Abstract: Disclosed are hair care compositions containing partially purified extracellular metabolite preparation from strains of Bacillus coagulans. Specifically, the uses of compositions containing extracellular metabolite preparation from a strain of Bacillus coagulans for increasing hair growth, inhibition of 5?-reductase and proliferation of follicle dermal papilla cells and in the management of androgenic alopecia, are disclosed.

Abstract: Disclosed is the use of partially purified extracellular metabolite isolated from Bacillus coagulans MTCC 5856 to prevent skin aging. More specifically the invention discloses the anti-collagenase, anti-elastase, anti-glycation activity and enhancement of TGF-?, epidermal growth factor and hyaluronic acid expression in human dermal fibroblasts, of extracellular metabolites isolated from Bacillus coagulans MTCC 5856.

Abstract: The invention provides a Pseudomonas exotoxin A (PE) comprising an amino acid sequence having a substitution of one or more B-cell and/or T-cell epitopes. The invention further provides related chimeric molecules, as well as related nucleic acids, recombinant expression vectors, host cells, populations of cells, and pharmaceutical compositions. Methods of treating or preventing cancer in a mammal, methods of inhibiting the growth of a target cell, methods of producing the PE, and methods of producing the chimeric molecule are further provided by the invention.

Abstract: The present invention is directed to pharmaceutical compositions and methods of treatment that relate to the inhibition, resolution and/or prevention of an array of the manifestations of metabolic syndromes, including Type 2 diabetes, hyperlipidemia, weight gain, obesity, insulin resistance, hypertension, atherosclerosis, fatty liver diseases and certain chronic inflammatory states that lead to these manifestations, among others. In additional aspects, the present invention relates to compositions and methods which may be used to treat, inhibit or reduce the likelihood of hepatitis viral infections, including Hepatitis B and Hepatitis C viral infections, as well as the secondary disease states and/or conditions which are often associated with such viral infections, including hepatic steatosis (steatohepatitis), cirrhosis, fatty liver and hepatocellular cancer, among other disease states or conditions.

Abstract: The present invention relates to a novel trimeric OprF/I fusion protein comprising a portion of the Pseudomonas aeruginosa outer membrane protein F which is fused with its carboxy terminal end to a portion of the amino terminal end of the Pseudomonas aeruginosa out membrane protein I, wherein said portion of the Pseudomonas aeruginosa outer membrane protein F comprises the amino acids 190-342 of SEQ ID NO: 1 and wherein said portion of the Pseudomonas aeruginosa outer membrane protein I comprises the amino acids 21-83 of SEQ ID NO: 2, and further to a novel Opr F/I fusion protein which contains a disulphide bond pattern, preferably selected from the group consisting of (a) Cys18-Cys27-bond, (b) Cys18-Cys27-bond and Cys33-Cys47-bond, and (c) Cys18-Cys47 and Cys27-Cys33-bond, and to immunogenic variants thereof having at least 85% identity to the amino acid sequence of SEQ ID NO: 3.

Abstract: The present invention relates to a synbiotic product composition comprising a blend or mixture of a prebiotic carbohydrate and a probiotic spore-forming Bacillus bacteria. Examples of prebiotic carbohydrates useful in synbiotic product include arabinoxylan, arabinoxylan oligosaccharides, xylose, soluble fiber dextrin, soluble corn fiber, and polydextrose. The present invention also relates to human foodstuffs and animal feed comprising such synbiotic products and methods of increasing the titer of spore-forming bacteria in the intestinal tracts of mammals by administration of symbiotic products.

Abstract: Provided are immunogenic compositions and methods for eliciting an immune response against B. anthracis and other bacteria that contain 3-methyl-3-hydroxybutyrate- or 3-hydroxybutyrate-substituted saccharides. Conjugates of 3-methyl-3-hydroxybutyrate- or 3-hydroxybutyrate-substituted saccharides elicit an effective immune response against B. anthracis spores in mammalian hosts to which the conjugates are administered.

Abstract: The present invention relates to a method for covalently attaching a compound to a stainless steel, tin, iron, or titanium substrate, by contacting exposed surface(s) of the substrate with a synthetic pilin peptide containing a disulfide loop derived from the C-terminal receptor binding protein of Type IV P. aeruginosa (T4P) pilin, to bind the pilin peptide to the exposed surface(s), and covalently attaching the compound to the pilin peptide. Also disclosed are a substrate formed by the method and a biosensor device that uses the uses. Also disclosed are methods for improving the corrosion resistance, adhesive force, hardness and electron work function of certain metals.

Abstract: The present invention provides improved Pseudomonas Exotoxin A (PE) molecules with high cytotoxicity and reduced immunogenicity, compositions containing the improved (PE), and methods of use.

Abstract: The invention provides mutated Pseudomonas exotoxins (PE) that have reduced immunogenicity compared to PEs containing the native sequence. The PEs of the invention have one or more individual mutations of positions of the native sequence of PE that reduce antibody binding to one or more PE epitopes. Nucleic acids encoding the mutated PEs, chimeric molecules comprising them, compositions comprising the chimeric molecules and methods of using them, are also provided.

Abstract: Disclosed are methods for identifying candidate compounds for treating, reducing, or preventing a pathogenic infection, the methods including: (a) contacting a pathogenic cell with a candidate compound; and (b) measuring the production of a molecule selected from the group consisting of an 4-hydroxy-2-alkylquinoline (HAQ) molecule, 4-hydroxy-2-heptylquinoline (HHQ) molecule, or a derivative or precursor thereof in the cell, a candidate compound that reduces the production relative to production of the molecule by a cell not contacted with the candidate compound, identifying a candidate compound useful for treating, reducing, or preventing a pathogenic infection.

Abstract: The present invention encompasses methods, assays and kits for the detection of pathogenic bacteria in a patient and for the differential diagnosis of pulmonary diseases associated with pathogenic bacteria from pulmonary diseases not associated with pathogenic bacteria.

Abstract: The present invention is directed to a bioconjugate vaccine, such as an O1-bioconjugate vaccine, comprising: a protein carrier comprising a protein carrier containing at least one consensus sequence, D/E-X-N-Z-S/T, wherein X and Z may be any natural amino acid except proline; at least one antigenic polysaccharide from at least one pathogenic bacterium, linked to the protein carrier; and, optionally, an adjuvant. In another aspect, the present invention is directed to a method of producing an O1-bioconjugate in a bioreactor comprising a number steps.

Abstract: The invention provides mutated, cytotoxic forms of Pseudomonas exotoxin A (PE) comprising a furin cleavage sequence conjugated or fused directly to residues 395-613 of PE or variants of that sequence. These minimal forms of PE are smaller than previous cytotoxic forms of PE, reduce non-specific toxicity, and reduce immunogenicity due to domain II or domain Ib of PE. The invention further provides nucleic acids encoding said PEs, chimeric molecules containing them, and methods of use thereof.

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

Abstract: The present invention relates to a pharmaceutical formulation comprising lipopolysaccharide derived from Burkholderia thailandensis and its various uses, including but not limited to its use in the treatment and/or prophylaxis of meliodosis or amelioration of symptoms associated therewith, and/or glanders or amelioration of symptoms associated therewith.

Abstract: The disclosure features vaccine adjuvants comprising prokaryotic mRNA, and methods of vaccination using the adjuvants. More specifically, the disclosure provides a vaccine composition comprising a nonviable immunogen (e.g., heat-killed bacterium), a tumor antigen, or an immunogenic peptide of microbial or mammalian origin, and an adjuvant, wherein adjuvant comprises prokaryotic mRNA (e.g., bacterial mRNA), as well as the methods of using the vaccine compositions. Further disclosed are the structural features of the prokaryotic mRNA used as the adjuvants.

Abstract: Methods for synthesis and manufacture of polysaccharide-protein conjugate vaccines at high yield are provided. The methods involve reaction of a hydrazide group on one reactant with an aldehyde or cyanate ester group on the other reactant. The reaction proceeds rapidly with a high conjugation efficiency, such that a simplified purification process can be employed to separate the conjugate product from the unconjugated protein and polysaccharide and other small molecule by-products.

Abstract: Provided herein are insoluble particles that include polypeptides. The polypeptides may have immunogenicity that is greater than the immunogenicity of the same polypeptides when they are not present in the particle. The polypeptides may be soluble before incorporation into the particles and insoluble after incorporation into the particles. The particles may include lipopolysaccharide, wherein the lipopolysaccharide is insoluble. The particles may include a carrier. In one embodiment, a carrier is present at no greater than 0.001 mg carrier/mg particles. In one embodiment, a carrier is present at a ratio of carrier to polypeptide (weight:weight) of no greater than 0.05:1. In one embodiment, a carrier is not detectable in the particles.

Abstract: The present invention shows that intranasal administration of E1/E3-defective adenovirus particles may confer rapid and broad protection against viral and bacterial pathogens in a variety of disease settings. Protective responses lasted for many weeks in a single-dose regimen in animal models. When a pathogen-derived antigen gene was inserted into the E1/E3-defective adenovirus genome, the antigen-induced protective immunity against the specific pathogen was elicited before the adenovirus-mediated protective response declined away, thus conferring rapid, prolonged, and seamless protection against pathogens. In addition to E1/E3-defective adenovirus, other bioengineered non-replicating vectors encoding pathogen-derived antigens may also be developed into a new generation of rapid and prolonged immunologic-therapeutic (RAPIT).

Abstract: The present invention relates to methods and compositions for treatment of microbial infections and for the enhancement of resistance to infection. The invention comprises administration of an effective amount of a protein isolated from bacterial lysate compositions for the treatment of pathological conditions of microbial infections. The present invention can also be used to enhance the immune system to prevent infections by the administration of an effective amount of the compositions.

Abstract: The present invention provides a novel immunogenic composition, vaccine and methods for making and using the immunogenic composition and vaccine. The immunogenic composition is capable of providing an immune response and/or a protective immunity into subjects, preferably mammals, against microorganism-associated disease. The immunogenic composition includes one or more extracellular proteins isolated from a microorganism capable of providing an immune response and/or a protective immunity into subjects against microorganism-associated disease. The isolated extracellular proteins range in molecular weight from about 10,000 Da to about 220,000 Da. Suitable microorganisms may include members of the genus Salmonella, Listeria, Pseudomonas, Staphylococcus, and Vibrio. Kits are also encompassed for detection, diagnosis and prevention of microorganism-associated disease.

Abstract: The present invention relates to immunogenic compositions for modulating the immune system, comprising a therapeutically effective quantity of two or more immuno-active antigenic agents with pathogen-associated molecular patterns (PAMPs) and/or danger-associated molecular patterns (DAMPs) and one or more physiologically acceptable carriers, excipients, diluents or solvents. The immunogenic compositions according to the present invention are used for producing medicaments for preventing and/or treating, and for preventing and/or treating infectious diseases, auto-immune diseases, allergic diseases, inflammation, arthritis, inflammatory diseases, transplant rejection, affections caused by vascular disorders, diseases caused by haemorrhagic or ischaemic cardiovascular accidents, ischaemia, heart attack and haemorrhagia leading to tissue destruction, heart, kidney, respiratory or liver insufficiency, cancer, malign and benign tumours and neoplasia.

Abstract: The invention relates to means and methods for preparing aqueous composition comprising aluminium and a protein said composition comprising less than 700 ppm heavy metal on the basis of weight with respect to the aluminium content. The invention further relates to aqueous compositions comprising a protein and an aluminium-salt, said composition comprising less than 350 ppb heavy metal based on the weight of the aqueous composition.

Abstract: The present invention discloses methods and materials for delivering a cargo compound into a cancer cell. Delivery of the cargo compound is accomplished by the use of protein transduction domains derived from cupredoxins. The invention further discloses methods for treating cancer and diagnosing cancer.

Abstract: The invention relates to use of one or more bacteriophages in vivo in a human or animal in order to induce sensitivity to chemical antibiotics in bacterial cells, where such susceptibility is heritable, independent of continuing bacteriophage metabolism within those cells, and does not relate to the destruction of a biofilm to induce such sensitivity.

Abstract: Methods for synthesis and manufacture of polysaccharide-protein conjugate vaccines at high yield are provided. The methods involve reaction of a hydrazide group on one reactant with an aldehyde or cyanate ester group on the other reactant. The reaction proceeds rapidly with a high conjugation efficiency, such that a simplified purification process can be employed to separate the conjugate product from the unconjugated protein and polysaccharide and other small molecule by-products.

Abstract: The present invention relates to a composition, device and method for preventing or inhibiting biofilm formation on biotic or abiotic surfaces. The composition comprises a peptide based on the C-terminal receptor binding domain of Pseudomonas aeruginosa type IV pilin, which binds to an abiotic surface (e.g., steel, plastic) with high affinity and prevents binding of a variety of P. aeruginosa strains to the surface. The inventive composition represents a non-toxic inhibitor for biofilm formation, particularly on an abiotic surface, which is responsible for a large number of problematic diseases and massive economic losses. The inventive method is useful as a safe and environmentally friendly means of modifying a surface of a variety of biomedical, nanotechnological, and biotechnological devices or articles.

Abstract: The present invention provides compositions including siderophore receptor polypeptides and porins from gram negative microbes, and preferably, lipopolysaccarhide at a concentration of no greater than about 10.0 endotoxin units per milliliter. The present invention also provides methods of making and methods of using such compositions.

Abstract: The present invention relates to methods for promoting dispersal of, or preventing formation of microbial biofilms, comprising: exposing a biofilm to an effective amount of nitric oxide or at least one nitric oxide generating or releasing agent; treating a surface or medium susceptible to biofilm formation with an effective amount of nitric oxide or at least one nitric oxide generating or releasing agent; incorporating an effective amount of nitric oxide or at least one nitric oxide generating or releasing agent in a surface or medium susceptible to biofilm formation; or inducing the accumulation of one or more reactive oxygen or nitrogen species within microorganisms within said biofilm or capable of forming a biofilm. The invention also relates to methods for maintaining or enhancing or maintaining and enhancing the functioning of a biofilm, comprising exposing a biofilm to at least one nitric oxide scavenger, at least one antioxidant or at least one nitric oxide scavenger and at least one antioxidant.

Abstract: The present invention relates in its broadest aspect to combined phage/antibiotic therapy. More particularly, it relates to use of (i) one or more bacteriophages and (ii) one or more antibiotics in the manufacture of a combined product for simultaneous, separate or sequential administration of (i) and (ii) to treat a bacterial infection characterized by biofilm formation, for example an infection comprising or consisting of P. aeruginosa. Treatment in this context may be either therapeutic or prophylactic treatment. Also provided are deposited bacteriophages each exhibiting different strain specificity against P. aeruginosa and combinations of such bacteriophages, e.g. a panel of six deposited bacteriophages which was found to be effective against a high percentage of clinical isolates of P. aeruginosa from canine ear infections.

Abstract: The present invention provides a chimeric protein capable of killing or modifying a cell expressing abnormally high levels of a ligand of a receptor of the TNF/NGF family, comprising the amino acid sequence of at least one polypeptide consisting of an extracellular portion of said receptor connected to an effector molecule. In addition the invention provides pharmaceutical compositions comprising said chimeric protein and use thereof.

Abstract: The present invention provides an immunogenic conjugate comprising biologically deacylated gram-negative bacterial moieties linked to D. discoideum proteinase 1, as well as novel subunits thereof, and methods of making and using the conjugates in vaccines to treat sepsis and other infectious complications.

Abstract: Methods for making and using therapeutic formulations of Proteosome-based immunoactive compositions are provided. The immunogenic compositions, which include Proteosomes and liposaccharides, may be used to elicit or enhance a nonspecific innate immune response to, for example, treat or prevent infectious disease. In addition, after activating the innate immune system, immunogenic compositions further containing an antigen may be used to elicit a specific adaptive immune response. Furthermore, provided are compositions capable of altering hyperreactive responses or inflammatory immune responses, such as allergic reactions. Such compositions may be used as a prophylactic, or in various clinical settings to treat or prevent infectious disease (such as parasite, fungal, bacterial or viral infections), or to alter inappropriate inflammatory immune responses (such as allergic reactions or asthma).

Abstract: The invention provides methods of formulating an anti-inflammatory composition for treating inflammatory conditions in a specific organ or tissue. The method involves selecting at least one pathogen that is pathogenic in the specific organ or tissue; producing an antigenic composition comprising antigenic determinants that together are specific for the pathogen; and formulating the antigenic composition for administration as an anti-inflammatory composition capable of eliciting an anti-inflammatory response in the specific organ or tissue. In embodiments of the invention the pathogen may be an endogenous pathogen, such as an endogenous bacterial pathogen. The pathogen may be an exogenous pathogen, such as a bacterial pathogen, viral pathogen, a fungal pathogen, or a helminth pathogen.

Abstract: This invention relates to a bacteriophage MPK6 (deposit number: KCCM 11044P) having a lytic activity to Pseudomonas aeruginosa, or a progeny bacteriophage thereof having a RFLP (Restriction fragment length polymorphism) DNA profile substantially equivalent to the bacteriophage MPK6. The present invention provides a bacteriophage MPK6 or a progeny bacteriophage thereof capable of treating a Pseudomonas aeruginosa infection disease, and suggests an anti-bacterial activity of MPK6 and its progeny bacteriophage using a mammalian and non-mammalian infection model. According to the present invention, the present bacteriophage MPK6 or progeny bacteriophage thereof represents very effective efficacy on treatment of P. aeruginosa-induced peritonitis-sepsis.

Abstract: The present invention provides compositions including siderophore receptor polypeptides from gram negative microbes, and preferably, lipopolysaccarhide at a concentration of no greater than about 10.0 endotoxin units per milliliter. The present invention also provides methods of making and methods of using such compositions.

Abstract: The present invention provides compositions including siderophore receptor polypeptides and porins from gram negative microbes, and preferably, lipopolysaccarhide at a concentration of no greater than about 10.0 endotoxin units per milliliter. The present invention also provides methods of making and methods of using such compositions.

Abstract: The present application relates to a composition including gut flora-derived extracellular vesicles, and to an animal disease model using same. In addition, the present application relates to a method for using the gut flora-derived extracellular vesicles to efficiently search for a candidate drug which may prevent or treat diseases that occur due to gut flora-derived extracellular vesicles, and to a vaccine which can efficiently prevent or treat infections caused by gut flora or diseases that occur due to gut flora-derived extracellular vesicles. Further, the development of diagnostic technology to discover, using the gut flora-derived extracellular vesicles of the present application, the etiology of diseases that occur due to gut flora-derived extracellular vesicles, can be achieved.

Abstract: The present invention discloses methods and materials for delivering a cargo compound into a cancer cell. Delivery of the cargo compound is accomplished by the use of protein transduction domains derived from cupredoxins. The invention further discloses methods for treating cancer and diagnosing cancer.

Abstract: Fusion antigen used as vaccine and method of making them. The method includes: (1) selecting a segment of a virus protein sequence that contains a least one epitope; (2) engineering a DNA fragment encoding the selected segment of the virus protein; (3) inserting the DNA fragment into a Pseudomonas Exotoxin A (PE) vector to obtain a chimeric gene plasmid, and expressing the chimeric gene plasmid in a host cell to obtain the chimeric vaccinal virus antigen. The PE vector contains a PE fragment, which has a binding domain and a translocating domain, and a carboxyl terminal moiety, which includes an endoplasmic reticulum retention sequence. The DNA fragment encoding the selected segment of the virus protein is inserted between the PE fragment and the carboxyl terminal moiety.

Abstract: The present invention relates to methods and compositions for treatment of microbial infections and for the enhancement of resistance to infection. The invention comprises administration of an effective amount of a protein isolated from bacterial lysate compositions for the treatment of pathological conditions of microbial infections. The present invention can also be used to enhance the immune system to prevent infections by the administration of an effective amount of the compositions.

Abstract: The present invention relates in its broadest aspect to combined phage/antibiotic therapy. More particularly, it relates to use of (i) one or more bacteriophages and (ii) one or more antibiotics in the manufacture of a combined product for simultaneous, separate or sequential administration of (i) and (ii) to treat a bacterial infection characterized by biofilm formation, for example an infection comprising or consisting of P. aeruginosa. Treatment in this context may be either therapeutic or prophylactic treatment. Also provided are deposited bacteriophages each exhibiting different strain specificity against P. aeruginosa and combinations of such bacteriophages, e.g. a panel of six deposited bacteriophages which was found to be effective against a high percentage of clinical isolates of P. aeruginosa from canine ear infections.

Abstract: This invention provides Pseudomonas exotoxin A-like chimeric immunogens that include a non-native epitope in the Ib domain of Pseudomonas exotoxin. Methods of eliciting an immune response using these immunogens also are provided.

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: An object of the present invention is to provide a protein or peptide antigen and an antibody against it, for use in the diagnosis, prevention, or treatment of diseases associated with Pseudomonas aeruginosa. According to the present invention, there is provided a protein or peptide derived from Pseudomonas aeruginosa outer membrane protein PA0427 and an antibody against it, for use in the diagnosis, prevention, or treatment of diseases associated with Pseudomonas aeruginosa.

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: The polynucleotides of the present invention are complementary to the Initiation Sites of microbes. Invading organisms, sensing the pH and nutrient deprivation of a physiologic environment quickly release these nucleotides triggering rapid growth and mutation—attributes to successfully establishing a nidus of infection. They also stimulate neutrophil functions. Accordingly, the nucleotides, compositions and methods of the present invention may be used to enhance, restore or stimulate an immune response or system of an animal, e.g. to prevent an infection caused by a microorganism, ameliorate an infection caused by a microorganism, or kill an invading microorganism that causes infection or re-establish balance to an immune system. In particular, the polynucleotides, compositions and methods of the present invention may be used to treat or prevent bacterial infections and auto-immune diseases in a mammal in need thereof.

Abstract: Abstract of the Disclosure Methods for synthesis and manufacture of polysaccharide-protein conjugate vaccines at high yield are provided. The methods involve reaction of a hydrazide group on one reactant with an aldehyde or cyanate ester group on the other reactant. The reaction proceeds rapidly with a high conjugation efficiency, such that a simplified purification process can be employed to separate the conjugate product from the unconjugated protein and polysaccharide and other small molecule by-products.

Abstract: The present invention relates to compositions comprising CpG rich DNA from Pseudomonas aeruginosa. The compositions optionally comprise a cupredoxin. The present invention includes specific CpG DNAs from Pseudomonas aeruginosa that are useful for treating cancer and other conditions in patients. These compositions are optionally in a pharmaceutically acceptable carrier and also optionally comprise a cupredoxin. The present invention further relates to methods to express proteins near cancer cells. These methods may be used to express therapeutic or diagnostic proteins near cancer cells in a patient suffering from cancer or other conditions, and can also be used for diagnosing cancer in a patient. This method uses the gene for azurin from P. aeruginosa as an expression system for azurin or heterologous proteins in P. aeruginosa or heterologous cells.