Title:
ANGIOGENICALLY EFFECTIVE UNIT DOSE OF FGF-2 AND METHOD OF USE
Document Type and Number:
WIPO Patent Application WO2000013701
Kind Code:
A3
Abstract:
The present invention has multiple aspects. In particular, in one aspect, the present invention is directed to a unit dose composition comprising 0.2 mu g/kg to 48 mu g/kg of an FGF-2 of SEQ ID NO: 2, or an angiogenically active fragment or mutein thereof in a pharmaceutically acceptable carrier. In another aspect, the present invention is directed to a method for treating a human patient for coronary artery disease, comprising administering into one or more coronary vessels or a peripheral vein of a human patient in need of treatment for coronary artery disease a safe and angiogenically effective dose of a recombinant FGF-2, or an angiogenically active fragment or mutein thereof. The single unit dose composition of the present invention provides an angiogenic effect in a human CAD patient that lasts six months before re-treatment is required. In another aspect, the present invention is directed to a method of administration which optimizes patient's safety. In this embodiment, fluids, heparin and/or rate of infusion all play a role. In another aspect, the present invention is directed to a pharmaceutical composition comprising a therapeutically effective amount of FGF-2, alone or in combination with heparin, in a therapeutically effective carrier. The magnitude and duration of benefit were unexpected; in addition benefit with the IV route was unexpected.
Inventors:
WHITEHOUSE MARTHA JO
Application Number:
PCT/US1999/019770
Publication Date:
August 03, 2000
Filing Date:
August 27, 1999
Export Citation:
Assignee:
CHIRON CORP (US)
International Classes:
A61K38/00; A61K38/18; A61P9/00; A61P9/10; (IPC1-7): A61K38/18; A61P9/10
Other References:
SELLKE FRANK W ET AL: "Therapeutic angiogenesis with basic fibroblast growth factor: Technique and early results.", ANNALS OF THORACIC SURGERY JUNE, 1998, vol. 65, no. 6, June 1998 (1998-06-01), pages 1540 - 1544, XP000891950, ISSN: 0003-4975
UCHIDA YASUMI 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 1995, vol. 130, no. 6, 1995, pages 1182 - 1188, XP000891915, ISSN: 0002-8703
SCHUMACHER B. ET AL: "Induction of neoangiogenesis in ischemic myocardium by human growth factors: First clinical results of a new treatment of coronary heart disease.", CIRCULATION, (24 FEB 1998) 97/7 (645-650)., XP000891969
UCHIDA YASUMI 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 1995, vol. 130, no. 6, 1995, pages 1182 - 1188, XP000891915, ISSN: 0002-8703
SCHUMACHER B. ET AL: "Induction of neoangiogenesis in ischemic myocardium by human growth factors: First clinical results of a new treatment of coronary heart disease.", CIRCULATION, (24 FEB 1998) 97/7 (645-650)., XP000891969
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