The present invention has multiple aspects. In particular, in one aspect, the present invention is directed to a unit
dose composition comprising 0.2 μg / kg to 48 μg / 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 2 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.