Angiogenically effective unit dose of FGF-2 and method of use

Patent Number: 7,541,333

Stimulation of therapeutic angiogenesis offers great potential, not only for the obvious conditions such as critical limb ischemia and angina, but also for other indications post-stroke recovery and liver failure.  Methods of stimulating angiogenesis range from administration of endometrial regenerative cells, to caloric restriction, to use of stem cell mobilizers.

The current patent covers the administration of fibroblast growth factor-2 (FGF-2 or basic fibroblast growth factor) at specific concentrations for the treatment of congestive heart failure. 

The first independent claim covers:

"A method for treating a human patient for congestive heart failure, comprising administering a single unit dose of a therapeutically effective amount of a recombinant FGF-2 or an angiogenically active fragment or an angiogenically active mutein thereof into one or more coronary vessels or into a peripheral vein in a human patient in need of treatment for said congestive heart failure, said therapeutically effective amount being about 0.2 .mu.g/kg to 48 .mu.g/kg of patient weight, wherein said recombinant FGF-2 comprises the sequence set forth in SEQ ID NO: 2, and wherein said angiogenically active mutein thereof has at least 90% sequence identity to SEQ ID NO: 2"

In the dependent claims various concentrations of heparin (remember FGF-2 is a heparin binding cytokine), sequences of administration, and routes of administration are covered.

The possibility of using FGF-2 in combination with other types of adult stem cells may offer, in our opinion, a potent method of overcoming some of the previous hurdles that the field of therapeutic angiogenesis has faced previously.

View this patent on the USPTO website.