Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Carbohydrate doai
Reexamination Certificate
1999-05-27
2001-03-06
Schwartzman, Robert A. (Department: 1636)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Carbohydrate doai
C424S278100
Reexamination Certificate
active
06197755
ABSTRACT:
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
247:1465-1468, 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. Felgner, 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.
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 genetic vaccine facilitator agent 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 genetic vaccine facilitator agent is selected from the group consisting of: anionic lipids; extracellular matrix-active enzymes; saponins; lectins; estrogenic compounds and steroidal hormones; hydroxylated lower alkyls; dimethyl sulfoxide (DMSO); and urea. 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 genetic vaccine facilitator agent 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 sequences. The nucleic acid molecule is capable of being expressed in the cells of the individual. The genetic vaccine facilitator agent is selected from the group consisting of: anionic lipids; extracellular matrix-active enzymes; saponins; lectins; estrogenic compounds and steroidal hormones; hydroxylated lower alkyls; dimethyl sulfoxide (DMSO); and urea.
The present invention relates to methods of immunizing an individual against a hyperproliferative disease or an autoimmune disease. The methods comprise the steps of contacting cells of said individual with a genetic vaccine facilitator agent and administering to cells of the individual, a nucleic acid molecule that comprises a nucleotide sequence that encodes a peptide that comprises at least an epitope identical or substantially similar to an epitope displayed on a hyperproliferative disease-associated protein or an autoimmune disease-associated protein, respectively, and is operatively linked to regulatory sequences; the nucleic acid molecule being capable of being expressed in the cells. The genetic vaccine facilitator agent is selected from the group consisting of: anionic lipids; extracellular matrix-active enzymes; saponins; lectins; estrogenic compounds and steroidal hormones; hydroxylated lower alkyls; dimethyl sulfoxide (DMSO); and urea.
The present invention relates to methods of treating an individual suffering from an autoimmune disease comprising the steps of contacting cells of said individual with a genetic vaccine facilitator agent and administering to cells of an individual, a nucleic acid molecule that comprises a nucleotide sequence which functions in place of a defective gene or which encodes a molecule that produces a therapeutic effect in the individual and is operatively linked to regulatory sequences; the nucleic acid molecule being capable of being expressed in the cells. The genetic vaccine facilitator agent is selected from the group consisting of: anionic lipids; extracellular matrix-active enzymes; saponins; lectins; estrogenic compounds and steroidal hormones; hydroxylated lower alkyls; dimethyl sulfoxide (DMSO); and urea.
The present invention relates to pharmaceutical compositions which comprise a nucleic acid molecule and a genetic vaccine facilitator. The present invention relates to pharmaceutical kits which comprise a container comprising a nucleic acid molecule and a container comprising a genetic vaccine facilitator. The genetic vaccine facilitator agent is selected from the group consisting of: anionic lipids; extracellular matrix-active enzymes; saponins; lectins; estrogenic compounds and steroidal hormones; hydroxylated lower alkyls; dimethyl sulfoxide (DMSO); and urea.
REFERENCES:
patent: 4394448 (1983-07-01), Szoka, Jr. et al.
patent: 4806350 (1989-02-01), Gerber
patent: 4863970 (1989-09-01), Patel et al.
patent: 4945050 (1990-07-01), Sanford et al.
patent: 5023252 (1991-06-01), Hseih
patent: 5049386 (1991-09-01), Eppstein et al.
patent: 5084396 (1992-01-01), Morgan, Jr. et al.
patent: 5187075 (1993-02-01), Green et al.
patent: 5273965 (1993-12-01), Kensil et al.
patent: 5459127 (1995-10-01), Felgner et al.
patent: 5580859 (1996-12-01), Felgner et al.
patent: 5593972 (1997-01-01), Weiner et al.
patent: 5739118 (1998-04-01), Carrano et al.
patent: 5817637 (1998-10-01), Weiner et al.
patent: 5830876 (1998-11-01), Weiner et al.
patent: 5962428 (1999-10-01), Carrano et al.
patent: 2 140822 (1984-12-01), None
patent: WO 86/00930 (1986-02-01), None
patent: WO 96/18372 (1996-06-01), None
Acsadi et al., “Human Dystrophin Expression in Mdx Mice After Intramuscular Injection of DNA Constructs”,Nature,1991, 352, 815-818.
Aida et al., “Removal of Endotoxin from Protein Solutions by Phase Separation using Triton X-114”,J. Immunol. Methods,1990, 132, 191-195.
Anilionis et al., “Structure of the Glycoprotein Gene in Rabies Virus”,Nature,1981, 294, 275-278.
Bogard et al., “Human Monoclonal Antibody HA-1A Binds to Endotoxin via an Epitope in the Lipid a Domain of Lipopolysaccharide”,J. Immunol.,1993, 150, 4438-4449.
Bogerd et al., “Dominant Negative Mutants of Human T-Cell Leukemia Virus Type I Rex and Human Immunodeficiency Virus Type I Rev Fail to Multimerize In Vivo”,J. Virol.,1993, 67, 2496-2502.
Bradley, “Virology, Mo
Carrano Richard A.
Wang Bin
Weiner David B.
Schwartzman Robert A.
The Trustees of the University of Pennsylvania
Woodcock Washburn Kurtz Mackiewicz & Norris LLP
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