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SEC Filings

FIBROCELL SCIENCE, INC. filed this Form 8-K on 11/13/2018
Entire Document
FCX-013 Moving into Clinical Trials • Product profile . Dermal fibroblasts genetically modified using lentivirus and encoded for matrix metalloproteinase 1 (MMP-1), a protein responsible for breaking down collagen . Incorporates Precigen’s RheoSwitch Therapeutic System® (RTS®) to control protein expression • Activated by an oral ligand (Veledimex) • FDA allowed IND in March 2018 • Completed GLP toxicology/biodistribution study . Bleomycin fibrosis model using immunocompromised mice (NOD/SCID) . No test article-related clinical observations, body weight changes, changes in clinical pathology parameters, gross observations or organ weight change . No significant vector biodistribution to target organs • Initiated the first investigator site for clinical enrollment in the Phase 1/2 clinical trial in August 2018 • FDA granted Fast Track Designation in late August 2018 19