Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Carbohydrate doai
Patent
1997-11-26
1999-11-09
Railey, II, Johnny F.
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Carbohydrate doai
4242781, 514615, 514818, A61K 4505, A61K 4800, A61K 3100
Patent
active
059815051
DESCRIPTION:
BRIEF SUMMARY
FIELD OF THE INVENTION
The present invention relates to compositions and methods for introducing genetic material into the cells of an individual. The compositions and methods of the invention can be used to deliver protective and/or therapeutic agents including genetic material that encodes protein targets for immunization and therapeutic proteins.
BACKGROUND OF THE INVENTION
The direct introduction of a normal, functional gene into a living animal has been studied as a means for replacing defective genetic information. In some studies, DNA is introduced directly into cells of a living animal without the use of a viral particle or other infectious vector. Nabel, E. G., et al., (1990) Science 249:1285-1288, disclose site-specific gene expression in vivo of a beta-galactosidase gene that was transferred directly into the arterial wall in mice. Wolfe, J. A. et al., (1990) Science 247:146-1468, disclose expression of various reporter genes that were directly transferred into mouse muscle in vivo. Acsadi G., et al., (1991) Nature 352:815-818, disclose expression of human dystrophin gene in mice after intramuscular injection of DNA constructs. Wolfe, J. A., et al., 1991 BioTechniques 11(4):474-485, which is incorporated herein by reference, refers to conditions affecting direct gene transfer into rodent muscle in vivo. Feigner, P. L. and G. Rhodes, (1991) Nature 349:351-352, disclose direct delivery of purified genes in vivo as drugs without the use of retroviruses.
The use of direct gene transfer as an alternative anti-pathogen vaccination method has been suggested. Use of direct gene transfer by single injection is suggested as a possible vaccination strategy against HIV. A cellular immune response to HIV gp120 resulting from introduction of plasmid DNA encoding the same into cells is reported to have been observed. PCT International Application Number PCT/US90/01515 published Oct. 4, 1990 discloses methods of immunizing an individual against pathogen infection by directly injecting naked polynucleotides into the individual's cells in a single step procedure. The use of transfecting agents other than lipofectins is specifically excluded from the disclosed methods. The stimulation of inoculated cells is neither disclosed nor suggested. An HIV vaccine is disclosed which consists of the introduction of polynucleotides that encode the viral protein gp120. The operability of this vaccine is not evidenced.
Thomason, D. B. et al., (1990) Cell Physiol. 27:C578-581 and PCT Patent Application Serial No. WO 91/12329 disclose administering bupivacaine to muscle cells in order to induce satellite cell proliferation as part of a retroviral-mediated gene delivery protocol.
SUMMARY OF THE INVENTION
The present invention relates to methods of introducing genetic material into the cells of an individual. The methods comprises the steps of contacting cells of said individual with a polynucleotide function enhancer agent, which is preferably an agent that facilitates the uptake of DNA by the cells or enhances an inflammatory response, and administering to the cells, a nucleic acid molecule that comprises a nucleotide sequence that either encodes a desired peptide or protein, or serves as a template for functional nucleic acid molecules. The nucleic acid molecule is administered free from retroviral particles. The desired protein may either be a protein which functions within the individual or it serves as a target for an immune response.
The present invention relates to a method of immunizing an individual against a pathogen. The method comprises the steps of contacting cells of said individual with a polynucleotide function enhancer agent, which is preferably an agent that facilitates the uptake of DNA by the cells or enhances the immune response, and administering to the cells, a nucleic acid molecule that comprises a nucleotide sequence that encodes a peptide which comprises at least an epitope identical or substantially similar to an epitope displayed on a pathogen antigen and is operatively linked to regulatory seque
REFERENCES:
patent: 3688765 (1972-09-01), Gasaway
patent: 4224404 (1980-09-01), Viza et al.
patent: 4394448 (1983-07-01), Szoka, Jr. et al.
patent: 4596556 (1986-06-01), Morrow et al.
patent: 4680027 (1987-07-01), Parsons et al.
patent: 4806463 (1989-02-01), Goodchild et al.
patent: 4945050 (1990-07-01), Sanford et al.
patent: 5017487 (1991-05-01), Stunnenberg et al.
patent: 5024656 (1991-06-01), Gasaway et al.
patent: 5036006 (1991-07-01), Sanford et al.
patent: 5185254 (1993-02-01), Linnenbach
patent: 5593972 (1997-01-01), Weiner et al.
Acsadi, G. et al., "Human Dystrophin expression in mdx Mice after Intramuscular Injection of DNA Constructs", Nature 1991, 352, 815-818.
Aldovini, A. et al., "Mutations of RNA and Protein Sequences Involved in Human Immunodeficiency Virus Type 1 Packaging Result in Production of Noninfectious Virus", J. of Virology 1990, 64, 1920-1926.
Desrosiers, R., "HIV with Multiple Gene Deletions as a Live Attenuated Vaccine for AIDS", AIDS Research and Human Retroviruses 1992, 8(3), 411-421.
Felgner, P.L. and Rhodes, "Gene Therapeutics", Nature 1991, 349, 351-352.
Ronen, D. et al., "Expressionof wild-type and mutant p53 proteins by recombinant vaccinia viruses", Nucleic Acids Research 1992, 20(13), 3435-3441.
Schauer, M. and Billich, "The N-Terminal Region of HIV-1 Integrase is Required for Integration Activity, but not for DNA-Binding", Biochemical and Biophysical Res. Comm. 1992, 185(3), 874-880.
Thomason, D.B. and Booth, F.W., "Stable incorporation of a bacterial gene into adult rat skeletal muscle in vivo", American Journal of Physiology 1990. 258(3), C578-C581.
Wolff, J.A. et al., "Direct gene transfer into mouse muscle in vivo", Science 1990, 247, 1465-1468.
Butini, L. et al., "Comparative Analysis of HIV-Specific CTL Activity in Lymphoid Tissue and Peripheral Blood", J. of Cellular Biochem. 1994, Suppl. 18B, 147, Abst. J 306.
Chaudhary et al., "A Rapid Method of Clonign Functional Variable-Region Antibody Genes in Escherichia coli as Single-Chain Immunotoxins", PNAS USA 1990, 87, 1066-1070.
Chen, L. et al., "Human Papillomavirus Type 16 Nucleoprotein E7 is a Tumor Rejection Antigen", PNAS USA 1991, 88, 110-114.
Estin, C.D. et al., "Transfected Mouse Melanoma Lines that Express Vairous Levles of Human Melanoma-Associated Antigen p97", J. of the National Cancer Institute 1989, 81(6), 445-448.
Fendly, B.M. et al., "The Extracellular Domain of HER2
eu is a Potential Immunogen for Active Specific Immunotherapy of Breast Cancer", J. of Biological Response Modifiers 1990, 9, 449-455.
FIdler, I. and Hart, "Biological and Experimental Consequences of the Zonal Composition of Solid Tumors", Cancer Research 1981, 41, 3266-3267.
Fisher et al., "A Molecular Clone of HTLV-III with Biological Activity", Nature 1985, 316, 262-265.
Garry, R.F. et al., "Detection of a Human Intracisternal A-Type Retroviral Particle Antigenically Related to HIV", Science 1990, 250, 1127-1129.
Haynes, B.F., "Scientific and Social Issues of Human Immunodeficiency Virus Vaccine Development", Science 1993, 260, 1279-1286.
Hoffenbach, A. et al., "Unusually High Frequencies of HIV-Specific Cytotoxic T Lymphocytes in Humans", The J. of Immunology 1989, 142, 452-462.
Howell et al., "Limited T-Cell receptor Beta-Chain heterogeneity Among Interleukin 2 Receptor-Positive Synovial T Cells Suggests a Role of Superantigen in Rheumatoir Arthritis", PNAS USA 1988, 88, 10921-10925.
Kabat et al., "Sequence of Proteins of Immunological Interest", U.S. Dept. of Health and Human Services, bethesda, MD, 1987.
Khoka, R. et al., "Suppressionof Invasion by Inducible Expression of Tissue Inhibitor of Metalloproteinase-1 (TIMP-1) in B16-F10 Melanoma Cells", J. of the National Cancer Institute 1992, 84(13), 1017-1022.
Knuth, A. et al., "Cellular and Humoral Immune Responses Against Cancer: Implications for Cancer Vaccines", Curr. Opin. Immunol. 1991, 3(5), 659-664.
Kundig et al., "Nonimmunogenic Tumor Cells May Efficiently Restimulate Tumor Antigen-Specific Cytotoxic T Cells", J. of Immu
Wang Bin
Weiner David B.
Williams William V.
Railey II Johnny F.
The Trustees of the University of Pennsylvania
The Wistar Institute
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