Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Liposomes
Reexamination Certificate
2008-05-20
2008-05-20
Kishore, Gollamudi S. (Department: 1612)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Liposomes
C424S489000, C424S501000, C424S078090, C514S772600
Reexamination Certificate
active
07374778
ABSTRACT:
Compositions and methods for transport or release of therapeutic and diagnostic agents or metabolites or other analytes from cells, compartments within cells, or through cell layers or barriers are described. The compositions include a membrane barrier transport enhancing agent and are usually administered in combination with an enhancer and/or exposure to stimuli to effect disruption or altered permeability, transport or release. In a preferred embodiment, the compositions include compounds which disrupt endosomal membranes in response to the low pH in the endosomes but which are relatively inactive toward cell membranes, coupled directly or indirectly to a therapeutic or diagnostic agent. Other disruptive agents can also be used, responsive to stimuli and/or enhancers other than pH, such as light, electrical stimuli, electromagnetic stimuli, ultrasound, temperature, or combinations thereof. The compounds can be coupled by ionic, covalent or H bonds to an agent to be delivered or to a ligand which forms a complex with the agent to be delivered. Agents to be delivered can be therapeutic and/or diagnostic agents. Treatments which enhance delivery such as ultrasound, iontopheresis, and/or electrophereis can also be used with the disrupting agents.
REFERENCES:
patent: 4657543 (1987-04-01), Langer et al.
patent: 5362308 (1994-11-01), Chien et al.
patent: 5451411 (1995-09-01), Gombotz et al.
patent: 5501584 (1996-03-01), Yamamoto et al.
patent: 5521291 (1996-05-01), Curiel et al.
patent: 5547932 (1996-08-01), Curiel et al.
patent: 5599908 (1997-02-01), Raso
patent: 5603931 (1997-02-01), Raso
patent: 5609590 (1997-03-01), Herbig et al.
patent: 5656609 (1997-08-01), Wu et al.
patent: 5753263 (1998-05-01), Lishko et al.
patent: 5770627 (1998-06-01), Inoue et al.
patent: 5807306 (1998-09-01), Shapland et al.
patent: 5876989 (1999-03-01), Berg et al.
patent: 5939453 (1999-08-01), Heller et al.
patent: 5998588 (1999-12-01), Hoffman et al.
patent: 6165509 (2000-12-01), Hoffman et al.
patent: 6210717 (2001-04-01), Choi et al.
patent: 6486213 (2002-11-01), Chen et al.
patent: WO 93/14142 (1993-07-01), None
patent: WO 96/40958 (1996-12-01), None
patent: WO 97/04832 (1997-02-01), None
patent: WO 97/09068 (1997-03-01), None
patent: WO 98/33520 (1998-08-01), None
patent: WO 99/33493 (1999-07-01), None
patent: WO 99/39741 (1999-08-01), None
Abelev, G.I., “Alpha-Fetoprotein in Ontogenesis and Its Association With Malignant Turmors,”Adv. Cancer Res. 14:295-358, 1971.
Anderson, D.C., et al., “Enhanced In Vitro Tumor Cell Retention and Internalization of Antibody Derivatized With Synthetic Peptides,”Bioconjugate Chem. 4(1):10-18, 1993.
Buschle, M., et al., “Receptor-Mediated Gene Transfer Into Human T Lymphocytes Via Binding of DNA/CD3 Antibody Particles to the CD3 T Cell Receptor Complex,”Hum. Gene Ther. 6:753-761, 1995.
Cheung, C. Y., et al., “A pH-Sensitive Polymer That Enhances Cationic Lipid-Mediated Gene Transfer,”Bioconjugate Chem. 12(6):906-910, 2001.
Choi, Y.H., et al., “Lactose-Poly(Ethylene Glycol)-Grafted Poly-L-Lysine as Hepatome Cell-Targeted Gene Carrier,”Bioconjugate Chem. 9(6):708-718, 1998.
Cordes, E.H., and H.G. Bull, “Mechanism and Catalysis for Hydrolysis of Acetals, Ketals, and Ortho Esters,”Chemical Reviews 74(5):581-603, 1974.
Ding, Z., et al., “Synthesis and Purification of Thermally Sensitive Oligomer-Enzyme Conjugates of Poly(N-isopropylacrylamide)-Trypsin,”Bioconjugate Chem. 7(1):121-125, 1996.
Donbrow, M. (ed.),Microcapsules and Nanoparticles in Medicine and Pharmacy, CRC Press, Boca Raton, 1992.
Feijen J., et al., “Thermosensitive Polymers and Hydrogels Based on N-Isopropylacrylamide,”11th European Conference on Biomaterials, Pisa, Italy, Sep. 10-14, 1994, pp. 256-260.
Fife, T.H., and L.K. Jao, “Substituent Effects in Acetal Hydrolysis,”Journal of Organic Chemistry 30(5):1492-1495, May 1965.
Geisow, M.J., “Fluorescein Conjugates as Indicators of Subcellular pH. A Critical Evaluation,”Experimental Cell Research 150:29-35, 1984.
Gold, P. and S.O. Freedman, “Specific Carcinoembryonic Antigens of the Human Digestive System,”J. Exp. Med. 122(3):467-481, 1965.
Guy, R.H., “Current Status and Future Prospects of Transdermal Drug Delivery,”Pharm. Res. 13(12):1765-1769, 1996.
Haensler J., and F.C. Szoka, Jr., “Polyamidoamine Cascade Polymers Mediate Efficient Transfection of Cells in Culture,”Bioconjugate Chem. 4(5):372-379, 1993.
Hansch, C., and W.R. Glave, “Structure-Activity Relationships in Membrane-Perturbing Agents,”Molecular Pharmacology 7:337-354, 1971.
Hughes, J.A., et al., “Evaluation of Adjuvants That Enhance the Effectiveness of Antisense Oligodeoxynucleotides,”Pharm. Res. 13(3):404-410, 1996.
Kircheis, R., et al., “Coupling of Cell-Binding Ligands to Polyethylenimine for Targeted Gene Delivery,”Gene Ther. 4(5):409-418, 1997.
Kost, J. and R. Langer, “Responsive Polymer Systems for Controlled Delivery of Therapeutics,”TIBTECH 10:127-131, 1992.
Kratz, F., et al., “Drug-Polymer Conjugates Containing Acid-Cleavable Bonds,”Critical Reviews in Therapeutic Drug Carrier Systems, 16(3):245-288, 1999.
Kyriakides, T.R., et al., “pH-Sensitive Polymers That Enhance Intracellular Drug Delivery In Vivo,”Journal of Controlled Release 78:295-303, 2002.
Linhardt, J.G., and D.A. Tirrell, “pH-Induced Fusion and Lysis of Phosphatidylcholine Vesicles by the Hydrophobic Polyelectrolyte Poly(2-ethylacrylic Acid),”Langmuir 16(1):122-127, 2000.
Murthy, N., et al., “The Design and Synthesis of Polymers for Eukaryotic Membrane Disruption,”Journal of Controlled Release 61:137-143, 1999.
Pawlak, M., et al., “Template-Assembled Melittin: Structural and Functional Characterization of a Designed, Synthetic Channel-Forming Protein,”Protein Science 3:1788-1805, 1994.
Perales, J.C., et al. “An Evaluation of Receptor-Mediated Gene Transfer Using Synthetic DNA-Ligand Complexes,”Eur. J. Biochem. 226(2):255-266, 1994.
Plank, C., et al., “The Influence of Endosome-Disruptive Peptides on Gene Transfer Using Synthetic Virus-Like Gene Transfer Systems,”J. Biol. Chem. 269:12918-12924, 1994.
Prausnitz, M.R., et al., “Electroporation of Mammalian Skin: A Mechanism to Enhance Transdermal Drug Delivery,”Proc. Natl., Acad. Sci, USA 90(22):10504-10508, 1993.
Prausnitz, M.R., “Reversible Skin Permeabilization for Transdermal Delivery of Macromolecules,”Critical Reviews in Therapeutic Drug Carrier Systems 14(4):455-483, 1997.
Prausnitz, M.R., et al., “Transdermal Delivery of Heparin by Skin Electroporation,”Biotechnology(N.Y.) 13(11):1205-1209, 1995.
Press, O.W., et al., “Endocytosis and Degradation of Murine Anti-Human CD3 Monoclonal Antibodies by Normal and Malignant T-Lymphocytes,”Cancer Research 48:2249-2257, 1988.
Ross, G., et al., “Gene Therapy in the United States: A Five-Year Status Report,”Hum. Gene Ther. 7(14):1781-1790, 1996.
Schroeder, U.K.O., and D.A. Tirrell, “Structural Reorganization of Phosphatidylcholine Vesicle Membranes by Poly(2-ethylacrylic acid). Influence of the Molecular Weight of the Polymer,”Macromolecules 22:765-769, 1989.
Thomas, J.L., et al., “Membrane Solubilization by a Hydrophobic Polyelectrolyte: Surface Activity and Membrane Binding,”Biophysical Journal 67:1101-1106, 1994.
Thomas, J.L. and D.A. Tirrell, “Polyelectrolyte-Sensitized Phospholipid Vesicles,”Acc. Chem. Res. 25:336-342, 1992.
Tolstikov, V.V., et al., “Influence of Endosome-Destabilizing Peptides on Efficacy of Anti-HIV Immunotoxins,”Bioconjug. Chem. 8(1):38-43, 1997.
Tycko, B., et al., “Rapid Acidification of Endocytic Vesicles Containing Asialoglycoprotein in Cells of a Human Hepatoma Line,”Journal of Cell Biology 97:1762-1776, 1983 (abstract only).
Vinogr
Crum Lawrence A.
Hoffman Allan S.
Mourad Pierre D.
Murthy Niren
Porter Tyrone M.
Christensen O'Connor Johnson & Kindness PLLC
Kishore Gollamudi S.
University of Massachusetts
University of Washington
LandOfFree
Enhanced transport using membrane disruptive agents does not yet have a rating. At this time, there are no reviews or comments for this patent.
If you have personal experience with Enhanced transport using membrane disruptive agents, we encourage you to share that experience with our LandOfFree.com community. Your opinion is very important and Enhanced transport using membrane disruptive agents will most certainly appreciate the feedback.
Profile ID: LFUS-PAI-O-2753029