Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Particulate form
Reexamination Certificate
2011-08-23
2011-08-23
Kishore, Gollamudi (Department: 1612)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Particulate form
C424S489000, C424S450000, C514S772600
Reexamination Certificate
active
08003129
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, iontophoresis, and/or electrophoresis 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 Tumors,”Advanced Cancer Research14:295-358, 1971.
Anderson, D.C., et al., “Enhanced In Vitro Tumor Cell Retention and Internalization of Antibody Derivatized With Synthetic Peptides,”Bioconjugate Chemistry4(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,”Human Gene Therapy6:753-761, Jun. 1995.
Cheung, C.Y., et al., “A pH-Sensitive Polymer That Enhances Cationic Lipid-Mediated Gene Transfer,”Bioconjugate Chemistry12(6):906-910, 2001.
Choi, Y.H., et al., “Lactose-Poly(Ethylene Glycol)-Grafted Poly-L-Lysine as Hepatome Cell-Targeted Gene Carrier,”Bioconjugate Chemistry9(6):708-718, 1998.
Cordes, E.H., and H.G. Bull, “Mechanism and Catalysis for Hydrolysis of Acetals, Ketals, and Ortho Esters,”Chemical Reviews74(5):581-603, Oct. 1974.
Ding, Z., et al., “Synthesis and Purification of Thermally Sensitive Oligomer-Enzyme Conjugates of Poly(N-isopropylacrylamide)-Trypsin,”Bioconjugate Chemistry7(1):121-125, 1996.
Donbrow, M. (ed.),Microcapsules and Nanoparticles in Medicine and Pharmacy, CRC Press, Boca Raton, Fla., 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 Chemistry30(5):1492-1495, May 1965.
Geisow, M.J., “Fluorescein Conjugates as Indicators of Subcellular pH. A Critical Evaluation,”Experimental Cell Research150:29-35, 1984.
Gold, P., and S.O. Freedman, “Specific Carcinoembryonic Antigens of the Human Digestive System,”Journal of Experimental Medicine122(3):467-481, Sep. 1965.
Guy, R.H., “Current Status and Future Prospects of Transdermal Drug Delivery,”Pharmaceutical Research13(12): 1765-1769, 1996.
Haensler J., and F.C. Szoka, Jr., “Polyamidoamine Cascade Polymers Mediate Efficient Transfection of Cells in Culture,”Bioconjugate Chemistry4(5):372-379, 1993.
Hansch, C., and W.R. Glave, “Structure-Activity Relationships in Membrane-Perturbing Agents,”Molecular Pharmacology7:337-354, 1971.
Hughes, J.A., et al., “Evaluation of Adjuvants That Enhance the Effectiveness of Antisense Oligodeoxynucleotides,”Pharmaceutical Research13(3):404-410, 1996.
Kircheis, R., et al., “Coupling of Cell-Binding Ligands to Polyethylenimine for Targeted Gene Delivery,”Gene Therapy4(5):409-418, 1997.
Kost, J., and R. Langer, “Responsive Polymer Systems for Controlled Delivery of Therapeutics,”Trends in Biotechnology10:127-131, Apr. 1992.
Kratz, F., et al., “Drug-Polymer Conjugates Containing Acid-Cleavable Bonds,”Critical Reviews in Therapeutic Drug Carrier Systems16(3):245-288, 1999.
Kyriakides, T.R., et al., “pH-Sensitive Polymers That Enhance Intracellular Drug Delivery In Vivo,”Journal of Controlled Release78:295-303, 2002.
Linhardt, J.G., and D.A. Tirrell, “pH-Induced Fusion and Lysis of Phosphatidylcholine Vesicles by the Hydrophobic Polyelectrolyte Poly(2-ethylacrylic Acid),”Langmuir16(1):122-127, 2000.
Murthy, N., et al., “The Design and Synthesis of Polymers for Eukaryotic Membrane Disruption,”Journal of Controlled Release61:137-143, 1999.
Pawlak, M., et al., “Template-Assembled Melittin: Structural and Functional Characterization of a Designed, Synthetic Channel-Forming Protein,”Protein Science3:1788-1805, 1994.
Perales, J.C., et al. “An Evaluation of Receptor-Mediated Gene Transfer Using Synthetic DNA-Ligand Complexes,”European Journal of Biochemistry226(2):255-266, 1994.
Plank, C., et al., “The Influence of Endosome-Disruptive Peptides on Gene Transfer Using Synthetic Virus-Like Gene Transfer Systems,”Journal of Biological Chemistry269:12918-12924, Apr. 1994.
Prausnitz, M.R., et al., “Electroporation of Mammalian Skin: A Mechanism to Enhance Transdermal Drug Delivery,”Proceedings of the National Academy of Sciences of the USA90(22):10504-10508, Nov. 1993.
Prausnitz, M.R., “Reversible Skin Permeabilization for Transdermal Delivery of Macromolecules,”Critical Reviews in Therapeutic Drug Carrier Systems14(4):455-483, 1997.
Prausnitz, M.R., et al., “Transdermal Delivery of Heparin by Skin Electroporation,”Biotechnology(N.Y.) 13(11): 1205-1209, Nov. 1995.
Press, O.W., et al., “Endocytosis and Degradation of Murine Anti-Human CD3 Monoclonal Antibodies by Normal and Malignant T-Lymphocytes,”Cancer Research48:2249-2257, Apr. 1988.
Ross, G., et al., “Gene Therapy in the United States: A Five-Year Status Report,”Human Gene Therapy7(14):1781-1790, Sep. 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,”Macromolecules22:765-769, 1989.
Thomas, J.L., et al., “Membrane Solubilization by a Hydrophobic Polyelectrolyte: Surface Activity and Membrane Binding,”Biophysical Journal67:1101-1106, Sep. 1994.
Thomas, J.L., and D.A. Tirrell, “Polyelectrolyte-Sensitized Phospholipid Vesicles,”Accounts of Chemical Research25:336-342, 1992.
Tolstikov, V.V., et al., “Influence of Endosome-Destabilizing Peptides on Efficacy of Anti-HIV Immunotoxins,”Bioconjugate Chemistry8(1):38-43, 1997.
Crum Lawrence A.
Hoffman Allan S.
Mourad Pierre D.
Murthy Niren
Porter Tyrone M.
Christensen O'Connor Johnson & Kindness PLLC
Kishore Gollamudi
Univeristy of Massachusetts
University of Washington
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