Limb Ischemia Drug Approved for Chinese Phase Two Clinical Trial

An advanced DNA-based drug for the treatment of limb ischemia has been approved for phase two clinical trials in China, which will augment similar studies already underway in Korea and the United States.

The drug, VM202-PAD, was developed by ViroMed Co., Ltd. (Seoul, South Korea). This drug is a nonviral plasmid DNA that expresses two isoforms of the gene for human hepatocyte growth factor (HGF). Since limb ischemia is characterized by the clogging of peripheral blood vessels, which blocks blood flow and leads to deficient blood supply to the nearby peripheral area; the intent of the drug is to introduce genes that will encourage angiogenesis – the development of new circulatory vasculature. These new collateral vessels increase blood flow and tissue perfusion and relieve clinical symptoms.

Results of a phase one clinical trial were recently published in the August 2011 issue of the journal Gene Therapy. These results indicated that the drug was safe and well tolerated with encouraging clinical results. Based on these results, phase two trials were begun in the United States and Korea. To complement these studies a recent favorable decision by the Chinese FDA will allow a phase two trial to be carried out in China.

“The phase II trial for VM202-PAD in China will be conducted on about 200 patients at five or six different hospitals,” said Dr. Jong-Mook Kim, director of clinical development at ViroMed. “We are expecting to start administrating the drug to patients in November 2011.”

Continued progress in the development of VM202-PAD comes as welcome news to the more than 62 million limb ischemia patients living in countries such as China, the US, Europe, and Japan.

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