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Fibrocell Announces FDA Allowance of Investigational New Drug Application for FCX-013
Mar. 06, 2018 09:33AM PST
Genetics InvestingFibrocell Science (NASDAQ:FCSC), a gene therapy company focused on transformational autologous cell-based therapies for skin and connective tissue diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted allowance of its Investigational New Drug (IND) Application for FCX-013—one of the Company’s gene therapy candidates—to begin clinical trials for the treatment of moderate …
Fibrocell Science (NASDAQ:FCSC), a gene therapy company focused on transformational autologous cell-based therapies for skin and connective tissue diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted allowance of its Investigational New Drug (IND) Application for FCX-013—one of the Company’s gene therapy candidates—to begin clinical trials for the treatment of moderate to severe localized scleroderma.
As quoted in the press release:
“We are pleased the FDA has granted allowance of our IND for FCX-013 to begin clinical trials for the treatment of moderate to severe localized scleroderma, offering patients the potential for relief from this chronic, painful and debilitating disorder,” said John Maslowski, President and Chief Executive Officer of Fibrocell. “With no FDA-approved therapies available, we look forward to advancing FCX-013 into the clinic.”