Completes Patient Enrollment/Administration of VM202-DPN Phase II Clinical Study for the Treatment of Diabetic Peripheral Neuropathy
SEOUL, KOREA, June. 13 – ViroMed Co., Ltd. (KOSDAQ: 084990), a leading biotechnology company, announced today the final enrollment and administration of 105 patients for the company’s ongoing phase II clinical trial of VM202-DPN in US/Korea for the treatment of diabetic peripheral neuropathy. ViroMed expects to confirm results of VM202-DPN phase II clinical trial by second quarter of 2014
The clinical trial is being held in total of 17 hospitals and has administered VM202 to 105 enrolled patients in both US and Korea. The leading investigator of this study is Dr. John Kessler, of Northwestern Medical School, Chicago. The structure of the study is a double-blind, randomized, placebo-controlled, multicenter study with 20% of the enrolled subjects receiving placebo to confirm the efficacy of the drug.
This clinical study was supported by the Korean Ministry of Health and Welfare for 『Health Care Research and Development Project』 as a national project under the title “US Phase II Clinical Study of Diabetic Peripheral Neuropathy drug (VM202-DPN)”.
VM202-DPN is part of a group of therapeutics derived from VM202. VM202-DPN is a DNA based drug that can create microvasculature and regenerate nerve cells. When VM202-DPN is injected into patients it produces what is called hepatocyte growth factor (HGF) protein that induces angiogenesis and acts as a neurotrophic factor, which leads to formation of new microvasculature and regenerate nerve cells. The results from Phase I clinical study already showed the possibility of VM202-DPN as a new concept drug and the results have already been published (Molecular Therapy 2013, 21: 1279–1286). It is expected that VM202-DPN will ultimately become the new drug that not only fundamentally treats the disease, but also improves pains in DPN patients.
About Diabetic Peripheral Neuropathy
DPN is the most common complication associated with diabetes patients. The abnormally high level of glucose damages the microvasculature of the patient, which in turns damages nerve cells due to lack of supply of nutrients to these cells. In the early stages of the disease the patients will only feel numbness at the end of the foot. As the disease progresses the pain will increase and spread to the whole foot and up to the knee where a slight graze can cause extreme pain equal to that of being stabbed with a knife or electrically shock. Currently, there are no drugs available for the treatment of DPN and maintaining glucose level in blood through strict diet is the only known method to diminish the disease incidence. As an adjuvant therapy to mitigate the pain there are analgesic drugs such as antidepressants and antiepileptic drugs based on serotonin/serotonin norepinephrine reuptake inhibitors. These, however, cannot treat the disease itself and are only symptomatic treatments.
About 50% of all diabetes patients suffer from DPN and in the US alone there are about 3.9 million DPN patients. The number of patients with diabetes associated complications is increasing at a faster rate than the increase in the number of diabetes patients. In Republic of Korea, about 33% of all diabetes patients suffer from DPN. (Diabetes Research and Clinical Practice, 2010, National Health Insurance Service)