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Subject VM BioPharma Announces Korea Food and Drug Administration Approval of Phase 2 Clinical Trial for Investigational Gene Therapy VM202 in Ischemic Heart Disease
Writer ViroMed
Date 2016/08/02
ATLANTA, Aug. 2, 2016 /PRNewswire/ -- VM BioPharma, the US division of ViroMed Co., Ltd. in Seoul, South Korea (KOSDAQ: 084990), announced today that the company has obtained Investigational New Drug approval from the Ministry of Food and Drug Safety in Korea (MFDS) for a Phase II clinical trial of the investigational gene therapy drug, VM202, for ischemic heart disease (IHD). The trial will assess 108 study participants with IHD who have received a percutaneous coronary intervention (PCI) for acute myocardial infarction 30 days prior to study enrollment. The objective of the trial is to test dose-related safety and tolerability of VM202, with secondary efficacy endpoints that include cardiac function and output.

VM202 is a novel DNA medicine that contains the human hepatocyte growth factor (HGF) gene and can produce two isoforms of HGF proteins that are naturally found in the human body. When injected, in this case into cardiac muscles, it is taken up by a cell and produces the HGF proteins, which are then released from the cell potentially inducing new blood vessel formation. Preclinical data published in the Journal of Gene Medicine, Journal of Cardiac Failure and American Journal of Physiology Heart Circulation Physiology demonstrated an angiogenic effect of VM202 via new vessel formation, elevated cardiac perfusion level, and reduced infarction by preventing myocardial tissue fibrosis in a porcine model.i ii iii In Phase 1 data published in Gene Therapy in 2013, VM202 demonstrated safety, as well as efficacy across various clinical parameters, such as cardiac perfusion, myocardial wall thickness and improvement of cardiac function in IHD patients upon VM202 injection.iv

"While the idea of therapeutic angiogenesis for IHD has been explored for more than 20 years through a number of preclinical trials, data from actual human studies have not delivered a potential therapeutic option," said Dr. Sunyoung Kim, chief scientific officer at ViroMed Co., Ltd. "Data from the Phase 1 trial of VM202 in IHD suggest that VM202 may be a promising option for IHD treaters and patients, where there is currently an unmet need for those that have developed necrosis and/or fibrosis of the myocardium despite reperfusion therapy such as percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG)."

In the Phase II study, VM202 will be injected percutaneously via the endocardial route using an innovative therapeutic catheter, C-CATHez® designed by Celyad SA.The therapeutic catheter can reach the infarcted endocardium through blood vessels, where VM202 can be injected without the need for open heart surgery.

About Ischemic Heart Disease and Current Treatment Options
Ischemic heart disease (IHD) collectively refers to disease resulting from coronary artery blockage and the subsequent compromised blood supply to the myocardium. The contributing factors to IHD are elevated cholesterol level, high blood pressure, smoking, obesity, family history, and lack of exercise. The current therapeutic approaches include pharmaceutical intervention with anti-ischemic and antithrombotic drugs, as well as surgical approaches including percutaneous coronary intervention to expand severely occluded or completely blocked blood vessels, and coronary artery bypass grafting to connect new blood vessels to improve perfusion to the myocardium.

Myocardial and acute myocardial infarction result in myocardial necrosis from limited blood supply due to arterial blockage. The reopening of occluded coronary artery ("reperfusion therapy") should be promptly applied to minimize cell death in the region adjacent to the affected myocardium. However, in many cases patients fail to receive timely treatment and will have ongoing infarction. These patients may develop necrosis and/or fibrosis of myocardium, leading to ongoing cardiac disease despite surgical intervention. Current medical options are not available for such cases, making angiogenesis and microvasculature formation of HGF an attractive therapeutic approach as a means to re-establish blood flow, increase blood perfusion, and prevent and treat myocardial necrosis or fibrosis.

About VM202
VM202 is a proprietary gene therapy from VM BioPhrama 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.

In addition to IHD, VM202 is currently being evaluated as a new concept drug in two Phase 3 studies to assess the safety and efficacy of VM202 in adult patients with painful diabetic peripheral neuropathy (DPN) and ischemic diabetic foot ulcer separately. VM202 has successfully completed a Phase 2 study for of critical limb ischemia in the U.S.,v and a phase 1/2 study for amyotrophic lateral sclerosis (ALS) in the U.S.

About VM BioPharma and ViroMed Co., Ltd.
VM BioPharma is a 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 diseases with unmet medical needs. The current development focus is on the proprietary plasmid DNA-based drug VM202 in cardiovascular and neurological diseases at various clinical stages in 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 constant track record of clinical efficacy and quality molecular biological research, ViroMed aims to become the trailblazer in the field of gene therapy.

About Therapeutic Catheter C-CATHez®
C-CATHez® is an intra-myocardial delivery catheter designed and developed by Celyad SA to reduce the risk of myocardium perforation, increase needle stability and deliver enhanced fluid dynamics to improve retention. C-CATHez® obtained a CE mark in April 2012 and is therefore available for clinical use worldwide and commercial use outside of the U.S.

Media Contact:
ViroMed Co., Ltd. (Headquarters) in Seoul, Korea
Suyoung Go, +82-2-2102-7212