Abstract: The present invention relates to novel diagnostic, prognostic and therapeutic reagents for infection of an animal subject such as a human by Pseudomonas aeruginosa, and conditions associated with such infections, such as, for example, an acute clinical exacerbation in a cystic fibrosis (CF) subject. In particular, the present invention relates to methods for diagnosing/prognosing an infection by P. aeruginosa in a subject comprising detecting the presence or amount of one or more proteins of P. aeruginosa or a fragment or epitope thereof or an antibody thereto in a sample from the subject.

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: 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 relates to a composition 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: 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: 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, including inducing the production of antibody in an animal.

Abstract: The present invention provides compositions including siderophore receptor polypeptides from gram negative microbes, and preferably, lipopolysaccharide 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, including inducing the production of antibody in an animal.

Abstract: The present invention relates to compounds which inhibit bacterial gyrase and pharmaceutically acceptable compositions comprising said compounds. These compounds, and compositions thereof, are useful in treating bacterial infection. Accordingly, the present invention also relates to methods for treating bacterial infections in mammals. The present invention also relates to a method for preparing these compounds.

Abstract: This invention provides methods and compositions for stabilizing proteins and vaccines in dried formulations. In particular, a cavitation method and compositions of preparing a dried vaccine are provided that stabilize the viability of live bacteria and live virus vaccines at room temperature.

Abstract: An object is to provide: a protein antigen or a peptide antigen usable as a vaccine composition which has an ability to practically prevent or treat a Pseudomonas aeruginosa infection, and which can cope with the diversity of clinical isolates derived from patients with a Pseudomonas aeruginosa infection; and an antibody directed against the antigen. The present invention provides a protein antigen or a peptide antigen and an antibody directed against these, which are for use in diagnosis, prevention, or treatment of a disease associated with Pseudomonas aeruginosa. According to the present invention, a protein or a peptide derived from a Pseudomonas aeruginosa-outer membrane protein PA4710, and an antibody directed against these are provided, which are for use in diagnosis, prevention, or treatment of a disease associated with Pseudomonas aeruginosa.

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: There is described a method for selecting microbial isolates for use in oral killed vaccines against abnormal microbial colonization of mucosal surfaces by the microbes. The method comprises evaluating capacity of a plurality of different isolates of a microbe to activate antigen responsive cells to provide activation data for each microbial isolate, and the effectiveness of the isolates in reducing infection of a mucosal surface by the microbe to provide clearance data for each microbial isolate. An isolate, the activation data and clearance data for which correlate and is optimal for generating mucosal immunity against the microbe compared to the, or each, other of the isolates, or an isolate the activation data for which is optimal and a further isolate the clearance data for which is optimal, compared to the, or each, other of the isolates, respectively, is then selected for use in the vaccine.

Abstract: An object is to provide an antibody and a vaccine composition which have an ability to practically prevent or treat a Pseudomonas aeruginosa infection, and which can cope with the diversity of clinical isolates derived from patients infected with Pseudomonas aeruginosa. According to the present invention, an antibody against a PA1698 protein that is a type III secretion system component protein of Pseudomonas aeruginosa or against a peptide of the protein, and a vaccine composition comprising the protein or the peptide are provided.

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

Abstract: This invention provides bioactive conjugates. The bioactive conjugates include: (1) a cell recognition moiety that binds to ?2 macroglobulin receptor ?2-MR and (2) a bioactive moiety which: (a) has a biological activity, (b) does not function solely as an immunogen to invoke an immune response and (c) does not have ADP ribosylating activity. The bioactive conjugates of this invention are useful in methods of transporting the bioactive moiety across a polar epithelial membrane. Thus, this invention provides methods for parenteral administration of proteins without injection.

Abstract: The present invention provides non-toxic Gram-negative bacteria. In particular, the present invention provides viable Gram-negative bacteria (e.g., E. coli) substantially lacking lipopolysaccharide (LPS, endotoxin) within the outer membrane. The present invention further provides methods of generating viable non-toxic Gram-negative bacteria and uses thereof. The present invention also provides compositions and methods for inducing immune responses and for researching and developing therapeutic agents.

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 discloses compositions derived from an isolated Bacillus species, spores, or an extracellular product of Bacillus coagulans comprising a supernatant or filtrate of a culture of said Bacillus coagulans strain, suitable for topical application to the skin or mucosal membranes of a mammal, which are utilized to inhibit the growth of bacterium, yeast, fungi, virus, and combinations thereof. The present invention also discloses methods of treatment and therapeutic systems for inhibiting the growth of bacterium, yeast, fungi, virus, and combinations thereof, by topical application of therapeutic compositions which are comprised, in part, of isolated Bacillus species, spores, or an extracellular product of Bacillus coagulans comprising a supernatant or filtrate of a culture of said Bacillus coagulans strain.

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: 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 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 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 present invention features homologous recombination methods and systems. The methods and systems promote highly efficient homologous recombination in cells (e.g., in prokaryotic cells). The methods and systems are useful, for example, in pharmaceutical drug development, vaccine development and cloning.

Abstract: A newly identified serum resistance factor of gram positive bacteria can be used to treat or prevent bacterial infection.

Abstract: The invention features methods and compositions for treating or preventing Gram-negative bacterial infections.

Abstract: The present invention relates to novel diagnostic, prognostic and therapeutic reagents for infection of an animal subject such as a human by Pseudomonas aeruginosa, and conditions associated with such infections, such as, for example, an acute clinical exacerbation in a cystic fibrosis (CF) subject. In particular, the present invention relates to methods for diagnosing/prognosing an infection by P. aeruginosa in a subject comprising detecting the presence or amount of one or more proteins of P. aeruginosa or a fragment or epitope thereof or an antibody thereto in a sample from the subject.

Abstract: A method of inhibiting, moderating or diagnosing Pseudomonas aeruginosa infection is disclosed. In one embodiment, this method comprises inoculating a patient with an effective amount of PcrV antigen.

Abstract: The present invention relates to compositions comprising cupredoxins, and their use to inhibit angiogenesis in mammalian cells, tissues, and animals, and particularly the angiogenesis that accompanies tumor development and particularly in humans. Specifically, the present invention relates to compositions comprising the cupredoxin(s), and or peptides that are variants, derivatives or structural equivalents of cupredoxins, which retain the ability to inhibit angiogenesis in mammalian cells, tissues or animals. These compositions may be peptides or pharmaceutical compositions, among others. The compositions of the invention may be used to treat any pathological condition that has as a symptom or cause, inappropriate angiogenesis, and particularly inappropriate angiogenesis related to tumor development.

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 PA5158 and an antibody against it, for use in the diagnosis, prevention, or treatment of diseases associated with Pseudomonas aeruginosa.

Abstract: Proteins derived from Pseudomonas aeruginosa are antigenic and are of use in the treatment, prophylaxis and diagnosis of P. aeruginosa infection.

Abstract: This invention provides methods of eliciting a secretory IgA-mediated immune response in a subject by administering a Pseudomonas exotoxin A-like chimeric immunogens that include a non-native epitope in the Ib domain of Pseudomonas exotoxin. Compositions comprising secretory IgA antibodies that specifically recognize an epitope of HIV-1 also are provided.

Abstract: The invention provides in part methods of treating cancers of a specific organ or tissue by administering a composition that is antigenically specific for one or more microbes that are pathogenic in the specific organ or tissue in which the cancer is situated. The formulations of the invention thereby facilitate activation of a treatment response to a cancer in a particular tissue or organ. The compositions may for example include killed or attenuated microbial pathogens, and may be administered at sites distant from the cancer, for example the skin. In some embodiments, microbial species of endogenous flora that are known to cause infection in the relevant organ or tissue may be used in the formulation of the antigenic compositions. In alternative embodiments, exogenous microbial pathogens that are known to cause infection in the relevant organ or tissue may be used in the formulation of the antigenic compositions.

Abstract: The present invention relates to polypeptides of Pseudomonas aeruginosa which may be used to prevent, diagnose and/or treat Pseudomonas aeruginosa infection.

Abstract: The present invention relates to an immunogenic conjugate comprising a carrier molecule coupled to an autoinducer of a Gram negative bacteria The immunogenic conjugate, when combined with a pharmaceutically acceptable carrier, forms a suitable vaccine for mammals to prevent infection by the Gram negative bacteria The immunogenic conjugate is also used to raise and subsequently isolate antibodies or binding portions thereof which are capable of recognizing and binding to the autoinducer. The antibodies or binding portions thereof are utilized in a method of treating infections, a method of inhibiting autoinducer activity, and in diagnostic assays which detect the presence of autoinducers or autoinducer antagonists in fluid or tissue samples.

Abstract: The present invention provides methods for reducing shedding in an animal. Generally, the method includes administcriirn to an animal a composition 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.

Abstract: A novel antigen from P. aeruginosa is provided. The use of the antigen in detecting/diagnosing P. aeruginosa as well as its use in eliciting an immune response are also provided.

Abstract: The present invention provides methods for treating mastitis in a milk producing animal. The methods include administering 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.

Abstract: The present invention provides active cytokine and/or chemokine compositions, as well as inexpensive means for the production, amended-cell encasement of active cytokine and/or chemokine compositions, processing, and delivery of active cytokine and/or chemokine compositions. The subject invention also provides methods of treatment and methods of accelerating an immune response comprising the administration of amended recombinant cell (ARC) containing cytokine and/or chemokine compositions to animals or humans.

Abstract: There is disclosed vaccines formulated for administration to the mucosa of the lungs of a mammal, and the use thereof in methods for prophylaxis or treatment of an infection by at least one pathogenic microorganism. The vaccines comprise a cellular fraction of the microorganism that is essentially free of particulate matter and includes polyvalent soluble antigen from the microorganism.

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: Peptides having, as constitutive amino acids, (1) 4 glutamine residues, 1 glutamic acid residue, 1 serine residue, 2 valine residues, 1 isoleucine residue and 5 leucine residues, and having a 3-hydroxydecanoyl group bonded, via an amide linkage, to the N-terminal leucine residue thereof; (2) 4 glutamine residues, 1 glutamic acid residue, 1 serine residue, 3 valine residues, and 5 leucine residues, and having a 3-hydroxydecanoyl group bonded, via an amide linkage, to the N-terminal leucine residue thereof; or (3) 4 glutamine residues, 1 glutamic acid residue, 1 serine residue, 2 valine residues, 1 isoleucine residue and 5 leucine residues, and having a 3-hydroxydodec-5-enoyl group bonded, via an amide linkage, to the N-terminal leucine residue thereof. The peptides have an antiviral activity. A strain capable of producing the above peptides and belonging to a new species of genus Pseudomonas.

Abstract: A bacterial protein which converts 2-methyl citrate to 2-methyl isocitrate is a previously unknown target for antibacterial agents. The protein of this activity is associated with mucoid bacteria and inhibitors of production or activity of this protein in combination with propionic acid mitigate the virulence of these bacteria.

Abstract: Screening procedures are disclosed for identifying compounds useful for inhibiting infection or pathogenicity. Methods are also disclosed for identifying pathogenic virulence factors.

Abstract: The present invention provides methods for making compositions including siderophore receptor polypeptides and porins from gram negative microbes. The methods include providing a gram negative microbe, disrupting the microbe, solubilizing the disrupted microbe, and isolating the polypeptides.

Abstract: DNA encoding a therapeutically suitable glutaminase has been molecularly cloned. This allows one to obtain a polypeptide which is a therapeutically suitable glutaminase free of contaminating endotoxin. It has been found that this polypeptide is a potent anti-viral agent and when coupled to an anti-tumor monoclonal antibody is a potent anticancer agent. The glutaminase of the present invention is particularly useful for treating lung, breast and colon cancer cells and in the treatment of HIV-infected cells.

Abstract: A novel antigen from P. aeruginosa is provided. The use of the antigen in detecting/diagnosing P. aeruginosa as well as its use in eliciting an immune response are also provided.

Abstract: A vaccine, effective in inducing the production of antibodies with which to immunize a second subject passively against infection by Gram-negative bacteria and LPS-mediated pathology, comprises a non-covalent polyvalent complex formed between purified, detoxified LPS derived from E. coli and purified outer membrane protein derived from N. meningitidis. The same vaccine will also actively immunize a host subject against Gram-negative bacterial infections and LPS-mediated pathology. Meningococcal infections are included among those Gram-negative bacterial infections protected against by the vaccine.

Abstract: A vaccine is disclosed which is useful for protecting a host from Gram negative infections and the effects of endotoxin, therefore preventing sepsis and septic shock. The vaccine is prepared by combining LPS free or in conjugate form with a stoichiometric excess of a peptide of the formula: (a) (A)n wherein A is Lysine or Arginine and n is an integer with a minimum value of 7; (b) (AB)m wherein A is Lysine or Arginine and B is a hydrophobic amino acid selected from the group consisting of Valine, Leucine, Isoleucine, Tyrosine, Phenylalanine and Tryptophan; m is an integer with a minimum value of 3; and (c) (ABC)p wherein A is a cationic amino acid which is Lysine or Arginine; B and C are hydrophobic amino acids which may be the same or different and are selected from the group consisting of Valine, Leucine, Isoleucine, Tyrosine, Phenylalanine and Tryptophan; p is an integer with a minimum value of 2.

Abstract: Purified, host-specific, non-toxic, wide host range and virulent bacteriophage preparations that are effective in killing bacterial organisms in vivo are disclosed. Also disclosed are compositions containing these bacteriophages, methods of making the bacteriophage preparations and methods of treating bacterial infections using the compositions. Methods of treating bacterial infections using the compositions containing the bacteriophages in combination with conventional antibiotics also are disclosed.

Abstract: Autoinducer molecules, e.g., N-(3-oxododecanoyl)homoserine lactone, for Pseudomonas aeruginosa are described. The molecules regulate gene expression in the bacterium. Therapeutic compositions and therapeutic methods involving analogs and/or inhibitors of the autoinducer molecules also are described. The molecules are useful for treating or preventing infection by Pseudomonas aeruginosa.

Abstract: The present invention relates to the use of the major OprI lipoprotein of Pseudomonas aeruginosa to elicit a Type-1 immune response towards a heterologous antigen. The invention relates specifically to the use of OprI—antigen fusion proteins to elicit the Type-1 response. More particularly, the present invention is directed to pharmaceutical formulations comprising OprI and/or OprI fusion proteins, optionally together with a suitable excipient, to stimulate the Th1 dependent, cellular immune response.