Methods and compositions for delivery of pharmaceutical agents

Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Carbohydrate doai

Reexamination Certificate

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C424S093200, C514S058000, C436S015000, C436S071000

Reexamination Certificate

active

07320963

ABSTRACT:
Methods and compositions for delivering pharmaceutical agents into cells, in particular urothelial cells of the bladder, are provided. In the methods and compositions of the invention, a solubilized cholesterol composition is used to facilitate delivery of pharmaceutical agents. Preferably, the cholesterol is solubilized by a cyclodextrin (e.g., methyl-β-cyclodextrin) and the pharmaceutical agent comprises a polynucleotide and either a cationic lipid, a cationic polymer or a dendrimer. Improved methods for transfecting polynucleotides into cells thus are also provided, using cationic lipids, cationic polymers or dendrimers and solubilized cholesterol, wherein the transfection efficiency is enhanced compared to use of cationic lipids, cationic polymers or dendrimers alone. Preferred methods of the invention involve transfecting polynucleotides into urothelial cells, preferably for therapeutic treatment of bladder cancer using, for example, a polynucleotide(s) encoding an interleukin(s), an interferon(s), a colony stimulating factor(s) and/or a tumor suppressor(s).

REFERENCES:
patent: 5264618 (1993-11-01), Felgner et al.
patent: 5580859 (1996-12-01), Felgner et al.
patent: 5605890 (1997-02-01), Agrawal et al.
patent: 5614503 (1997-03-01), Chaudhary et al.
patent: 5691316 (1997-11-01), Agrawal et al.
patent: 2003/0166601 (2003-09-01), Woodle et al.
patent: 2161225 (1994-10-01), None
patent: 2193502 (1995-12-01), None
patent: 2199004 (1996-03-01), None
patent: 2263705 (1998-02-01), None
patent: 2303884 (1999-04-01), None
patent: WO 94/23697 (1994-10-01), None
patent: WO 96/08235 (1996-03-01), None
patent: WO 96/37194 (1996-11-01), None
patent: WO 96/40962 (1996-12-01), None
patent: WO 96/40963 (1996-12-01), None
patent: WO 98/07408 (1998-02-01), None
patent: WO 98/13026 (1998-04-01), None
patent: WO 98/40499 (1998-09-01), None
patent: WO 98/44909 (1998-10-01), None
patent: WO 98/51285 (1998-11-01), None
patent: WO 99/15206 (1999-04-01), None
Lawrencia et al (Conference Supplement to Cancer Gene Therapy, Gene Therapy of Cancer VII, Dec. 1999).
Lawrencia et al (Gene Therapy (8: 760-768, 2001).
Sutton (Mol. Ther. 2(3): 211-217, 2000).
Cardillo et al (Anticancer Res. 20(6B): 4579-4583, 2000).
Syrigos et al (Urology 61(3): 677-680, 2003).
Grignon et al (Cancer Res. 56(7): 1654-1659, 1996).
Medline Accession No. 2002430653 (2002).
Medline Accession No. 2004528586 (2004).
Bennett, M.J. et al. (Feb. 1995). “Cholesterol Enhances Cationic Liposome-Mediated DNA Transfection of Human Respiratory Epithelial Cells,”Biosci. Rep. 15(1):47-53.
A Conference Supplement to Cancer Gene Therapy. ( Nov./Dec. 1999) Gene Therapy of Cancer VIII. San Diego, California Dec. 9-11, 1999. 6(6):total pp. 2.
Abe, K. et al. (Dec. 1995). Enhanced Nasal Delivery of Luteinizing Hormone Releasing Hormone Agonist Buserelin by Oleic Acid Solubilized and Stabilized in Hydroxyproply-Beta-Cyclodextrin, Chem Pharm Bull 43(12) 2232-2237.
Abdou, S. et al. (1997). “Beta-Cyclodextrin Derivatives as Carriers to Enhance the Antiviral Activity of an Antisense Oligonucloetide Directed Toward a Coronavirus Intergenic Consensus Sequence,” Arch. Virol. 142(8):1585-1602.
Alton, E.W.F.W. et al. (Oct. 1993). “Non-Invasive Liposome-Mediated Gene Delivery Can Correct the Ion Transport Defect in Cystic Fibrosis Mutant Mice,”Natl. Genet. 5:135-142.
Belldegrun, A. S. et al. ( Jun. 1998). “Superficial Bladder Cancer: The Role of Interferon-α,”The J. of Urology159:1793-1801.
Becket, G. et al. (Mar. 1999). “Improvement of the In Vitro Dissolution of Praziquantel by Complextion with Alpha-, Beta- and Gamma-Cyclodextrins,” Int. J. Pharm. 79(1):65-71.
Bibby, D.C, et al. (Mar. 2000). “Mechanisms by which Cyclodextrins Modify Drug Release from Polymeric Drug Delivery,” Int. J. Pharm. 197(1-2):1-11.
Brigham, K. L. MD et al. (Oct. 1989). “Rapid Communication: In Vivo Transfection of Murine Lungs with a Functioning Prokaryotic Gene Using a Liposome Vehicle,”Am. J. Med. Sci.298(4):278-281.
Brosman, S. A. (Aug. 1992). “Bacillus Calmette-Guérin Immunotherapy,”Urol. Clin. of North Am. 19(3):557-564.
Chang, s. L. and Banga, a. K. (Jun. 1998). “Transdernal Iontophoretic Delivery of Hydrocortisone from Cyclodextrin Solutions,” J. Pharm. Pharmacol. 50(6):635-640.
Bui, L. A. (Dec. 1997). “In Vivo Therapy of Hepatocellular Carcinoma with a Tumor-Specific Adenoviral Vector Expressing Interleukin-2,”Hum. Gene Ther. 8:2173-2182.
Chen, L. (1997). “Eradication of Murine Bladder Carcinoma by Intratumor Injection of a Bicistronic Adenoviral Vector Carrying cDNAs for the IL-12 Heterodimer and its Inhibition by the IL-12 p40 Subunit Homodimer,”J. Immunology159:351-359.
Chow, N-H. et al. (1998). “Potential Value of Urinary Intercellular Adhesion Molecule-1 Determination in Patients with Bladder Cancer,”Adult Urol. 52(6):1015-1019.
Colombo, M. P. and Forni, G. (Feb. 1994). “Cytokine Gene Transfer in Tumor Inhibition and Tumor Therapy: Where Are We Now?”Imm. Today15(2):48-51.
Crook, K. et al. (1998). “Inclusion of Cholesterol in DOTAP Transfection Complexes Increases the Delivery of DNA to Cells In Vitro in the Presence of Serum,”Gene Ther. 5:137-143.
Cross, A. H. et al. (2000). “A Catalyst of Peroxynitrite Decomposition Inhibits Murine Experimental Autoimmune Encephalomyelitis,”J. of Neuoro. 107:21-28.
Croyle, M. A. et al. (1998). “Beta Cyclodextrins Enhance Adenoviral-Mediated Gene Delivery to the Intestine,”Pharm. Res. 15(9):1348-1355.
Debs, R. J. et al. (Jun. 1990). “Regulation of Gene Expression In Vivo by Liposome-mediated Delivery of a Purified Transcription Factor,”J. Biol. Chem. 265(18):10189-10192.
Eastman, S. J. et al. (Apr. 1997). “A Concentrated and Stable Aerosel Formulation of Cationic Lipid: DNA Complexes Giving High-level Gene Expression in Mouse Lung,”Hum. Gene. Ther. 8(6):765-773.
Felgner, P. L. et al. (Nov. 1987). “Lipofection: A Highly Efficient, Lipid-mediated DNA-transfection Procedure,”Proc. Natl. Acad. Sci. U.S.A.84:7413-7416.
Felgner, J. H. et al. (Jan. 1994). “Enhanced Gene Delivery and Mechanism Studies with a Novel Series of Cationic Lipid Formulations,”J. Biol. Chem. 269(4):2550-2561.
Freeman, D. J. and Niven, R. W. (1996). “The Influence of Sodium Glycocholate and other Additives on the In Vivo Transfection of Plasmid DNA in the Lungs,”Pharm. Res.13(2):202-209.
Gabrilovich, D. I. et al. (1996). “Dendritic Cells in Antitumor Immune Response. I. Defective Antigen Presentation in Tumor-Bearing Hosts,”Cell. Imm.170(0139):101-110.
Gan, Y. H. et al. (1999). “Antitumor Immunity of Bacillus Calmette-Guerin and Interferon Alpha in Murine Bladder Cancer,”Eur. J. Cancer35(7):1123-1129.
Gao, X. and Huang, L. (Jan. 1996). “Potentiation of Cationic Liposome-Mediated Gene Delivery by Polycations,”Biochem. 35(3):1027-12036.
Gimpl, G. et al. (1997). “Cholesterol as Modulator of Receptor Function,”Biochem. 36(36):10959-10974.
Goeddel, D. V. ed. (1990).Methods in Enzymology:Gene Expression Technology. Academic Press Inc., San Diego, Calif. (Table of Contents). 185:v-ix.
Golumbek, P. T. et al. (Nov. 1991). “Treatment of Established Renal Cancer by Tumor Cells Engineered to Secrete Interlukin-4,”Science254(5032):713-716.
Gonzalez, H. et al. (1999). “New Class of Polymers for the Delivery of Macromolecular Therapeutics,”Bioconj.. Chem. 10:1068-1074.
Grosse, P. Y. et al. (1998). “Antiproliferative Effect of Methyl-β-Cyclodextrin In Vitro and in Human Tumour Xenografted Athymic Nude Mice,”Br. J. of Can. 78(9):1165-1169.
Harimoto, K. et al. (1998). “In Vivo Gene Transfer Methods in the Bladder Without Viral Vectors,”Br. J. of Urol. 81:870-874.
Hirayama, F. and Uekama, K. (Mar. 1999). “Cyclodextrin-Based Controlled Drug Release System,ȁ

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