Abstract: The present invention refers to the use of Lixisenatide or/and a pharmaceutically acceptable salt thereof, for the manufacture of a medicament for the treatment of diabetes mellitus type 2, for inducing weight loss in diabetes type 2 patients or/and for preventing weight gain in diabetes type 2 patients.

Abstract: The present invention relates to compositions and methods for treatment and/or prevention of a cardiovascular disease. In one embodiment, the compositions and methods of the invention relate to continuous administration of a GLP-1 or a metabolite thereof for the treatment and/or prevention of a cardiovascular disease.

Abstract: Highly concentrated drug particle formulations are described, wherein the drug comprises between about 25 wt % and 80 wt % of the particle formulation. The particle formulations of the present invention comprise, for example, macromolecules, such as proteins and/or small molecules (such as steroid hormones). The particle formulation typically further includes one or more additional component, for example, one or more stabilizer (e.g., carbohydrates, antioxidants, amino acids, and buffers). Such concentrated particle formulations can be combined with a suspension vehicle to form suspension formulations. The suspension formulation comprises (i) a non-aqueous, single-phase vehicle, comprising one or more polymer and one or more one solvent, wherein the vehicle exhibits viscous fluid characteristics, and (ii) a highly concentrated drug particle formulation. Devices for delivering the suspension formulations and methods of use are also described.

Abstract: This invention relates to stable non-aqueous single phase viscous vehicles and to formulations utilizing such vehicles. The formulations comprise at least one beneficial agent uniformly suspended in the vehicle. The formulation is capable of being stored at temperatures ranging from cold to body temperature for long periods of time. The formulations are capable of being uniformly delivered from drug delivery systems at en exit shear rate of between about 1 to 1×10?7 reciprocal second.

Abstract: An insulin, insulin analog or derivative of insulin for use in the treatment of diabetes. The use comprises new administration routes of insulin analogs.

Abstract: The present invention provides a method of administering porcine B-domainless factor VIII (OBI-1) to a patient having factor VIII deficiency to provide more rapid and effective protection against bleeding episodes, compared to formerly available methods, or to provide more effective protection to such patients during non-bleeding periods. This invention is based on the discovery that the recombinant B-domainless porcine fVIII, termed OBI-1, has greater bioavailability compared to the natural porcine fVIII partially purified from porcine plasma, termed HYATE:C. Therefore, the inventive method employs lower unit doses of OBI-1, including, alternatively, omission of antibody-neutralizing dosage, or has longer intervals between the administration, compared to HYATE:C, to provide equivalent protection in patients having fVIII deficiency.

Abstract: The instant invention provides methods and compositions for modulation of the immune system. Specifically, the present disclosure provides methods and compositions for increasing T cell mediated immune response useful in the treatment of cancer and chronic infection.

Abstract: The present disclosure provides novel compositions and methods for treating an infection by Middle East respiratory syndrome coronavirus (MERS-CoV). In particular, the present disclosure provides methods that entail administering agents having an anchoring domain that anchors the compound to the surface of a target cell, and a sialidase domain that can act extracellularly to inhibit infection of a target cell by MERS:CoV.

Abstract: Administering an effective dose of glutenase to a Celiac or dermatitis herpetiformis patient reduces levels of toxic gluten oligopeptides, thereby attenuating or eliminating the damaging effects of gluten.

Abstract: Methods and compositions for the treatment or prevention of amyloidosis are provided. In some embodiments, the methods comprise administering to the subject a therapeutically effective amount of at least one catabolic enzyme or a biologically active fragment thereof. Such methods and compositions may be employed to reduce, prevent, degrade and/or eliminate amyloid formation in the lysosome and/or extracellularly.

Abstract: Provided are preparations of tissue kallikrein-1 (KLK1) glycoforms having a defined number of oligosaccharide units per KLK1 molecule. Also provided are mixtures of such glycoforms, pharmaceutical compositions containing such glycoforms or mixtures thereof, methods of obtaining the rhKLK1 glycoforms, and therapeutic uses thereof.

Abstract: This invention relates to novel uses of recombinant clostridial neurotoxins exhibiting decreased duration of effect, in particular uses for the treatment of patients having experienced tendon-related disorders and/or injuries.

Abstract: Substantially stable vaccine compositions are provided, as are methods for their use and manufacture.

Abstract: Provided are a method of ex-vivo culture of natural killer (NK) cells by treating the cells with a reactive oxygen species (ROS) inhibitor and/or a p53 protein inhibitor; and a composition comprising the cultured NK cells. By reducing the activity of ROS and p53 proteins during ex-vivo culture, NK cells may have achieved greater expansion efficiency without altering their anti-tumor cytotoxicity.

Abstract: This invention provides novel carbonic anhydrase (CAIX) nucleic acid and peptide sequences, as well as related methods and compositions, including anti-cancer immunogenic agent(s) (e.g. vaccines and chimeric molecules) that elicit an immune response specifically directed against cancer cells expressing a CAIX antigenic marker. The novel CAIX variant and related compositions are useful in a wide variety of treatment modalities including, but not limited to protein vaccination, DNA vaccination, and adoptive immunotherapy.

Abstract: The present invention provides a vaccine composition comprising: (i) an adjuvant; and (ii) at least one fusion peptide conjugated to a carrier protein, wherein the carrier protein is the diphtheria toxin variant CRM-197 (GenBank Accession No. and wherein the at least one fusion peptide comprises two or more non- contiguous B cell epitopes of Her2/neu selected from the group consisting of SEQ ID Nos:1-7 and 15-60 and amino acid sequences that have at least 85% identity to any of the foregoing. The present invention also extends to pharmaceutical compositions and methods of using the vaccine and/or pharmaceutical compositions, as herein described, for the treatment or prevention of a cancer characterised by the expression or over-expression of Her2/neu in a patient in need thereof.

Abstract: Factor H binding protein (fHBP) has been proposed for use in immunising against serogroup B meningococcus (‘MenB’). This antigen can be efficiently adsorbed to an aluminium hydroxyphosphate adjuvant by (i) ensuring that adsorption takes place at a pH which is equal to or below the adjuvant's point of zero charge (PZC), and/or (ii) selecting a fHBP and adjuvant with an isoelectric point/PZC within the range of 5.0 to 7, and/or (iii) selecting a fHBP with an isoelectric point above the adjuvant's PZC and using a buffer to bring the pH to within 1.2 pH units of the PZC. The adsorption is particularly useful for compositions which include multiple fHBP variants, and also in situations where an aluminium hydroxide adjuvant should be avoided. Buffered pharmaceutical compositions can include at least two different meningococcal fHBP antigens, both of which are at least 85% adsorbed to aluminium hydroxyphosphate adjuvant.

Abstract: Dengue Fever (DF) and Dengue Hemorrhagic Fever (DHF) are significant global public health problems and understanding the overall immune response to infection will contribute to appropriate management of the disease and its potentially severe complications. Live attenuated and subunit vaccine candidates, which are under clinical evaluation, induce primarily an antibody response to the virus and minimal cross-reactive T cell responses. Currently, there are no available tools to assess protective T cell responses during infection or post vaccination. Herein, we report novel, naturally processed and presented MHC class I restricted epitopes, a subset of which binds to and activates T cells in both an HLA-A2 and HLA-A24 restricted manner.

Abstract: The present invention relates i.a. to a CSFV (classical swine fever virus) comprising a substitution of proline to lysine at amino acid position 44 of the E2 protein and a substitution of threonine to aspartic acid at amino acid position 45 of the E2 protein. Further, the present invention provides an immunogenic composition comprising the CSFV of the present invention and the use of the immunogenic composition for reducing the incidence of or severity in an animal of one or more clinical signs associated with CSF. Moreover, the present invention provides a method of differentiating animals infected with CSFV from animals vaccinated with the immunogenic composition of the present invention.

Abstract: An influenza vaccine lacks at least three of: a mercurial preservative; an antibiotic; formaldehyde; and egg-derived materials. In some embodiments, the vaccine includes none of these four components.

Abstract: Influenza vaccines are administered using solid biodegradable microneedles. The microneedles are fabricated from the influenza vaccine in combination with solid excipient(s) and, after penetrating the skin, they dissolve in situ and release the vaccine to the immune system. The influenza vaccine is (i) a purified influenza virus surface antigen vaccine, rather than a live vaccine or a whole-virus or split inactivated vaccine (ii) an influenza vaccine prepared from viruses grown in cell culture, not eggs, (iii) a monovalent influenza vaccine e.g. for immunising against a pandemic strain, (iv) a bivalent vaccine, (v) a tetravalent or >4-valent vaccine, (vi) a mercury-free vaccine, or (vii) a gelatin-free vaccine.

Abstract: A recombinant vector comprises simian adenovirus sequences and a heterologous gene under the control of regulatory sequences. A cell line which expresses simian adenovirus gene(s) is also disclosed. Methods of using the vectors and cell lines are provided.

Abstract: The present invention provides for a vector and a gene expression system for producing a soluble pentameric protein complex comprising the HCMV glycoproteins UL128, UL130, UL131, gH and gL or sequence variants thereof, as well as vaccine compositions comprising the same. The present invention further provides for a vaccine composition for use in prophylactically or therapeutically vaccinating against HCMV infections. Also disclosed are methods of producing the inventive vaccine. Furthermore, the present invention pertains to methods of vaccination of humans with the inventive vaccine composition.

Abstract: The invention relates to amino sphingoglycolipid analogues and peptide derivatives thereof, compositions comprising these compounds and methods of treating or preventing diseases or conditions using such compounds, especially diseases or conditions relating to cancer, infection, atopic disorders, autoimmune disease or diabetes.

Abstract: The present invention relates to the use of a recombinant LAG-3 or derivatives thereof in order to boost a monocyte-mediated immune response, in particular to elicit an increase in the number of monocytes in blood. This finds use in the development of novel therapeutic agents for the treatment of an infectious disease or cancer.

Abstract: The present invention is directed to the use of VISTA agonists alone or in association with other immune inhibitors, preferably another inhibitor of humoral immunity such as an iNOS/NO promoter or nitric oxide or a PD-1 or PD-L1 agonist or a CD40 antagonist for the treatment or prevention of conditions wherein the suppression of humoral immunity is therapeutically beneficial. The present invention is further directed to the use of VISTA antagonists alone or in association with other immune agonists, preferably another enhancer of humoral immunity such as iNOS/NO inhibitor or a PD-1 or PD-L1 antagonist or anti-CTLA-4 antibody or a CD40 agonist for the treatment or prevention of conditions wherein the enhancement of humoral immunity is therapeutically beneficial. Also, the invention relates to the use of VISTA antagonists alone or in association with another immune agonist, e.g., an iNOS/NO inhibitor or a CD40 agonist to promote the efficacy of therapeutic and prophylactic vaccines, e.g.

Abstract: The invention provides a combination pharmaceutical composition comprising a) at least one activated-potentiated form of an antibody to at least one cytokine or at least an activated-potentiated form of an antibody to at least one receptor; and b) an effective amount of a nucleoside reverse transcriptase inhibitor, wherein said at least one cytokine or at least one receptor is participating in the regulation of immune process. Various embodiments and variants are contemplated. The invention also provides a method of treatment or prophylaxis of HIV, including AIDS, which includes administration of the combination pharmaceutical composition described in the specification to the patient in need thereof.

Abstract: The preset invention relates to combination pharmaceutical composition comprising an activated-potentiated from of an antibody to gamma interferon, and an activated-potentiated form of an antibody to S-100 protein and method of treating multiple sclerosis and other neurodegenerative diseases, as well as the diseases and conditions associated with neuroinfections.

Abstract: The present invention relates to compositions and methods for characterizing, regulating, diagnosing, and treating cancer. For example, the present invention provides compositions and methods for inhibiting tumorigenesis of certain classes of cancer cells, including breast cancer cells and preventing metastasis. The present invention also provides systems and methods for identifying compounds that regulate tumorigenesis.

Abstract: The present invention provides, inter alia, methods for treating or ameliorating the effects of a disease, such as cancer, in a subject. The methods include: administering to a subject in need thereof (a) a therapeutically effective amount of a microtubule inhibitor; and (b) a therapeutically effective amount of a monoclonal antibody or antigen binding fragment thereof, wherein the monoclonal antibody contains: (i) a heavy chain variable region (VH), which includes an amino acid sequence selected from SEQ ID NO:1, SEQ ID NO:3, SEQ ID NO:5, and SEQ ID NO:7; and (ii) a light chain variable region (VL), which includes an amino acid sequence selected from SEQ ID NO:2, SEQ ID NO:4, SEQ ID NO:6, and SEQ ID NO:8. Compositions, including pharmaceutical compositions, and kits for treating diseases, such as cancer, are also provided herein.

Abstract: The present invention provides, inter alia, methods for treating or ameliorating the effects of a disease, such as cancer, in a subject. The methods include: administering to a subject in need thereof (a) a therapeutically effective amount of an agent selected from the group consisting of an anti-angiogenic agent, a vascular disrupting agent (VDA), and combinations thereof; and (b) a therapeutically effective amount of a monoclonal antibody or antigen binding fragment thereof, wherein the monoclonal antibody contains: (i) a heavy chain variable region (VH), which includes an amino acid sequence selected from SEQ ID NO:1, SEQ ID NO:3, SEQ ID NO:5, and SEQ ID NO:7; and (ii) a light chain variable region (VL), which includes an amino acid sequence selected from SEQ ID NO:2, SEQ ID NO:4, SEQ ID NO:6, and SEQ ID NO:8. Compositions, including pharmaceutical compositions, and kits for treating diseases, such as cancer, are also provided.

Abstract: Methods, pharmaceutical compositions, and kits for treating a disease, such as cancer, in a subject. The methods include: administering to a subject in need thereof (a) a therapeutically effective amount of a platinum agent; and (b) a therapeutically effective amount of a monoclonal antibody or antigen binding fragment thereof.

Abstract: A drug is provided with an emulsifier and additive free fatty compound, and steroids. The fatty compound has a core structure similar to stratum corneum. In one embodiment, the fatty compound includes 75-85 wt % of aqua, 35-45 wt % of caprylic/capric triglyceride, 1-10 wt % of pentylene glycol, 1-9 wt % of hydrogenated lecithin, 1-9 wt % of butyrospermum parkii butter, 1-7 wt % of glycerin, 1-5 wt % of ceramide NP, and 1.2-2.2 wt % of squalane.

Abstract: Ophthalmic solutions are provided for use as tear substitutes and contact lens solutions. These solutions contain a cationic polymeric surfactant that has an affinity for the surface of the eye or a contact lens. Also disclosed are ophthalmic solutions containing a combination of the cationic polymeric surfactant and a water soluble anionic polymer which forms a complex in aqueous solution. The complex has an affinity for the surface of the eye or contact lens. In this manner, the present solutions provide improved duration of comfort to the user. The present compositions are also useful as carriers for ophthalmic drugs.

Abstract: A fiber may comprise an electrospun polymer and a contrast agent. A method of making an electrospun fiber may comprise configuring a receiving surface to receive a polymer fiber, applying a charge to one or more of the receiving surface, a polymer injection system, and a polymer solution ejected from the polymer injection system, and depositing a polymer solution ejected from the polymer injection system onto the receiving surface. The polymer solution may comprise a polymer and a contrast agent.

Abstract: An object of the present invention is to provide lipid particles which have low cytotoxicity, can stably hold nucleic acid molecules outside cells, and can promptly release nucleic acids in cytoplasm after escaping from endosome, and a nucleic acid delivery carrier. According to the present invention, there are provided lipid particles containing a compound represented by the following General Formula (1), sterol, at least one lipid selected from the group consisting of a neutral lipid and a lipid having a polyethylene glycol chain, and nucleic acids, and a nucleic acid delivery carrier. In the formula, R1 and R2 are the same as or different from each other, and are alkyl groups having 10 to 22 carbon atoms.

Abstract: The invention provides a composition containing hyaluronic acid (HA) or a pharmaceutically-acceptable salt thereof preserved with a cationic preservative and related methods. In one embodiment, the pharmaceutically-acceptable salt is sodium hyaluronate. In another embodiment, the cationic preservative includes benzalkonium chloride (BAK).

Abstract: Various biodegradable polyglutamate-amino acids comprising recurring units of the general formulae (I) and (II) are prepared. Such polymers are useful for variety of drug, biomolecule and imaging agent delivery applications.

Abstract: The present invention relates to a pH-sensitive and bioreducible polymer-virus complex which can destroy tumor cells more effectively by increasing the efficiency of virus transduction, to a pH-sensitive and bioreducible polymer, and to a pharmaceutical composition containing the polymer-virus complex.

Abstract: Methods, systems, and devices are disclosed for fabricating and implementing nanoscale and microscale structured carriers to provide guided, targeted, and on-demand delivery of molecules and biochemical substances for a variety of applications including diagnosis and/or treatment (theranostics) of diseases in humans and animals. In some aspects, a nanostructure carrier can be synthesized in the form of a nanobowl, which may include an actuatable capping particle that can be opened (and in some implementations, closed) on demand. In some aspects, a nanostructure carrier can be synthesized in the form of a hollow porous nanoparticle with a functionalized interior and/or exterior to attach payload substances and substances for magnetically guided delivery and controlled release of substance payloads.

Abstract: The present invention provides refillable drug delivery devices. The invention is based in part on the development of systemically administered drug payloads that home to and refill resident, e.g., previously administered/implanted, drug delivery systems, e.g., hydrogel drug delivery systems. In one aspect, the drug delivery depots of the invention are systemically administered, e.g., enterally administered or parenterally administered. The invention provides a method of nanotherapeutic drug delivery, e.g., a DNA nanotechnology-based approach for blood-based drug refilling of intra-tumor drug depots.

Abstract: The present invention relates to a compound which is a polysaccharide derivative of EPO, or of an EPO like protein, wherein the polysaccharide is anionic and comprises between 2 and 200 saccharide units. The present invention also relates to pharmaceutical compositions comprising the novel compounds, and methods for making the novel compounds.

Abstract: Methods of increasing the plasma concentration of resveratrol in a mammal in need thereof by administering to a mammal in need thereof an effective amount of trans-resveratrol and arginine for a period of at least two weeks.

Abstract: A method of treating neoplasia in a subject in need of treatment is provided by administering to the subject an amount of a prodrug of mitomycin C that yields a therapeutically effective amount of mitomycin C, in combination with radiation therapy. In one embodiment, the prodrug of mitomycin C is a liposomal-prodrug of mitomycin C. Together, the prodrug of mitomycin C and radiation therapy provide a synergistic antineoplastic effect.

Abstract: A terminally modified polymer is provided herein. At least one terminus of the polymer is —O—(CH2)2-LM or —O—CH2—CH(OH)—CH2—CR1?CR2R3. LM, R1, R2, and R3 are defined herein Also disclosed are terminal conjugates comprising the polymer and a pharmaceutically useful modifier, as well as compositions comprising the conjugates, methods of their preparation, and methods of treating various disorders with the conjugates or their compositions.

Abstract: A dendrimer formulation, such as a PAMAM dendrimer or a multiarm PEG polymeric formulation has been developed for oral administration to the gastrointestinal tract for treatment of inflammatory diseases associated with infection or cancer. In the preferred embodiment, the dendrimers are in the form of dendrimer nanoparticles comprising poly(amidoamine) (PAMAM) hydroxyl-terminated dendrimers covalently linked to at least one therapeutic, prophylactic or diagnostic agent for treatment of one or more symptoms of necrotizing enterocolitis.

Abstract: The present invention relates to the field of drug carrier systems and polymer therapeutics and diagnostics. It provides derivatized unimolecular polyols with a hydrophobic core moiety and a polyanionic, preferably, sulfated hydrophilic shell, N in particular to unimolecular hyperbranched sulfated polyglycerol micelles having a hydrophilic shell and a hydophrobic core. These may be used for the supramolecular encapsulation and transport of hydrophobic guest molecules into biological systems. The micelles can be applied as a drug carrier system for therapy and for diagnosis. They may also be therapeutic agents on their own. The invention also relates to preparation of said micelles.

Abstract: Compositions and methods for treating, alleviating, and/or preventing one or more symptoms associated with axonal degeneration in individuals in need thereof, such as individuals with peroxisomal disorders and leukodystrophies include one or more poly(amidoamine) dendrimers G1-G10, preferably G4-G6, complexed with therapeutic, prophylactic and/or diagnostic agent in an effective amount to treat, and/or prevent one or more symptoms associated with axonal degeneration are provided. Compositions are particularly suited for targeted delivery of therapeutics to the affected spinal neurons and may contain one or more additional targeting moieties.

Abstract: A series of peptides and a peptide-siRNA complex are disclosed, wherein the peptide based complex effectively enhances delivery of siRNA molecules into the cells and release of siRNA in the cell, and improves siRNA mediated gene silencing efficiency of cellular targets. Pharmaceutical compositions that include the complex, as well as a use of the complex in the gene therapy field, are also disclosed.

Abstract: Disclosed are prodrugs of therapeutic or imaging agents, which prodrugs are selectively cleaved by fibroblast activating protein (FAP) to release the agents. Upon cleavage by FAP of the FAP substrate, the prodrug releases the agent in its active form or in a form that is readily metabolized to its active form. Pharmaceutical compositions comprising the prodrugs, as well as methods of using the prodrugs to treat a disorder characterized by FAP upregulation are also disclosed.