SEOUL, KOREA, Mar. 10 – ViroMed Co., Ltd. (KOSDAQ: 084990) today announced that VM202-PAD, the company’s proprietary DNA medicine for the treatment of peripheral artery disease (PAD), has received approval from the US FDA for a Phase II clinical trial. The trial will be performed under the supervision of the Principal Investigator, Dr. Timothy Henry of Minneapolis Heart Institute. Seven other hospitals and medical centers will also be involved in the recruitment and treatment of patients with PAD.
Unlike other treatments, VM202-PAD is designed to treat the fundamental causes of PAD. It represents a huge unmet need, as millions of people with PAD experience debilitating pain every day. ViroMed is dedicated to bringing VM202-PAD to patients with the hope of improving their pain and everyday quality of life. About Peripheral Artery Disease Peripheral artery disease (PAD) blocks the arteries that supply blood to the arms and legs, leading to a lack of oxygen and nutrients. Eventually, the limbs form ulcers and the patient experiences severe pain.
Various causes include smoking, high blood pressure, and diabetes mellitus. Current treatment methods include bypass surgery to reroute blood flow and stents to open up blocked arteries, but they are all limited in their usage.
There are about 8 million Americans with PAD, with more than 250,000 requiring hospitalization and 150,000 undergoing amputations each year. The total estimated annual cost of PAD is US$22 billion. (Source: American Heart Association, 2007 and Datamonitor, 2007) About VM202 VM202-PAD is part of a group of therapeutics derived from VM202, ViroMed’s proprietary DNA medicine based on the novel concept of therapeutic angiogenesis.
Therapeutic angiogenesis (growth of new vessels) represents a novel strategy for the treatment of cardiovascular disease and diabetic peripheral neuropathy by the formation of new blood vessels when injected into the ischemic sites. These new collateral vessels will increase blood flow and tissue perfusion and relieve clinical symptoms. Evidence of VM202’s superior therapeutic effect has been shown through studies that compare its effectiveness against other competitors’ products in creating new blood vessels in various kinds of animal models.
The findings have been published in international medical journals such as AJP – Heart and Circulatory Physiology (295): H522-532, 2008 and Radiology (249):1-2, 107-118, 2008 by a University of California, San Francisco (UCSF) research team. About ViroMed ViroMed Co., Ltd. is a biotechnology company located in Seoul, Korea, focusing on DNA and protein-based therapeutics for various diseases. ViroMed now has four products in development targeting cardiovascular disease, cancer, and genetic disease. To learn more about the company and its products, visit www.viromed21.com.
