Fibrocell Science, Inc. announced the submission of an Investigational New Drug (IND) Application with the U.S. Food and Drug Administration (FDA) for FCX-013, the Company's gene therapy candidate for the treatment of moderate to severe localized scleroderma. Localized scleroderma is a chronic autoimmune skin disorder that manifests as excess production of collagen resulting in thickening, or fibrosis, of the skin and connective tissue. Moderate to severe forms of localized scleroderma, including the linear subtype, can result in significant morbidity, including pain, restricted motion, disfigurement and developmental issues. FCX-013 is an autologous fibroblast genetically modified to express matrix metalloproteinase 1 (MMP-1), a protein responsible for breaking down collagen. FCX013 incorporates Intrexon Corporation's proprietary RheoSwitch Therapeutic System®, a biologic switch activated by an orally administered compound to control protein expression once the initial fibrosis has been resolved.