This should look familiar to long term investors in Sangamo BioSciences (SGMO) although SGMO did not get past phase II in Diabetic Neuropathy.
VM202-DPN is an innovative new biopharmaceutical that can induce the regeneration of damaged microvasculature and nerve cells
□ Differs from currently used pain killers by providing fundamental treatment for the disease
ViroMed Co., Ltd. (KOSDAQ: 084990:KS) today announced that VM202-DPN, the company's proprietary DNA medicine for the treatment of diabetic peripheral neuropathy (DPN), has received approval from the US FDA for a Phase III clinical trial.
VM202-DPN is an innovative new drug that induces regeneration of damaged microvasculature and nerve cells. When VM202-DPN is injected, a protein called Hepatocyte Growth Factor (HGF) is produced around the injection sites, which induces the formation of new blood vessels and regeneration of nerve cells. The HGF protein produced can treat the extreme pain experienced by diabetic peripheral neuropathy patients. This pain relieving effect has been confirmed through phase I and II clinical study conducted in both the US and Korea.
ViroMed submitted phase III IND based on these results and received approval from US FDA without any additional modification. This indicates that the US FDA, once again, confirms the superb safety and efficacy profile of VM202-DPN. VM202-DPN phase III will be a double-blind study targeting diabetic peripheral neuropathy patients distributed between placebo and VM202-DPN treated groups. The total number of patients will be 477 and the efficacy evaluation will be based on comparison with the placebo group.
Mr. Yong Soo Kim (CEO) commented “If VM202-DPN phase III is successfully completed, it will be the first Korean biopharmaceutical to challenge entry into global market. Currently, we are considering partnership with a global pharmaceutical company to enter the global market.”.
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