Fibrocell Science (FCSC) Completes Enrollment in NC1+ Cohort of Phase I/II Clinical Trial of FCX-007 to Treat RDEB

September 19, 2016 8:07 AM EDT

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Fibrocell Science, Inc. (NASDAQ: FCSC) today announced that two additional adult subjects were enrolled in the Phase I/II clinical trial of FCX-007 for the treatment of Recessive Dystrophic Epidermolysis Bullosa (RDEB), satisfying enrollment in one of two cohorts in the Phase I portion of the trial.

“We are excited about the steady progress of the trial, as four of the six adult RDEB patients required for the Phase I portion of the study have been enrolled since late July,” said David Pernock, Chairman and Chief Executive Officer of Fibrocell. “This advancement is an important milestone toward potentially offering patients the first gene therapy to treat the underlying cause of this devastating disease.”

Six adult subjects are targeted for enrollment in the Phase I portion of the trial. The subjects are divided into two cohorts in order to evaluate the safety of FCX-007 in each population type. One cohort is comprised of those who have positive expression of the non-collagenous portion of the type VII collagen (COL7) protein (NC1+). The second cohort includes those who do not express the non-collagenous portion of the protein (NC1-).

Enrollment of the latest subjects fulfills the NC1+ cohort and also provides the first subject for the NC1- cohort. Two more subjects are required for the NC1- cohort to complete enrollment in the Phase I portion of the trial.

Fibrocell continues to expect to dose the first subject in this trial at the end of 2016. Additional adult subjects will be dosed after a required 90-day waiting period is complete to ensure there are no safety concerns for the first dose of the new gene-therapy product. Three-month post-treatment follow-up data for safety, mechanism of action and efficacy in the Phase I portion of the trial are expected in the second half of 2017, as well as six-month data for multiple subjects.



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