ViroMed Co., Ltd. (KOSDAQ: 084990), a leading biotechnology company, announced today the final enrollment and administration of 52 patients for the company’s ongoing phase II clinical trial of VM202-PAD in US/Korea for the treatment of critical limb ischemia. ViroMed expects to confirm results of VM202-PAD phase II clinical trial by third quarter of 2013.
The clinical trial is being held in total of 16 hospitals and has administered VM202 to 52 enrolled patients in both US and Korea. The principal investigator of this study is Dr. Emerson C. Perin, MD, of Texas Heart Institute. ViroMed plans to demonstrate the efficacy of VM202-PAD through data analysis comparison of placebo group and administered group.
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 critical limb ischemia by the formation of new blood vessels when injected into the ischemic sites.
VM202 is a DNA-based drug designed to express the formation of two isoforms of hepatocyte growth factor (HGF) HGF728 and HGF723. When taken up by a cell and expressed, HGF performs two very important biological functions, angiogenesis (formation of new blood vessels) and nerve cell regeneration.
About Critical Limb Ischemia
Critical limb ischemia (CLI) is a complication that is a form of peripheral artery disease (PAD). PAD occurs wherever the blood supply is obstructed. One of the main causes is atherosclerosis, a thickening of artery wall as a result of the accumulation of fatty materials such as cholesterol. This can cause vessel obstruction and embolism. In PAD the arteries supplying blood to the arms and legs are blocked, leading to lack of oxygen and nutrient supply to the limbs. If left untreated it can lead to intense pain, formation of ulcers and in worst cases lead to amputation. Some of the causes for PAD include smoking, high blood pressure, and diabetes mellitus.
When PAD occurs in arms and legs it is called ischemic limb disease. CLI is the late stage manifestation of ischemic limb disease and most commonly occurs in the lower limbs. Symptoms of CLI include ischemic rest pain, ischemic skin lesions, and ulcers or gangrene. Currently there is limited number of not very effective treatments such revascularization through percutaneous transluminal angioplasty (PTA) and bypass surgery. These treatments, however, do not address the underlying causes of the disease, causing the symptoms to come back over time and eventually lead to death of the patients.
In the United States alone there are 8 million critical limb ischemia patients and about 200,000 patients go through amputation every year. The medical costs are estimated at $8 billion annually.