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Subject Strides Toward New Approaches: Dawn of a New Era in DFU Treatment
Writer ViroMed
Date 2017/08/25

Strides Toward New Approaches: Dawn of a New Era in Diabetic Foot Ulcers Treatment


Regeneration of blood vessels in chronic patients: ViroMed conducting U.S. Phase III clinical trials • Anterogen conducting Phase III in Korea & Phase I/II in US


SEOUL, Korea - As the duration of their illness grows, patients with diabetes can become susceptible to foot ulcers as a result of impeded blood flow to their lower extremities. Despite the fact that as many as 15% of diabetics are afflicted with foot ulcers, the lack of a cure still regularly leads to amputation, and, even to death. In this climate, Korean bio biopharmaceutical companies are drawing attention with their novel approaches to diabetic foot ulcer treatment.   


VM202, a gene therapy medicine currently in development at ViroMed, was recently approved by the US FDA for a Phase III trial in the US. Aimed at treating diabetic/ischemic non-healing foot ulcers (NHU), VM202 differs from established medications in that it is designed to regenerate blood vessels. Diabetic foot ulcers are notoriously difficult to cure once they develop: because they are caused by blocked vessels, the environment for wound treatment tends to be poor, and once they are formed, the ulcers can easily recur—a cycle that eventually results in a chronic, non-healing condition.


To date, treatment for diabetic foot ulcers have been limited to oral medications for pain relief (most effective during the development of neuropathy, a stage prior to the foot ulcers), and procedures like debridement (the removal of damaged tissues) of the wound surface itself. A distinct departure from such methods, VM202, a plasmid DNA that contains the human hepatocyte growth factor (HGF) gene, treats the condition by actually inducing both the formation of new blood vessels and the regeneration of damaged nerves.           


In the process, formerly lost sensations are likely to be recovered and circulation in the blocked arterial blood vessels of the foot can improved, which may help encourage the formation of new granulation and cicatricial tissues and aid overall wound healing by inducing blood supply to the surrounding skin tissue.


A representative from ViroMed explained that “in the Phase II trial, the low dose group alone saw 52% of ischemic foot ulcer patients actually experience complete healing, while 70% of all low dose patients saw a 50% reduction in their ulcer size.  In the high does group, 62% of patients were completely healed, making the rate of complete healing significantly higher than the placebo group.” He went on to add that “ViroMed plans to apply in 2020-2021 for BLA in the United States,” and that “with VM202, US Phase III trials for diabetic neuropathy, US Phase II for Lou Gehrig’s Disease, and Phase II in Korea for heart diseases such as myocardial infarction and angina are all currently underway.”


Phase II for NHU was participated by 52 subjects, and the Phase III will be conducted in a larger scale with 300 subjects.


Meanwhile, a Korean biotech Anterogen is currently in the process of developing stem-cell based treatment for diabetic foot ulcers. Recently approved for Phase III by Korea’s Ministry of Food and Drug Safety, Anterogen’s ALLO-ASC_DFU is a treatment that uses adipose-derived mesenchymal stem cell to enhance wound healing. Constructed as a hydrogel sheet that contains the necessary stem cells, it is more suited to long-term storage and mass production, one of its strengths over previous stem-cell based treatments. Phase I/IIa for ALLO-ASC_DFU was approved by the US FDA in November last year.


Translated by English Editor

Original text in Korean [메디파나뉴스]족부궤양 치료시대 열리나신개념 개발 '성큼'