- Thinly traded nano cap Fibrocell Science (FCSC -7.4%) slumps on almost a 7x surge in volume, albeit on turnover of only 373K shares, in apparent response to the company's announcement of preliminary data from its Phase 1/2 clinical trial assessing FCX-007 in patients with recessive dystrophic epidermolysis bullosa (RDEB), an inherited disorder characterized by fragile skin that blisters easily.
- The company announced results from three patients who received a single intradermal injection session of FCX-007 in the margins and across targeted wounds in addition to separate intact skin sites.
- Four weeks after treatment, all (n=5/5) wounds were 75% healed. At week 12, 80% (n=4/5) of the wounds were 70% healed, implying that the treatment effect may not be durable.
- FCX-007 was well-tolerated with no serious adverse events and no treatment-related adverse events reported.
- After reviewing the results, the independent Data Safety Monitoring Board recommended the study continue as planned.
- Investigators now intend to increase expression and dosing.
- Fibrocell is developing FCX-007 in collaboration with Intrexon (XON -0.2%).
- Now read: Fibrocell Science (FCSC) Presents At Rodman & Renshaw 19th Annual Global Investment Conference - Slideshow
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