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US5670488: Adenovirus vector for gene therapy

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Filing Information

Inventor(s) Richard J. Gregory · Donna Armentano · Larry A. Couture · Alan E. Smith ·
Assignee(s) Genzyme Corporation ·
Attorney/Agent(s) Brumbaugh, Graves Donohue & Raymond ·
Primary Examiner Deborah Crouch ·
Application Number US8136742
Filing date 10/13/1993
Issue date 09/23/1997
Predicted expiration date 12/03/2012
U.S. Classifications 514/44  · 424/932  ·
International Classifications A61K 4800  ·
Kind CodeA
International Classifications 435320.1 ·
Related U.S. Application DataRELATED APPLICATIONS
This application is a continuation-in-part of application U.S. Ser. No. 07/985,478, filed Dec. 3, 1992, abandoned.
19 Claims, No Drawings


Abstract

Gene Therapy vectors, which are especially useful for cystic fibrosis, and methods for using the vectors are disclosed.

Independent Claims | See all claims (19)

  1. 1. An adenoviral vector comprising an adenovirus genome from which one or more of the E4 open reading frames has been deleted, but retaining sufficient E4 sequences to promote virus replication in vitro, and additionally comprising a DNA sequence of interest operably linked to expression control sequences and inserted into said adenoviral genome.
  2. 13. A method for providing cystic fibrosis transmembrane conductance regulator protein to airway epithelial cells of a cystic fibrosis patient comprising administering directly to airway epithelial cells of the patient an adenoviral vector, said vector comprising an adenovirus genome from which one or more E4 open reading frames has been deleted, but retaining sufficient E4 sequences to promote virus replication in vitro, and additionally comprising a DNA sequence encoding cystic fibrosis transmembrane regulator protein operably linked to expression control sequences and inserted into the E1 region said adenoviral genome, under conditions whereby the DNA sequence encoding cystic fibrosis transmembrane regulator protein is expressed and a functional chloride ion channel is produced in the airway epithelial cells of the patient.

References Cited

U.S. Patent Documents

Document NumberAssigneesInventorsIssue/Pub Date
US4920209 American Home Products Corporation Davis Apr 1990

Foreign Patent Documents

Document NumberAssigneesInventorsIssue/Pub Date
EP0185573INSTITUT PASTEURJun 1986
EP0446017GENZYME CORPORATIONSep 1990
WO20WO9102796Aug 1990
WO20WO9312240Dec 1992
WO20WO9312756Dec 1992
WO20WO9110734Dec 1992
WO199319191Sep 1993

Other Publications

Zabner, J. et al. (1993) "Adenovirus-Mediated Gene Transfer Transiently Corrects the Chloride Transport Defect in Nasal Epithelia of Patients with Cystic Fibrosis" Cell 75:207-216.
Rosenfeld, M.A. et al. (1992) "In Vivo Transfer of the Human Cystic Fibrosis Transmembrane Conductance Regulator Gene to the Airway Epithelium" Cell 68: 143-155.
Sassone-Corsi, P. et al. (1983) "Far upstream sequences are required for efficient transcription from the adenovirus-2 E1A transcription unit" Nucleic Acid Research 11:8735-8745.
Yoshimura, K. et al. (1993) "Adenovirus-mediated Augmentation of Cell Transfection with Unmodified Plasmid Vectors" J. Biol. Chem. 268(4):2300-2303.
Engelhardt, J.F. et al. (1993) "Direct Gene Transfer of Human CFTR into Human Bronchial Epithelia of Xenografts with E1-deleted Adenovirus" Nat. Gen. 4:27-34.
Flotte, T.R. et al. (1993) "Expression of the Cystic Fibrosis Transmembrane Conductance Regulator from a Novel Adeno-associated Virus Promoter" J. Biol. Chem. 268(5):3781-3790.
Johnson, L.G. et al. (1992) "Efficiency of Gene Transfer for Restoration of Normal Airway Epithelial Function in Cystic Fibrosis" Nat. Gen. 2:21-25.
Welsh, M.J. and Smith, A.E. (1993) "Molecular Mechanisms of CFTR Chloride Channel Dysfunction in Cystic Fibrosis" Cell 73:1251-1254.
Hyde, S.C. et al. (1993) "Correction of the Ion Transport Defect in Cystic Fibrosis Transgenic Mice by Gene Therapy" Nature 362:250-255.
Smith, A.E. (1992) "Emerging Therapies for Cystic Fibrosis" Section V-Topics in Biology in Ann. Rep. Med. Chem. 27:235-243.
Yoshimura, K. et al. (1992) "Expression of the Human Cystic Fibrosis Transmembrane Conductance Regulator Gene in the Mouse Lung after in Vivo Intratracheal Plasmid-Mediated Gene Transfer" Nucleic Acids Res. 20:(12):3233-3240.
Rosenfeld, M.A. et al. (1991) "Adenovirus-Mediated Transfer of a Recombinant .alpha.-1-Antitrypsin Gene to the Lung Epithelium in Vivo" Science 252:431-434.
Rosenfeld, M.A. et al. (1991) "In Vivo Transfer of the Human Cystic Fibrosis Gene to the Respiratory Epithelium" Clin. Res. 39(2):311A.
Anderson, M.P. et al. (1991) "Generation of cAMP-Activated Chloride Currents by Expression of CFTR" Science 251:679-682.
Kartner, N. et al. (1991) "Expression of the Cystic Fibrosis Gene in Non-Epithelial Invertebrate Cells Produces a Regulated Anion Conductance" Cell 64:681-691.
Anderson, M.P. et al. (1991) "Demonstration That CFTR Is a Chloride Channel by Alteration of Its Anion Selectivity" Science 253:202-205.
Tabcharani, J.A. et al. (1991) "Phosphorylation-Regulated C1-Channel in CHO Cells Stabley Expressing the Cystic Fibrosis Gene" Nature 352:628-631.
Rich, D.P. et al. (1991) "Effect of Deleting the R Domain on CFTR-Generated Chloride Channels" Science 253:205-207.
Berger, H.A. et al. (1991) "Identification and Regulation of the Cystic Fibrosis Transmembrane Conductance Regulator-Generated Chloride Channel" J. Clin. Invest. 88:1422-1431.
Drumm, M.L. et al. (1990) "Correction of the Cystic Fibrosis Defect In Vitro By Retrovirus-Mediated Gene Transfer" Cell 1227-1233.
Gregory, R.J. et al. (1990) "Expression and Characterization of the Cystic Fibrosis Transmembrane Conductance Regulator" Nature 347:382-386.
Rich, D.P. et al. (1990) "Expression of the Cystic Fibrosis Transmembrane Conductance Regulator Corrects Defective Chloride Channel Regulation in Cystic Fibrosis Airway Epithelial Cells" Nature 347:358-363.
Huang, M.T.F. et al. (1990) "Intervening Sequences Increase Efficiency of RNA 3'Processing and Accumulation of Cytoplasmic RNA" Nucleic Acids Res. 18(4):937-947.
Riordan, J.R. et al. (1989) "Identification of the Cystic Fibrosis Gene: Cloning and Characterization of Complementary DNA" Science 245:1066-1073.
Rommens, J.H. et al. (1989) "Identification of the Cystic Fibrosis Gene: Chromosome Walking and Jumping" Science 245: 1059-1065.
Kerem, B.S. et al. (1989) "Identification of the Cystic Fibrosis Gene: Genetic Analysis" Science 245:1073-1080.
Berker (1988) Biotechniques 6, 616-627.

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