March 6, 2018 9:08am
FCSC closed at $0.59 and is up +$0.045 or +7.60% - BUY
The FDA has granted allowance of an Investigational New Drug (IND) Application for FCX-013—one of FCSC’s gene therapy candidates—to begin clinical trials for the treatment of moderate to severe localized scleroderma.
FCSC expects to initiate enrollment for an open label, single arm Phase 1/2 clinical trial in the third quarter of 2018. The primary objective of the trial is to evaluate the safety of FCX-013. Secondary analyses consist of several fibrosis assessments including histology, skin scores, ultrasound and additional measurements of targeted sclerotic lesions and control sites at various time points up to 16 weeks post-administration of FCX-013.
Ten patients with any subtype of localized scleroderma are targeted for enrollment (approximately 5 patients per Phase). The P1 portion will enroll adult patients, and dosing for the first three adult patients will be staggered prior to dosing the rest of the trial’s population.