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Helixmith Announces Phase 3 Study Results of Novel Gene Therapy Treatment for Diabetic Foot Ulcers at 2021 Annual Meeting of Diabetic Foot Ulcer Conference (DFCon)

Data indicate that gene therapy appears to be effective, particularly in neuroischemic ulcers

Excerpt from the Press Release:

SAN DIEGO, Oct. 22, 2021 /PRNewswire/ — Helixmith, a gene therapy company based in Seoul, Korea and San Diego, CA, announced today the results of a Phase 3 study for the treatment of diabetic foot ulcers with their novel gene therapy VM202 (Engensis) at the 2021 annual meeting of the Diabetic Foot Conference (DFCon) held in San Francisco and virtually. The study, “Gene Therapy for Diabetic Foot Ulcers: Analysis of a Randomized, Placebo-Controlled Phase 3 Study of Engensis (VM202), a Plasmid DNA Expressing Two Isoforms of Human Hepatocyte Growth Factor (HGF),” demonstrated a positive trend toward wound closure, potential healing effects and an acceptable safety profile. This is the first study using gene therapy for the treatment of diabetic foot ulcers. DFCon is the premier international, interdisciplinary diabetic foot conference in North America.

The purpose of the un-prespecified interim analysis was to evaluate the status of a 7-month Phase 3 study conducted to test the effect of intramuscular injection of Engensis into the calf muscles of participants having chronic nonhealing diabetic foot ulcers (DFU) with concomitant peripheral artery disease. In the interim ITT population (n=44), there was a positive trend toward wound closure in the VM202 group from month 3 to month 7. Ulcer closure effects were prominent, particularly in neuroischemic ulcer. In 23 patients having this type of foot ulcers, the percentage of subjects reaching complete ulcer closure was significantly higher in the VM202 group at months 3, 4 and 5 (p = 0.0391, 0.0391, and 0.0361, respectively). Engensis seems to also improve hemodynamic features; a potentially clinically meaningful 0.15 increase in ABI was observed in the VM202 group at day 210 in ITT population (p=0.0776). The company believes that intramuscular injections of VM202 plasmid DNA to calf muscle may have promise in treatment of chronic neuroischemic DFUs.

“Diabetic foot ulcers are one of the most serious complications associated with diabetes, contributing to high levels of morbidity, mortality, and health-care costs in this population, and there have been limited treatment options to date,” said David G. Armstrong, DPM, MD, PhD Principal Investigator and Professor of Surgery, Co-Director, USC Limb Preservation Program, Keck School of Medicine of University of Southern California (USC). “Given the safety profile and potential healing effects we identified in this study, continuing a larger DFU study is warranted with iterations of the current protocol and expansion of the number of sites.”

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