Date: 2015-09-01
Type of information: Clinical trial autorization
phase: 3
Announcement: clinical trial authorization
Company: ViroMed (Republic of Korea)
Product: VM202
Action
mechanism: gene therapy. VM202 is a DNA based drug that can create microvasculature and regenerate nerve cells. When VM202 is injected into patients, it produces a protein called hepatocyte growth factor (HGF). HGF protein is known to induce angiogenesis and acts as a neurotrophic factor, which leads to formation of new microvasculature and regenerate nerve cells. The results from Phase II CLI clinical study already showed the possibility of VM202 as a new concept drug with high therapeutic effect on ulcer healing.
Disease: chronic non-healing ischemic diabetic foot ulcers
Therapeutic area: Cardiovascular diseases - Metabolic diseases
Country: USA
Trial
details: The Phase III study will involve a total of 300 patients in a randomized, double-blind, multicenter study. Patients will be selected if no improvement is shown after undergoing standard of care (SOC) for the first two weeks. Patients will then be intramuscularly injected with placebo or 16 mg of VM202 in the leg while undergoing SOC. The follow-up period will be 7 months and the study will evaluate the safety and efficacy of VM202. The primary study endpoint is the proportion of subjects with a confirmed target wound closure by the 4 month follow-up. Complete wound closure is defined as skin re-epithelization without drainage or dressing confirmed at two consecutive study visits two weeks apart. Active and placebo arms will be compared to determine treatment effect.
Latest
news: * On September 1, 2015, ViroMed announced that the company has received an approval from the FDA to launch a pivotal Phase III clinical trial utilizing VM202, a proprietary DNA based biopharmaceutical, for chronic non-healing ischemic diabetic foot ulcers. This is the first gene therapy trial specifically targeting ulcers which affects millions of people in the US alone. ViroMed previously completed a phase II study for critical limb ischemia (CLI). The results from phase II study for CLI showed statistically significant wound healing effects in all treatment groups. A large proportion of the patients (approximately 60%) in the phase II study were diabetic, indicating that VM202 is highly effective in this population. Chronic non-healing ischemic foot ulcers in diabetic patients are two to three times more prevalent than ulcers found in critical limb ischemia patients. For this reason, the phase III study will focus on diabetic patients with chronic non-healing ischemic foot ulcers. This randomized, double-blind, multi-center study will enroll approximately 300 patients and plan to initiate in 2016 in the US.
