Drug – bio-affecting and body treating compositions – Whole live micro-organism – cell – or virus containing – Bacteria or actinomycetales
Reexamination Certificate
2005-11-08
2005-11-08
Shukla, Ram R. (Department: 1632)
Drug, bio-affecting and body treating compositions
Whole live micro-organism, cell, or virus containing
Bacteria or actinomycetales
C435S320100, C435S252800, C435S007350
Reexamination Certificate
active
06962696
ABSTRACT:
The present application discloses the preparation and use of attenuated tumor-targeted bacteria vectors for the delivery of one or more primary effector molecule(s) to the site of a solid tumor. The primary effector molecule(s) of the invention is used in the methods of the invention to treat a solid tumor cancer such as a carcinoma, melanoma, lymphoma, or sarcoma. The invention relates to the surprising discovery that effector molecules, which may be toxic when administered systemically to a host, can be delivered locally to tumors by attenuated tumor-targeted bacteria with reduced toxicity to the host. The application also discloses to the delivery of one or more optional effector molecule(s) (termed secondary effector molecules) which may be delivered by the attenuated tumor-targeted bacteria in conjunction with the primary effector molecule(s).
REFERENCES:
patent: 4436727 (1984-03-01), Ribi
patent: 5021234 (1991-06-01), Ehrenfeld
patent: 5344762 (1994-09-01), Karapetian
patent: 5705151 (1998-01-01), Dow et al.
patent: 5824538 (1998-10-01), Branstrom
patent: 5877159 (1999-03-01), Powell et al.
patent: 5997881 (1999-12-01), Powell et al.
patent: 6080849 (2000-06-01), Bermudes et al.
patent: 6150170 (2000-11-01), Powell et al.
patent: 6190657 (2001-02-01), Pawelek et al.
patent: 6251406 (2001-06-01), Haefliger et al.
patent: 6410012 (2002-06-01), Sizemore et al.
patent: 6537558 (2003-03-01), Kaniga et al.
patent: 2001/0006642 (2001-07-01), Steidler et al.
patent: 2001/0029043 (2001-10-01), Haefliger et al.
patent: WO 9106317 (1991-05-01), None
patent: WO 9211361 (1992-07-01), None
patent: WO 9502048 (1995-01-01), None
patent: WO 9611277 (1996-04-01), None
patent: WO 9634631 (1996-11-01), None
patent: WO 9640238 (1996-12-01), None
patent: WO 9718225 (1997-05-01), None
patent: WO 9718837 (1997-05-01), None
patent: WO 9719688 (1997-06-01), None
patent: WO 9725061 (1997-07-01), None
patent: WO 9833923 (1998-08-01), None
patent: WO 9853854 (1998-12-01), None
patent: WO 9913003 (1999-03-01), None
patent: WO 9952563 (1999-10-01), None
patent: WO 00/09733 (2000-02-01), None
Boehm et al. Nature 390:404-407, 1997.
Hakkaart et al. Mol Gen Genet 183:326-332, 1981.
Pascual et al. Behring Inst. Mitt, 1997, 98: 143-152.
Dietrich et al. Nature Biotechnology, 1998, 16: 181-185.
Grillot-Courvalin. Nature Biotechnology, 1998, 16: 862-866.
Tiball et al Vaccine 19:4175-4184, 20001.
Curtiss R. J. Clin. Invest. 110(8):1061-1066, 2002.
Dietrich et al. Antisense & Nucleic Acid Drug Development 10:391-399, 2000.
Adler, 1973, “A Method for Measuring Chemotaxis and Use of the Method to Determine Optimum Conditions for Chemotaxis byEscherichia coli”, J. Gen. Microbiol. 74:77-91.
Allzadeh et al., 1994, “Apoptosis as a Mechanism of Cytolysis of Tumor Cells by a Pathogenic Free-Living Amoeba”, Infect. Immun. 62:1298-1303.
Anderson et al., 1996, “Development of attenuatedSalmonellastrains that express heterologous antigens”, Methods in Molecular Medicine: Vaccine Protocols, ed. Robinson A, Farrar G, Wilblin C., Humana Press New Jersey, pp. 47-62.
Bagshawe, 1995, “Antibody-Directed Enzyme Prodrug Therapy: A Review”, Drug Dev. Res. 34:220-230.
Barry et al., 1995, “Protection Against Mycoplasma Infection Using Expression-Library Immunization”, Nature 377:632-635.
Barth and Morton, 1995, “The Role of Adjuvant Therapy in Melanoma Management”, Cancer 75 (Suppl.):726-734.
Bermudes et al., 2000, “Tumor targeted Salmonella. Strain development and expression of the HSV TK effector gene” Gene Therapy, Methods and Protocols, vol. 35, 419-436.
Bermudes et al., 2000, “Tumor-targeted Salmonella.Highly selective delivery vectors”, Advances in Exp. Med. And Bio. 465: 57-63.
Bone, 1993, “Gram-Negative Sepsis: A Dilemma of Modern Medicine”, Clin. Microbiol. Rev. 6:57-68.
Bonnekoh et al., 1995, “Inhibition of Melanoma Growth by Adenoviral-Mediated HSV Thymidine Kinase Gene Transfer in vivo”, J. Invest. Derm. 104:313-317.
Carey et al., “Clostridial Oncolysis in Man”, Eur. J. Cancer 3:37-46.
Carrier et al., 1992, “Expression of Human IL-1β inSalmonelle typhimurium;a Model System for the Delivery of Recombinant Therapeutic Proteins in vivo”, J. Immunol. 148:1176-1181.
Carswell et al., 1975, “An Endotoxin-Induced Serum Factor that Causes Necrosis of Tumors”, Proc. Natl. Acad. Sci. USA 72:3666-3670.
Chabalgoity et al., 1996, “ASalmonella typhimurium htrALive Vaccine Expressing Multiple Copies of a Peptide Comprising Amino Acids 8-23 of Herpes Simplex Virus Glycoprotein D as a Genetic Fusion to Tetanus Toxin Fragment C Protects Mice from Herpes Simplex Virus Infection”, Mol. Microbiol. 19:791-801.
Chen et al., 1999, “Liposomes complexed to plasmids encoding angiostatin and endostatin inhibit breast cancer in nude mice”, Cancer Res. 59 (14):Abstract.
Christ et al., 1995, “E5531, a Pure Endotoxin Antagonist of High Potency”, Science 268:80-83.
Clairmont et al., 2000, “Biodistribution and genetic stability of the novel antitumor agent VNP 20009, a genetically modified strain ofSalmonella typhimurium”, J. Infect. Diseases 181:1996-2002.
Clementz et al., 1997, “Function of theEscherichia coli msbBGene, a Multicopy Suppressor ofhtrBKnockouts, in the Acylation of Lipid A”, J. Biol. Chem. 272(16):10354-10360.
Cunningham et al., 1992, “Actin-Binding Protein Requirement for Cortical Stability and Efficient Locomotion”, Science 255:325-327.
Elsenstadt, 1987, “Analysis of Mutagenesis”, fromEscherichia coli and Salmonella typhimurium, Cellular and Molecular Biology,Neidhardt et al. (ed.), pp. 1016-1033.
Elsenstein et al., 1995, “Immunotherapy of a Plasmacytoma with Attenuated Salmonella”, Med. Oncol. 12:103-108.
Engel et al., 1992, “Murein-metabolizing enzymes fromEscherichia coli:existence of a second lytic transglycosylase”, J. Bacteriol. 174:6394-6403.
Engelbart and Gericke, 1963, “Oncolysis by Clostridia. V. Transplanted Tumors of the Hamster”, Cancer Res. 24:239-243.
Falkow, 1991, “Bacterial Entry Into Eukaryotic Cells”, Cell 65:1099-1102.
Fields et al., 1989, “A Salmonella locus that controls resistance to microbiocidal proteins from phagocytic cells.” Science 243:1059-1062.
Fields et al., 1986, “Mutants ofSalmonella typhimuriumthat cannot survive within themacrophage are avirulent”. Proc. Natl Acad Sci USA, 83:5189-5193.
Fox et al., 1996, “Anaerobic Bacteria as a Delivery System for Cancer Gene Therapy: In vitro Activation of 5-Fluorocytosine by Genetically Engineered Clostridia”, Gene Therapy 3:173-178.
Friberg, 1993, “BCG in the Treatment of Superficial Cancer of the Bladder: A Review”, Med. Oncol. Tumor Pharmacother. 10:31-36.
Gatan et al., 1990, “Cloning and characterization of the asd gene ofSalmonella typhimurium: use in stable maintenance of recombinant plasmids in Salmonella vaccine strains”, Gene 94:29-35.
Gericke and Engelbart, 1963, “Oncolysis by Clostridia. II. Experiments on a Tumor Spectrum with a Variety of Clostridia in Combination with Heavy Metal”, Cancer Res. 24:217-221.
Hall et al., 1994, “Induced Regression of Bovine Papillomas by Intralesional Immunotherapy”, Therapeutic Immunol. 1:319-324.
Han et al., 1967, “Salmonellosis in Disseminated Malignant Diseases”, New Eng. J. Med. 276:1045-1052.
Hoiseth and Stocker, 1981, “Aromatic dependentSalmonella typhimuriumare non virulent and effective as live vaccines”, Nature 291:238-239.
Jain, 1994, “Barriers to Drug Delivery in Solid Tumors”, Sci. American 271:58-65.
Jones et al., 1992, “Invasion bySalmonella typhimuriumis Affected by the Direction of Flagellar Rotation”, Infect. Immun. 60:2475-2480.
Karow and Georgopoulos, 1992, “Isolation and Characterization of theEscherichia
Belcourt Michael
Bermudes David G.
Clairmont Caroline A.
King Ivan C.
Lin Stanley L.
Law Offices of Albert Wai-Kit Chan LLC
Shukla Ram R.
Vion Pharmaceuticals Inc.
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