Method of treating gram-negative bacterial infection by administration of bactericidal/permeability-increasing (BPI) protein product and antibiotic
Patent 5523288 Issued on June 4, 1996. Estimated Expiration Date: September 22, 2014. Estimated Expiration Date is calculated based on simple USPTO term provisions. It does not account for terminal disclaimers, term adjustments, failure to pay maintenance fees, or other factors which might affect the term of a patent.
514/12, 25 or more peptide repeating units in known peptide chain structure424/114, PLURAL FERMENTATES OF DIFFERENT ORIGIN (E.G., MIXTURES OF ANTIBIOTICS, ETC.)514/152, 3,10-dihydroxy-2-naphthacene carboxamide or derivative (e.g., tetracycline, etc.) DOAI514/192, 1-thia-4-aza-bicyclo (3.2.0) heptane ring containing (including dehydrogenated) (e.g., penicillins, etc.)530/319, Polymyxin; related peptides530/350, PROTEINS, I.E., MORE THAN 100 AMINO ACID RESIDUES536/13.6, Gentamicin or derivative536/16.8Antibiotics
The present invention relates to methods and compositions for treating gram-negative bacterial infections, using BPI protein products. Co-treatment, or concurrent administration, of BPI protein product with an antibiotic in treatment of gram-negative bacterial infections improves the therapeutic effectiveness of the antibiotic, including increasing antibiotic susceptibility of gram-negative bacteria and reversing resistance of the bacteria to antibiotics.
Other References
Davies, "Inactivation of Antibiotics and the Dissemination of Resistance Genes", Science, 264:375-381 (Apr. 15, 1994)
Eliopoulos and Moellering, "Antimicrobial Combinations", in Antibiotics in Laboratory Medicine, 3rd ed., pp. 432-492, (Lorian ed., Baltimore, MD) (1991)
Elsbach, "Antibiotics from Within: Antibacterials from Human and Animal Sources", Trends. Biotech., 8(1):26-30 (Jan. 1990)
Elsbach and Weiss, "Oxygen-Independent Bactericidal Systems of Polymorphonuclear Leukocytes", in Advances in Inflammation Research, vol. 2, pp. 95-113 (Weissmann ed., Raven Press, Ltd.) (1981)
Elsbach and Weiss, "Oxygen-Independent Antimicrobial Systems of Phagocytes," in Inflammation: Basic Principles and Clincial Correlates, pp. 603-636, (Gallin et al. eds., Raven Press, Ltd.) (1992)
Elsbach et al., "Separation and Purification of a Potent Bactericidal/Permeability-Increasing Protein and a Closely Associated Phospholipase A2 from Rabbit Polymorphonuclear Leukocytes", J. Biol. Chem., 254(21):11000-11009 (Nov. 10, 1979)
Gazzano-Santoro et al., "High-Affinity Binding of the Bactericidal/Permeability-Increasing Protein and a Recombinant Amino-Terminal Fragment to the Lipid A Region of Lipopolysaccharide", Infect. Immun., 60(11):4754-4761 (Nov. 1992)
Gray et al., "Cloning of the cDNA of a Human Neutrophil Bactericidal Protein", J. Biol. Chem., 264(16):9505-9509 (Jun. 5, 1989)
Kadurugamuwa et al., "Interaction of Gentamicin with the A Band and B Band Lipopolysaccharides of Pseudomonas aeruginosa and Its Possible Lethal Effect", Antimicrobial Agents and Chemotherapy, 37(4):715-721 (Apr. 1993)
Kingman, "Resistance a European Problem, Too", Science, 264:363-365 (Apr. 15, 1994)
Levy et al., "Antibacterial 15-kDa Protein Isoforms (p15s) are Members of a Novel Family of Leukocyte Proteins", J. Biol. Chem., 268(8):6058-6068 (Mar. 16, 1993)
Mannion et al., "Preferential Binding of the Neutrophil Cytoplasmic Granule-Derived Bactericidal/Permeability Increasing Protein to Target Bacteria", J. Clin. Invest., 142(8):2807-2812 (Apr. 15, 1989)
Mannion et al., "Separation of Sublethal and Lethal Effects of Polymorphonuclear Leukocytes on Escherichia coli", J. Clin. Invest., 86:631-641 (Aug. 1990)
Mannion et al., "Separation of Sublethal and Lethal Effects of the Bactericidal/Permeability Increasing Protein on Escherichia coli", J. Clin. Invest., 85:853-860 (Mar. 1990)
Nikaido, "Prevention of Drug Access to Bacterial Targets: Permeability Barriers and Active Efflux", Science, 264:382-387 (Apr. 15, 1994)
Ooi et al., "A 25-kDa NH2 -terminal Fragment Carries All the Antibacterial Activities of the Human Neutrophil 60-kDa Bactericidal/Permeability-Increasing Protein", J. Biol. Chem., 262(31):14891-14894 (1987)
Ooi et al., "Endotoxin-neutralizing Properties of the 25 kD N-Terminal Fragment and a Newly Isolated 30 kD C-Terminal Fragment of the 55-60 kD Bactericidal/Permeability-Increasing Protein of Human Neutrophils", J. Exp. Med., 174:649-655 (Sep. 1991)
Ooi et al., "Isolation of Two Isoforms of a Novel 15-kDa Protein from Rabit Polymorphonuclear Leukocytes that Modulate the Antibacterial Actions of Other Leukocyte Proteins", J. Biol. Chem., 265(26):15956-15962 (Sep. 15, 1990)
Spratt, "Resistance to Antibiotics Mediated by Target Alterations", Science, 264:388-393 (Apr. 15, 1994)
Stratton, "In Vitro Testing: Correlations Between Bacterial Susceptibility, Body Fluid Levels and Effectiveness of Antibacterial Therapy", in Antibiotics in Laboratory Medicine, pp. 849-879 (Lorian ed., Williams & Wilkins) (1991)
Taber et al., "Bacterial Uptake of Aminoglycoside Antibiotics", Microbiological Reviews, 51(4):439-457 (Dec. 1987)
Travis, "Reviving the Antibiotic Miracle", Science, 264:360-362 (Apr. 15, 1994)
Vaara, "Agents that Increase the Permeability of the Outer Membrane", Microbiological Reviews, 56(3):395-411 (Sep. 1992)
Veld et al., "Effects of the Bactericidal/Permeability-Increasing Protein of Polymorphonuclear Leukocytes on Isolated Bacterial Cytoplasmic Membrane Vesicles", Infect. Immun., 56(5):1203-1208 (May 1988)
Weiss and Olsson, "Cellular and Subcellular Localization of the Bactericidal/Permeability-Increasing Protein of Neutrophils", Blood, 69(2):652-659 (Feb. 1987)
Weiss et al., "Human Bactericidal/Permeability-Increasing Protein and a Recombinant NH2 -Terminal Fragment Cause Killing of Serum-resistant Gram-negative Bacteria in Whole Blood and Inhibit Tumor Necrosis Factor Release Induced by the Bacteria", J. Clin. Invest., 90:1122-1130 (Sep. 1992)
Weiss et al., "Resistance of Gram-negative Bacteria to Purified Bactericidal Leukocyte Proteins", J. Clin. Invest., 65:619-628 (Mar. 1980)
Weiss et al., "The Role of Lipopolysaccharides in the Action of the Bactericidal/Permeability-Increasing Neutrophil Protein on the Bacterial Envelope", J. Immunol., 132(6):3109-3115 (Jun. 1984)
Cross et al. "Choice of Bacteria in Animal Models of Sepsis" Infection & Immunity 61(7):2741-2747 1993