VM BioPharma Announces First Patient Dosed in Phase 3 Study of Gene Therapy Candidate VM202 for Non-Healing Diabetic Foot Ulcers

First Pivotal Gene Therapy Trial to Target Underlying Peripheral Artery Disease in Non-Healing Diabetic Foot Ulcers

ATLANTA, GA, USA I August 3, 2017 I VM BioPharma, the United States division of ViroMed Co., Ltd. in Seoul, Korea (KOSDAQ: 084990), today announced the first patient was dosed in the recently initiated Phase 3 clinical study evaluating VM202, a proprietary, DNA-based biopharmaceutical product, in patients with non-healing diabetic foot ulcers (NHU) and concomitant peripheral artery disease (PAD).

This is the first pivotal gene therapy trial specifically targeting diabetic foot ulcers with underlying involvement of peripheral arteries. Foot ulcers are a significant complication of diabetes in which neuropathy, PAD and mechanical changes in the bony architecture of the foot result in skin and soft tissue breakdown. Results of a Phase 2 trial published in the journal Gene Therapy demonstrated that VM202 injections have the potential to treat foot ulcers in patients with critical limb ischemia, with complete wound closure occurring in 52 and 62 percent of treated patients.

"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," said Dr. David Armstrong, DPM, MD, PhD, distinguished outreach professor of surgery at the University of Arizona and director of the Southwestern Academic Limb Salvage Alliance (SALSA), who is serving as co-principal investigator of the Phase 3 study. "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."

Dr. Emerson Perin, MD, PhD, Director of Clinical Research at the Texas Heart Institute and co-principal investigator of this trial, expressed that, "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 is a plasmid DNA that contains the human hepatocyte growth factor (HGF) gene, which in vivo produces two isoforms of HGF proteins that are naturally found in the human body. HGF is a growth factor that induces angiogenesis and acts as a neurotrophic factor to the peripheral nervous system. 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. In this way, VM202 is believed to provide clinical benefit to patients with diabetic NHU.

"This milestone marks the start of the second Phase 3 study for VM202, the first being a pivotal trial for painful diabetic peripheral neuropathy," said Dr. Sunyoung Kim, chief scientific officer of ViroMed Co., Ltd. "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."

Study Design
The Phase 3, double-blind, randomized, placebo-controlled, multicenter study is designed to assess the safety and efficacy of VM202 in 300 adult patients with a diabetic foot ulcer and concomitant PAD. Patients will be randomized in a 2:1 ratio to either VM202 (n=200) or placebo (n=100) and will receive ongoing wound care for the duration of the trial. The primary clinical efficacy outcome will be the proportion of subjects with confirmed target wound closure by the 4-month follow-up. Secondary endpoints will include changes in ankle-brachial index and toe-brachial index. For more information on this study, please visit ClinicalTrials.gov and reference Identifier NCT02563522.

About Diabetic Non-Healing Foot Ulcers (NHU)
Diabetic foot ulcers initially form when trauma, pressure loading, and/or neuropathy result in skin and soft tissue breakdown. Non-healing foot ulcers occur when wounds fail to heal despite appropriate care. The majority (approximately 90 percent) of NHU occur in patients with diabetes, 10 – 50 percent of whom have concomitant peripheral arterial disease (PAD).1-7 Foot ulcers may be difficult to heal, since the underlying metabolic derangements of diabetes, neuropathy and PAD are not reversed with standard wound care measures. The lifetime risk of developing non-healing foot ulcers for individuals with diabetes is 15 – 25 percent and doubles with concomitant PAD; recurrence rates within five years are 50 – 70 percent.2,3,4,8-11

Current standard of care includes debridement of the wound, management of any infection, revascularization procedures when indicated, mechanical offloading of the ulcer, blood glucose control, and foot care education.  These strategies result in healing approximately 50 percent of ulcers, while 25 percent of open wounds progress to gangrene or require amputation.

About VM202
VM202 is a proprietary gene therapy from ViroMed targeting four different indications. When injected into patients, VM202 produces hepatocyte growth factor (HGF) protein, which induces angiogenesis and acts as a neurotrophic factor, leading to the formation of new microvasculature and inducing regeneration of nerve cells. The results from a Phase 2 study in critical limb ischemia showed that the two VM202 treatment groups had statistically significant complete wound closure and wound improvement rates over placebo at the 12-month follow-up (Gene Therapy 2016, 23: 306-12).

VM202 also completed a successful Phase 2 study for painful diabetic peripheral neuropathy(Annals of Clinical and Translational Neurology 2015, Volume 2, Issue 5,  465–478), leading to an ongoing Phase 3 study (NCT02427464); and has successfully completed a phase 1/2 study for amyotrophic lateral sclerosis (ALS) in the U.S. A Phase 2 trial is also launching in Korea for the indication of coronary artery disease.

About VM BioPharma and ViroMed Co., Ltd.
VM BioPharma is the U.S. division of ViroMed Co., Ltd., an R&D focused biopharmaceutical company founded in 1996 and based in Seoul, Korea. ViroMed is developing new and innovative biopharmaceuticals for the treatment of currently untreatable diseases. The company is actively focusing development on the proprietary plasmid DNA-based drug VM202 in cardiovascular and neurological diseases at various clinical stages in the U.S., Korea, and China.

ViroMed has assembled a diverse yet technologically- and conceptually-linked pipeline. Other research areas include antibody-based cancer therapeutics, immune disorders, recombinant protein-based thrombocytopenia treatment, and CAR-T technology. With a proven track record of clinical efficacy and quality molecular biological research, ViroMed aims to become the trailblazer in the field of gene therapy.

References

  1. Peripheral arterial disease in people with diabetes. Diabetes care 2003;26:3333-41.
  2. Prompers L, Schaper N, Apelqvist J, et al. Prediction of outcome in individuals with diabetic foot ulcers: focus on the differences between individuals with and without peripheral arterial disease. The EURODIALE Study. Diabetologia 2008;51:747-55.
  3. Althouse AD, Abbott JD, Forker AD, et al. Risk Factors for Incident Peripheral Arterial Disease in Type 2 Diabetes: Results From the Bypass Angioplasty Revascularization Investigation in Type 2 Diabetes (BARI 2D) Trial. Diabetes care 2014;37:1346-52.
  4. Madanchi N, Tabatabaei-Malazy O, Pajouhi M, Heshmat R, Larijani B, Mohajeri-Tehrani MR. Who are diabetic foot patients? A descriptive study on 873 patients. Journal of diabetes and metabolic disorders 2013;12:36.
  5. Brechow A, Slesaczeck T, Munch D, et al. Improving major amputation rates in the multicomplex diabetic foot patient: focus on the severity of peripheral arterial disease. Therapeutic advances in endocrinology and metabolism 2013;4:83-94.
  6. Morbach S, Furchert H, Groblinghoff U, et al. Long-term prognosis of diabetic foot patients and their limbs: amputation and death over the course of a decade. Diabetes care 2012;35:2021-
  7. Hinchliffe RJ, Andros G, Apelqvist J, et al. A systematic review of the effectiveness of revascularization of the ulcerated foot in patients with diabetes and peripheral arterial disease. Diabetes/metabolism research and reviews 2012;28 Suppl 1:179-217.
  8. Singh N, Armstrong DG, Lipsky BA. Preventing foot ulcers in patients with diabetes. JAMA 2005;293:217-28.
  9. Sen CK, Gordillo GM, Roy S, et al. Human skin wounds: a major and snowballing threat to public health and the economy. Wound repair and regeneration : official publication of the Wound Healing Society [and] the European Tissue Repair Society 2009;17:763-71.
  10. Reiber GE, Raugi GJ. Preventing foot ulcers and amputations in diabetes. Lancet 2005; 366:1676-7.
  11. Greer N, Foman NA, MacDonald R, et al. Advanced wound care therapies for nonhealing diabetic, venous, and arterial ulcers: a systematic review. Annals of internal medicine 2013; 159:532-42.

SOURCE: VM BioPharma

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