Abstract: Pharmaceutical compositions and kits including a tyrosine hydroxylase inhibitor; melanin, a melanin promoter, or a combination thereof; a p450 3A4 promoter; and a leucine aminopeptidase inhibitor are provided. Also provided are methods of treating cancer in a subject, comprising administering an effective amount of a tyrosine hydroxylase inhibitor, a melanin promoter, a p450 3A4 promoter, and a leucine aminopeptidase inhibitor to the subject in need thereof. Also provided are methods of reducing cell proliferation in a subject comprising administering an effective amount of a tyrosine hydroxylase inhibitor, a melanin promoter, a p450 3A4 promoter, and a leucine aminopeptidase inhibitor to the subject in need thereof.

Abstract: The present invention relates to a composition for preventing or treating sepsis or septic shock including a Mycobacterium tuberculosis-derived adenosine kinase (ADK) protein as an active ingredient. The Mycobacterium tuberculosis-derived ADK protein according to one exemplary embodiment of the present invention has an effect of inhibit binding between the LPS and cells by binding to LPS, and also has an excellent therapeutic effect against sepsis by enhancing viability in a sepsis animal model and suppressing inflammatory response in the lung and cell death in the spleen.

Abstract: This invention relates to compositions and methods for activating and promoting mineralization in tissue that does not normally mineralize, specifically intervertebral discs. The composition comprises agents that increase the expression of the gene that encodes TNAP and/or the activation, amount or activity of TNAP protein, and agents that decrease the expression of ANK and/or ENPP and/or the activation, amount or activity of these proteins. The composition can be in the form of a cell or cells. The invention also relates to methods of using the composition.

Abstract: An enteric-coated oral dosage form comprising an acid labile active pharmaceutical ingredient where the composition is substantially free of monomeric phthalic acid esters and synthetic oils is described herein. Also provided are methods for making and using the enteric-coated oral dosage form. The disclosed pharmaceutical compositions comprise an enteric coating which includes at least one plasticizer, at least one film-forming agent and optionally at least one anti-sticking agent.

Abstract: Disorders such as headaches can be treated by administration of a botulinum toxin to a patient suffering therefrom, such as a migraine headache. A combined a fixed site/fixed dose and an optional follow the pain variable dosage and injection site paradigm is disclosed for optimizing clinical effectiveness of botulinum toxin administration for patients suffering headache, particularly chronic migraine.

Abstract: The invention provides compositions and methods related to human telomerase reverse transcriptase (hTRT), the catalytic protein subunit of human telomerase. The polynucleotides and polypeptides of the invention are useful for diagnosis, prognosis and treatment of human diseases, for changing the proliferative capacity of cells and organisms, and for identification and screening of compounds and treatments useful for treatment of diseases such as cancers.

Abstract: The invention provides a nucleic acid construct comprising a sequence that encodes a human telomerase reverse transcriptase (hTERT) protein which is devoid of telomerase catalytic activity and of a nucleolar localization signal. The construct is useful triggering an immune response in a subject, against cells that overexpress telomerase, preferably dysplasia cells or tumor cells.

Abstract: The present invention relates to CTL peptide epitopes, high-throughput methods for their identification, and their uses. In particular, the present invention relates to peptide epitopes for cancer immunotherapy and Hepatitis C Virus vaccines. The present invention also relates to methods and systems for identifying antigen-specific CTLs.

Abstract: Certain embodiments of the invention are directed to methods for inducing an immunologic response to a tumor in a patient using mature dendritic cells transfected with a nucleic acid composition encoding one or more tumor antigens and loaded with a corresponding tumor antigen composition.

Abstract: The present invention is directed to compositions and methods for treating an animal diagnosed with Glioblastoma multiforme (GBM).

Abstract: A method for preventing, treating or reducing the effects of influenza infection in a subject by administering an influenza vaccine to the skin of the subject. The administration can be intradermal or by microneedle patch. The method can provide increased protection for pregnant subjects and their offspring, and have an increased duration of action over conventional intramuscular vaccination.

Abstract: The invention provides in part methods of treating cancers of a specific organ or tissue by administering a composition that is antigenically specific for one or more microbes that are pathogenic in the specific organ or tissue in which the cancer is situated.

Abstract: This disclosure describes a modified live infectious laryngotracheitis virus (ILTV) developed from a strain of ILTV grown at a reduced incubation temperature, vaccines that include the modified live ILTV, methods for producing the live modified ILTV, and methods that include administering the modified ILTV to a subject.

Abstract: The present invention provides methods for inducing an immune response to a pathogen in neonatal mammals. In particular, the present invention provides methods for inducing an immune response to a pathogen in a neonatal mammal comprising administering to the neonatal mammal a composition comprising a fusion protein between interleukin-4 (IL-4) and a first antigen of the pathogen.

Abstract: Compositions and methods can be used for tolerizing the immune system. The compositions can be physiologically acceptable and can include any of a wide variety of allergens that are designed to be administered in escalating doses to, for example, an infant. The compositions can include other active ingredients (e.g., one or more of a steroid, vitamin, mineral, vasodilator, hormone, decongestant, anticholinergic agent, leukotriene inhibitor, immunomodulator, mast cell stabilizer, expectorant, immune suppressant, anti-histamine, or anti-inflammatory agent) and/or a carrier.

Abstract: The invention relates to a conjugate based on Vi polysaccharide which is fragmented and a carrier protein, to compositions comprising said conjugate and to methods for making said conjugates and compositions.

Abstract: Compositions comprising calcium fluoride composites comprising Ca, F, and an organic molecule are provided, as are methods for their use.

Abstract: An adjuvant composition of the present invention contains lauryl alcohol and propylene glycol. Contents of the lauryl alcohol and the propylene glycol are 0.5 to 25% by mass and 8.0 to 99.5% by mass, relative to the total mass of the adjuvant composition, respectively. The lauryl alcohol is dissolved, and the adjuvant composition is used for transdermal or transmucosal administration.

Abstract: The invention improves TdaP vaccines by including a TLR agonist in them. This agonist can provide stronger protection, longer-lasting protection, and/or can reduce the amount of antigen which is required to achieve a particular immune response.

Abstract: The disclosure relates to supplement formulations comprising amino acids in ratios that are protein-specific. Described herein is a protein-specific supplement formulation comprising amino acids in the ratio present in the protein's polypeptide sequence. Further described herein is a protein-specific supplement formulation comprising: a base protein and essential amino acids; wherein the relative amounts of amino acids in the formulation match the relative amounts of amino acids naturally occurring in the protein.

Abstract: The present invention relates to antigen-specific immune regulatory response. Methods for detecting an antigen-specific immune regulatory response, methods for selecting candidate vaccine recipients, and methods for improved vaccination strategies are presented.

Abstract: The present invention provides methods for selecting treatment methods for rheumatoid arthritis based on an objective selection process (algorithm). The present invention also provides methods for treating rheumatoid arthritis with treatment methods selected based on the algorithm disclosed herein. The methods of the present invention provide a more effective means for treating patients with rheumatoid arthritis.

Abstract: The invention relates to formulations of single domain antigen binding molecules, e.g., nanobody molecules, in particular formulations of TNF-binding nanobody molecules. The single domain antigen binding molecules can include one or more single binding domains that interact with, e.g., bind to, one or more target proteins. The formulations are useful, e.g., as pharmaceutical formulations. Method of preparing, and using the formulations described herein, to treat, e.g., TNF-associated disorders, are also disclosed.

Abstract: The present invention proposes the development of technology in the domain of targeted therapy and local drug delivery to the affected area of the tumor. The invention relates to surface modification nano-/micro-containers (spheres of organic and inorganic polymers), which are sensitive to acidic environment, elevated temperature (T˜41-43° C.), redox potential as well as the application of external applied magnetic field. These nano-/micro-containers are made suitable to be able to carry drugs, such as antibiotics, anti-cancer, cytostatic and antimicrobials and their release will be carried to the patient tissue due to the prevailing conditions. The composition of nano-/miocro-containers based on organic and inorganic polymers which exhibit sensitivity to the aforementioned conditions. The adjustment is carried out through the surface with aminosilanes or amino acids as ligands or small molecules such maleamide molecules which can undergo nucleophilic addition and further binding of targeting molecule.

Abstract: The invention disclosed herein relates to a method of cavitation-induced delivery of a therapeutic or diagnostic agent to a human or animal subject. In particular the invention provides an agent for use in a method of diagnosis or treatment of a human or animal subject, the method comprising exposing the subject to ultrasound, wherein the agent comprises a therapeutic or diagnostic component which is covalently bound to a dense component, the dense component having a density greater than that of the therapeutic or diagnostic component, and wherein either the dense component is a cavitation initiator or the method comprises administering to the subject a further agent which is a cavitation initiator. Binding of the dense component enhances cavitation-induced transport of the therapeutic or diagnostic component.

Abstract: The present invention relates generally to stable formulations comprising CTLA4Ig molecules, including lyophilized, and liquid formulations for administration via various routes including, for example, routes such as intravenous (IV) and subcutaneous (SC) for treating immune system diseases and tolerance induction.

Abstract: A platform drug delivery system and a method of improving the delivery of low solubility pharmaceuticals utilizing crystal engineering and Theanine dissolution resulting in enhanced bioactivity, dissolution rate, and solid state stability.

Abstract: The compositions and methods described herein are topically applied to the skin with negligible or no skin irritation and can direct or prevent transport through the skin. The compositions contain neat ionic liquids, optionally in combination with a drug to be delivered. In a preferred embodiment, the compositions increase transdermal transport of the drug to be delivered. In some embodiments, the compositions disrupt bacterial biofilms. This is particularly beneficial in the treatment of antibiotic resistant skin infections. In other embodiments, the compositions direct delivery within the skin. In still other embodiments, the compositions prevent transfer of substances through the stratum corneum. The disclosed compositions and methods can be tuned and modified such that they can be used to treat or prevent a variety of different diseases and disorders.

Abstract: The invention provides aqueous pharmaceutical adalimumab compositions suitable for long-term storage of adalimumab, methods of manufacture of these compositions, methods of administration, and kits containing same.

Abstract: A method of producing a drug-loaded Poly (Glycerol Sebacate) (PGS) comprising providing PGS; dissolving at least one drug in a solvent; incubating the PGS in the solvent; and evaporating the solvent.

Abstract: The present disclosure provides certain silk-fibroin compositions with particular characteristics and/or properties. In some embodiments, the disclosure provides low molecular weight compositions. In some embodiments, the disclosure provides silk fibroin compositions that comprise an active (e.g., a biological) agent or component. In some embodiments, the disclosure provides low molecular weight silk fibroin compositions that comprise an active (e.g., a biological) agent or component. In some embodiments, an active agent is stabilized in a silk composition, e.g., for a period of time and/or against certain conditions or events. In some embodiments, a component present in a silk fibroin composition may be subject to analysis and/or characterization. In some embodiments, a component present in a silk fibroin composition may be recovered from the composition.

Abstract: A method of making a water-soluble doxorubicin-theanine cocrystal composition. The method includes the steps of providing a quantity of doxorubicin, adding a quantity of a theanine enantiomer to the quantity of doxorubicin to form a mixture of the quantity of doxorubicin and the enantiomer of theanine, wetting the mixture, and grinding the mixture for a length of time sufficient to produce a dried crystalline mass.

Abstract: The current invention relates to: procoagulant proteins which may, for example, be fusion proteins or chemical conjugates; methods of producing said procoagulant proteins; polynucleotides that encode said fusion proteins and cells that expresses them. Furthermore, the current invention relates to procoagulant proteins for use as a medicament. Individuals that have a coagulopathy, such as haemophilia A and B with or without inhibitors, may be treated with the procoagulant proteins of the current invention.

Abstract: Disclosed herein are compounds, compositions and methods related to viral inhibition. In some forms, the compounds, compositions and methods are related to binding RNA.

Abstract: The present application provides a pharmaceutical formulation comprising a folate receptor (FR)-targeting antineoplastic substance or composition, wherein the pharmaceutical formulation is configured for administration by inhalation, wherein the FR-targeting antineoplastic substance or composition is comprised in a nanoparticle and wherein the nanoparticles are comprised in microparticles, and its use in the treatment of a proliferative disease affecting at least part of the respiratory tract. The present application further provides a pharmaceutical formulation comprising an antineoplastic agent and a FR-targeting excipient, for use in the treatment of a proliferative disease affecting at least part of the respiratory tract.

Abstract: Methods for treating a subject in need thereof are provided which include administering a pharmaceutical composition comprising a protein transduction reagent-modified reprogramming protein to the subject, wherein the protein transduction reagent is non-covalently bound to the reprogramming protein and wherein the protein transduction reagent comprises a cation reagent and a lipid. According to aspects, such methods provide delivery of protein-transduction reagent-modified reprogramming proteins to cancer cells, such as tumor cells, as well as diseased cells of diseased tissues and provide in vivo conversion of diseased cells into normal cells via protein-induced in situ cell reprogramming without administration of nucleic acids to the subject.

Abstract: This disclosure features compounds that are useful as pro-drugs of epoxy ketone protease inhibitors.

Abstract: The present invention features a compound having the formula A-X-B, where A is peptide vector capable of enhancing transport of the compound across the blood-brain barrier or into particular cell types, X is a linker, and B is a peptide therapeutic. The compounds of the invention can be used to treat any disease for which the peptide therapeutic is useful.

Abstract: The present invention relates to short polypeptides (e.g., fewer than 19 amino acids in length) and longer polypeptides (e.g., 19 or more amino acids in length) having one or more D-amino acids as targeting moieties. These polypeptides, when conjugated to agents (e.g., therapeutic agents or transport vectors) are capable of transporting the agents across the BBB or into particular cell types. In particular, the short polypeptides can include one or more D-amino acids. These compounds are therefore particularly useful in the treatment of neurological diseases or diseases associated with particular cell types, organs, or tissues.

Abstract: Conjugates of antifolates, releasable linkers, and drugs, and pharmaceutical compositions containing them are described. The conjugates are useful for treating diseases arising from pathogenic cell populations. Methods for treating such diseases are also described.

Abstract: The invention relates to novel cell-binding agent-cytotoxic agent conjugate having a peptide linkers and more specifically to conjugates of formula (I). The invention also provides novel cytotoxic agents of formula (II), linker compounds represented by formula (III), and drug-linker compounds represented by formula (IV). The invention further provides compositions and methods useful for inhibiting abnormal cell growth or treating a proliferative disorder in a mammal using the compounds or conjugates of the invention.

Abstract: Conjugates of specific PBD dimers with an antibody that binds to PSMA, the antibody comprising a VH domain having the sequence according to any one of SEQ ID NOs. 1, 3, 5, 7, 8, 9, or 10, optionally further comprising a VL domain having the sequence 5 according to any one of SEQ ID NOs. 2, 4, 6, 11, 12, 13, 14, 15, 16, 17, or 18.

Abstract: The present invention generally relates to antigen-specific immunoconjugates for selectively delivering effector moieties that influence cellular activity. More specifically, the invention provides novel immunoconjugates comprising a first antigen binding moiety, an Fc domain and a single effector moiety. In addition, the present invention relates to polynucleotides encoding such immunoconjugates, and vectors and host cells comprising such polynucleotides. The invention further relates to methods for producing the immunoconjugates of the invention, and to methods of using these immunoconjugates in the treatment of disease.

Abstract: This document provides methods and materials related to treating myelomas. For example, methods and materials relating to the use of a composition containing albumin-containing nanoparticle/antibody complexes (e.g., ABRAXANE®/anti-CD38 polypeptide antibody complexes) to treat myelomas are provided.

Abstract: Conjugates of specific PBD dimers with an antibody that that binds to CD19, the antibody comprising a VH domain having the sequence according to any one of SEQ ID NOs. 1, 2, 3, 4, 5 or 6, optionally further comprising a VL domain having the sequence according to any one of SEQ ID NOs. 7, 8, 9, 10, 11 or 12.

Abstract: Antibody drug conjugates (ADC's) that bind to 191P4D12 protein and variants thereof are described herein. 191P4D12 exhibits tissue specific expression in normal adult tissue, and is aberrantly expressed in the cancers listed in Table I. Consequently, the ADC's of the invention provide a therapeutic composition for the treatment of cancer.

Abstract: The present invention relates to matriptase antibodies and immunoconjugates of matriptase antibodies with cytotoxic agents and the use thereof for killing or inhibiting the growth of matriptase-expressing cancer cells, such as those of multiple myeloma and breast cancers. In particular, immunoconjugates comprising a matriptase monoclonal antibody and anticancer agents such as auristatin, including monomethyl auristatin E (MMAE) and monomethyl auristatin F (MMAF) are introduced, which have potent antitumor activity in vivo. Moreover, importantly; there was no weight loss or other evidence of toxicity in the animals, indicating that no significant free drug was released into the circulation from the conjugate. The present invention also provides compositions comprising these new immunoconjugates and use of them for treatment of malignancies comprising cells that express matriptase.

Abstract: The invention provides novel formulations comprising a stable inclusion complex of tributyrin and a cyclodextrin. In one particular embodiment, the formulation comprises an oven dried inclusion complex of tributyrin and ?-cyclodextrin that is effective in minimizing or preventing the unpleasant taste and odor of tributyrin, thus making it suitable for oral administration and delivery to the digestive tract and intestines. The invention provides compositions of these inclusion complexes and methods of using them that are advantageous as food, medicinal and other products, where the negative sensory properties of tributyrin can be a liability.

Abstract: A method for treating an ocular disorder characterized by the defect or absence of a normal gene in the ocular cells of a human or animal subject involves administering to the subject by subretinal injection an effective amount of a recombinant adeno-associated virus carrying a nucleic acid sequence encoding the normal gene under the control of a promoter sequence which expresses the product of the gene in the ocular cells. The ocular cells are preferably retinal pigment epithelial (RPE) cells, and the gene is preferably an RPE-specific gene, e.g., RPE65. The promoter is one that can express the gene product in the RPE cells. Compositions for subretinal administration are useful in this method.

Abstract: The methods and systems of the present invention provide for an expression vector containing a disease-specific promoter or a constitutive promoter linked to a gene encoding a therapeutic agent, such as a protein, microRNA, siRNA or other therapeutical molecule, e.g., other oligonucletide. The therapeutic agent may be, for example, Interleukin 10 (IL10), Forkhead box P3 (FOXP3), or a member of a transforming growth factor beta 1 (TGF?1) signaling pathway, such as SMAD3.