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Scioderm Initiates Phase 2B Study of SD-101, A Novel Topical Therapy, for Patients with Epidermolysis Bullosa
Date:1/6/2014

BSA) coverage of lesional areas on the skin in patients with EB (Simplex, Recessive Dystrophic, or Junctional (non-Herlitz)). In addition, improvement on pain and itching will also be assessed. Approximately 48 subjects aged six months and older are planned to enroll in the trial, which is being conducted in 7 sites across the US. The study will comprise application of SD-101 cream over the entire body daily for a period of three months.  Patients completing the study will be eligible to continue receiving SD-101 once the study is completed.  Additional information about Study SD-003 can be found at www.clinicaltrials.gov.

"Our patients with EB have few therapeutic options available and none have demonstrated evidence of accelerated closure of chronic wounds, said the study's Principal Investigator, Amy Paller, MD, Walter J. Hamlin Professor and Chair of the Department of Dermatology, Northwestern University Feinberg School of Medicine.  "We look forward to testing this new potential intervention in the double-blind, randomized trial. If the lives of the EB patients are improved with topical use of SD-101 through faster wound healing, as well as decreased pain and itchiness, this cream would be welcomed by our affected families."

"We are very excited that Scioderm has developed this potential therapy to treat some of the more profound symptoms of EB," said Brett Kopelan, MA, Executive Director of the Dystrophic Epidermolysis Bullosa Research Association of America (debra of America).  "The impact on the quality of life of those with EB would be immeasurable if SD-101 was to be proven safe and effective." 

About Epidermolysis Bullosa (EB)

Epidermolysis Bullosa (EB) is a rare genetic connective tissue disorder, with many genetic and symptomatic variations. All forms of EB share the common symptom of fragile skin that blisters and tears from
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1. 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)
2. Scioderms Investigational New Drug (IND) Application for SD-101 for Treatment of Epidermolysis Bullosa (EB) Allowed by the FDA
3. Scioderms SD-101 Receives Breakthrough Therapy Designation from FDA for Treatment of Epidermolysis Bullosa
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