ViroMed Receives Approval from US FDA for Phase I/II Trial for Diabetic Neuropathy
SEOUL, KOREA, Mar. 3 - ViroMed (CEO: Dr. Sunyoung Kim) announced today that the company has received approval from the US FDA to start clinical trials for diabetic neuropathy, a major complication of diabetes mellitus.
The Phase I/II clinical trial will take place at various medical centers, including Northwestern Memorial Hospital, under the guidance of Dr. Douglas Losordo (Director, Feinberg Cardiovascular Research Institute), a foremost expert in the field of cardiovascular treatment.
"The clinical trial approval of VM202-DPN allows us to not only anticipate the globalization of Korean technology and the possibility of a new worldwide drug," says Dr. Kim, "but to also look forward to a vast improvement in the quality of life for patients with diabetes who have no other alternatives."
VM202-DPN is ViroMed’s DNA medicine using Hepatocyte Growth Factor (HGF), a gene that stimulates the growth of arteries. Recent experiments have shown that HGF also stimulates the growth and recreation of nerve cells, which makes it a perfect candidate as a therapeutic for diabetic neuropathy. It is this point that facilitated Northwestern Memorial Hospital’s partnership with ViroMed for the clinical trial.
About Diabetic Neuropathy
Diabetic neuropathy is a common complication that affects 60 to 70% of patients with type 2 diabetes, a form of diabetes mellitus that accounts for half of all cases. It usually manifests itself as a disease affecting the nerves in the leg and causes intense pain and difficulty in movement. If left untreated, it can lead to ulcers and, in the worst cases, amputation.
Diabetic neuropathy is characterized by the impairment of functions in nerve cells due to a high blood-sugar level in the patient’s blood which leads to the cells’ deaths, and is further accelerated by damage to peripheral arteries from other complications. Therefore, a key component of treating this disease is the recovery of damaged nerve cells and the regrowth of peripheral arteries; however, there is no such fundamental cure currently available. The occurrence of the disease can only be minimized by controlling the blood-sugar level through a healthy diet, while symptoms can only be eased through supplemental treatments such as pain-killers and physical therapy.
There are about 143 million people affected by diabetic neuropathy worldwide. In the US alone, 3.9 million people are affected, with medical costs estimated at $13 billion annually. (International Diabetes Federation, 2007 / Economic Cost of Diabetes in the USA, 2007)