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Subject US FDA Approves VM202 for Phase III Clinical Study of Chronic Non-Healing Ischemic Diabetic Foot Ulcer by US FDA
Writer ViroMed
Date 2015/09/01

US FDA Approves Initiation of ViroMed’s VM202 for Phase III Clinical Study of Chronic Non-Healing Ischemic Diabetic Foot Ulcer

ATLANTA & SEOUL, South Korea - September 1, 2015 ViroMed Co., Ltd. (084990:KS, KOSDAQ) today announced that the company has received an approval from the US 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.
Chronic non-healing foot ulcer is defined as an ulcer(s) on or around the foot area that is unresponsive to standard therapies and persists despite 4 weeks of appropriate care. Once onset of a foot ulcer occurs, 50~70% of the patients progress to chronic non-healing foot ulcer, which occurs in large numbers of diabetic patients. [1]
According to reports from 2014, [2][3] it is estimated that there are 4.5 million patients with chronic non-healing foot ulcer in the US alone. About 45 %, or 2 million, of these patients have chronic non-healing ischemic diabetic foot ulcers.[4] This Phase III study will target chronic non-healing ischemic foot ulcer in diabetic patients, which is caused by occluded collateral vessels in the leg.
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.
Current treatment options include tissue debridement, use of anti-inflammatory/antibiotics to manage infections, moist wound dressings (hydrocolloids, hydrogels, etc.) to accelerate wound healing, and skin substitutes/gels that contain growth factors. The medical costs of these treatments in the US alone are reported to be more than $5 billion.[5] Many drugs are currently being developed utilizing growth factors needed for wound healing. The effects of these treatments, however, are limited to topical treatment of the ulcers and cannot penetrate deep inside the patients’ skin dermis to treat the cause of the disease. VM202, however, is intramuscularly injected and produces HGF (hepatocyte growth factor) proteins known to induce therapeutic angiogenesis, leading to the induction of smooth blood flow that is expected to heal ulcers.
Dr. Sunyoung Kim, the CSO of ViroMed stated “This is an exciting time to be a part of the research for this devastating condition of non-healing foot ulcers that affects millions. Our study for the treatment of non-healing foot ulcers will employ the newest approach in treatment for this condition. This treatment method is unique to ViroMed as no other companies have traversed this treatment pathway.”
This randomized, double-blind, multi-center study will enroll approximately 300 patients and plan to initiate in 2016 in the US.
[1] SAM Medical Products 2009, Thomas Miller, MD, Scott A. Clark, DPM, and Barry Stults, MD. Managing and Preventing Diabetic Foot Ulcers. Emerg Med 36(8):14-23, 2004
[2] IDF 2014
[3] Diabetic Ulcers, Medscape 2014
[4] Critical Limb Ischemia. Updates in Diagnosis Evidence and Therapies. Edizroni Minerva Medical
[5] Wound Management, Worldwide Market and Forecast to 2021: MedMarket Diligence, March 2013

About the Phase III study
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.

About wound healing process and the cause of chronic non-healing ischemic diabetic foot ulcer
Wound healing of skin goes through inflammation, proliferation, and remodeling steps within the body.
(1) Inflammation Step: To stop the bleeding, platelets are delivered to the wound area with the blood and signals white blood cells and macrophages to fight and remove infections.
(2) Proliferation Step: Various growth factors in the blood signals for re-epithelialization, the regeneration of outer most skin. Then new skin tissue called granulation tissues form at the wounded area and is reinforced through oxygen and nutrients delivered by newly formed blood vessels. 
(3) Remodeling Step: Granulation tissues go through maturation to resemble the original skin tissue closely, finalizing wound healing process.

Patients with blocked collateral vessel going down the leg that obstructs the blood flow (peripheral artery disease) and patients with reduced blood flow due to damaged microvasculature and blocked peripheral blood vessel (diabetes) cannot properly deliver oxygen, nutrients, immune cells, and growth cells necessary for normal healing process, leading to extension of the inflammation step in the wound healing process. Also, due to lack of blood flow, the effect of growth factors is reduced, delaying the re-epithelialization and preventing remodeling of granulation tissues that leads to non-healing. If this state persists, it increases the chance of infection that leads to worsening of the wound area.

About VM202
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.

About ViroMed
ViroMed Co., Ltd. dba VM BioPharma; is an R&D focused Biopharmaceutical company founded in 1996 and located in Seoul, Korea. ViroMed is developing new and innovative biopharmaceuticals for the treatment of currently untreatable diseases. VM202 has been developed by ViroMed using proprietary vector system and genetically modified HGF gene.