Medicament comprising HGF gene

Patent Number: 7,285,540

Stimulation of angiogenesis is a method of treating numerous diseases associated with lack of oxygen, or ischemia. While numerous methods of inducing angiogenesis have been attempted (FGF injection, VEGF gene therapy, etc), there is still a need in the art for methods of reproducibly stimulating formation of new blood vessel development for conditions such as myocardial ischemia and peripheral artery disease.

The current patent covers the use of hepatocyte growth factor (HGF) delivered into a patient having a myocardial infarction. The rationale for this is that after the infarction, stimulation of angiogenesis will allow for healing and regrowth of injured myocardium. The patent covers "a method of treatment of myocardial infarction" using local injection of a vector containing HGF.

This patent is important because clinical trials of HGF have already been conducted with some degree of success by the owner of this patent. For example, in the paper Morishita et al. Safety Evaluation of Clinical Gene Therapy Using Hepatocyte Growth Factor to Treat Peripheral Arterial Disease. Hypertension. 2004;44:203, 6 patients were treated with naked DNA encoding HGF plasmid.

3 patients had arteriosclerosis obliterans and three had Buerger disease. But groups were classified as critical limb ischemia of a Fontaine III or IV grade.

12 weeks after injection, pain reduction was detected in 5 of 6 patients, Ankle Brachial Index was improved in 5 of 5 patients, and diameters of 8 of 11 ulcers in four patients were decreased.

No adverse effects were noted.

It will of course be interesting to combine such gene therapy with stem cell mobilization by G-CSF since patients with CLI who respond to these approaches often have stem cell mobilization associated with response.

View this patent on the USPTO website.