Score for gene therapy in critical limb ischemia
Vical, yesterday reported that its licensee, AnGes MG, a Japanese gene therapy firm, achieved an important milestone in its development of gene therapy for critical limb ischemia. The therapy delivers plasmid-containing hepatocyte growth factor gene directly to the affected vessel via catheter and balloon.
The Phase 3 study reported that over 70% of HGF-treated subjects experienced improvement in symptoms or ulcer size compared with 30% on placebo. AnGes plans too submit an NDA to Japan’s MHW. A similarly designed Phase 2 study of the therapy is currently recruiting in the U.S.
If approved, pHGF would be the first gene therapy approved in an ICH territory country for treatment of peripheral arterial disease (PAD). Genzyme is currently testing an unrelated gene therapy for severe peripheral arterial disease. This is a disease in need of drastic medical and surgical treatment improvements. I’ll be watching for additional evidence of gene therapy effectiveness in PAD and will provide updates as warranted.
