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Scioderm Announces Positive Phase II Data of Topical SD-101 on Wound Closure and Reduction of Lesions and Blisters in Children with Epidermolysis Bullosa (EB)
Date:6/19/2012

RALEIGH, N.C., June 19, 2012 /PRNewswire-iReach/ -- Scioderm today announced results from its Phase II clinical trial investigating the efficacy, safety and tolerability of topical administration of SD-101, a dermal pharmaceutical in development for treatment of chronic wounds and lesions in children with various types of Epidermolysis Bullosa. The open label study was conducted in children with either Simplex, Recessive Dystrophic (RDEB), or Junctional EB. Eight children with EB (Simplex, RDEB, or Junctional EB) were enrolled and received daily administration by their caregivers of topically applied SD-101 over their entire body for a period of up to 3 months. The primary outcome measures were assessment of target wound area reduction and closure, and reduction in BSA coverage of lesions and erosions.  In the Phase II trial, SD-101 application resulted in closure of 85% of target chronic lesions, in addition to a 55% reduction in BSA coverage of lesions and erosions. SD-101 was well tolerated by the children, with daily administration up to 3 months.

SD-101 has also been designated as an orphan drug by the U.S. Food and Drug Administration for the treatment of Epidermolysis Bullosa (EB). Orphan drug designation provides a number of benefits to the company, including seven years of market exclusivity once SD-101 receives FDA clearance, assistance from the FDA with guiding SD-101 through the regulatory approval process, and waiver or partial payment of application fees and tax credits for clinical testing expenses conducted after orphan designation is received.

Robert Ryan, Ph.D., Chief Executive Officer of Scioderm added, "Epidermolysis Bullosa is a devastating disease. Our results from this trial indicate that SD-101 is a product candidate for treatment of the lesions and blistering on skin in children with EB, who have no other treatment alternatives, and it appears to have a favorable safety profile. We believe these data support the use of
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SOURCE Scioderm
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