal delivery) of such nucleic acids without the need for nucleic acid modification, or for use of chemical or mechanical abrasion or disruption of skin.

Abstract: A polymeric material comprising a polyethylenimine-based material including the following moiety: attached thereto, wherein R1 is a group including at least one carbon atom and n is from 2 to 4 is disclosed. A method for preparing a polyethylenimine-based material is disclosed. A gene therapy method using a polymeric material including polyethylenimine-based material is also disclosed.

Abstract: New liposomes are described, comprising: (i) phosphatidic acid and/or cardiolipin; (ii) apolipoprotein E (ApoE) or derivatives thereof. The so modified liposomes, administered systemically, obtain a dramatic in-vivo reduction of the amyloid plaque in the central nervous system, allowing an effective treatment of neurodegenerative diseases, in particular Alzheimer's disease.

Abstract: Disclosed are synthetic nanocarrier methods, and related compositions, comprising administering MHC Class I-restricted and/or MHC Class II-restricted epitopes of an antigen and immunosuppressants in order to generate tolerogenic immune responses against the antigen, such as the generation of antigen-specific CD8+ regulatory T cells.

Abstract: Provided are liposomes encapsulating mupirocin, with particular benefit for systemic therapeutically effective delivery. Also provided herein are pharmaceutical compositions including the liposomes and methods of using them. The liposomes include a lipid membrane and an intraliposomal compartment, the intraliposomal compartment encapsulating mupirocin, at least one cyclodextrin compound and a pH dependent ionizable anion, e.g. acetate.

Abstract: Obesity is inhibited by administering to a person in need thereof an effective amount of entacapone ((2E)-2-cyano-3-(3,4-dihydroxy-5-nitrophenyl)-N,N-diethylprop-2-enamide), or a pharmaceutically-acceptable salt thereof, particularly in conjunction with a second, different anti-obesity medicament. Pharmaceutical compositions comprise entacapone copackaged or coformulated with a second, different anti-obesity medicament.

Abstract: The present invention provides liposome compositions containing sparingly soluble drugs that are used to treat life-threatening diseases. A preferred method of encapsulating a drug inside a liposome is by remote or active loading. However, this process as described in the literature has been limited to drugs that are freely soluble in aqueous solution or solubilized as a water-soluble complex. This invention describes compositions and methods for remote loading drugs with low water solubility (<2 mg/mL). In the preferred embodiment the drug in the solubilizing agent is mixed with the liposomes in aqueous suspension so that the concentration of solubilizing agent is lowered to below its capacity to completely solubilize the drug. This results in the drug precipitating but remote loading is capability retained.

Abstract: The instant invention is drawn to a hepatocyte targeted composition comprising insulin associated with a lipid construct comprising an amphipathic lipid and an extended amphipathic lipid that targets the construct to a receptor displayed by an hepatocyte. The composition can comprise a mixture of free insulin and insulin associated with the complex. The composition can be modified to protect insulin and the complex from degradation. The invention also includes methods for the manufacture of the composition and loading insulin into the composition and recycling various components of the composition. Methods of treating individuals inflicted with diabetes.

Abstract: Formulations and methods for their preparation including a hydrogel including a crosslinked matrix comprising a polymer, and a one or more liposomes containing a therapeutic agent.

Abstract: The present invention provides, among other things, nanoparticle compositions including a plurality of nanoparticles, each of which is comprised of a biodegradable or biocompatible polymer arranged in a nanoparticle structure defining an internal lumen and an external surface and one or more of a preparation of hydrophilic cellular components and a preparation of hydrophobic cellular components. In some embodiments, the preparation of hydrophilic cellular components is encapsulated within the internal lumen and the preparation of hydrophobic cellular components is associated with the external surface. Various methods of making and using disclosed nanoparticle compositions are also provided.

Abstract: The present invention relates to a liposomal formulation containing a therapeutic agent and a process for producing the formulation. The liposomal formulation comprises particular characteristics that enhance uniformity and stability of the formulation. The manufacturing process is a novel process that produces a liposomal formulation of a uniform size with many desirable properties that may be independently controlled. Further, the invention relates to a liposome formulation made in accordance with the manufacturing process.

Abstract: What is described is a pharmaceutical formulation for intranasal delivery of insulin to a patient, comprising an aqueous mixture of human insulin, a solubilizing agent, a surface active agent, and a thickening agent, wherein said formulation provides a ultra-rapid acting profile to regular human insulin.

Abstract: The present invention relates to compositions in the form of oil-in-water dispersions comprising a silicone oil having an average droplet diameter from about 30 microns to about 2000 microns and a polymeric thickening agent. These compositions are useful for stimulating collagen production in human patients and other mammals, and have applications for soft tissue augmentation for various medical and cosmetic procedures. The present invention also relates to methods for preparing these compositions and to methods for stimulating collagen production in human patients and other mammals in need thereof. In contrast to the prior art, the compositions and methods of the present invention are particularly useful for stimulating the production of high quality collagen that is uniform, smooth, long-lasting, and having good structural integrity.

Abstract: A method and composition for treating a cancerous tumor in a subject by targeting the tumor's vasculature using an enzyme conjugate comprising a ligand which binds to endothelial cells in the tumor vasculature and converts a prodrug administered to the subject into an anticancer drug in the tumor vasculature.

Abstract: Nanolipidic Particles (NLPs) having average mean diameters of 1 nm to 20 nm are made from a precursor solution. NLPs can be loaded with a desired passenger molecule. Assemblies of these particles, called NLP assemblies, result in a vehicle population of a desired size. Single application or multifunction NLP assemblies are made from the loaded NLPs and range in size from about 30 to about 200 nm. A method of using preloaded NLPs to make larger carrier vehicles or a mixed population provides increased encapsulation efficiency. NLPs have application in the cosmetics, pharmaceutical, and food and beverage industries.

Abstract: Methods for formulating and compositions of immediate and sustained release liposomal products which comprise a surfactant that interacts with liposomes to effect drug release therefrom, and delivery of such for treatment of respiratory tract infections and other medical conditions, and devices and formulations used in connection with such are described.