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Mytogen, Inc., a wholly-owned subsidiary of Advanced Cell Technology, Inc., is developing cell-therapy products to treat a variety of difficult or impossible to treat medical indications. Mytogen’s Myoblast Program focuses on using myoblasts – stem cells that form muscle – to treat patients with cardiac indications such as congestive heart failure, a progressive deterioration of the heart muscle that afflicts approximately 5 million people in the United States. To restore cardiac function in patients with heart failure, an optimized catheter system is used to deliver a proprietary formulation of cultured autologous human myoblasts to the site of cardiac damage. Mytogen successfully completed Phase I human clinical trials for the Myoblast Program utilizing the therapy safely in over forty patients. The FDA has reviewed the “end-of-Phase I” data and will allow the company to proceed with Phase II human clinical trials. The company plans to begin the Phase II human clinical trial for the treatment of heart failure in approximately 160 patients. The company is a consolidation of experts in the areas of clinical manufacturing of biologics, cell transplantation, and stem cell biology. Mytogen’s intellectual property was acquired from Genvec and Diacrin, Inc., where Mytogen’s principal researchers worked prior to founding Mytogen. |
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