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8-K
FIBROCELL SCIENCE, INC. filed this Form 8-K on 05/10/2018
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Fibrocell Reports First Quarter 2018 Financial Results and Recent Highlights - Company to Host Conference Call and Webcast Today at 8:30 a.m. EDT - EXTON, PA – May 10, 2018 – Fibrocell Science, Inc. (NASDAQ: FCSC), a gene therapy company focused on transformational autologous cell-based therapies for skin and connective tissue diseases, today reported financial results for the first quarter ended March 31, 2018 and recent operational highlights. Fibrocell will host a conference call and webcast today at 8:30 a.m. EDT. “Our achievements in the first quarter of 2018 have set the stage for continued progress of Fibrocell’s gene therapy clinical programs that address rare conditions of the skin and connective tissue with high unmet needs,” said John Maslowski, President and Chief Executive Officer of Fibrocell. “In January, we obtained allowance from the U.S. Food and Drug Administration to enroll pediatric patients in the Phase 2 portion of our Phase 1/2 clinical trial of FCX-007 for the treatment of recessive dystrophic epidermolysis bullosa. In addition, the Phase 1 portion of this trial continued to advance and we expect to report additional interim adult data in the second quarter of 2018.” “Furthermore, our FCX-013 program for the treatment of moderate to severe localized scleroderma made important progress. In March 2018, Fibrocell was granted allowance by the FDA of the Investigational New Drug Application for FCX-013 to proceed to clinical trials,” said Mr. Maslowski. Recent program highlights and new updates are as follows: FCX-007  Fibrocell obtained allowance from the U.S. Food and Drug Administration (FDA) to initiate enrollment of pediatric patients in the Phase 2 portion of its Phase 1/2 clinical trial of FCX- 007, based on evidence of safety and potential benefit of FCX-007 in adult patients dosed in the Phase 1 portion of the clinical trial. Fibrocell plans to enroll six patients ages seven and older in the Phase 2 portion of the clinical trial. One recessive dystrophic epidermolysis bullosa (RDEB) adult patient has been enrolled in Phase 2, and dosing is expected to occur in the second quarter of 2018.  Fibrocell expects to report additional interim data on the adult patients in the Phase 1 portion of its Phase 1/2 clinical trial of FCX-007 and provide a trial update in the second quarter of 2018, which includes an oral presentation at the 7th International Investigative Dermatology meeting on May 19, 2018.  Fibrocell expects to complete enrollment of patients in the Phase 2 portion of the Phase 1/2 clinical trial of FCX-007 in the third quarter of 2018. Another interim data report and trial update is expected in the first quarter of 2019.