ViroMed Receives Approval for VM202 Phase II Trial in China
- Category: DNA RNA and Cells
- Published on Wednesday, 12 October 2011 03:00
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ViroMed announced that VM202-PAD, the company's proprietary DNA medicine(VM202-PAD) for the treatment of Critical Limb Ischemia (CLI), has received approval from the Chinese FDA for a Phase II clinical trial
SEOUL, KOREA | October 12, 2011 | ViroMed Co., Ltd. (KOSDAQ: 084990) today announced that VM202-PAD, the company's proprietary DNA medicine(VM202-PAD) for the treatment of Critical Limb Ischemia (CLI), has received approval from the Chinese FDA for a Phase II clinical trial. VM202-PAD Phase II trials are currently being conducted in Korea and the US, and the Chinese FDA approval will give ViroMed a jump-start to initiate a Phase II trial of the same design in China as well.
This means there is now a greater possibility for concurrently entering markets of pharmaceutical giant nations including the US, the world’s largest pharmaceutical market; China, which will rise as the 3rd biggest market in 2013; and Korea.
The therapeutic effects of VM202-PAD had already been proven by previous clinical trials conducted in China and the US which completed with impressive results such as prevention of amputation, pain reduction, reduction in size of ulcer, and improved blood pressure index in affected areas of limb. This study result was presented at American College of Cardiology (ACC) and Chinese International Congress of Vascular Medicine (CCVM), and published on Gene Therapy 2011(18) 788-794, one of the world-renowned scientific journal Nature’s sister journals.
“The phase II trial for VM202-PAD in China will be conducted on about 200 patients at 5 or 6 different hospitals including Xuanwu Hospital of Capital University of Medical Sciences and Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine. We are expecting to start administrating the drug to patients in November.” commented Jong-Mook Kim, the director of Clinical Development Department of ViroMed.
Overview of critical limb ischemia (CLI) and current treatment methods
Limb ischemia is a disease caused by clogging of peripheral blood vessels which blocks blood flow, leading to deficient sufficient blood supply to the nearby peripheral area. As a result, the affected area cannot be healed if irritations such as fungal infections occur, and this eventually progresses to necrosis. . Critical limb ischemia (CLI) patients suffer from extreme pain, and most patients try to alleviate the pain via treatments such as angioplasty (stent insertion) or analgesic medications. However, because these treatment methods does not directly address the underlying causes of the disease, ulcer worsens with time, and it eventually leads to death of 20% of the patients within a year, 50% within 5 years, 90% within 10 years.
In 2011, the number of limb ischemia patients in major countries such as China, the US, EU nations, and Japan is estimated to be about 62 million, including 39 million patients in China alone. However, all of them are receiving treatments for temporary ease of symptoms and this mostly leads up to severe pain and finally to amputation or death, since there is no treatment currently available to directly address the underlying disease and cure it for good.
VM202-PAD is part of a group of therapeutics derived from VM202, ViroMed's proprietary DNA medicine based on the novel concept of therapeutic angiogenesis. Therapeutic angiogenesis (growth of new vessels) represents a novel strategy for the treatment of cardiovascular disease and diabetic peripheral neuropathy by the formation of new blood vessels when injected into the ischemic sites. These new collateral vessels will increase blood flow and tissue perfusion and relieve clinical symptoms.
Evidence of VM202's superior therapeutic effect has been shown through studies that compare its effectiveness against other competitors' products in creating new blood vessels in various kinds of animal models. The findings have been published in international medical journals such as Gene Therapy 2010(17)1442-1452, Also, Cardiovasc Revasc Med. 2011;12(2):111-122, AJP - Heart and Circulatory Physiology (295): H522-532, 2008 and Radiology (249):1-2, 107-118, 2008 by a University of California, San Francisco (UCSF) research team.
Overview of VM202 and its development status
ViroMed’s VM202 is a noble biologic drug which is attracting worldwide attention for surpassing the limits of the current treatments and curing the underlying causes of the disease. VM202 is being developed for not only CLI but also diabetic neuropathy and ischemic heart disease.