Osaka-Based Anges MG Submits NDA To MHLW For HGF Gene Therapy
This article was originally published in PharmAsia News
Osaka-based Anges MG submitted a new drug application to Japan's Ministry of Health, Labor and Welfare for an HGF gene therapy for treating critical limb ischemia and Buerger's disease. The product is injected to the ischemic lesion, leading to the formation of new blood vessels through the effect of the HGF protein, which improves ischemic symptoms, according to the company. Originally developed in Japan through university research, a Phase III study in Japan last June has shown positive results with arteriosclerosis obliterans patients. In the U.S., a Phase II study treating peripheral arterial diseases and a Phase I study treating ischemic heart disease are ongoing. After approval, Anges MG plans to market the product under name Collategene. (Click here for more - Japanese language)
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