Abstract: An endotoxin nanovesicle for enhancing type 1 T helper cell-induced immunological responses is disclosed. The endotoxin nanovesicle comprises: (a) lipopolysaccharide molecules, assembled into a vesicle with a wall surrounding an inner space; and (b) hydrophilic gold nanodots, localized in the wall of the vesicle. Methods of suppressing formation of cubosomes and/or hexosomes in lipopolysaccharide aggregation or assembly, and methods of preparing a lipopolysaccharide adjuvant are also disclosed. Also disclosed are compositions comprising an endotoxin aggregate or an endotoxin nanoversicle and optionally an immunogenic antigen.

Abstract: Disclosed herein are compounds and related compositions for the treatment of viral infection, including RNA viral infection, and compounds that can modulate the RIG-I pathway in vertebrate cells, including compounds that can activate the RIG-I pathway.

Abstract: Disclosed are methods, kits, polypeptides, and pharmaceutical compositions for inducing an immune response in a subject, which may include a T-cell mediated immune response. The methods comprise administering to the subject, or to explanted cells of the subject, a pharmaceutical composition comprising an effective amount of versikine or a variant of versikine that induces the T-cell mediated immune response. The methods, kits, polypeptides, and pharmaceutical compositions may be used, in particular, to treat a subject having a cell proliferative disease or disorder.

Abstract: The present invention relates to a therapy for treating or preventing several diseases in animals, based on the administration of a highly concentrated avian derived immunoglobulins formulation, obtained from the egg yolk from hens previously hiper-immunized with a vaccine formulation comprising infectious agents or toxins antigens, a light mineral oil and a particulate adjuvant.

Abstract: Polyphosphazene polymers having immunomodulating activity, and the biomedical use of such polyphosphazene polymers, in conjunction with an antigen or an immunogen are disclosed.

Abstract: Embodiments described herein relate to restorative solutions for segmental peripheral nerve (PN) defects using allografted PNs for stimulating PN repair. More specifically, embodiments described herein provide for localized immunosuppression (LIS) surrounding PN allografts as an alternative to systemically suppressing a patient's entire immune system. Methods include localized release of immunosuppressive (ISV) agents are contemplated in one embodiment. Methods also include localized application of immunosuppressive (ISV) regulatory T-cells (Tregs) in other embodiments. Hydrogel carrier materials for delivery of ISV agents and are also described herein.

Abstract: Immunogenic influenza hemagglutinin-derived peptide conjugates described herein induce a specific therapeutic antibody response against influenza virus. The immunogenic peptide conjugates comprise a segment from the fusion initiation region (FIR) domain of an influenza hemagglutinin protein conjugated to an immunogenic carrier protein, such asbovine serum albumin (BSA), an influenza hemagglutinin (HA) protein (i.e., full length HA), and the like. The immunogenic peptide conjugates described herein can be utilized to treat or prevent influenza infection and to prepare influenza-specific therapeutic antibodies that interfere with influenza virus-host cell membrane fusion. The peptide conjugates can be formulated in pharmaceutical compositions useful for broad spectrum treatment or prevention of influenza infections.

Abstract: Methods for treating cancer patients (e.g., cancer patients resistant or intolerant to pertuzumab and ado-trastuzumab emtansine) with HER2-positive tumors are disclosed. The methods comprise administering to a patient a therapeutically effective amount of a combination of a doxorubicin-loaded immunoliposome with a targeting moiety that is an anti-HER2 antibody that is not an inhibitor of HER2 signaling and an anti-cancer therapeutic comprising a doxorubicin-free anti-cancer therapeutic comprising a different anti-HER2 antibody.

Abstract: Inhibition of the VIP signaling pathway with VIP antagonist is contemplated. In certain embodiments, the disclosure relates to methods of enhancing the immune response to a cell therapy comprising administering a VIP antagonist to a subject in combination with a cell. In certain embodiments, the subject is diagnosed with leukemia or lymphoma. In certain embodiments, the cell is a blood cell, bone marrow cell, leukocyte, T-cell, natural killer cell, a hematopoietic stem cell, a G-CSF mobilized or non-mobilized blood mononuclear cell.

Abstract: The invention provides methods or compositions for enhancing the potency of a targeted cancer immunotherapy in a subject by using a superantigen in combination with an immunopotentiator (for example, a PD-1 inhibitor).

Abstract: The present disclosure relates to a composition for transduction of a virus in a cell by using a crosslinked product of PEGylated magnetic nanoparticles and catechol grafted poly-L-lysine by application of an external magnetic field. When the composition is used, a virus may be delivered into cells more rapidly and efficiently than in intracellular uptake of a virus by CAR-mediated endocytosis.

Abstract: A responsive hydrogel-based material may be used as a carrier system for the in situ delivery of various cargo substances, including bioactive moieties. The hydrogel structure, which includes photodegradable and thioether moieties in its three dimensional network, enables finely tuned local release of cargo substances as a function of the in vivo tissue environment (e.g., enzyme concentration or reducing environment) and externally applied stimuli (e.g., light) by selective spatiotemporal hydrogel degradation.

Abstract: Methods for the treatment of a cell proliferation disorder in a subject, involving: (1) administering to the subject at least one activatable pharmaceutical agent that is capable of effecting a predetermined cellular change when activated, either alone or in combination with at least one energy modulation agent; and (2) applying an initiation energy from an initiation energy source to the subject, wherein the applying activates the activatable agent in situ, thus causing the predetermined cellular change to occur, wherein the predetermined cellular change treats the cell proliferation disorder, preferably by causing an increase or decrease in rate of cell proliferation, and a kit for performing the method, a computer implemented system for performing the method, a pharmaceutical composition useful in the method and a method for causing an autovaccine effect in a subject using the method.

Abstract: The invention provides methods of attenuating, e.g., inhibiting or reducing, cellular proliferation and migration, particularly endothelial cell proliferation and migration, including that associated with angiogenesis, using opioid antagonists, including, but not limited to, those that are peripherally restricted antagonists.

Abstract: The invention is related to compositions including saponins and saponin-protective agents and related methods. In an embodiment, a composition is included herein. The composition can specifically include a saponin composition comprising saponins and a saponin-protective agent, wherein the saponin-protective agent prevents deglycosylation of the saponins in an aqueous environment containing glycosidase enzymes. Other embodiments are included herein.

Abstract: Stable pharmaceutical compositions useful for administering methylnaltrexone are described, as are methods for making the same. Kits, including these pharmaceutical compositions, also are provided.

Abstract: Drug delivery formulations, uses thereof and methods of making same are provided in order to reduce the potential for abuse, misuse or improper administration of an addictive substance or any active substance and to prevent, reduce, inhibit, or delay purposeful or accidental overdose of an active substance by ingesting too many dosage forms at once, for example.

Abstract: In one embodiment, a confectionary comprises 50 to 75 wt. % erythritol, 0 to 75 wt. % of at least one additional sweetener, at least one stabilizer, water, and a first active ingredient. The water may comprise 0.5 to 3 wt. % of the confectionary. The water may have a water activity of from 0.3 to 0.5. The confectionary may be aerated such that the density of the confectionary is 0.05 to 0.3 grams per cubic centimeter.

Abstract: There is provided a pharmaceutical composition for the treatment of fungal infection of the nail comprising a anti-fungal allylamine compound present in an amount of about 10%, an organic acid or an ester thereof, a diol and a sequestering agent where the pharmacological composition is essentially water-free

Abstract: Provided are formulations, compositions and methods for delivering biological moieties such as modified nucleic acids into cells to modulate protein expression. Such compositions and methods include the delivery of biological moieties, and are useful for production of proteins.

Abstract: A pharmaceutical composition is provided which contains a water soluble acid salt of a sympathomimetic amine, e.g., pseudoephedrine, and an additive, e.g., a volatile amine or other odorant, that is co-distillable, e.g., by steam distillation, with the sympathomimetic amine and/or its derivatives, e.g., its free base.

Abstract: Disclosed herein are methods and compositions to improve the solubility of therapeutic agents. In one embodiment, a method of improving solubility of a therapeutic agent includes mixing fullerene in a lipid solution to form a lipofullerene mixture, and mixing the therapeutic agent with the lipofullerene mixture.

Abstract: In one embodiment, a confectionary comprises at least one sweetener, at least one stabilizer, at least one emulsifier, water, a first active ingredient, and an enrobing layer. The water may comprise 2 to 20 wt. % of the confectionary. The confectionary may have a water activity of from 0.45 to 0.65. The confectionary may be aerated such that the density of the confectionary is 0.7 to 1.25 grams per cubic centimeter. The confectionary may have a pH of 5.0 to 8.0.

Abstract: The invention provides a colon cleansing solution comprising: a) 300 to 800 mmol per litre ascorbate anion provided by a mixture of: (i) ascorbic acid and (ii) one or more salts of ascorbic acid the components (i) and (ii) being present in a molar ratio of from 1:4.5 to 1:7.0; and b) 10 to 200 g per litre polyethylene glycol. The invention also provides methods an kits associated with, or making use of the solutions, and compositions for the preparation of the solutions.

Abstract: This invention relates to a stable liquid formulation comprising hyaluronidase and a stabilizer for hyaluronidase and more particularly, to a stable liquid formulation by the addition of the stabilizer to the hyaluronidase.

Abstract: The invention relates to compositions comprising (i) biocompatible hydrogel and (ii) one or more therapeutic agents contained within said hydrogel; wherein the hydrogel is cross-linked utilizing a cross-linker comprising a peptide sequence that is capable of being degraded by an enzyme; the therapeutic agent being effective as a treatment of a condition related to the presence of the enzyme.

Abstract: The problem addressed by the present invention is to develop a pharmaceutical having therapeutic efficacy against epirubicin-resistant tumors. The present invention provides a micelle having an anti-cancer agent disposed inside the core of the micelle formed by an epirubicin-conjugated copolymer.

Abstract: Described herein are prostate specific membrane antigen (PSMA) binding conjugates that are useful for delivering therapeutic, diagnostic and imaging agents. Also described herein are pharmaceutical composition containing them and methods of using the conjugates and compositions. Also described are processes for manufacture of the conjugates and the compositions containing them.

Abstract: An ester of a phospholipid with conjugated linoleic acid for use in the therapeutic treatment of or as a food supplement for psychiatric disorders with neuroinflammatory and neurodegenerative basis, such as depression and schizophrenia.

Abstract: One aspect of the invention provides polymer conjugated MetAP2 inhibitors. While not being bound by any particular theory, it is believed that coupling the MetAP2 inhibitory core via the linkers described herein provides compounds with superior efficacy to the parent small molecules and superior pharmacokinetic profiles. In one aspect of the invention, the polymer conjugated MetAP2 inhibitors are useful in methods of treating disease, comprising administering to a subject in need thereof a therapeutically effective amount of a polymer conjugated MetAP2 inhibitor.

Abstract: The present invention relates to micellar nanocomplexes and a method of forming the same. The micellar nanocomplex comprises a micelle and an agent encapsulated within said micelle, where the micelle comprises a polymer-flavonoid conjugate, wherein said polymer is bonded to the B ring of said flavonoid. The micellar nanocomplex may have useful applications as a drug-delivery system.

Abstract: Provided herein are methods and compositions and kits related to uricase compositions and/or compositions comprising synthetic nanocarriers comprising an immunosuppressant. Also provided herein are methods and compositions and kits for the treatment of subjects, including subjects with hyperuricemia, gout or a condition associated with gout, and for preventing gout flare.

Abstract: A cell-penetrating peptide characterized in that it comprises an amino acid sequence X3X4X1X2X5X4X1X2X6X7X1X8X9X10X11X12X13 (SEQ ID No: 11), wherein X1 is F or W, X2 is F, W or Y, X3 is beta-A or S, X4 is K, R or L, X5 is E, R or S, X6 is R. T or S, X7 is E, R or S, X8 is none, F or W, X9 is P or R, X10 is R or L, X11 is K, W or R, X12 is R or F and X13 is R or K.

Abstract: The invention provides combinations and formulations including a luteinizing hormone-releasing hormone (LHRH) or a LHRH analog; and curcumin or a curcumin analog. LHRH or LHRH analog can be fused or conjugated to a curcumin or curcumin analog. Invention combinations and formulations can also include an anti-cell proliferative drug. Invention combinations and formulations can be used for inhibiting proliferation of a cell; treating a hyperproliferative disorder; and treating a neoplasia, tumor, cancer or malignancy.

Abstract: The present disclosure provides peptides and peptide compositions, optionally in the from of a vaccine, which facilitate the delivery of an active agent or an active agent carrier wherein the compositions are capable of penetrating the stratum corneum (SC) and/or the cellular membranes of viable cells. Also provided are methods of employing the peptides and peptide compositions to deliver active agents; treat diseases or disorders; and inducing immune responses.

Abstract: The present invention provides a stable peptide-conjugated, ascorbic acid derivative, a method for preparing the same, and a cosmetic composition comprising the same as an active ingredient. The stable peptide-conjugated ascorbic acid derivative of the present invention has both the effect of whitening the skin by inhibiting melanin production and the effect of reducing skin wrinkles by activating collagen production, and may be used in a cosmetic composition.

Abstract: The invention described herein pertains to the diagnosis, imaging, and/or treatment of pathogenic cell populations. In particular, the invention described herein pertains to the diagnosis, imaging, and/or treatment of diseases caused by PSMA expressing cells, such as prostate cancer cells, using compounds capable of targeting PSMA expressing cells.

Abstract: The present disclosure provides methods and compositions related to the cytosolic delivery of proteins and cell-impermeable small molecules into live cells using an endosomolytic dimer of cell-penetrating peptide TAT.

Abstract: The present disclosure relates to the use of antibody-drug conjugates (ADCs) comprising pyrrolobenzodiazepine (PBD) dimers and anti-CD25 antibodies for use in treating disorders characterized by the presence of CD25+ve cells.

Abstract: Disclosed herein are anti-ERB B2/NEU antibodies conjugated with maytansinoid drugs for targeted delivery to disease tissues. Methods relating to the preparation and uses of such drug conjugates to treat ERB B2/NEU positive cells in cancers are provided.

Abstract: A novel acid labile linker for targeted delivery and/or controlled phosphoryl hydroxypropylglycine release of agents is introduced herein. There is further disclosed a method of developing a therapeutic or diagnostic conjugate for targeted cell-specific delivery. More specifically, the invention is focused on linkers used to deliver anticancer agents to specific tumor cells.

Abstract: The invention relates to a pharmaceutical composition comprising the combination of (i) at least one biocompatible nanoparticle, said biocompatible nanoparticle comprising at least one oligomer of albumin (n?2) or consisting in an oligomer of albumin, and of (ii) at least one compound of interest, typically at least one pharmaceutical compound, to be administered to a subject in need of such at least one compound of interest, wherein the at least one nanoparticle potentiates the at least one compound of interest efficiency. The longest dimension of the biocompatible nanoparticle is typically between about 4 and about 500 nm. The invention also relates to such a composition for use for administering the at least one compound of interest in a subject in need thereof, wherein the at least one biocompatible nanoparticle and the at least one compound of interest are to be administered in said subject sequentially, typically between more than 5 minutes and about 72 hours one from each other.

Abstract: Methods for introducing nucleic acids to cells via exosomes for use in gene modulation and therapy, such as for gene silencing and to introduce genetic material into cells to compensate for abnormal genes or to induce or repress a process in the recipient cell.

Abstract: The invention is directed to a staining composition and to the use of the staining composition in staining ocular tissue. In a first aspect, the invention provides a staining composition comprising a vital dye and a density increasing compound chosen from the group consisting of water soluble polymers and small inert molecules.

Abstract: The subject invention pertains to transgenic non-human animals comprising a transgenic nucleotide sequence, integrated into the genome of the animals, comprising a nucleotide sequence encoding human FKBP51 operably linked to a tetracycline response element. In some embodiments, the transgenic animal comprises an additional transgenic nucleotide sequence, integrated into the genome of the animal, comprising a nucleotide sequence encoding a tetracycline transactivator (tTA) operably linked to a promoter; wherein the tTA is expressed upon activation of the promoter and binds the tetracycline response element, thereby causing expression of FKBP51. The invention also pertains to methods for screening for agents for the prevention and/or treatment of psychiatric disorders, such as depression.

Abstract: The present invention relates to a topical agent that binds specifically to myelin basic protein and its method of use and determining myelination in the subject by detecting the agent present in the subject. A kit containing the agent or its derivatives for use in detecting myelin basic protein is also provided.

Abstract: This invention relates to, in part, methods and compositions that are useful for the diagnosis, treatment, or prevention of a blinding eye disease, including in the discovery of drugs that are efficacious against these diseases. Diseases include, for example, age related macular degeneration and reticular pseudodrusen disease, and the methods described herein include, for example, the method named delayed near infrared analysis (DNIRA).

Abstract: A method of using an imaging contrast agent is provided for hydrogen magnetic resonance imaging (H MRI). The agent uses replacement and chemical exchange of hydrogen (H) and deuterium (D) on obtaining MRI images for comparison. An isotonic physiologic saline solution with deuterium oxide (D2O) is made. The solution is intravenously injected to obtain the intensity alterations on MRI images. The injected D2O is perfused into tissue and replaces the original water. Exchanges between H and D occur and a solution of hydrogen deuterium oxide (HDO) is obtained. After such mechanisms, MRI images are compared for differences. Thus, a novel, non-radioactive, non-toxic and non-invasive MRI agent is provided for people who are allergic to general imaging agents.

Abstract: The present invention relates to a method of preparation of formulations of gadolinium metal complexes of the macrocyclic chelator DOTA, which further comprise a small excess of free DOTA. The method uses controlled conditions such that excess gadolinium is present as a precipitate of gadolinium oxide, with filtration to remove the excess, prior to the addition of a defined excess of DOTA chelator. Also provided is a method of preparation of MRI contrast agents based on Gd-DOTA.

Abstract: The present invention relates to a method of removal of metal ion impurities, such as calcium, from lanthanide metal complexes of macrocyclic chelators. The method uses a scavenger resin to remove metal ions, displaced from chelator, by an excess of lanthanide ions. Also provided is a method of preparation of MRI contrast agents, from the purified lanthanide metal complex, by the addition of a defined excess chelator.