ViroMed Takes One Step Closer to Finding a Cure for Diabetic Neuropathy through US Clinical Trial I/II  
10/14/2011 11:02:32 AM

SEOUL, KOREA (Oct. 14, 2011) - ViroMed Co., Ltd. (KOSDAQ: 084990) today announced that the results of the Phase I/II study on its diabetic neuropathy therapeutic drug (VM202-DPN) were presented at ‘BIO KOREA 2011 Conference & Exhibition’ held at COEX (Seoul, Korea) from 28th to 30th Sept., and showed the world the possibility of an innovative treatment method completely different from the currently available diabetic neuropathy treatments.

VM202-DPN clinical study was conducted in Northwestern Memorial Hospital in Chicago and Diablo Clinical Research Center in California, US. Its results showed that among 12 patients who received 3 different doses of VM202-DPN, about 80% experienced reduction in pain and none experienced any adverse effects during the 6 to 12 months follow-up period, proving the efficacy and safety of the drug.

“After the successful completion of the clinical trial, VM202-DPN has been recognized as an experimental drug with therapeutic effects superior than those of Lyrica, a drug highly recommended by the US Food and Drug Administration (FDA) for treatment of DPN and profiting its developer Pfizer with worldwide sales of $1 billion per year,” said ViroMed’s Director of R&D Center, Jong-Mook Kim. “Existing drugs are mostly pain killers with reported side-effects such as headache, insomnia and depression experienced if taken repeatedly, not to mention the hassle of taking them twice a day for years, even for decades. On the contrary, VM202-DPN showed to have excellent therapeutic effects even though it was taken at much lesser frequency – only two injections at 2-week intervals,” he said.

According to Pelham Smithers Associates’ analysis report of diabetic peripheral neuropathy, ViroMed is now appraised to have competitive technologies in DNA therapeutic field for diabetes neuropathy when compared to its competitors such as Vical, Sangamo Bioscience and Anges.

ViroMed is preparing to apply for Phase II study in the US by the end of 2011, and plans for Phase II study in Korea are also being put together.

about Diabetic Peripheral Neuropathy

Diabetic peripheral neuropathy (DPN), one of the most common complications of diabetes, is developed in more than 50% of the entire diabetes patient base, and in 60 to 70% of patients with type II diabetes. High concentration of glucose present in blood of diabetes patients causes abnormal cellular activities and accumulation of free oxygen radicals. This results in deaths of nerve cells surrounding the peripheral arteries, leading to diabetic neuropathy. It is reported that this process is accelerated by degradation and loss of capillary network. In other words, restoring damaged neurons and capillaries is the key for treating diabetic neuropathy.

Current treatment options include analgesics for temporary pain relief and symptomatic treatments for short delay of symptoms, and there is none that treats the underlying disease. ViroMed’s proprietary VM202-DPN attends to the needs for a DPN cure by regenerating damaged nerve cells and nearby capillaries (micro-vessels).

Diabetic Peripheral Neuropathy market

There are approximately 285 million diabetes patients around the world, 50% of whom are also suffering from diabetic peripheral neuropathy (DPN) as a complication of diabetes. The number of DPN patients reaches 3.9 million in the US alone. (Diabetes Research and Clinical Practice, 2010)

According to Pelham Smithers Associates, an UK consulting firm specialized in data analysis, the sales of existing medicines currently used to treat diabetic neuropathy were $15 billion in 2009. After disease-modifying drugs like VM202-DPN are out to the global market (estimated launching year: 2016), it is forecast that the size of the market will be $2.5 billion in 2017, and grow to $5 billion in 2020.

Results of clinical studies on VM202-DPN

(1) Safety Test: No adverse effect related to VM202

(2) Pain Index 1 - Study results: 83% of the subjects experienced reduction in pain

(3) Pain Index 2 - Study results: 67% of the subjects experienced reduction in pain