Abstract: Methods of making ligand-decorated polymer conjugates of therapeutic glycoproteins are described. Improved targeting of glycoproteins to specific tissues is achieved by masking the natural carbohydrate and other surface determinants with high molecular weight polymers, such as, e.g., PEG, polysialic acid, etc., which in turn are decorated with target-specific ligands. In some embodiments, acid-labile linkages in such conjugates or rapidly degradable masking groups allow for the intracellular release of the polymer from the glycoprotein, for example, under conditions found in lysosomes.

Abstract: The present invention involves using a keratinase enzyme to degrade beta-amyloid proteins and plaques related to Alzheimer's disease.

Abstract: The present invention relates to dosing regimens with half-life extended Factor VIIa (FVIIa) for prophylactic and “on-demand” treatment of bleeding, as well as for preventing a bleeding episode during or after surgery in patients with congenital or acquired bleeding disorders. The present invention further relates to the use of half-life extended FVIIa for treating or preventing blood loss in patients without bleeding disorders in situations of hemorrhage, i.e., due to trauma or surgery. Another aspect of the invention is the treatment of acquired haemophilia.

Abstract: The invention relates to the prevention and treatment of pathologic scars using APC or analogue thereof.

Abstract: The invention relates to the use of an animal-protein-free botulinum toxin composition to treat a disease, disorder or condition in a patient in need thereof whereby the animal-protein-free botulinum toxin composition exhibits a longer lasting effect in the patient compared to an animal-protein-containing botulinum toxin composition.

Abstract: The invention provides compositions and methods for treating incontinence associated with sexual activity.

Abstract: An effective amount of a composition comprising (i) a plasmid having a cyclooxygenase-prostacyclin synthase fusion gene, and (ii) a carrier fluid for use in treating an individual having a vascular disease or at risk of developing a vascular disease. A composition comprising a carrier fluid; and a DNA sequence encoding for a triple catalytic enzyme, a cDNA sequence encoding for a triple catalytic enzyme, a plasmid comprising a DNA sequence encoding for a triple catalytic enzyme, a fusion gene encoding for a triple catalytic enzyme, a cyclooxygenase-prostacyclin synthase fusion gene, or combinations thereof, for use in treating an individual having a vascular disease or at risk of developing a vascular disease.

Abstract: A streamlined method for purifying alpha-1-antitrypsin (AAT) from an AAT-containing protein mixture, such as Coh fraction IV precipitate, is provided. In the method of the invention, contaminating proteins are destabilized by cleavage of disulfide bonds with a reducing reagent, such as dithiol, which does not affect AAT. The destabilized proteins are then preferentially adsorbed on a solid protein-adsorbing material, without the addition of a salt as a precipitante. Spearation of the solid absorbent from the solution leaves a purified AAT solution that is directly suitable for chromatographic purification, without the need for extensive desalting as in prior art processes. A process incorporating this method, which provides pharmaceutical grade AAT in high yield on a commercial scale, is also described.

Abstract: A method of transdermal delivery of a vaccine, comprising preparing microparticles of encapsulated vaccine by spray drying a mixture of the vaccine and at least one polymer, and injecting the microparticles transdermally using a microneedle delivery apparatus.

Abstract: A surface protein of the murine fungal pathogen Pneumocystis murina can be used to generate an immune response in a recipient animal or human that provides prophylactic protection and an anti-fungal activity in subjects already infected with a Pneumocystis species. Further, the disclosure provides novel polypeptides or peptides derived from the P. murina surface protein Surface Peptidase 1 (SPD-1) that are useful, alone or in combination with the SPD-1 polypeptide, in compositions and methods for the generation of an anti-Pneumocystis immune reaction by a recipient subject. The compositions and methods of the disclosure provide advantageous alternatives to available immunogenic determinants for the treatment or prevention of fungal pneumonia.

Abstract: Disclosed herein are methods and compositions for the delivery of polypeptides, including vaccine candidate polypeptides, into mammalian cells comprising the use of photosensitized trypanosomatid organisms. Also disclosed are methods of treatment of trypanosomatid infections comprising administering phthalocyanine compounds or phthalocyanine-treated trypanosomatid microorganisms as vaccines, as well as and polypeptide delivery vectors comprising phthalocyanine-treated trypanosomatid microorganisms.

Abstract: Disclosed herein are DNA-based vaccines against amyloid ? peptide for use in treating and alleviating Alzheimer's Disease and related conditions. A DNA construct comprising DNA encoding one or more amyloid ? peptides, such as amino acids 1-11 of A?, and DNA encoding a hepatitis B antigens, is administered with an adjuvant or by electroporation. The vaccine can also be formulated using a fusion protein expressed by the disclosed DNA, in combination with an adjuvant.

Abstract: Provided herein are compositions, methods, and kits related to compositions comprising at least one gluten peptide. In some aspects, compositions, methods, and kits useful for subjects having Celiac disease.

Abstract: Compositions containing Tr1 cells directed to a multiple sclerosis associated antigen and methods for treating multiple sclerosis are presented.

Abstract: Synthetic bacterial messenger RNA can be used to prepare autologous, allogenic or direct nucleic acid cancer vaccines. Cancer cells are transfected either in vitro or in vivo with mRNA obtained from DNA that encodes an immunogenic bacterial protein. An immune response to the cancer is generated from direct administration of the mRNA in vivo or administration of vaccines prepared from cancer cells in vitro.

Abstract: A composition that can be used as a vaccine containing means for targeting at least one antigen to dendritic cells and as adjuvants a granulocyte macrophage colony stimulating factor and a CpG oligodeoxynucleotide and/or a CpG-like oligodeoxynucleotide. This composition can used to treat cancers, infectious diseases caused by bacterial, viral, fungal, parasitic or protozoan infections, allergies and/or autoimmune diseases.

Abstract: The present invention comprises compositions, methods, and devices for enhancing an endogenous immune response against a cancer. Devices and methods provide therapeutic immunity to subjects against cancer.

Abstract: The present invention provides methods of treating, protecting against and inducing an immune response against a tumor or cancer, comprising the step of administering to a subject a recombinant Listeria strain. In one embodiment the present invention relates to a recombinant Listeria strain, said recombinant Listeria strain comprising a recombinant nucleic add, said nucleic add comprising a first open reading frame encoding a recombinant polypeptide comprising a first N-terminal fragment of an LLO protein fused to a heterologous antigen or fragment thereof, and wherein said recombinant nucleic add further comprises a second open reading frame encoding a mutant PrfA protein.

Abstract: The present invention relates to a pharmaceutical combination of compositions for use in the treatment or prevention of a disease having cells bearing a target antigen as a vaccine and to a method for vaccination of a mammal, especially of a human for raising a cellular immune response directed against cells of the mammalian recipient, especially human recipient, which cells express a target antigen. The target antigen can e.g. be an autoantigen like a malignant antigen, i.e. a tumour-specific antigen. The pharmaceutical combination of compositions comprises a first composition and a second composition, wherein the second composition is for administration to recipient subsequent to the administration of the first composition, e.g. 2 to 10 days after the first composition. The pharmaceutical combination of compositions has the advantage of raising an effective antigen-specific T-cell response against cells bearing a target antigen that can be a malignant autoantigen, e.g.

Abstract: The invention involves generating a T cell response to subdominant antigens and using the cells to therapeutically change the cellular homeostasis and nature of the immune response. In a preferred embodiment, the cells are generated outside of the patient avoiding the influence of the patient's immunologic milieu. By stimulating and growing the T cells from a patient in a tissue culture to one or more subdominant antigens and the transplanting them into the patient, if enough cells are expanded and transplanted, the transplanted cells overwhelm the endogenous dominant T cells in the response to either break or induce immune tolerance or otherwise modify the immune response to the cells or organism expressing that antigen. When the memory cells are established they are then reflective of this new immunodominance hierarchy so that the desired therapeutic effect is long lasting.

Abstract: The invention involves generating a T cell response to subdominant antigens and using the cells to therapeutically change the cellular homeostasis and nature of the immune response. In a preferred embodiment, the cells are generated outside of the patient avoiding the influence of the patient's immunologic milieu. By stimulating and growing the T cells from a patient in a tissue culture to one or more subdominant antigens and the transplanting them into the patient, if enough cells are expanded and transplanted, the transplanted cells overwhelm the endogenous dominant T cells in the response to either break or induce immune tolerance or otherwise modify the immune response to the cells or organism expressing that antigen. When the memory cells are established they are then reflective of this new immunodominance hierarchy so that the desired therapeutic effect is long lasting.

Abstract: The invention involves generating a T cell response to subdominant antigens and using the cells to therapeutically change the cellular homeostasis and nature of the immune response. In a preferred embodiment, the cells are generated outside of the patient avoiding the influence of the patient's immunologic milieu. By stimulating and growing the T cells from a patient in a tissue culture to one or more subdominant antigens and the transplanting them into the patient, if enough cells are expanded and transplanted, the transplanted cells overwhelm the endogenous dominant T cells in the response to either break or induce immune tolerance or otherwise modify the immune response to the cells or organism expressing that antigen. When the memory cells are established they are then reflective of this new immunodominance hierarchy so that the desired therapeutic effect is long lasting.

Abstract: The invention involves generating a T cell response to subdominant antigens and using the cells to therapeutically change the cellular homeostasis and nature of the immune response. In a preferred embodiment, the cells are generated outside of the patient avoiding the influence of the patient's immunologic milieu. By stimulating and growing the T cells from a patient in a tissue culture to one or more subdominant antigens and the transplanting them into the patient, if enough cells are expanded and transplanted, the transplanted cells overwhelm the endogenous dominant T cells in the response to either break or induce immune tolerance or otherwise modify the immune response to the cells or organism expressing that antigen. When the memory cells are established they are then reflective of this new immunodominance hierarchy so that the desired therapeutic effect is long lasting.

Abstract: Provided herein are novel p62 compositions for the prophylaxis and treatment of cancer and related methods. The invention also provides modified p62 compositions that increase the anti-cancer activity of p62.

Abstract: The present invention is directed to a fusion protein, antigen cocktails and immunological compositions such as vaccines against infections caused by virulent mycobacteria, e.g. by Mycobacterium tuberculosis, Mycobacterium africanum, Mycobacterium bovis, Mycobacterium microti, Mycobacterium canettii, Mycobacterium pinnipedii or Mycobacterium mungi. The fusion protein, antigen cocktails and immunological compositions are based on proteins secreted by the ESAT-6 secretion system 1 (ESX-1) and are among the most immunodominant M. tuberculosis (MTB) antigens.

Abstract: Precipitated bacterial capsular polysaccharides can be efficiently re-solubilised using alcohols as solvents. The invention provides a process for purifying a bacterial capsular polysaccharide, comprising the steps of (a) precipitation of said polysaccharide, followed by (b) solubilisation of the precipitated polysaccharide using ethanol. CTAB can be used for step (a). The material obtained, preferably following hydrolysis and sizing, can be conjugated to a carrier protein and formulated as a vaccine. Also, in vaccines comprising saccharides from both serogroups A and C, the invention provides that the ratio (w/w) of Men A saccharide: MenC saccharide is >1.

Abstract: The present invention provides novel chlamydia antigens, nucleic acids encoding the antigens, and immunogenic compositions including the antigens. The present invention further provides methods of using the antigens to elicit immune responses (e.g., T cell-mediated and/or B cell-mediated immune responses). The present invention provides methods of prophylaxis and/or treatment of chlamydia-mediated diseases comprising administering an immunogenic composition including one or more of the novel antigens described herein.

Abstract: The present disclosure provides a recombinant viral vector comprising at least one transgene inserted into a Marek's disease viral genome for treatment of diseases in poultry. Also provided are immunogenic compositions comprising such recombinant viral vectors and methods for preventing or inhibiting Marek's disease in combination with at least a second disease in poultry.

Abstract: The present invention relates to a biodegradable nanocomplex. The biodegradable nanocomplex comprises a first electrically charged substance, a charge-redistribution substance, a second electrically charged substance and a carried substance, for holding the carried substance inside. The first electrically charged substance and the carried substance have the same electrical polarity, and the biodegradable nanocomplex has a nonuniformally and positively charge distribution along a radial direction thereof.

Abstract: Provided herein are recombinant modified vaccinia virus Ankara (MVA) strains as improved vaccines against infection with Respiratory Syncytial Virus (RSV virus) and to related products, methods and uses. Specifically, provided herein are genetically engineered recombinant MVA vectors comprising at least one nucleotide sequence encoding an antigenic determinant of an RSV membrane glycoprotein and at least one nucleotide sequence encoding an antigenic determinant of an RSV nucleocapsid protein. Also provided herein are products, methods and uses thereof, e.g., suitable to affect an immune response in a subject, or suitable to diagnose an RSV infection, as well as to determine whether a subject is at risk of recurrent RSV infection.

Abstract: The present invention relates to novel compositions of active agents and methods for the treatment of HIV infection and AIDS. In particular, the present invention relates to novel methods for treatment of HIV infection and prevention of AIDS.

Abstract: Disclosed herein are methods and compositions related to therapy for cancer. More specifically, the disclosed methods and compositions are related to the use of smallpox vaccine to induce an effective anti-tumor immune response.

Abstract: Synthetic representative HCV subtypes, including a 1a and 1b genome, dubbed Bole1a and Bole1b, are provided using an inventive method of Bayesian phylogenetic tree analysis, ancestral sequence reconstruction and covariance analysis. Bole1a branches centrally among 390 full-genome sequences used in its design, a carefully curated 143 sequence full-genome dataset, and separate genomic regions including an independent set of 214 E1E2 sequences from a Baltimore cohort. Bole1a is phylogenetically representative of widely circulating strains. Full genome non-synonymous diversity comparison and 9-mer peptide coverage analysis showed that Bole1a is able to provide more coverage (94% and 78% respectively) than any other sequence in the dataset including H77, a traditional reference sequence. Bole1a also provides unsurpassed epitope coverage when compared to all known T cell epitopes.

Abstract: Chimeric therapeutics are disclosed that include a modified viral core protein comprising at least one mutation or modification in an immunogenic epitope and a therapeutic agent. The therapeutic agent may be associated with the modified viral core protein and may be a nucleic acid, a protein, or a small molecule. Also disclosed are particles and compositions that include the disclosed chimeric therapeutics.

Abstract: The invention relates to an immunogenic composition far sublingual, perlingual or oral administration, comprising at least an antigen and at least an adjuvant that is a bacterium selected from a Bifidobacterium and a lactic acid bacterium, and or a combination of a corticosteroid with vitamin D3 or any metabolite or analog of the latter, in a pharmaceutically acceptable carrier that is suitable tor sublingual, perlingual, or oral administration. Such compositions allow to elicit antigen-specific immune tolerance.

Abstract: The present invention relates to use of a GLP-1 agonist and an anti-IL-2 antibody in treatment and/or prevention of type 1 diabetes.

Abstract: Described are compositions and methods of using verteporfin-based photodynamic therapy (PDT) to increase the biomechanical strength of the cornea. More particularly, described herein are compositions and methods for cross-linking collagen in corneal tissue which are useful in the treatment of corneal ectatic disorders.

Abstract: The present specification discloses pharmaceutical compositions, methods of preparing such pharmaceutical compositions, and methods and uses of treating a severe pain in an individual using such pharmaceutical compositions.

Abstract: The purpose of the present invention is to provide a polymer gel that can increase drug content ratio and reduce undesirable influence on gel strength and shape stability after the drug release, compared with the conventional techniques. The purpose can be achieved by an anionic drug-containing medical device comprising: (1) an anionic drug; and (2) a copolymer which contains, as constituents, a cationic monomer comprising a condensation product of an alkyl quaternary ammonium compound having a substituted or unsubstituted aralkyl group and (meth)acrylic acid or a salt of the condensation product and a monomer capable of copolymerizing with the condensation product or the salt of the condensation product.

Abstract: The present invention relates to a pharmaceutical composition in form of emulsion or microemulsion and the use thereof as aid during endoscopic procedures in which it is injected in a target tissue in order to form a cushion. More in details, the invention relates to a method for performing an endoscopic procedure, which comprises injecting said pharmaceutical composition in form of emulsion or microemulsion in a target tissue of a patient, in order to form a cushion, which cushion is then optionally subjected to an endoscopic surgical procedure, such as a resection.

Abstract: The present invention is directed to compositions comprising topiramate and a sulfoalkyl ether cyclodextrin, and methods of making and using the same.

Abstract: The invention provides an immunogenic molecular entity and related vaccines that can be used to inhibit Gram-positive bacterial quorum sensing, prevent infection or development of a disease condition associated with a Gram-positive bacterial infection. The invention also provides methods of inhibiting Gram-positive bacterial quorum sensing, and methods of preventing infection or development of a disease condition associated with a Gram-positive bacterial infection.

Abstract: The present inventors employed cyclodextrins for use as a proteoglycan substitute to engineer a biomimetic collagen-based matrix composition. The resulting incorporation of cyclodextrin in the inventive collagen compositions increased collagen thermal stability and reduced collagen fibrogenesis. As a result, a thick, transparent and mechanically strong collagen-based composition was formed. This cyclodextrin-collagen composition holds a great potential to be used as a therapeutic eye patch for corneal repair. Methods for making these inventive compositions and their use are also provided.

Abstract: Oil-in-water emulsions are prepared using phospholipids purified from krill.

Abstract: Compositions and methods are provided for treating a patient suffering from a disease associated with endothelial dysfunction by administering to the patient a pharmaceutical composition containing an effective amount of a synthetic collagen binding peptidoglycan.

Abstract: Provided herein are self-delivering oligonucleotides that are characterized by efficient RISC entry, minimum immune response and off-target effects, efficient cellular uptake without formulation, and efficient and specific tissue distribution.

Abstract: Provided herein are improved methods for the synthesis of reactive conjugate clusters and intermediates used in such methods. In particular, improvements are provided that enhance the synthesis of reactive conjugate clusters by reducing the number of synthetic steps required. The reactive conjugate clusters prepared using the improved methods don't include any transacylation impurities that are formed using existing methods. The improved methods also provide an increase in overall yield and a cost benefit over existing methods.

Abstract: The present invention relates to the field of gastroenterology and, more particular, to the field of intestinal diseases. More specifically, it concerns uses and methods for the treatment of inflammatory bacterial diseases of the intestine. In particular, it relates to diseases that are associated with bacterial invasion of the intestinal mucus, including, inflammatory bowel diseases, and infectious bacterial diseases. Therefore, the present invention provides agents, a pharmaceutical composition and a kit for treating said diseases. It further relates to a use and a method for treating invasive bacterial diseases of the large intestine.

Abstract: The present invention provides compositions comprising PAMAM dendrimers conjugated with one or more biologically active agents, and their use systemically to target activated microglia/macrophages in retina/choroid and generally, inflammatory and/or angiogenic diseases of the eye.

Abstract: Methods for use of a multi-arm polyethylene glycol (PEG) modifier in modification of asparaginase. The described multi-arm PEG modifier enhances the subunit interaction of a multimeric protein to maintain the multimeric protein in a polymerized form, thereby improving the stability of the multimeric protein, maintaining the bioactivity of the multimeric protein, and reducing the probability of exposure of the antigen binding site after depolymerization of the subunits, so as to reduce the immunogenicity.