Abstract: Antitoxin and vaccine compositions based on nodavirus VLPs are provided. Anthrax antitoxin and vaccine compositions are provided. Methods of treating toxins with VLP-based antitoxins are provided. Methods of raising an immune response with immunogen decorated VLPs are provided.

Abstract: A composition for topical application of a botulinum toxin (including botulinum toxin derivatives) comprises a botulinum toxin and a carrier comprising a polymeric backbone comprising a long-chain polypeptide or nonpeptidyl polymer having attached positively charged branching or “efficiency” groups. The invention also relates to methods for reducing muscle paralysis and other conditions that may be treated with a botulinum toxin, particularly paralysis of subcutaneous, and most particularly, facial, muscles, by topically applying an effective amount of the botulinum toxin and carrier, in conjunction, to the subject's skin or epithelium. Kits for administration are also described.

Abstract: A composition for topical application of a botulinum toxin (including botulinum toxin derivatives) comprises a botulinum toxin and a carrier comprising a polymeric backbone comprising a long-chain polypeptide or nonpeptidyl polymer having attached positively charged branching or “efficiency” groups. The invention also relates to methods for reducing muscle paralysis and other conditions that may be treated with a botulinum toxin, particularly paralysis of subcutaneous, and most particularly, facial, muscles, by topically applying an effective amount of the botulinum toxin and carrier, in conjunction, to the subject's skin or epithelium. Kits for administration are also described.

Abstract: A pharmaceutical preparation comprising one of the botulinum neurotoxins from Clostridium botulinum of types A, B, C, D, E, F or G or a mixture of two or more of these neurotoxins, wherein the neurotoxin or the mixture of neurotoxins is free of the complexing proteins which naturally form the botulinum neurotoxin complexes together with the neurotoxins.

Abstract: Disclosed herein are methods of using extracellular matrix digesting enzymes and neurotoxins, such as a Clostridial neurotoxins, to treat various medical conditions, such as overactive bladder, benign prostatic hyperplasia, hyperhidrosis, for example.

Abstract: Methods for enhancing destruction and killing of bacterial spores via phagocytosis, where phagocytosis of bacterial spores is enhanced by using a glycoconjugate. In one embodiment, the method includes the steps of modifying a surface of a bacterial spore to increase adherence to a phagocyte; and ingesting the adherence-increased spore with the phagocyte, thereby destructing and killing the spore by blocking spore-induced phagocyte cell death, while increasing phagocyte activation level and production of antimicrobial and cytocidal agents such as NO and inflammatory cytokines. The adherence of spore to a phagocyte is increased after the surface thereof is coated with a glycoconjugate to form a glycoconjugate-coated spores. The glycoconjugate-coated spores also increase ingestion of the spores by phagocytes and facilitate phagosome-lysosome fusion, which in turn results in destruction and killing of bacterial spores via phagocytosis.

Abstract: Disclosed herein are methods of using extracellular matrix digesting enzymes and neurotoxins, such as a Clostridial neurotoxins, to treat various medical conditions, such as overactive bladder, benign prostatic hyperplasia, hyperhidrosis, and cholecystitis for example.

Abstract: Methods for treating obsessions and compulsions by local administration of a Clostridial toxin. The obsessions or compulsions can be eye poking, body rocking, finger biting, counting, checking and related disorders treated by low dose, intramuscular administration of a botulinum toxin.

Abstract: The present invention pertains to pharmaceutical compositions which comprise a botulinum neurotoxin from Clostridium botulinum, the neurotoxin being free of the complexing proteins naturally present in the botulinum neurotoxin complex or being chemically modified or being modified by genetic manipulation. Moreover the pharmaceutical compositions of the instant invention have good stability and are advantageously formulated free of human serum albumin.

Abstract: A method is disclosed for blocking or reducing physiological reaction in a mammal to the interaction of IgE antibodies present in said mammal upon contact with the corresponding antigen, by the administration to said mammal of a therapeutically effective amount of a neurotoxin (CnT) derived from Clostridia sp.

Abstract: The present invention relates to methods and systems for administering antibody therapeutic agents. The methods include administering one or more (e.g., two or three) binding agents, wherein each of the binding agents has one or more monomers that have a binding region that is specific to a portion of a disease agent and one or more copies of a tag. The binding agents can be specific to one or more portions of the same or different disease agents. The tag is the same for each of the binding agents. The methods include administering an anti-tag antibody, wherein the anti-tag antibody has an anti-tag region that is specific to the tag, and can have an immunoglobulin (e.g., IgA, IgD, IgE, IgG, and IgM). Disease agents include bacteria, bacterial proteins, viruses, viral proteins, cancer cells, and proteins or toxins produced therefrom or from other sources such as snakes, insects, plants, etc.

Abstract: The invention describes therapeutic compositions including a lactic acid-producing bacteria, such as isolated Bacillus coagulans, in combination with a cholesterol-reducing agent for use in reducing LDL cholesterol and serum triglycerides. Also described are therapeutic methods using the compositions and systems containing the therapeutic compositions.

Abstract: This invention provides botulinum antitoxin compositions and methods of production, and methods of treating animals and humans prophylactically and also those suspected of having contacted botulism toxin. The botulinum antitoxin is prepared by inoculating an animal with a monovalent botulinum toxoid and toxin. The animal's plasma is collected and purified at a high pH by affinity chromatography. The resulting monovalent immunoglobulins are de-speciated by digestion with pepsin. Monovalent antitoxins for all seven botulinum serotypes are then combined to produce a high titered heptavalent botulinum antitoxin composition.

Abstract: Liquid-based phamaceutical and/or veterinary and/or nutraceutical compositions comprising non pathogenic sporogenic bacteria, component SP), and the following components: O) from 0.001 to 95% by weight of one or more oils selected from esters of C4-C32 acids, C4-C32, S) from 0 to 90% by weight of one or more amphiphilic compounds, selected from surfactants, polymers forming organized structures such as aggregates, micelles, liquid crystals, vesicles, in the liquid in which they are solubilized, AD) from 0 to 60% by weight of one or more additive compounds selected from modifiers of the water and/or oil polarity, modifiers of the film curvature of component S), co-surfactants, PA) from 0.001 to 70% of one or more compounds selected from food supplements and pharmaceutical and/or veterinary active principles, W) from 0.1 to 99.9% by weight of water or saline aqueous solution, optionally buffered, the sum of the percentages by weight of the components, excluding SP), is 100%.

Abstract: The invention discloses pharmaceutical compositions in liquid form comprising a peptide with the amino acid sequence KLKL5KLK and an oligodeoxynucleotide with the nucleic acid sequence (dIdC)13 and wherein the peptide and the oligodeoxynucleotide are present as sterile-filterable nanoparticles in the composition, thereby forming a suspension, characterized in that the mean particle size of the solid particles is less than 1 ?m.

Abstract: Atoxic Clostridium difficile toxin proteins were expressed in an endotoxin-free Bacillus system top develop a vaccine to reduce incidence and severity of C. difficile infection (CDI). Immunogens evaluated as potential vaccine candidates are mutated toxin A (encoded by TcdA) and toxin B (TcdB), and a rationally designed chimeric protein containing full-length TcdB protein except that the receptor binding domain is replaced with that of TcdA (designated as cTxAB). A small deletion (97 amino acids) in the transmembrane domain was used to reduce or eliminate toxicity.

Abstract: The present invention is directed to multivalent Clostridial toxin comprising more than one binding domain directed to a cell surface molecule of a target cell. Such modified toxins are useful as therapeutic compositions to prevent exocytosis and secretion by the target cell. Conditions in which such compositions may be useful include, without limitation, disorders of the sensory or motor nervous system, acute or chronic pain, cancer, pancreatitis, hyperhydrosis, glandular disorders, viral infections, cystic fibrosis and the like. The invention is also directed to methods of using and administering such a composition, and methods of treating a given condition using such a composition.

Abstract: The present invention relates to a method of treating or preventing pain or pains induced by an anti-neoplastic agent, comprising the step of administering an effective amount of at least one botulinum neurotoxin to a patient in need thereof.

Abstract: The present invention relates to a polypeptide based toxin that originates from Clostridium perfringens. The invention further relates to immunogenic compositions comprising the toxin and methods to vaccinate animals, for example chickens, such that they are less susceptible to clostridial diseases. Methods to determine whether an animal has been exposed to the toxin, polynucleotides encoding the toxin and attenuated bacteria that express a reduced or less active form of the toxin are also disclosed.

Abstract: Antibodies that specifically bind to toxins of C. difficile, antigen binding portions thereof, and methods of making and using the antibodies and antigen binding portions thereof are provided herein.

Abstract: A method for using bird eggs to detect the presence of at least one botulinum toxin.

Abstract: Botulinum toxin, a well know systemic poison, produces favorable therapeutic effect by virtue of regionally attaching to nerves within the myoneural junction and possibly other tissues in a target region of a particular tissue. The present invention provides compositions of botulinum toxin and a sequestration agent that increase sequestration and delivery of the botulinum toxin to neural and associated tissues, as compared with available formulations of botulinum toxins, and thereby produce a beneficial clinical effect. The sequestration agents of the present invention include proteins, lipids and carbohydrates. A preferred composition of the present invention comprises a botulinum toxin and an albumin. The present invention also provides methods of treating neuromuscular diseases and pain using the disclosed compositions and methods of making the disclosed compositions.

Abstract: Antibodies that specifically bind to toxins of C. difficile, antigen binding portions thereof, and methods of making and using the antibodies and antigen binding portions thereof are provided herein.

Abstract: The present invention provides improved media for the cultivation of Clostridium histolyticum and culture supernatants for the biotechnological production of collagenase enzymes. The nutrient media according to the invention comprise one or more peptones from a non-mammalian source, preferably plant-derived peptones. The media can additionally comprise fish gelatin. The invention provides media, culture supernatants comprising Clostridium histolyticum collagenase, and methods to produce said collagenase.

Abstract: This invention relates to the use of a composition comprising a polysaccharide and a botulinum toxin for reducing a skin wrinkle. In some embodiments, the polysaccharide comprises disaccharides. In some embodiments, the average molecular weight of a disaccharide unit of the polysaccharide is between about 345 D and about 1,000 D.

Abstract: Cell-based methods for rapid real time assay of a presence of Clostridium difficile toxin and/or cells are provided, using an assay having a toxin-enhancing antibody and a sensitive cell line carrying FcyR receptors, and kits for this assay. An ultrasensitive cell based immunocytotoxicity assay for detecting less then 1 pg/ml of C. difficile toxins in clinical samples. A TcdA-specific monoclonal antibody, AIH3, was found to significantly enhance the cytotoxicity of TcdA to macrophages and monocytes. The AIH3-dependent enhancement of glucosyltransferase activity, cytoskeleton disruption, and TNF-a production induced by TcdA was demonstrated also in RAW 264.7 cells. Methods for high level recombinant expression of C. difficile toxins in Bacillus cells, and vectors for expression, strains of Bacillus carrying the vectors are provided.

Abstract: Devices, methods and kits are disclosed for preparing and administering less-painful formulations of Botulinum toxin. The devices, methods and kits of the present invention are comprised of or use an acidic formulation of Botulinum toxin, or, in certain embodiments, a freeze- or flash-dried composition of Botulinum toxin, having a long shelf-life which is subsequently mixed with an acid-neutralizing solution and, optionally a sequestration agent prior to administration to a patient in need thereof. The pH-neutralized formulation of Botulinum toxin is pharmaceutically acceptable for administration to a patient and is significantly less painful than acidic formulations of Botulinum toxin or formulations of Botulinum toxin having unnecessary antigens.

Abstract: A method and composition for treating a patient suffering from a disease, disorder or condition and associated pain include the administration to the patient of a therapeutically effective amount of a neurotoxin selected from a group consisting of botulinum toxin types A, B, C, D, E, F and G.

Abstract: The invention includes liquid formulations of botulinum toxin that are stable to storage in liquid form at standard refrigerator temperatures for at least 1-2 years and to storage at higher temperatures for at least 6 months. The invention also includes methods of treatment using such formulations for various therapeutic and cosmetic purposes.

Abstract: Animal protein-free, solid-form Clostridial toxin pharmaceutical compositions comprising a Clostridial toxin active ingredient and at least two excipients.

Abstract: The present invention provides BoNT/A peptides as well as methods of predicting or determining immunoresistance to botulinum toxin therapy in an individual using BoNT/A peptides.

Abstract: A Clostridial toxin pharmaceutical composition comprising a Clostridial toxin, such as a botulinum toxin, wherein the Clostridial toxin present in the pharmaceutical composition is stabilized by a non-protein excipient such as a polyvinylpyrrolidone, a disaccharides, a trisaccharide, a polysaccharide, an alcohol, a metal, an amino acid, a surfactant and/or a polyethylene glycol.

Abstract: Methods of treating one or more autoimmune disorders include a step of administering a Clostridial neurotoxin, such as a botulinum toxin, to a patient that has an autoimmune disorder. In one aspect, a method includes a step of administering the neurotoxin to the thymus gland or near the thymus gland of the patient. In another aspect, a method includes a step of administering the neurotoxin in combination with administering a cytokine inhibitor to the patient. Compositions are also described.

Abstract: The present disclosure relates to spore surface display compositions comprising a spore having at least one nucleic acid sequence encoding for at least one polypeptide and operable to express the polypeptide on a surface of the spore. In some embodiments, the displayed polypeptide is displayed with a spore carrier protein. In some embodiments, the spore may be derived from a Clostriduim sp. such as Clostriduim taeniosporum. Spore display compositions of the disclosure may include vaccines, fusion proteins, drug delivery devices, systems for generating an antibody to an antigen/peptide expressed on a spore surface, an anticancer drug, an immobilized enzyme system, a system for serological reagent preparation, a contaminant removal system, a biocatalysis system, a screening platform, a nanotechnology platform, a bioanalytical sensor, a molecular electronic system and/or a signal processing system. Methods for making and using these compositions are described.

Abstract: A method is disclosed for blocking or reducing physiological reaction in a mammal to the interaction of IgE antibodies present in said mammal upon contact with the corresponding antigen, by the administration to said mammal of a therapeutically effective amount of a neurotoxin (CnT) derived from Clostridia sp.

Abstract: The present invention provides methods and compositions for the stimulation of immune responses. Specifically, the present invention provides nanoemulsion compositions harboring one or more immunogens within the oil phase of the nanoemulsion and methods of using the same for the induction of immune responses (e.g., innate and/or adaptive immune responses (e.g., for generation of host immunity against an environmental pathogen)). Compositions and methods of the invention find use in, among other things, clinical (e.g., therapeutic and preventative medicine (e.g., vaccination)) and research applications.

Abstract: A method is disclosed for blocking or reducing physiological reaction in a mammal to the interaction of IgE antibodies present in said mammal upon contact with the corresponding antigen, by the administration to said mammal of a therapeutically effective amount of a neurotoxin (CnT) derived from Clostridia sp.

Abstract: A method is disclosed for blocking or reducing physiological reaction in a mammal to the interaction of IgE antibodies present in said mammal upon contact with the corresponding antigen, by the administration to said mammal of a therapeutically effective amount of a neurotoxin (CnT) derived from Clostridia sp.

Abstract: A composition and dosage regime including a vaccine and levamisole for the treatment of clostridial diseases and helminthiasis. New methods of administration relating to particular dosage regimes of such a composition are also claimed.

Abstract: Disclosed are dosage forms and related methods, that include a first population of synthetic nanocarriers that have one or more first antigens coupled to them, one or more second antigens that are not coupled to the synthetic nanocarriers, and a pharmaceutically acceptable excipient.

Abstract: Methods for treating obsessions and compulsions by local administration of a Clostridial toxin. The obsessions or compulsions can be eye poking, body rocking, finger biting, counting, checking and related disorders treated by low dose, intramuscular administration of a botulinum toxin.

Abstract: The present invention related to methods for treating neurological-urological conditions. This is accomplished by administration of at least one neurotoxin.

Abstract: A method for treating a patient suffering from arthritis and associated pain include the administration to the patient of a therapeutically effective amount of a neurotoxic component of neurotoxin selected from a group consisting of Botulinum toxin types A, B, C, D, E, F and G.

Abstract: This invention provides novel injectable compositions comprising botulinum toxin that may be administered to a subject for various therapeutic, aesthetic and/or cosmetic purposes. The injectable compositions contemplated by the invention exhibit one or more advantages over conventional botulinum toxin formulations, including reduced antigenicity, a reduced tendency to undergo unwanted localized diffusion following injection, increased duration of clinical efficacy or enhanced potency relative, faster onset of clinical efficacy, and/or improved stability.

Abstract: Methods for treating skin disorders by local administration of a Clostridial toxin, such as a botulinum toxin, to a patient with a skin disorder.

Abstract: An object of the present invention is to provide a peptide vaccine for preventing and/or treating diseases caused by amyloid ?-peptide, such as Alzheimer's disease. The present invention solves the above object by providing a peptide vaccine constructed by inserting a peptide having an amino acid sequence of a cell attachment motif of a cell adhesive molecule to a peptide which consists of a peptide having an amino acid sequence of multiagretope type T-cell epitope, which has been generated immunological memory, or a peptide including the same; an linker peptide; and a peptide having an amino acid sequence of a B cell epitope which is a specific region of amyloid ?-peptide or a peptide including the same.

Abstract: The invention relates to the transdermal application of oligopeptides for reducing synaptic transmission in tissues of an animal. In one aspect, this invention relates to compositions comprising an oligopeptide and optionally a carrier comprising a positively charged “backbone” having positively charged branching or “efficiency” groups, as described herein. Most preferably the positively charged carrier is a long-chain positively charged polypeptide or a positively charged nonpeptidyl polymer, for example, a polyalkyleneimine. The invention further relates methods for producing a biologic effect of reducing synaptic transmission in a tissue by topically applying an effective amount of such a composition, preferably to the skin, of a subject or patient in need of such treatment.

Abstract: A single polypeptide is provided which comprises first and second domains. The first domain enables the polypeptide to cleave one or more vesicle or plasma-membrane associated proteins essential to exocytosis, and the second domain enables the polypeptide to be translocated into a target cell or increases the solubility of the polypeptide, or both. The polypeptide thus combines useful properties of a clostridial toxin, such as a botulinum or tetanus toxin, without the toxicity associated with the natural molecule. The polypeptide can also contain a third domain that targets it to a specific cell, rendering the polypeptide useful in inhibition of exocytosis in target cells. Fusion proteins comprising the polypeptide, nucleic acids encoding the polypeptide and methods of making the polypeptide are also provided. Controlled activation of the polypeptide is possible and the polypeptide can be incorporated into vaccines and toxin assays.

Abstract: Antigenic compositions are provided comprising a single chain polypeptide comprising first and second domains, wherein said first domain is a clostridial neurotoxin light chain or a fragment or a variant thereof and is capable of cleaving one or more vesicle or plasma membrane associated proteins essential to exocytosis; and said second domain is a clostridial neurotoxin heavy chain HN portion or a fragment or a variant thereof, wherein said second domain is capable of (i) translocating the polypeptide into a cell or (ii) increasing the solubility of the polypeptide compared to the solubility of the first domain on its own or (iii) both translocating the polypeptide into a cell and increasing the solubility of the polypeptide compared to the solubility of the first domain on its own; and wherein the second domain lacks a functional C-terminal part of a clostridial neurotoxin heavy chain designated HC thereby rendering the polypeptide incapable of binding to cell surface receptors that are the natural cell sur

Abstract: A single polypeptide is provided which comprises first and second domains. The first domain enables the polypeptide to cleave one or more vesicle or plasma-membrane associated proteins essential to exocytosis, and the second domain enables the polypeptide to be translocated into a target cell or increases the solubility of the polypeptide, or both. The polypeptide thus combines useful properties of a clostridial toxin, such as a botulinum or tetanus toxin, without the toxicity associated with the natural molecule. The polypeptide can also contain a third domain that targets it to a specific cell, rendering the polypeptide useful in inhibition of exocytosis in target cells. Fusion proteins comprising the polypeptide, nucleic acids encoding the polypeptide and methods of making the polypeptide are also provided. Controlled activation of the polypeptide is possible and the polypeptide can be incorporated into vaccines and toxin assays.