The first patient was recently dosed in the Phase 3 trial evaluating the use of proprietary DNA-based pharmaceutical VM202 for patients with diabetic foot ulcers and concomitant peripheral artery disease.
“We are truly excited at launching this pivotal clinical trial using VM202 for diabetic foot ulcers. This is a unique and promising approach to addressing non-healing wounds, and a positive outcome could be revolutionary in a population with limited or no options for improving their chance of complete ulcer healing,” says David Armstrong, DPM, MD, PhD, the study’s co-principal investigator.
“These wounds impose an enormous burden of care to patients, caretakers, and providers; 25 percent may progress to gangrene or amputation, and the five-year mortality rate equals that of many cancers,” adds Armstrong, outreach professor of surgery at the University of Arizona and director of the Southwestern Academic Limb Salvage Alliance (SALSA), in a media release from VM BioPharma, the US division of ViroMed Co Ltd, headquartered in Seoul, South Korea.
Dr Emerson Perin, MD, PhD, director of clinical research at the Texas Heart Institute and the trial’s co-principal investigator, states, “There have been a lot of ups and downs in developing potential therapeutic applications of growth factors. However, VM202 produced consistently positive results in our Phase 1 and 2 trials, and I am delighted to continue its clinical development into Phase 3.”
VM202, produced by VM BioPharma, is described in the release as a plasmid DNA that contains the human hepatocyte growth factor (HGF) gene. After VM202 is injected into a patient’s muscle, it is taken up by cells, which produce HGF protein. When released from skeletal muscle cells, HGF may induce new blood vessel formation locally by activating various signaling pathways.
“This milestone marks the start of the second Phase 3 study for VM202, the first being a pivotal trial for painful diabetic peripheral neuropathy,” says Dr Sunyoung Kim, chief scientific officer of ViroMed Co, Ltd, in the release.
“There have been numerous efforts to treat foot ulcers, mostly involving complex wound dressings; VM202 stands to alter the lower leg’s ischemic environment, one of the critical causes of this condition, and these pivotal data will help us better understand the potential of this novel approach that could improve the quality of life for the millions of patients who suffer from this debilitating condition.”
[Source(s): VM BioPharma, PR Newswire]