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Scioderm's Investigational New Drug (IND) Application for SD-101 for Treatment of Epidermolysis Bullosa (EB) Allowed by the FDA
Date:2/13/2013

to the clinic," said Brett Kopelan , Executive Director of the Dystrophic EB Research Association of America (DebRA ) and father to a 5-year-old girl with recessive dystrophic EB.  "I look forward to working with Scioderm as they work towards improving the quality of life of those with EB by targeting the chronic wounds that are the hallmark of this disease."

About SD-101

SD-101 is a topical cream that has previously demonstrated potential to provide improvement in treating the severe skin effects seen in patients across all EB subtypes.  An open- label study was conducted previously in children with either Simplex, Recessive Dystrophic (RDEB), or Junctional EB.  The primary outcome measurements were assessment of target wound reduction and closure, and reduction in body surface area (BSA) coverage of lesions and erosions.  In the clinical trial, SD-101 application resulted in complete closure of 88% of target chronic lesions within one month, in addition to a 57% reduction in BSA coverage of lesions and erosions after 3 months of daily treatment.   SD-101 was well tolerated by the children, with daily administration up to 3 months.

About Scioderm

Scioderm is a privately held, clinical-stage pharmaceutical company focused on developing topical products to address critical medical needs in the treatment of chronic skin diseases.  Additional information about Scioderm can be found at www.sderm.com. 

Company Contact:

Robert Coull
Chief Operating Officer
robert.coull@sderm.com  
(917) 345-2504   

Forward-Looking Statements 

Except for the historical information contained herein, the matters discussed in this press release are forward-looking statements that involve risks and uncertainties, i
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