ViroMed Announces Final Patient Enrollment for US VM202-DPN Clinical Trial
SEOUL, KOREA, Mar. 18 – ViroMed Co., Ltd. (KOSDAQ: 084990), a leading biotechnology company, announced today the final patient enrollment for the company’s ongoing Phase I/II clinical trial of VM202 for the treatment of diabetic peripheral neuropathy.
The clinical trial is being held in two locations – Northwestern Memorial Hospital in Chicago and Diablo Clinical Research Center in California near San Francisco. The primary endpoints are testing for the safety and tolerability of each dosage, evaluating the efficacy, and choosing the optimal dosage. The trial is divided into three cohorts, each with four patients, for a total of 12 patients. Each cohort has a different dosage level, with the lowest dosage cohort being tested first. The company plans to submit an IND application for the Phase II trial in the third quarter of this year after testing of the third cohort is completed.
VM202-DPN is ViroMed’s proprietary 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 raises exciting possibilities as a therapeutic for diabetic peripheral neuropathy. VM202-DPN has also been designed to have minimal side effects and to safely disappear from the body after its intended therapeutic effect has been produced.
About Diabetic Peripheral 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. Diabetic peripheral neuropathy is a form of the disease that affects 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 peripheral 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.
ViroMed Co., Ltd. is a leading biotechnology company located in Seoul, Korea with a US presence in Atlanta and the San Francisco Bay Area. The company has two main areas of focus: DNA/protein-based biopharmaceuticals and phytotherapeutics (botanical drugs/nutraceuticals). ViroMed now has five main products in its pipeline targeting cardiovascular disease, cancer, and immune-related disorder, with clinical trials ongoing in the US, Korea, and China. To learn more about the company and its products, visit www.viromed21.com.