AnGes 0205 for Critical Limb Ischemia: A Phase II Double-Blind, Randomized, Placebo-Controlled Study to Assess the Safety and Efficacy of AMG0001 to Improve Perfusion in Critical Leg Ischemia in Subjects Who Have Peripheral Vascular Ulcers.

Study of:
Gene transfer agent HGF Plasmid.

This study will look at the safety and effectiveness of an experimental gene transfer agent called HGF Plasmid, which will be injected into the leg muscles. AMG0001 is the product code name for HGF Plasmid.

A plasmid is essentially a ring of DNA, or genetic code material. HGF Plasmid is an experimental drug that uses genes. Genes are the DNA codes present in each cell in the body that control the activities of the cells. When HGF Plasmid is injected into the leg muscles the DNA ring (“plasmid”) temporarily causes the cells to produce a protein substance called “Hepatocyte Growth Factor” (HGF). However, HGF Plasmid does not become a permanent part of your genetic material (DNA). Hepatocyte Growth Factor is a substance that your body produces naturally in the liver and other organs of the body. Hepatocyte Growth Factor is one of several substances referred to as “angiogenic” growth factors, which are being studied to see if they can cause the growth of new blood vessels. HGF Plasmid is being developed for use in people who have a medical condition called Critical Leg Ischemia. This condition results from severely reduced blood flow caused by blocked arteries of the leg. The purpose of this research study is to see if HGF Plasmid can form new blood vessels.

• Timothy D. Henry, MD, FACC

• Alan T. Hirsch, MD, FACC
• Daniel Lips, MD, FACC
• Yale Wang, MD, FACC, FSCAI

• JoAnne Goldman, RTR, RCIS, CCRC
• Vicki R. Pink, RN, CCRC

For more information about this study or the Cardiovascular Research program at the Minneapolis Heart Institute Foundation, please contact Vicki Pink, RN at 612-863-6286.