Angiogenesis gene therapy: Phase I assessment of direct intramyocardial administration of an adenovirus vector expressing VEGF121 cDNA to individuals with clinically significant severe coronary artery disease

Circulation

Volumn 100, Issue 5, 1999, Pages 468-474

  Rosengart, Todd K ^a   Lee, Leonard Y ^a   Patel, Shailen R ^a   Sanborn, Timothy A ^a   Parikh, Manish ^a   Bergman, Geoffrey W ^a   Hachamovitch, Rory ^a   Szulc, Massimiliano ^a   Kligfield, Paul D ^a   Okin, Peter M ^a   Hahn, Rebecca T ^a   Devereux, Richard B ^a   Post, Martin R ^a   Hackett, Neil R ^a   Foster, Taliba ^a   Grasso, Tina M ^b   Lesser, Martin L ^c   Isom, O Wayne ^a   Crystal, Ronald G ^a  

^a WEILL CORNELL MEDICAL COLLEGE   (United States)

^b GENVEC INC   (United States)

^c NORTH SHORE UNIVERSITY HOSPITAL   (United States)

Author keywords

Angiogenesis; Coronary disease; Gene therapy; Genetics; Ischemia

Indexed keywords

COMPLEMENTARY DNA; VASCULOTROPIN; VIRUS VECTOR;

ADULT; AGED; ANGIOGENESIS; ARTICLE; CLINICAL ARTICLE; CLINICAL TRIAL; CORONARY ARTERY DISEASE; FEMALE; GENE THERAPY; GENE TRANSFER; HEART MUSCLE ISCHEMIA; HUMAN; MALE; PHASE 1 CLINICAL TRIAL; PRIORITY JOURNAL; SAFETY; TREATMENT OUTCOME;

EID: 0033520056     PISSN: 00097322     EISSN: None     Source Type: Journal    
DOI: 10.1161/01.CIR.100.5.468     Document Type: Article

References (31)

1. Rosengart TK, Patel SR, Crystal RG. Therapeutic angiogenesis: protein and gene therapy delivery strategies. J Cardiovasc Res. 1999;6:29-40.
2. Simons M, Ware JA. Food for starving hearts. Nat Med. 1996;2:519-520.
3. Banai S, Shweiki D, Pinson A, Chandra M, Lazarovici G, Keshet E. Upregulation of vascular endothelial growth factor expression induced by myocardial ischaemia: implications for coronary angiogenesis. Cardinvasc Res. 1994;28:1176-1179.
4. Li J, Brown LF, Hibberd MG, Grossman JD, Morgan JP, Simons M. VEGF, flk-1, and flt-1 expression in a rat myocardial infarction model of angiogenesis. Am J Physiol. 1996;270:H1803-H1811.
5. Ferrara N, Houck KA, Jakeman LB, Winer J, Leung DW. The vascular endothelial growth factor family of polypeptides. J Cell Biochem. 1991; 47:211-218.
6. Folkman J, Haudenschild C. Angiogenesis in vitro. Nature. 1980;288: 551-556.
7. Thomas KA. Vascular endothelial growth factor, a potent and selective angiogenic agent. J Biol Chem. 1996;271:603-606.
8. Mack CA, Patel SR, Schwarz EA, Zanzonico P, Hahn RT, Ilercil A, Devereux RB, Goldsmith SJ, Christian TF, Sanborn TA, Kovesdi I, Hackett N, Isom OW, Crystal RG, Rosengart TK. Biologic bypass with the use of adenovirus-mediated gene transfer of the complementary deoxyribonucleic acid for vascular endothelial growth factor 121 improves myocardial perfusion and function in the ischemic porcine heart. J Thorac Cardiovasc Surg. 1998;115:168-176; discussion 176-177.
9. Losordo DW, Vale PR, Symes JF, Dunnington CH, Esakof DD, Maysky M, Ashare AB, Lathi K, Isner JM. Gene therapy for myocardial angiogenesis: initial clinical results with direct myocardial injection of phVEGF165 as sole therapy for myocardial ischemia. Circulation. 1998; 98:2800-2804.
10. Magovern CJ, Mack CA, Zhang J, Hahn RT, Ko W, Isom OW, Crystal RG, Rosengart TK. Direct in vivo gene transfer to canine myocardium using a replication-deficient adenovirus vector. Ann Thorac Surg. 1996; 62:425-433; discussion 433-434.
11. Mack CA, Magovern CJ, Budenbender KT, Patel SR, Schwarz EA, Zanzonico P, Ferris B, Sanborn T, Isom P, Isom OW, Crystal RG, Rosengart TK. Salvage angiogenesis induced by adenovirus-mediated gene transfer of vascular endothelial growth factor protects against ischemic vascular occlusion. J Vasc Surg. 1998;27:699-709.
12. Muhlhauser J, Merrill MJ, Pili R, Maeda H, Bacic M, Bewig B, Passaniti A, Edwards NA, Crystal RG, Capogrossi MC. VEGF165 expressed by a replication-deficient recombinant adenovirus vector induces angiogenesis in vivo. Circ Res. 1995;77:1077-1086.
13. Springer ML, Chen AS, Kraft PE, Bednarski M, Blau HM. VEGF gene delivery to muscle: potential role for vasculogenesis in adults. Mol Cell. 1998;2:549-558.
14. Rosenfeld MA, Yoshimura K, Trapnell BC, Yoneyama K, Rosenthal ER, Dalemans W, Fukayama M, Bargon J, Stier LE, Stratford-Perricaudet L, Perricaudet M, Guggino WB, Pavirani A, Lecocq J-P, Crystal RG. In vivo transfer of the human cystic fibrosis transmembrane conductance regulator gene to the airway epithelium. Cell. 1992;68:143-155.
15. Crystal RG, McElvaney NG, Rosenfeld MA, Chu CS, Mastrangeli A, Hay JG, Brody SL, Jaffe HA, Eissa NT, Danel C. Administration of an adenovirus containing the human CFTR cDNA to the respiratory tract of individuals with cystic fibrosis. Nat Genet. 1994;8:42-51.
16. Mittereder N, March KL, Trapnell BC. Evaluation of the concentration and bioactivity of adenovirus vectors for gene therapy. J Virol. 1996;70: 7498-7509.
17. Mack CA, Song WR, Carpenter H, Wickham TJ, Kovesdi I, Harvey BG, Magovern CJ, Isom OW, Rosengart T, Falck-Pedersen E, Hackett NR, Crystal RG, Mastrangeli A. Circumvention of anti-adenovirus neutralizing immunity by administration of an adenoviral vector of an alternate serotype. Hum Gene Ther. 1997;8:99-109.
18. Banks RE, Forbes MA, Kinsey SE, Stanley A, Ingham E, Walters C, Selby PJ. Release of the angiogenic cytokine vascular endothelial growth factor (VEGF) from platelets: significance for VEGF measurements and cancer biology. Br J Cancer. 1998;77:956-964.
19. Campeau L. Grading of angina pectoris. Circulation. 1976;54:522-523. Letter.
20. Kligfield P, Hochreiter C, Kramer H, Devereux RB, Niles N, Kramer-Fox R, Borer JS. Complex arrhythmias in mitral regurgitation with and without mitral valve prolapse: contrast to arrhythmias in mitral valve prolapse without mitral regurgitation. Am J Cardiol. 1985;55:1545-1549.
21. Rentrop KP, Cohen M, Blanke H, Phillips RA. Changes in collateral channel filling immediately after controlled coronary artery occlusion by an angioplasty balloon in human subjects. J Am Coll Cardiol. 1985;5: 587-592.
22. Williams KA, Taillon LA. Reversible ischemia in severe stress technetium 99m-labeled sestamibi perfusion defects assessed from gated single-photon emission computed tomographic polar map Fourier analysis. J Nucl Cardiol. 1995;2:199-206.
23. Okin PM, Kligfield P. Heart rate adjustment of ST segment depression and performance of the exercise electrocardiogram: a critical evaluation. J Am Coll Cardiol. 1995;25:1726-1735.
24. Hanahan D. Signaling vascular morphogenesis and maintenance. Science. 1997;277:48-50.
25. Laitinen M, Hartikainen J, Eranen J, Kiviniemi M, Hiltunen MO, Laakso M, Ya-Herttuala S. Catheter-mediated VEGF gene transfer to human coronary arteries after angioplasty: safety results from phase I Kuopio angioplasty gene transfer trial (KAT trial). Circulation. 1998;98(suppl I):I-322. Abstract.
26. Harvey B-G, Hackett N-R, El-Saw YT, Rosengart TK, Hirschowitz EA, Lieberman MO, Lesser ML, Crystal RG. Variability of human systemic humoral immune responses to adenovirus gene transfer vectors administered to different organs. J Virol. In press.
27. Ohwada A, Hirschowitz EA, Crystal RG. Regional delivery of an adenovirus vector containing the Escherichia coli cytosine deaminase gene to provide local activation of 5-fluorocytosine to suppress the growth of colon carcinoma metastatic to liver. Hum Gene Ther. 1996;7:1567-1576.
28. Gao GP, Yang Y, Wilson JM. Biology of adenovirus vectors with E1 and E4 deletions for liver-directed gene therapy. J Virol. 1996;70:8934-8943.
29. Worgall S, Wolff G, Falck-Pedersen E, Crystal RG. Innate immune mechanisms dominate elimination of adenoviral vectors following in vivo administration. Hum Gene Ther. 1997;8:37-44.
30. Wilson JM. Adenoviruses as gene-delivery vehicles. N Engl J Med. 1996;334:1185-1187.
31. Hariawala MD, Horowitz JJ, Esakof D, Sheriff DD, Walter DH, Keyt B, Isner JM, Symes JF. VEGF improves myocardial blood flow but produces EDRF-mediated hypotension in porcine hearts. J Surg Res. 1996;63:77-82.