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ARTICLE | Clinical News

Fibrocell reports Phase I/II data for FCX-007 in epidermolysis bullosa

November 30, 2017 11:27 PM UTC

In September, Fibrocell Science Inc. (NASDAQ:FCSC) reported interim data from a Phase I/II trial in 3 patients with recessive dystrophic epidermolysis bullosa (EB) showing that a single intradermal injection of FCX-007 led to >75% wound healing in all wounds at 4 weeks and >70% wound healing in 80% of wounds at 12 weeks. On secondary endpoints, the company said anchoring fibrils have not been detected, while collagen type VII (COL7A1) has been confirmed in multiple patient samples. The gene-modified autologous fibroblast that carries COL7A1 was well tolerated, with no serious adverse events reported.

The open-label, U.S. trial's primary endpoint is evaluating safety. Secondary endpoints include the presence of anchoring fibrils and COL7A1 at weeks 4, 12, 25 and 52. The Phase I portion is enrolling 6 adults, and the Phase II portion is enrolling 6 patients aged 7 and older...

BCIQ Target Profiles

Collagen type VII (COL7A1)