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: Improved (safer and more effective) methods of therapy using TNF-R agonists, e.g., CD40 agonists are provided. These methods provide for the addition of an amount of a type 1 interferon and/or a TLR agonist that is effective to prevent or reduce the toxicity (liver toxicity) that may otherwise result in some patients of the TNF-R agonist is used as a monotherapy (without the type 1 interferon and/r TLR agonist).

Abstract: The present invention discloses attenuated Clostridium perfringens organisms that express a substantially nontoxic alpha-toxin. The expressed alpha-toxin is a deletion mutein that relative to the alpha-toxin of the mature alpha-toxin of Clostridium perfringens strain 13, is missing at least nine consecutive amino acid residues including His68. The present invention also discloses attenuated organisms that encode the muteins, as well as the use of such attenuated organisms as vaccines.

Abstract: Booster immunization can lead to rapid induction of protective immunity against pathogens (e.g. ?7 days after the booster dose). This rapid response means that booster immunization can be used at short notice prior to an event that might require an activated immune response. For instance, a subject can be primed at a young age against a pathogen that typically affects more elderly subjects under specific circumstances such that, when the subject is older, the immune response can be mobilized rapidly if those specific circumstances are expected. An example would be to prime a subject against infections that are typically acquired nosocomially and then, soon before a scheduled hospital appointment, to boost their immune response so that they enter hospital in an immune-alert state.

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: The present invention provides materials and methods to facilitate the transcutaneous delivery of therapeutic agents. In some embodiments, agonists of tight junctions are used in compositions to facilitate the uptake of therapeutic agents from the skin. In a particular embodiment, the present invention provides immunogenic compositions comprising a tight junction agonist and an antigen. In a particular embodiment, the present invention provides vaccine compositions comprising a tight junction agonist and an antigen.

Abstract: The invention provides, inter alia, immunogenic compositions that comprise (a) a first antigen, (b) at least first and second adjuvants, wherein the first adjuvant comprises microparticles and wherein the second adjuvant comprises an imidazoquinoline compound, and (c) a pharmaceutically acceptable excipient, which compositions elicits an immune response when administered to a vertebrate subject. The invention also provides methods of producing immunogenic compositions and methods for using immunogenic compositions (e.g., for treatment), among other benefits.

Abstract: The present invention relates to vaccines that are made in transgenic soybeans for use in humans, animals of agricultural importance, pets, and wildlife. These vaccines are used as vaccines against viral, bacterial, fungal, parasitic or prion related diseases, cancer antigens, toxins, and autologous or self proteins. The transgenic soybeans of the instant invention also can be used for inducing tolerance to allergens or tolerance to autoimmune antigens, wherein an individual shows hypersensitivity to said allergen or has developed autoimmunity to autologous or self proteins, respectively. The invention also relates to prophylactically treating individuals and/or populations prior to showing hypersensitivity to allergens. Other aspects of the invention include using the transgenic soybeans as an oral contraceptive, and the expression of protein adjuvants in transgenic soybeans.

Abstract: Sympathetic nerves run through the adventitia surrounding renal arteries and are critical in the modulation of systemic hypertension. Hyperactivity of these nerves can cause renal hypertension, a disease prevalent in 30-40% of the adult population. Hypertension can be treated with neuromodulating agents (such as angiotensin converting enzyme inhibitors, angiotensin II inhibitors, or aldosterone receptor blockers), but requires adherence to strict medication regimens and often does not reach target blood pressure threshold to reduce risk of major cardiovascular events. A minimally invasive solution is presented here to reduce the activity of the sympathetic nerves surrounding the renal artery by locally delivering neurotoxic or nerve-blocking agents into the adventitia. Extended elution of these agents may also be accomplished in order to tailor the therapy to the patient.

Abstract: Disclosed are vaccines and vaccine adjuvants useful in the treatment and/or prevention of infection and diseases associated with infectious pathogens, such as tetanus, as well as diseases associated with biological toxins. Also provided are methods of preparing an adjuvant and the vaccine containing the adjuvant. Methods are also provided for vaccinating/immunizing an animal against infection and diseases associated with infectious pathogens, such as tetanus, and other diseases associated with biological toxins. Adjuvant materials are presented that are prepared from an extracellular matrix material. The adjuvant may also be described as a heterologous acellular collagenous tissue preparation. The adjuvants are demonstrated to enhance the immunogencity of an infectious pathogen antigen or biological toxin antigen of interest, as well as to enhance the survival of an immunized animal.

Abstract: Methods for treating gastric disorders, such as GERD and delayed gastric emptying, by intramuscular administration of a botulinum toxin to a head, neck and/or shoulder muscle of a patient with a gastric disorder.

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: 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 invention relates to polypeptide carrier proteins that comprise at least five CD4+ T cell epitopes, for conjugation to capsular polysaccharides. The carrier proteins are useful as components of vaccines that can elicit a T-cell dependent immune response. These vaccines are particularly useful to confer protection against infection from encapsulated bacteria in infants between the ages of 3 months and about 2 years.

Abstract: The application relates to Clostridium difficile cell surface polysaccharides, compositions comprising Clostridium difficile cell surface polysaccharides, and includes kits, methods and uses thereof.

Abstract: The invention provides compositions and methods for the treatment of diseases associated with amyloid deposits of A? in the brain of a patient, such as Alzheimer's disease. Such methods entail administering an immunogenic fragment of A?, lacking a T-cell epitope, capable of inducing a beneficial immune response in the form of antibodies to A?. In another aspect, the immunogenic fragment of A? is capable of elevating plasma A? levels. The immunogenic fragments comprise linear or multivalent peptides of A?. Pharmaceutical compositions comprise the immunogenic fragment chemically linked to a carrier molecule which may be administered with an adjuvant.

Abstract: A method for treating a mammary gland disorder, including hyperplastic, hypertonic, cystic and/or neoplastic mammary gland tissue by local administration of a botulinum toxin to or to the vicinity of the afflicted breast tissue.

Abstract: A method of temporarily elevating the eyebrow position and softening undesirable glabellar muscle activity to affect a more desirable appearance. In a broad aspect the invention comprises injecting small quantities of botulinum toxin (BTX) equivalent in activity to 0.001 to 1.0 Units of botulinum toxin A, dissolved in 10 to 50 microliters microdroplets of injectable saline carrier, and injected 0.5 to 1.0 millimeters below the skin surface to treat the septal and orbital orbicularis oculi muscles, on each side of a patient's face. In sufficient numbers, injected microdroplets of BTX are able to selectively weaken these muscles. This method preferably also includes using microdroplets of BTX to treat: a) the depressor supercilii muscle, on each side; b) the procerus muscle; c) the corrugator supercilii muscle, on each side; and d) the inferior limit of the frontalis muscle where it meets the superior aspect of the orbital portion of the orbicularis oculi muscle.

Abstract: A method for treating a mammary gland disorder, including hyperplastic, hypertonic, cystic and/or neoplastic mammary gland tissue by local administration of a botulinum toxin to or to the vicinity of the afflicted breast tissue.

Abstract: The invention relates to the use of a pre-synaptic neuromuscular blocking substance for preparing a medicament intended to treat a gland, organ or duct obstructed by a naturally formed stone. This method can be applied notably for salivary gland, gall bladder, kidney or pancreas stones.

Abstract: Methods for treating diverse cancers by local administration of a botulinum toxin to or to the vicinity of the cancer.

Abstract: The invention provides processes for improving the ability of a peptide to stimulate an immune response, comprising exposing the peptide to a chemical modifying agent. It further provides compositions comprising an antigenic peptide, wherein the peptide has been treated with a chemical modifying agent to improve its ability to stimulate an immune response. It also provides methods of stimulating an immune response in a mammal, comprising administering to the mammal an effective amount of a vaccine.

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: The present invention provides a Withania somnifera fraction rich in withanolides and a vaccine comprising a “Withania somnifera fraction” as an adjuvant.

Abstract: The present composition combines an RNAIII-inhibiting peptide (RIP) with an antimicrobial peptide, such as a cathelicidin, that is capable of binding and neutralizing lipidic and polyanionic components of bacterial cell envelope. In another embodiment, the RIP is combined with an antibiotic, with or without an antimicrobial peptide. The present composition is advantageously used in a method of treatment of bacterial sepsis.

Abstract: The present invention relates to methods for enhancing the therapeutic effects of a neurotoxin, e.g., a botulinum toxin, where the methods comprise a “wash-down” (e.g., a decreased intake) of a current pain medication and an administration of a neurotoxin. In some embodiments, the present inventions relates to methods for enhancing the therapeutic effects of a neurotoxin for treating pain, e.g., headache pain.

Abstract: An immunogenic or vaccine composition comprising an immunoadjuvant compound consisting of a Rho GTPase activator. The Activators of Rho GTPases, namely the cytotoxic necrotizing factor 1 (CNF1), and DNT bear immunostimulatory properties towards the systemic response to orally administered ovalbumine.

Abstract: The present invention relates to an adjuvant derived from human lymphocytes. The adjuvant can be used in combination with traditional vaccines or cancer immunotherapy, to enhance the response of the patient's immune system to the vaccine or other immunotherapeutic agent. The adjuvant is derived from the supernatant collected from cultured activated lymphocytes.

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 man 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: Method for alleviating testicular pain in a patient in need thereof. The method can comprise the step of locally administering a neurotoxin (e.g., a botulinum toxin) to at least one anatomical site selected from the group consisting of a testicle and a tissue associated with the testicle of the patient.

Abstract: Methods for treating psychiatric disorders include intracranial administration of a therapeutically effective amount of a neurotoxin, such as a botulinum toxin type A, to a human patient.

Abstract: There is provided a vaccine for controlling Clostridium perfringens in animals, and particularly necrotic enteritis in poultry. The vaccine may comprise a C. perfringens antigenic polypeptide or variant thereof, a nucleic acid encoding the C. perfringens antigenic polypeptide or variant thereof, or a recombinant cell producing the C. perfringens antigenic polypeptide or variant thereof.

Abstract: Adjuvant combinations comprising at least one NKT activator, such as alpha-galactosylceramide (?-Gal-Cer) or iGb3, a CD40 agonist and optionally an antigen are disclosed. The use of these immune adjuvants for treatment of various chronic diseases such as cancers is also provided.

Abstract: This invention provides pharmaceutical compositions, such as vaccines, and methods of making and using such compositions.

Abstract: The disclosure provides an antigenic composition useful for immunization against tularemia. The disclosure provides a method for producing a vaccine for preventing tularemia in humans and animals, a new vaccine against tularemia in humans and animals, and a new approach to producing vaccines against tularemia.

Abstract: A Clostridial toxin pharmaceutical composition comprising a Clostridial toxin, such as a botulinum toxin and a polysaccharide, such as a hydroxyethyl starch, wherein the pharmaceutical composition has a reduced toxicity. The Clostridial toxin pharmaceutical composition can be essentially free of any blood or serum derived proteins, filtrates or fractions.

Abstract: The invention relates to the discovery of novel soluble neutral active Hyaluronidase Glycoproteins (sHASEGPs), methods of manufacture, and their use to facilitate administration of other molecules or to alleviate glycosaminoglycan associated pathologies. Minimally active polypeptide domains of the soluble, neutral active sHASEGP domains are described that include asparagine-linked sugar moieties required for a functional neutral active hyaluronidase domain. Included are modified amino-terminal leader peptides that enhance secretion of sHASEGP. The invention further comprises sialated and pegylated form of a recombinant sHASEGP to enhance stability and serum pharmacokinetics over naturally occurring slaughterhouse enzymes. Further described are suitable formulations of a substantially purified recombinant sHASEGP glycoprotein derived from a eukaryotic cell that generate the proper glycosylation required for its optimal activity.

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: Pharmaceutical compositions for transdermal administration of neurotoxins to a patient include a neurotoxin, such as a botulinum toxin, and an enhancing agent that facilitates absorption of the neurotoxin through the skin of the patient and does not eliminate the bioactivity associated with the neurotoxin. The pharmaceutical compositions are topically applied on a patient, and may be provided in a transdermal patch.

Abstract: Methods are disclosed herein for treating depression in the subject. A method includes the use of Botulinum toxin to cause paralysis of a facial muscle, such as the depressor anguli oris, procerus, frontalis, orbicularis oculi, or corrugator supercilii muscle to treat depression in the subject.

Abstract: The present invention discloses attenuated Clostridium perfringens organisms that express a substantially nontoxic alpha-toxin. The expressed alpha-toxin is a deletion mutein that relative to the alpha-toxin of the mature alpha-toxin of Clostridium perfringens strain 13, is missing at least nine consecutive amino acid residues including His68. The present invention also discloses attenuated organisms that encode the muteins, as well as the use of such attenuated organisms as vaccines.

Abstract: A stable composition including botulinum neurotoxin and a cyclodextrin and a method of preserving botulinum neurotoxin and for producing a botulinum neurotoxin composition with improved stability properties in an efficient and economically advantageous manner. The invention seeks to alleviate the problems associated with rapid degradation or denaturation of botulinum neurotoxin by providing a novel composition that exhibits improved stability properties. The botulinum neurotoxin is preferably stabilized by forming a cyclodextrin inclusion complex.

Abstract: The present invention relates to the field of prevention and treatment of tumors and gastrointestinal disorders. The present invention relates to the prevention and treatment of Core-1-positive carcinomas. The invention relates to coreotics and a method of producing the same and to a method of prevention and treatment of core-1 positive disorders using the same. The invention relates to microorganisms or fractions thereof capable of activating cellular immunity against carbohydrates.

Abstract: The present invention discloses attenuated Clostridium perfringens organisms that express a substantially nontoxic alpha-toxin. The expressed alpha-toxin is a deletion mutein that relative to the alpha-toxin of the mature alpha-toxin of Clostridium perfringens strain 13, is missing at least nine consecutive amino acid residues including His68. The present invention also discloses attenuated organisms that encode the muteins, as well as the use of such attenuated organisms as vaccines.

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 relates to a method of reducing injury to cells, a tissue or organ to be explanted from a body and upon implantation into a body by administering a composition to the cell, tissue or organ, including: (i) a potassium channel opener or agonist and/or an adenosine receptor agonist; and (ii) an antiarrhythmic agent. The invention also provides a composition for reducing injury to vasculature ex vivo including: (i) a potassium channel opener or agonist and/or an adenosine receptor agonist; and (ii) an antiarrhythmic agent.

Abstract: The present invention provides a vaccine composition comprising an effective amount of antigen or a nucleic acid encoding antigen, encapsulated in polymeric particles, wherein said polymeric particles comprises nanoparticles, microparticles or combinations thereof, wherein surprisingly the nanoparticle induces cellular response and the microparticle induces humoral response. The invention further provides a method of inducing cellular and/or humoral immune response.

Abstract: The present invention features methods for selecting a patient with an enhanced therapeutic response to a botulinum toxin treatment of a headache. In some embodiments, the methods comprise the step of identifying a patient who is not using a prophylactic headache pain medication, a patient who is overusing an acute pain medication, a patient who suffers four or more hours of headache pain per headache, a patient who has a chronic daily headache for twenty or more years, and/or a patient who has twenty or more headache days out of a 30-day-month.

Abstract: Pharmaceutical compositions for transdermal administration of neurotoxins to a patient include a neurotoxin, such as a botulinum toxin, and an enhancing agent that facilitates absorption of the neurotoxin through the skin of the patient and does not eliminate the bioactivity associated with the neurotoxin. The pharmaceutical compositions are topically applied on a patient, and may be provided in a transdermal patch.