Abstract: A new approach for the treatment of a malignant disease is provided. The new method comprises administering a traditional anti-cancer therapy in combination with a DNA or protein vaccine comprising CTLA-4 and PD-1, or a DNA or protein vaccine comprising CTLA-4 and PD-L1.

Abstract: This invention describes compositions comprising at least 75 mg/mL of solubilized otherwise poorly soluble drug in an aqueous environment, wherein the composition further comprises a combination of 3 or more acids. Methods of providing analgesia, anti-pyretic effects or reducing pain in a subject presenting with a pain condition, and methods of reducing administration site irritation, inflammation or a combination thereof in a subject presenting with a pain condition, comprising the steps of administering such compositions and infusion pumps containing such compositions are also described.

Abstract: The present invention relates to the field of viral disorders, and in particular to the use of natural compounds to inhibit viruses and viral infection. Compositions comprising NGNA are provided for treating or preventing viral infections, such as those causing the common cold.

Abstract: The present invention relates to compositions and methods for inducing an adaptive immune response against Hepatitis C virus (HCV) in a subject. In some embodiments, the present invention provides a composition comprising a nucleoside-modified nucleic acid molecule encoding a HCV antigen, adjuvant, or a combination thereof. For example, in some embodiments, the composition comprises a vaccine comprising a nucleoside-modified nucleic acid molecule encoding a HCV antigen, adjuvant, or a combination thereof.

Abstract: Antibodies and antigen-binding fragments thereof that specifically bind to human DCLK1 protein, hybridomas or other cell lines which express such antibodies and antigen-binding fragments thereof, nucleic acids, vectors, and host cells comprising nucleic acids which encode such antibodies and antigen-binding fragments thereof, and methods of use thereof are disclosed. In at least certain non-limiting embodiments, the antibodies or antigen-binding fragments thereof specifically bind to an epitope within isoform 2 or 4 of DCLK1 protein.

Abstract: Aspects of the disclosure relate to nucleic acid vaccines. The vaccines include at least one RNA polynucleotides having an open reading frame encoding at least one varicella zoster virus (VZV) antigen. Methods for preparing and using such vaccines are also described.

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: Described herein are liposome-based nanocarriers that selectively target bone marrow, minimize tumor delivery, and maintain high drug concentrations in bone marrow when compared to conventional systemic delivery. The composition of the liposome-based nanocarriers may also be tuned to selectively target lymph nodes and other reticuloendothelial system organs (e.g., spleen, e.g., liver). Also described herein are methods of imaging and mapping the bone marrow and/or other reticuloendothelial system organs using the described liposome-based nanocarriers. These methods provide high resolution non-invasive and quantitative imaging via PET, which offers advantages over conventional imaging/tracking methods. Furthermore, in certain embodiments, the liposome-based carriers are used to stabilize and deliver radioprotectant/free radical scavenger drugs to the bone marrow, thereby protecting the bone marrow from subsequent radiation exposure, thereby limiting the adverse impact of radiation exposure on the individual.

Abstract: Disclosed are formulations for providing a therapeutic bioactive polypeptide to injured tissue. Formulations include mineral coated microparticles wherein a polynucleotide is adsorbed to the mineral layer. Other formulations include a carrier including mineral coated microparticles wherein mineral coated microparticles include a polynucleotide. Also disclosed are methods for sustained delivery of a bioactive polypeptide and methods for treating chronic wounds using a formulation for providing sustained delivery of the bioactive peptide.

Abstract: Compositions and methods are disclosed herein for inducing (up-regulating) the expression of sulfotransferases in the hair follicles, e.g., the scalp. Increasing sulfotransferase is beneficial for metabolizing pro-drugs that require sulfonation to be activated, e.g., minoxidil sulfate is the active metabolite of minoxidil. A method for combining the compositions described herein with topical minoxidil to enhance minoxidil treatment for androgenetic alopecia is described. Additional methods and compositions include the use of retinoid X receptor agonists, retinoic acid receptor agonists, and nuclear receptor agonists in an RXR—NR heterodimer. Additional methods and compositions include the use of a topical solution containing an alkalinizing agent or an alkalinizing agent used with a penetration enhancer for up-regulating the sulfonating capacity of hair bearing skin, hair follicles, and/or keratinocyte cells.

Abstract: The present disclosure relates generally to the use of sphingolipid-metabolizing proteins to mitigate or minimize tissue damage resulting from injury or from disease, for example, pulmonary arterial hypertension (PAH) when the sphingolipid-metabolizing protein is delivered via expression from an Anc80 vector.

Abstract: The present invention relates to a composition for preventing hair loss and, more specifically, to a compound having a structure in which Minoxidil and a peptide are chemically connected, and to a pharmaceutical composition or cosmetic composition for preventing hair loss or promoting hair growth comprising the compound. The compound having a structure in which Minoxidil and a peptide are chemically connected according to the present invention has not only excellent physiological activity such as hair loss reduction, hair growth promotion or cell growth promotion, but also excellent stability in water, and can therefore be useful as a composition for preventing hair loss and promoting hair growth.

Abstract: Disclosed herein are compositions and methods for inhibiting the growth of cells or inducing cell death. The composition capable of inhibiting the growth of cells or inducing cell death comprises a 5?-triphosphate non-linear RNA. The RNA comprises a first stem-loop formed from the complete or partial hybridization of at least 8 nucleotide pairings and may optionally comprise a second stem-loop formed from the complete or partial hybridization of at least 8 nucleotide pairings and a spacer between the first stem-loop and the second stem loop. Methods for inhibiting the growth of cells or inducing cell death comprise contacting cells with the composition or administering the composition to a subject in an amount effective to inhibit the growth of the cells or induce death of the cells.

Abstract: Provided are liposomes that encapsulate adenosine. The liposomes may be formed from sphingomyelin or a combination of sphingomyelin and 1,2-dimyristoyl-sn-glycero-3-phosphocholine (DMPC) or a combination of sphingomyelin and 1,2-dimyristoyl-sn-glycero-3-phosphorylglycerol (DMPG) or a combination of sphingomyelin, DMPG, and DMPC. The liposomes encapsulating adenosine may be used to induce cartilage regeneration, treat osteoarthritis, alleviate joint pain, and/or slow, arrest, and/or reverse progressive structural tissue damage associated with osteoarthritis or treat osteoarthritis, rheumatoid arthritis, acute gouty arthritis, and/or synovitis. The liposomes may release adenosine for up to two weeks.

Abstract: In an embodiment of the invention, a composition for treating a cell population comprises a medicant. The medicant moiety can be an illudofulvene analog. In an embodiment of the invention, a composition for treating a cell population comprises an Affinity Medicant Conjugate (AMC). The affinity moiety can be an antibody, an antibody fragment, a receptor protein, a peptidic growth factor, an anti-angiogenic protein, a specific binding peptide, protease cleavable peptide, a glycopeptide, a peptide, a peptidic toxin, a protein toxin and an oligonucleotide. The affinity moiety can be covalently bound to the medicant via a linker.

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. Remote loading of a drug into liposomes containing a transmembrane electrochemical gradient is initiated by co-mixing a liposome suspension with a solution of drug, whereby the neutral form of the compound freely enters the liposome and becomes electrostatically charged thereby preventing the reverse transfer out of the liposome. There is a continuous build-up of compound within the liposome interior until the electrochemical gradient is dissipated or all the drug is encapsulated in the liposome. 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).

Abstract: Provided are antigenic compositions and uses thereof that include at least two human herpesvirus (HHV) polypeptides involved in mediating HHV binding, fusion, and entry into host cells, such as gp350, gH, gL, and gB, or nucleic acids encoding the polypeptides. The two HHV polypeptides comprise any combination of: a gB polypeptide; a gp350 polypeptide; a gL polypeptide; and a gH polypeptide, and optionally any one or more of the following polypeptides: gp42, gM, gN, gl, gC, gE, gD, ORF68, BMRF-2, BDLF2, UL128, UL130, UL131A, and gpK8.1. Also disclosed are methods of inducing an immune response or treating or preventing an HHV infection in a subject by administering to the subject at least two of the HHV polypeptides or nucleic acid(s) encoding the same. Methods of passively transferring immunity using high-titer anti-HHV antibodies or immune cells are also disclosed.

Abstract: Embodiments herein described provide antigen-presenting cell-mimetic scaffolds (APC-MS) and use of such scaffolds to manipulating T-cells. More specifically, the scaffolds are useful for promoting growth, division, differentiation, expansion, proliferation, activity, viability, exhaustion, anergy, quiescence, apoptosis, or death of T-cells in various settings, e.g., in vitro, ex vivo, or in vivo. Embodiments described herein further relate to pharmaceutical compositions, kits, and packages containing such scaffolds. Additional embodiments relate to methods for making the scaffolds, compositions, and kits/packages. Also described herein are methods for using the scaffolds, compositions, and/or kits in the diagnosis or therapy of diseases such as cancers, immunodeficiency disorders, and/or autoimmune disorders.

Abstract: The present invention provides compositions and systems for delivery of nanocarriers to cells of the immune system. The invention provides vaccine nanocarriers capable of stimulating an immune response in T cells and/or in B cells, in some embodiments, comprising at least one immunomodulatory agent, and optionally comprising at least one targeting moiety and optionally at least one immunostimulatory agent. The invention provides pharmaceutical compositions comprising inventive vaccine nanocarriers. The present invention provides methods of designing, manufacturing, and using inventive vaccine nanocarriers and pharmaceutical compositions thereof. The invention provides methods of prophylaxis and/or treatment of diseases, disorders, and conditions comprising administering at least one inventive vaccine nanocarrier to a subject in need thereof.

Abstract: The present embodiment provides a compound represented by the formula (1): Q-CHR2??(1) (Q is a nitrogen-containing aliphatic group containing two or more tertiary nitrogens but no oxygen, and R is an aliphatic group containing a biodegradable group). From the compound in combination with other lipids such as a lipid capable of reducing aggregation, lipid particles can be formed. Further, the compound can be used for a pharmaceutical composition to deliver an activator into cells.

Abstract: The present invention relates to a nanoemulsion comprising at least one aqueous component and a carrier, wherein the carrier comprises at least one lipophilic component, at least one surfactant and at least one alcohol. The present invention further relates to a composition comprising said nanoemulsion and an active agent. In particular, the composition is present as a gel and the active agent is 5-aminolevulinic acid, a derivative, precursor and/or metabolite thereof. The invention further relates to the preparation of said nanoemulsion and/or composition and to their use for the treatment of dermatological diseases, virus-associated diseases as well as diseases associated with cell proliferation, in particular, tumor diseases and/or psoriasis. The present invention is further directed to the use of said nanoemulsion in cosmetics.

Abstract: The invention concerns lipid assemblies, liposomes having an outer surface comprising a mixture of anionic and cationic moieties; wherein at least a portion of the cationic moieties are imino moieties that are essentially charged under physiological conditions, and their use for serum resistant transfection of cells.

Abstract: Microparticulate drug compositions comprising nanocrystals of poorly soluble drugs combined with a carrier are disclosed. Also disclosed are pharmaceutical compositions that include the microparticulate drug compositions. Further disclosed are methods of preparing and using the microparticulate drug compositions/pharmaceutical compositions.

Abstract: Described herein are peptides that can be used to treat pain or increase pain sensitivity in subject in need of treatment. Additionally, peptides of the present disclosure can be administered with an analgesic agent and/or anesthetic agent. Peptides of the present disclosure are suitable for use when a subject in need of treatment has an injury, a chronic disease, a chronic inflammation, Morton's neuroma, operative/post-operative pain, or a combination thereof.

Abstract: Provided is a liposomal sustained-release composition for use in treatment of pulmonary disease. The liposomal sustained release composition comprises a liposome that includes a polyethylene glycol (PEG)-modified lipid and encapsulates a tyrosine kinase inhibitor. Tyrosine kinase inhibitor is stably entrapped in the liposome, and the resulting liposomal drug formulation can be aerosolized or nebulized for administration via inhalation. This aerosolized liposomal drug formulation yields consistent pharmacokinetic and pharmacodynamic profiles while achieving desired efficacy and safety.

Abstract: Outer membrane vesicles from bacteria of the Burkholderia pseudomallei complex can be used as adjuvants in compositions and methods to potentiate the immune response to immunogens.

Abstract: Compositions and regimens useful in treating type I citrullenemia are provided. The compositions include recombinant adeno-associated virus (rAAV) with a transthyretin enhancer and promoter driving expression of a human Argininosuccinate Synthase 1 (ASS1).

Abstract: The present disclosure provides particles for delivering a nucleic acid that encodes an immunogenic peptide in an antigen presenting cell. The disclosed particles can function as a vaccine and can be used to treat or prevent a viral or bacterial infection in a subject by expressing in vivo an immunogenic peptide, thereby stimulating the subject's immune system to attack the virus or bacteria that naturally express the immunogenic peptide.

Abstract: Methods and compositions are provided for the therapeutic use of hedgehog agents, for enhancing bone growth and regeneration in diabetic or pre-diabetic patients, including repair following injury, osseointegration of implants, and the like. In some embodiments of the invention, the compositions are administered locally, e.g. by injection or implantation at the site of an injury.

Abstract: Disclosed herein are nanoparticles comprising a lipid core comprising a sterol; and a complex comprising a cationic agent and a therapeutic agent, wherein the complex is encapsulated within the lipid core. Methods to produce the nanoparticle comprise: combining a cationic agent, a therapeutic agent, and a first water-immiscible solvent with a first aqueous solution, thereby forming a mixture comprising a complex comprising the cationic agent and the therapeutic agent; combining the mixture with a second waterim-miscible solvent, thereby forming an aqueous phase and an organic phase, and separating the organic phase comprising the complex; combining the organic phase comprising the complex with a sterol and a first water-miscible organic solvent; and dispersing the complex in a second aqueous solution to form a herein disclosed nanoparticle. Methods for treating a disease and for reducing nanoparticle burst rate are also disclosed.

Abstract: Provided nucleic acid-based expression construct for the target cell-specific production of a therapeutic protein, such as a pro-apoptotic protein, within a target cell, including a target cell that is associated with aging, disease, or other condition, in particular a target cell that is a senescent cell or a cancer cell.

Abstract: A method for treating a person's skin is disclosed. The method includes topically applying to the skin a composition comprising from 0.001% to 20% by weight of an aqueous, alcoholic, or aqueous-alcoholic extract from a plant extract.

Abstract: Disclosed herein are macrocyclic polypeptides having no more than 3 ammo acid substitutions compared to the amino acid sequence of any one of SEQ ID NO: 1-2.37 or a mirror image thereof, wherein the polypeptide includes both L and D amino acids, libraries of such polypeptides, and uses thereof.

Abstract: Lipid-based delivery vehicles are provided. Nanoparticulate compositions typically including a p21 activated kinase (PAK) inhibitor and a lipid-based delivery vehicle are also provided. In preferred embodiments, the lipid-based delivery vehicle is a liposome, most preferably a sterically-stabilized liposome. Typically the lipid-based delivery vehicle includes one or more phospholipids, and optionally a sterol. In some embodiments, at least one of the phospholipids is PEGylated. In particular embodiments, the lipid-based delivery vehicle includes DSPC, DSPE-PEG2000, and cholesterol. In specific embodiments, the ratio of DSPC, DSPE-PEG, and cholesterol is 9:1:5. The nanoparticulate composition typically includes a PAK inhibitor, preferably a PAK-1 inhibitor such as IPA-3 or a derivative, prodrug, or pharmaceutically acceptable salt thereof.

Abstract: Formulations and methods, including vaccines and pharmaceutical compositions for inducing or enhancing an immune response are disclosed. The formulations generally comprise a TLR4 agonist and a metabolizable oil at a concentration of about 0.01%-1% v/v, wherein the hydrophobic:lipophilic balance (HLB) of the emulsion is greater than about 9.

Abstract: Disclosed is a method of treating a fine line or wrinkle in a person's skin, the method comprising topically applying to the fine line or wrinkle a composition comprising an effective amount of Commiphora mukul resin or an extract thereof that includes oleo gum resin, glycerin, water, and hyaluronic acid or a salt form thereof, wherein topical application of the composition to the fine line or wrinkle reduces the appearance of the fine line or wrinkle.

Abstract: Provided herein are antigenic combinations and related compositions, methods and systems for immunizing a host from an infection caused by Francisella bacterium. The antigenic combination comprises an antigenic polysaccharide component from a Francisella bacterium capable of triggering a humoral immune response in an individual, a protein antigen component from the Francisella bacterium capable of triggering a cellular immune response in the individual, and an adjuvant, the antigenic Francisella polysaccharide component, the Francisella protein antigen component and the adjuvant are in a suitable amount to immunize an individual against the Francisella bacterium.

Abstract: The invention relates to the treatment of brain tumors, specifically to improved therapy for glioblastoma utilizing specific endocrine modulators and drug combinations. The compositions and uses thereof according to the invention employ androgen receptor (AR) inhibitors, either alone or in combination with receptor tyrosine kinase inhibitors and/or chemotherapeutic agents. According to certain advantageous embodiments, the use of the AR inhibitor enzalutamide, optionally in combination with epidermal growth factor receptor inhibitors such as erlotinib and alkylating agents such as carmustine and temozolomide, is contemplated.

Abstract: Nutritional products, uses thereof, methods for the manufacture and methods for improving the cohesiveness of the nutritional products are disclosed. The nutritional products have improved cohesiveness for promoting safer swallowing of food boluses for individuals having swallowing difficulties such as dysphagia.

Abstract: A method for treating a cancer comprises administering to a subject in need of such treatment an effective amount of a pharmaceutical composition comprising an anti-cancer agent having at least one secretion modifying region (SMR) peptide from HIV-1 Nef fused to at least one cell-penetrating peptide (CPP) or at least one Clusterin (Clu)-binding peptide (Clu-BP).

Abstract: The present invention relates to a pharmaceutical composition comprising the combination of (i) at least two distinct biocompatible nanoparticles and (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 two distinct biocompatible nanoparticles potentiate the compound(s) of interest efficiency. The at least two biocompatible nanoparticles can be administered sequentially or simultaneously to the subject but are to be administered separately, typically with an interval of between more than about 5 minutes and about 72 hours, from the at least one compound of interest, preferably before the administration of the at least one compound of interest, to said subject. The longest dimension of the at least two biocompatible nanoparticles is typically between about 4 nm and about 500 nm.

Abstract: The present invention relates to methods and compositions for inhibiting metastatic spread of cancer and/or inhibiting progression of pre-existing metastatic disease in a subject using L1CAM inhibition.

Abstract: The present invention relates to pharmaceutical formulations comprising an anti angiogenic compound such as a monoclonal antibody or fragment thereof selected from, for example, ranibizumab, which is a vascular endothelial growth factor binder which inhibits the action of VEGF, and a delivery agent selected from a pharmaceutically acceptable liposome. The formulations are useful in the treatment of a variety of angiogenic disorders and diseases in animals and people, and, preferably, in ophthalmic disorders selected from age-related macular degeneration, diabetic macular edema and corneal neovascularization.

Abstract: Disclosed is a recombinant polypeptide for facilitating membrane fusion. The recombinant polypeptide having a sequence with at least 80% sequence identity with the ectodomain of p14 fusion-associated small transmembrane (FAST) protein and having a functional myristoylation motif, a transmembrane domain from a FAST protein and a sequence with at least 80% sequence identity with the endodomain of p15 FAST protein. A targeting ligand can be added to the recombinant polypeptide for selective fusion. The recombinant polypeptide can be included in the membrane of a liposome, or the like, to facilitate the delivery of bioactive compounds, such as siRNA, or the recombinant polypeptide can be mixed with a lipid carrier and added to cultured cells to induce cell-cell fusion and heterokaryon formation.

Abstract: Methods are provided for inducing granulation tissue on chronic third-degree post-escharotomy burn wounds present on the skin of a mammalian subject, which includes human subjects. A method according to the disclosure comprises contacting a third-degree burn wound with an extract of Hamelia patens, in combination with a dermatologically-acceptable carrier. Methods according to the disclosure are applicable to chemically-induced, electrically-induced, and thermally-induced third-degree burn wounds on skin.

Abstract: The present invention refers to an oxygen carrier, preferably hemoglobin or myoglobin, for use in the treatment of an unpleasant feeling of a body surface due to a disease or a disorder.

Abstract: A pharmaceutical composition for administering directly to the pulmonary tract of a subject includes a salt of triiodothyronine and a pharmaceutically acceptable buffer, adjusted to pH of 5.5-8.5. The composition can be administered prophylactically or therapeutically to a subject to treat lung inflammation or pulmonary edema.

Abstract: The present invention relates to a composition, preferably a cosmetic composition, and more preferably a skin cosmetic composition, comprising: (a) at least one particle, comprising at least one cationic polymer, at least one anionic polymer and at least one non-polymeric base having two or more pKb values or salt(s) thereof; and (b) at least one physiologically acceptable volatile medium. The composition according to the present invention is stable, and can have a variety of cosmetic functions.

Abstract: Provided herein are methods for treating a pulmonary infection in a patient in need thereof, for example, a nontuberculous mycobacterial pulmonary infection for at least one treatment cycle. The method comprises administering to the lungs of the patient a pharmaceutical composition comprising a liposomal complexed aminoglycoside comprising a lipid component comprising electrically neutral lipids and an aminoglycoside. Administration comprises aerosolizing the pharmaceutical composition to provide an aerosolized pharmaceutical composition comprising a mixture of free aminoglycoside and liposomal complexed aminoglycoside, and administering the aerosolized pharmaceutical composition via a nebulizer to the lungs of the patient. The methods provided herein result in a change from baseline on the semi-quantitative scale for mycobacterial culture for a treated patient, and/or NTM culture conversion to negative during or after the administration period.

Abstract: The present invention relates to compositions comprising an antiemetic, particularly including 5-HT3 antagonist and/or NK-1 antagonist antiemetics, in combination with a choline esterase inhibitor such as an acetylcholine esterase inhibitor and/or a butyrylcholine esterase inhibitor, and methods of using the composition to provide improved protection of subjects at risk of organophosphorus poisoning, or, for the treatment, prevention, or alleviation/reduction of toxicity from an organophosphorus compound, by enabling the use of a highly protective daily dose of the choline esterase inhibitor without the typical adverse effects.