Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Particulate form
Reexamination Certificate
2005-02-01
2005-02-01
Nguyen, Dave T. (Department: 1632)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Particulate form
C424S491000, C424S450000, C514S04400A
Reexamination Certificate
active
06849272
ABSTRACT:
The present invention provides improved cell delivery compositions. In particular, the invention provides biocompatible endosomolytic agents. In a preferred embodiment, the endosomolytic agents are also biodegradable and can be broken down within cells into components that the cells can either reuse of dispose of. In one aspect, the present invention provides endosomolytic agents capable of effecting the lysis of an endosome in response to a change in pH, and methods for effecting the lysis of an endosome. These inventive endosomolytic agents obviate the need for known agents (i.e., chloroquine, fusogenic peptides, inactivated adenoviruses and polyethyleneimine) that can burst endosomes and have negative effects on cells. In another aspect, the present invention provides cell delivery compositions comprising an endosomolytic component that is capable of effecting the lysis of the endosome in response to a change in pH, and an encapsulating, or packaging, component capable of packaging a therapeutic agent to be delivered to cellular or subcellular components.
REFERENCES:
patent: 5633234 (1997-05-01), August et al.
patent: 5762918 (1998-06-01), Thorpe
patent: 5830730 (1998-11-01), German et al.
patent: 6218370 (2001-04-01), Bischoff et al.
patent: 6267987 (2001-07-01), Park et al.
patent: 20010006817 (2001-07-01), Pack et al.
patent: 20030002841 (2003-01-01), Trubetskoy
Coessens. J. Controlled Release. 1996, 38, pp. 141-150.*
Zignani. J Controlled Release. 1997, vol. 48, pp. 115-129.*
Hwang et al., Cationic ploymers for gene delivery: Designs for overcoming barriers to systemic administration, 2001, Molecular Therapautic, vol. 3, No. 2, pp. 1830-191.*
Mahato et al., Peptide-based gene delivery, 1998, Molecular Theapautic, vol. 1, No. 2, pp. 226-243.*
Heller et al., Release of Insulin from pH-Sensitive Poly(Ortho Ester), 1990, Journal of Controlled Release, vol. 13, pp. 295-302.*
Richardson et al., Poly ( amidoamine)s as Potential Endosomloytic Polymers: Evaluation In Vitro and Body Distribution in Normal and Tumour-Bearing Animals, 1999, Journal of Targeting, vol. 6, No. 6, pp. 391-404.*
Rollan, Advance Gene Delivery, 1996, Control Rel, vol. 39, pp. 357-372.*
Hope et al., Cationic lipids, phosphatidlethanolamine and the intracellular delivery of polymeric, nucleic acid-based drugs (Review), 1998, Membrane Biology, vol. 15, pp. 1-14.*
Felgner et al. “Lipofection: A Highly Efficient, Lipid-Mediated DNA-Transfection Procedure”Proc. Natl. Acad. Sci. USA84:7413-7417, 1987.
Goldman et al. “In vitro and in vivo gene delivery mediated by a synthetic polycationic amino polymer”Nature Biotechnology15(5):462-466, 1997.
Gottschalk et al., “Synthetic Vehicles for Efficient Gene Transfer and Expression in Mammalian Cells (Meeting Abstract)”,J. Cell Biochem.,(Suppl. 21A) 393, 1995.
Hagmann, et al., “Release of Endosomal Content Induced by Plasma Membrane Tension: Video Image Intensification Time Lapse Analysis”,Experimental Cell Research,198: 298-304, 1992.
Harris “Gene Delivery and Therapy Strategies”The Lancet342:234, 1993.
Harris, et al., “Receptor-Mediated Gene Transfer to Airway Epithelial Cells in Primary Culture”,Am. J. Respir. Cell Mol. Biol.9(4): 441-447, 1993.
Hui, et al., “The Role of Helper Lipids in Cationic Liposome-Mediated Gene Transfer”Biophys. J.71:590-599, 1996.
Kabonov et al., “DNA Complexes with Polycations for the Delivery of Genetic Material into Cells”Bioconjugate Chemistry,6(1): 7-20, 1995.
Kornguth et al., “Effect of Polylystine on the Leakage and Retention of Compounds by Ehrlich Ascites Tumor Cells”Cancer Research,21:907-912, 1961.
Kuo et al. “Novel systems for controlled delivery of macromolecules”Critical Reviews Euk. Gene Exp.6(1):59-73, 1996.
Ledley “Pharmaceutical approach to somatic gene therapy”Pharmaceutical Research13(11):1595-1614, 1996.
Ledley “Nonviral gene therapy: The promise of genes as pharmaceutical products”Human Gene Therapy6(9):1129-1144, 1995.
Liang, et al., Characterization of a pH-Sensitive Surfactant Biochimica ET Biophysica Acta, 1369(1): 39-50.
Midoux et al. “Efficient Gene Transfer by Histidylated Polylysine/pDNA Complexes”Bioconjugate Chemistry10(3):406-411, 1999.
Miller et al. “Studies of the Mechanistic Diversity of Sodium Cyanoborohydride Reduction of Tosylhydrazones”,J. Org. Chem.54:4175-4188, 1989.
Plank et al. “The Influence of Endosome-Disruptive Peptides on Gene TransferUsing Synthetic Virus-Like Gene Transfer Systems”,J. Biol. Chem.269(17):12918-12924, 1994.
Schwarzenberger et al., “Receptor-Targeted Recombinant Adenovirus Conglomerates: A Novel Molecular Conjugage Vector with Improved Expression Characteristics”J. Virol.71(11): 8563-8571, 1997.
Seglen “Inhibitors of lysosomal function”Methods Enzymol.96:737-764, 1983.
Suh et al. “Ionization of Poly(ethylenimine) and Poly(allylamine) at Various pH's”,ioorg. Chem.22:318-327, 1994.
Tomlinson et al. “Controllable gene therapy pharmaceutics of non-viral gene delivery systems”J. Controlled Release39(2-3):357-372, 1996.
Wagner, et al., “Transferrin-Polycation Conjugates as Carriers for DNA Uptake Into Cells”Proc. Nat. Acad. Sci. USA.,873410-3414, 1990.
Wagner, et al., “Influenza Virus Hemagglutinin HA-2N-Terminal Fusogenic Peptides Augment Gene Transfer by Transferrin-Polylysine-DNA Complexes: Toward a Synthetic Virus-Like Gene-Transfer Vehicle”Proc. Natl. Acad. Sci. USA,89:7934-7938, 1992.
Wagner, “Receptor-Mediated Gene Transfer: The Answer in Tumor Immunotherapy?”Molekularbiol. Grundlagen Gastroenterol.,(Beger et al., eds.) Berlin: Springer-Verlag, 389-392, 1995.
Wagner, et al., “Receptor-Mediated Delivery of Plasmid DNA”Biogenic Amines,14(5): 519-536, 1998.
Wu et al., “Incorporation of Adenovirus into a Ligand-Based DNA Carrier System Results in Retention of Original Receptor Specificity and Enhances Targeted Gene Expression”,J. Biol. Chem.269:11542, 1994.
Wu et al., “Receptor-Mediated Gene Delivery and Expression in Vivo”Biol. Chem.263:14621, 1998.
Zatloukal et al., “Tranferrinfection: A Highly Efficient Way to Express Gene Constructs in Eukaryotic Cells”Ann. N.Y. Acad. Sci.660136-153, 1992.
Zauner, et al., “Glycerol and Polylysine Synergize in their Ability to Rupture Vesicular Membranes: A Mechanism for Increased Transferrin-Polylysine-Medicated Gene Transfer”Exp Cell Res.,232: 137-145, 1997.
Zauner, et al., “Polylysine-Based Transfection Systems Utilizing Receptor-Mediated Delivery”Adv. Drug Delivery Res.,30: 97-113, 1998.
Zauner et al. “Glycerol Enhancement of Ligand-Polylysine/DNA Transfection”Biotechniques20:905-913, 1996.
Zenke, et al., “Receptor-Mediated Endocytosis of Transferrin-Polycation Conjugates: An Efficient Way to Introduce DNA into Hematopoietic Cells”Proc. Natl. Acad. Sci. USA,87: 3655-3659, 1990.
Langer Robert S.
Putnam David A.
Baker C. Hunter
Choate Hall & Stewart
Herschbach Jarrell Brenda
Massachusetts Institute of Technology
Nguyen Dave T.
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