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Subject VM202 to Begin Patient Enrollment for Diabetic/Ischemic Non-healing Foot Ulcer (NHU) Phase III Clinical Trial in US
Writer ViroMed
Date 2017/07/07

VM202 to Begin Patient Enrollment for Diabetic/Ischemic Non-healing Foot Ulcer (NHU) Phase III Clinical Trial in US

 

SEOUL, Korea ViroMed (KOSDAQ 084990) announced on July 4th that it begins Phase III for VM202-PAD by receiving written consent from patients at the Miami Dade Medical Research Institute in the US, adding another Phase III to its already ongoing Phase III in the US for VM202-DPN (diabetic peripheral neuropathy) which has a huge market potential.

Diabetic/ischemic non-healing foot ulcer (NHU) is well known as “diabetic foot,” a type of foot ulcer caused by microvessels that are blocked by hyperglycemia. Poor blood circulation along the blocked microvessels often aggravates small wounds to become ulcers. It is reported that about 15% of diabetic patients experience diabetic foot at least once in their life time. There are some 4.5 million patients in the US alone, and one in every four diabetic patients in Korea is reported to experience diabetic foot.

Ideally, the poor blood flow around an ulcer needs to be improved in order for the affected area to get enough oxygen for treatment, for which, unfortunately, no drug with such mechanism is available. Only conservative treatments such as dressings, antibiotics, vasodilators, tissue regenerative epidermal growth factor, and hyperbaric oxygen therapy are available, and when the condition exacerbates, surgical treatments are used, for instance debridement and artificial skin graft. However, such conservative or surgical treatments hardly lead to formation of granulation tissue (new connective tissue and microscopic blood vessels in the process of wound healing) or cicatrization, resulting in recurrence of ulcer in 70% of NHU patients.  

VM202 is plasmid DNA containing hepatocyte growth factor (HGF), which, when intramuscularly injected, induces formation of new blood vessels and regeneration of nerve cells, leading to symptom alleviation. VM202 for NHU, when injected to a leg with blocked vessels, stimulates formation of new microvessels, enabling blood circulation around the wound area, thereby helping granulation tissue formation and ulcer treatment.

In the Phase I and II conducted in China and the US in patients with critical limb ischemia (CLI), VM202 was found to improve ulcers and, when compared to placebo groups, to increase tissue oxygen saturation ((TcPo2 level) in a clinically meaningful way.

The Phase III involves 300 subjects with an aim to evaluate the safety and efficacy of VM202 (16mg) in NHU patients. The follow-up period will be 7 months with the primary endpoint being the complete closure of ulcer at 4 months. Also, changes in ulcer size, time to complete ulcer healing, and new ulcer formation will be evaluated.


[Information on VM202-PAD Phase III in the US]

  1. Target indication: Non-healing ischemic ulcer with diabetes

  2. Patients: 300

  3. Plan: Randomized, double blind, placebo-controlled, multi-centered study

  4. Injection scheme: four (4) rounds of injections at two-week intervals (Day 0, 14, 28, 42), 16mg in total.

  5. Efficacy evaluation
    -Primary endpoint: patient rate of complete ulcer closure at 4 months
    -Secondary endpoints: time of complete ulcer healing, change in ulcer size, occurrence of new ulcer

  6. Safety evaluation