Fibrocell Awarded $1.4 Million FDA Orphan Grant for FCX-007 for Treatment of Recessive Dystrophic Epidermolysis Bullosa

- September 25th, 2018

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’s (FDA) Office of Orphan Products Development (OOPD) has awarded a $1.4 million clinical trial research grant for Fibrocell’s continued clinical development of FCX-007, the Company’s gene therapy … Continued

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’s (FDA) Office of Orphan Products Development (OOPD) has awarded a $1.4 million clinical trial research grant for Fibrocell’s continued clinical development of FCX-007, the Company’s gene therapy candidate for the treatment of recessive dystrophic epidermolysis bullosa (RDEB), a devastating, rare skin blistering disease with high mortality.

As quoted in the press release:

“We are delighted with the FDA’s recognition to support the ongoing progress of our clinical trials of FCX-007,” said John Maslowski, President and Chief Executive Officer of Fibrocell. “With no FDA approved therapies available, this grant further validates the significant opportunity of FCX-007’s potential to relieve the pain and suffering from the debilitating, chronic blisters and open wounds of RDEB and offer hope to patients and their families.”

Fibrocell’s $1.4 million grant, which will be distributed over the next four years, was awarded by the FDA through the OOPD’s Orphan Products Clinical Trials Grants Program. This program supports the clinical development of products for use in rare diseases or conditions for which “no current therapy exists or where the proposed product will be superior to the existing therapy.” FDA stated in a press release for these awards that “[g]rant applications were reviewed and evaluated for scientific and technical merit by more than 100 rare disease experts, which included representatives from academia, the National Institutes of Health and the FDA.”

FCX-007 is currently being evaluated in the Phase 2 portion of a Phase 1/2 clinical trial for the treatment of RDEB.  Six patients ages seven and older are targeted to be treated with FCX-007 in the Phase 2 portion of the clinical trial. Fibrocell expects to report an interim data analysis for FCX-007 and provide a clinical trial update from Phase 1 patients and available data from Phase 2 patients in the first quarter of 2019.

Click here to read the full press release.

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