Drug – bio-affecting and body treating compositions – Whole live micro-organism – cell – or virus containing
Reexamination Certificate
2007-08-07
2007-08-07
Campell, Bruce R. (Department: 1648)
Drug, bio-affecting and body treating compositions
Whole live micro-organism, cell, or virus containing
C530S350000, C530S300000
Reexamination Certificate
active
10649480
ABSTRACT:
The present invention relates to the treatment of coronary heart disease by revascularization therapy, and more particularly to the intramyocardial injection of a pharmaceutical composition comprising a recombinant fibroblast growth factor-1 protein or a fragment of a recombinant fibroblast growth factor-1 protein, optionally, with a physiologic glue for inducing local neoangiogenesis in ischemic myocardium. Methods of producing the recombinant fibroblast growth factor 1 protein and fragments are also disclosed.
REFERENCES:
patent: 4444760 (1984-04-01), Thomas, Jr.
patent: 4642120 (1987-02-01), Nevo et al.
patent: 4693995 (1987-09-01), Prino et al.
patent: 5209776 (1993-05-01), Bass et al.
patent: 5401832 (1995-03-01), Linemeyer et al.
patent: 5520191 (1996-05-01), Karlsson et al.
patent: 5571790 (1996-11-01), Jaye et al.
patent: 5683989 (1997-11-01), Lau et al.
patent: 5792453 (1998-08-01), Hammond et al.
patent: 5814462 (1998-09-01), Weinberger
patent: 5827826 (1998-10-01), Jaye et al.
patent: 6045565 (2000-04-01), Ellis et al.
patent: 6060454 (2000-05-01), Duhaylongsod
patent: 6268178 (2001-07-01), Kordyum et al.
patent: 6773899 (2004-08-01), Kordyum et al.
patent: 0 298 723 (1989-01-01), None
patent: 1 089 119 (1984-04-01), None
patent: WO 92/09301 (1992-06-01), None
patent: WO 92/13565 (1992-09-01), None
patent: WO 98/39436 (1998-09-01), None
Schumacher e tal. Circulation, 1998, vol. 97, pp. 645-650.
Fasol. et al. The Journal of Thoracic and Cardiovascular Surgery, 1994, vol. 107, pp. 1432-1439.3.
Htun et al. J. Mol. Cell Cardiol. 1998, vol. 30, pp. 867-877.
Pu et al. Circulation 1993, vol. 88, No. 1, pp. 208-215.
Battegay E.J. 1995, vol. 73, pp. 333-346.
Banai et al. Circ. Res. 1991, vol. 69, No. 1, pp. 76-85.
Hendel, et al. “Effect of Intracoronary Recombinant Human Vascular Endothelial Growth Factor on Myocardial Perfusion,”Circulation, vol. 101, pp. 118-121, 2000.
Laham, et al. “Subxyphoid Access of the Normal Pericardium: A Novel Drug Delivery Technique,”Catheterization and Cardiovascular Interventions, vol. 47, pp. 109-111, 1999.
Laham, et al. “Local Perivascular Delivery of Basic Fibroblast Growth Factor in Patients Undergoing Coronary Bypass Surgery, Results of a Phase I Randomized, Double-Blind, Placebo-Controlled Trial,”Circulation, vol. 100, pp. 1865-1871, 1999.
Rosengart, et al. “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, vol. 100, pp. 468-474, 1999.
Stegmann, et al. “First Angiogenic Treatment of Coronary heart Disease by FGF-1: Long-Term Results After 3 years,”Cardiac and Vascular Regeneration, vol. 1, No. 1, pp. 5-10, Mar. 2000.
Symes, et al. “Gene Therapy with Vascular Endothelial Growth Factor for Inoperable Coronary Artery Disease,”Annals of Thoracic Surgery, vol. 68, pp. 830-837, 1999.
Udelson, et al. “Therapeutic Angiogenesis with Recombinant Fibroblast Growth Factor-2 Improves Stress and Rest Myocardial Perfusion Abnormalities in Patients with Severe Symptomatic Chronic Coronary Artery Disease,”Circulation, vol. 102, pp. 1605-1610, 2000.
Waxman, et al. “Persistent Primary Coronary Dilation Induced by Transatrial Delivery of Nitroglycerin into the Pericardial Space: A Novel Approach for Local Cardiac Drug Delivery,”Journal of the American College of Cardiology, vol. 33, No. 7, pp. 2073-2077, Jun. 1999.
Sorochinskaya, et al. “Study of Beta Lactamase Tem1 Synthesis in VariousEscherichia coliStrains Infected by the Phage Lambda-BLA with Amber Mutations in Different Regulatory Genes,”Biopolimery I Kletka, vol. 7, No. 1, pp. 101-107, 1991 (abstract).
Watanabe, et al. “Molecular Characterization of Recombinant Human Acidic Fibroblast Growth Factor Produced inE. coli: Comparative Studies with Human Basic Fibroblast Growth Factor,”Molecular Endocrinology, vol. 4, No. 6, pp. 869-879, 1990.
Zazo, et al. “High-Level Synthesis inEscherichia coliof Shortened and Full-Length Human Acidic Fibroblast Growth Factor and Purification in a Form Stable in Aqueous Solutions,”Gene, vol. 113, No. 2, pp. 231-238, Jan. 1992.
Supplementary European Search Report completed May 31, 2005 and issued to a related foreign application.
Lei, et al. “Effects of Ribosomal Protein Mutations on the Expression of Bacteriophage Lambda N Gene inEscherichia-coli,”Acta Genetica Sinica, vol. 14, No. 4, pp. 318-322, 1987, Abstract only.
Ratajska, et al. “Modulation of cell migration and vessel formation by vascular endothelial growth factor and basic fibroblast growth factor in cultured embryonic heart,”Developmental Dynamics, 1995, 203/4, pp. 399-407.
Sellke, et al. “Enhanced microvascular relaxations to VEGF and bFGF in chronically ischemic porcine myocardium,”American journal of Physiology, 1996 271/2, pp. 713-720.
Fasol, et al. “Experimental use of a modified fibrin glue to induce site-directed angiogenesis from the aorta to the heart,”Journal of Thoracic Cardiovascular Surgery, Jun. 1994, pp. 1432-1439.
Weatherford, et al. “Vascular endothelial growth factor and heparin in a biologic glue promotes human aortic endothelial cell proliferation with aortic smooth muscle cell inhibition,”Surgery, Aug. 1996, 120(2), pp. 433-439.
Kang, et al. Selective stimulation of endothelial cell proliferation with inhibition of smooth muscle cell proliferation by fibroblast-growth factor-1 plus heparin delivered from fibrin glue suspensions,Surgery, Aug. 1995, 118(2), pp. 280-286, discussion pp. 286-287.
Watabene, et al. “Effect of basic fibroblast growth factor on angiogenesis in the infarcted porcine heart,”Basic Research in Cardiology, Feb. 1998, 93(1), pp. 30-37.
Lopez. “Angiogenic potential of perivascularly delivered aFGF in a porcine model of chronic myocardial ischemia,”American journal of Physiology, Mar. 1998, 274, pp. 930-936.
Schumacher, et al. “Induction of neoangiogenesis in ischemic myocardium by human growth factors, first clinical results of a new treatment of coronary heart disease,”Circulation, Feb. 24, 1998, 97(7), pp. 645-650.
Lazarous et al. “Pharmacodynamics of basic fibroblast growth factor: route of administration determines myocardial and systemic distribution,”Cardiovascular Research, Oct. 1997, 36(1), pp. 78-85.
Scheinowitz, et al. “The role of insulin-like and basic fibroblast growth factors on ischemic and infarcted myocardium: a mini review,”International Journal of Cardiology, Mar. 1997, 59(1), pp. 1-5.
Shou, et al. “Effect of basic fibroblast growth factor on myocardial angiogenesis in dogs with mature collateral vessels,” Journal of American College of Cardiology, Apr. 1997, 29(5), pp. 1102-1106.
Gu, “Basic fibroblast growth factor as a biochemical marker of exercise-induced ischemia,”Circulation, Mar. 4, 1997, 95(5), pp. 1165-1168.
Horrigan, et al. “Reduction in myocardial infarct size by basic fibroblast growth factor after temporary coronary occlusion in a canine model,”Circulation, Oct. 15, 1996, 94(8), pp. 1927-1933.
Schaper, “Collateral vessel growth in the human heart. Role of fibroblast growth factor-2,”Circulation, Aug. 15, 1996, 94(4), pp. 600-601.
Sellke, et al. “Angiogenesis induced by acidic fibroblast growth factor as an alternative method of revascularization for chronic myocardial ischemia,”Surgery, Aug. 1996, 120(2), pp. 182-188.
Uchida, et al. “Angiogenic therapy of acute myocardial infarction by intrapericardial injection of basic fibroblast growth factor and heparin sulfate: an experimental study,”American Heart Journal, Dec. 1995, 130(6), pp. 1182-1188.
Slavin, “Fibroblast growth factors: at the heart of angiogenesis,”Cell Biology International, May 1995, 19(5), pp. 431-444.
Landau, et al.
Campell Bruce R.
CardioVascular BioTherapeutics, Inc.
Knobbe Martens Olson & Bear LLP
Li Bao Qun
LandOfFree
Method of producing biologically active human acidic... does not yet have a rating. At this time, there are no reviews or comments for this patent.
If you have personal experience with Method of producing biologically active human acidic..., we encourage you to share that experience with our LandOfFree.com community. Your opinion is very important and Method of producing biologically active human acidic... will most certainly appreciate the feedback.
Profile ID: LFUS-PAI-O-3868234