Abstract: The present invention relates to an isolated Clostridial neurotoxin propeptide having a light chain region, a heavy chain region, where the light and heavy chain regions are linked by a disulfide bond, and an intermediate region connecting the light and heavy chain regions. An isolated nucleic acid molecule encoding a Clostridial neurotoxin propeptide is also disclosed. Also disclosed is an isolated, physiologically active Clostridial neurotoxin produced by cleaving a Clostridial neurotoxin propeptide, a vaccine or antidote thereof, and methods of immunizing against or treating for toxic effects of Clostridial neurotoxins. Methods of expressing recombinant physiologically active Clostridial neurotoxins are also disclosed. Also disclosed is a chimeric protein having a heavy chain region of a Clostridial neurotoxin and a protein with therapeutic functionality. A treatment method is also disclosed.

Abstract: This invention is directed to preparation and expression of synthetic genes encoding polypeptides containing protective epitopes of botulinum neurotoxin (BoNT). The invention is also directed to production of immunogenic peptides encoded by the synthetic genes, as well as recovery and purification of the immunogenic peptides from recombinant organisms. The invention is also directed to methods of vaccination against botulism using the expressed peptides.

Abstract: A method for the differentiation of inflammatory bowel disease (IBD) from irritable bowel disease (IBS) followed by distinguishing ulcerative colitis and Crohn's disease from other gastrointestinal illnesses. This highly differential method first uses the presence of elevated lactoferrin as a marker of intestinal inflammation to differentiate IBD from IBS. Patients suspected of IBD are then analyzed for fecal anti-Saccharomyces cerevisiae antibodies (ASCA) as an indicator of Crohn's disease and fecal anti-neutrophil cytoplasmic antibodies (ANCA) as an indicator of ulcerative colitis. IBD patients are further monitored for intestinal inflammation using fecal lactoferrin to evaluate the effectiveness of medical therapy and to predict relapse. The apparatus comprises either a qualitative enzyme-linked immunoassay or other immunoassay that utilizes antibodies specific to human immunoglobins for the measurement of total endogenous lactoferrin, ASCA and ANCA in human feces.

Abstract: An isolated polypeptide and immunogenic fragments thereof are described together with their variants and derivatives as novel immunogenic agents for treating or preventing Helicobacter infection in a mammalian host. The polypeptide comprises a C-terminal portion of a Helicobacter catalase, which portion lacks significant amino acid sequence identity with human catalase, wherein the polypeptide is other than full-length Helicobacter catalase.

Abstract: The present invention provides methods for diagnosing the presence or severity of inflammatory bowel disease (IBD) in an individual and methods for stratifying IBD by determining the level of one or more IBD markers in a sample from the individual and calculating an index value using an algorithm based upon the level of the IBD markers. Methods for monitoring the efficacy of IBD therapy, monitoring the progression or regression of IBD, and optimizing therapy in an individual having IBD are also provided.

Abstract: This invention relates to conjugates of the Vi polysaccharide of S. typhi with the carrier Pseudomonas aeruginosa recombinant exoprotein A (rEPA), and compositions thereof, and to methods of using of these conjugates and/or compositions thereof for eliciting an immunogenic response in humans, including responses which provide protection against, or reduce the severity of, S. typhi bacterial infections. The conjugates, and compositions thereof, are useful as vaccines to induce serum antibodies against S. typhi and are useful to prevent and/or treat illnesses caused by S. typhi.

Abstract: Provided are an oligonucleotide primer set for amplifying at least one target sequence of the cagA gene of Helicobacter pylori, a method of detecting Helicobacter pylori using the primer set, and a kit for detecting Helicobacter pylori, including the primer set.

Abstract: The present invention provides compositions useful in preparing and/or serving as antitoxins against Bacillus anthracis, the causative agent of anthrax. The present invention also provides polypeptides and polynucleotides relating to the capillary morphogenisis gene 2 (CMG-2), vectors containing the polynucleotides and polypeptides, and host cells containing related polynucleotide molecules, all used in association with the treatment of, or the research and development of treatments for anthrax. The present invention also relates to methods for identifying molecules that bind CMG-2 and molecules that reduce the toxicity of anthrax toxin. Finally, the present invention provides methods for treating human and non-human animals suffering from anthrax.

Abstract: The present invention relates to an oral composition and an immunogenic composition for the suppression of the pathogenic effects of the intra-oral bacterium Porphyromonas gingivalis associated with periodontal disease.

Abstract: Testing of flowing media for microbial toxins via whole blood incubation in a flow vessel containing a separation element and assaying for mediators.

Abstract: The present invention is directed to isolated bacteriophage having strong lytic activity against strains of Staphylococcus aureus, in particular, MRSA, and methods of using that bacteriophage, and/or progeny or derivatives derived therefrom, to control the growth of Staphylococcus aureus in various settings.

Abstract: High affinity antibodies for binding epitopes of BoNT/Aand hybridomas that produce such antibodies are described. The antibodies may be used in a kit for detecting BoNT/A in a sample.

Abstract: Provided are compositions and methods for stimulating an immune response against Mycobacterium avium subspecies paratuberculosis (MAP). The compositions include a recombinant polypeptide that contains from its N-terminus to C-terminus a C-terminal fragment of MAP protein Map3527, a Map1519 protein amino acid sequence, followed by an N-terminal portion of Map3527. The method comprises administering the composition to an animal in an amount effective to stimulate an immunological response against MAP bacteria. The method is of benefit to any animal susceptible to MAP infection, but is particularly beneficial for ruminants.

Abstract: The present invention relates to antibodies immunologically specific for an attaching and effacing Escherichia coli (AEEC) virulence-associated protein, products, compositions and methods and to their use thereof in the prevention of an AEEC infection in a mammal. The antibody of the invention is immunologically specific for an AEEC virulence-associated protein and is capable of preventing an in vivo AEEC intestinal infection when administered to a mammal. The antibody of the invention is preferably useful for preventing the development of A/E intestinal lesions associated with the AEEC. This is achieved by preferably using IgY antibodies immunologically specific for one or more AEEC virulence-associated proteins, such as Eae, Tir, EspA and Paa.

Abstract: The present invention provides improved formulations of botulinum toxin that increase delivery of the botulinum toxin to neural and associated tissues and exhibit a higher specific neurotoxicity and higher potency (in LD50 Units) than available formulations of botulinum toxins. These improved formulations enable physicians to treat a wide variety of pathological conditions with a lower toxin load that reduces the risk of inducing an immune response against the toxin and its associated proteins that may ultimately lead to the development of toxin resistance. These benefits are particularly important in the treatment of conditions that require high-dose or chronic administration of botulinum toxin. Additionally, the decreased in LD50 Unit doses of inventive formulations allows for controlled administration limits diffusion. The present invention also provides methods of treating neuromuscular diseases and pain, using low-dose botulinum toxin.

Abstract: The present invention provides a method of determining the presence or activity of a clostridial toxin by (a) treating with a sample, under conditions suitable for clostridial toxin protease activity, a clostridial toxin substrate which includes a fluorophore; a bulking group; and a clostridial toxin recognition sequence containing a cleavage site that intervenes between the fluorophore and the bulking group; (b) exciting the fluorophore with plane polarized light; and (c) determining fluorescence polarization of the treated substrate relative to a control substrate, where a change in fluorescence polarization of the treated substrate as compared to fluorescence polarization of the control substrate is indicative of the presence or activity of the clostridial toxin.

Abstract: Botulinum toxin has been shown to be useful for the treatment of pain when administered for cervical dystonia. Given efficacy for pain relief in regional dystonia, further expanded applications have included myofascial pain, muscle tension headaches, and other forms of headache syndromes. The application in headache practice has expanded to migraine as well as certain secondary headache syndromes. Although multiple case reports involving the use of botulinum toxin have shown promise in its utility for the treatment of primary pain syndromes, to date, controlled trials have failed to consistently and more definitively prove utility. Described herein is a method for selection of patients with headache syndromes more likely to respond to botulinum administration.

Abstract: Mutant cholera holotoxins having single or double amino acid substitutions or insertions have reduced toxicity compared to the wild-type cholera holotoxin. The mutant cholera holotoxins are useful as adjuvants in antigenic compositions to enhance the immune response in a vertebrate host to a selected antigen from a pathogenic bacterium, virus, fungus, or parasite, a cancer cell, a tumor cell, an allergen, or a self-molecule.

Abstract: This invention provides methods for treating infections in a subject which comprise administering to the subject an amount of a radiolabeled antibody effective to treat the infection, wherein the antibody specifically binds to the agent causing the infection. The invention also provides compositions and methods of making compositions comprising radiolabeled antibodies for the treatment of infections.

Abstract: Methods for detecting BoNT/A activity in a sample, methods for screening molecules able to compete with BoNT/A receptor binding, methods for reducing BoNT/A activity in a human and methods of marketing a neurotoxin capable of selectively binding to FGFR3 to a governmental or regional regulatory authority.