Viromed said Friday that Beijing Northland Biotech, its Chinese partner, will begin phase 3 clinical trials for VM202, the company’s plasmid DNA-based gene therapy drug containing hepatocyte growth factor (HGF) genes.
The company transferred technology regarding VM202 to Beijing Northland Biotech for the commercialization of the treatment in 2004. Since then the Chinese firm has been conducting clinical trials on VM202 to receive approval for treating critical limb ischemia (CLI).
China has a large population that has a high risk of obtaining CLI disease due to an unbalanced diet, lack of exercise, smoking and eating habits. The company finished phase 2 clinical trials last year. During the phase 2 clinical trials, it conducted a randomized, double-blind and placebo-controlled trial on 200 patients with CLI at nine clinical trial sites in China.
As with the U.S. phase 2 clinical trials, the research conducted in China also showed no severe drug-related side effects. Regarding efficacy, the pain reduction effect at 180 days of administration was more significant in the VM202 treated group than in the placebo control group. Also, the ulcer healing rate was 64.3 percent in VM202 high-dose group compared to the 21.05 percent in the placebo control group.
“The results of the VM202’s phase 2 clinical trials on CLI patients are encouraging,” Beijing Northland Biotech CEO Xu Songshan said. “We expect that VM202 will become the first gene therapy product in China to enter phase 3 clinical trial.”
The company will do its best to complete phase 3 clinical trials as soon as possible and deliver a safe, effective and innovative drug to Chinese patients, Xu added.
Viromed also showed its satisfaction with the two companies’ growth potential in China.
“Our treatment has proved its safety and efficacy in phase 2 clinical trial conducted on 200 patients in China,” Viromed CEO Kim Sun-young said. “The results have once again proved the possibility of VM202 becoming a commercial success.”
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