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Shire Regenerative Medicine Initiates Phase 3 Study of ABH001 for Patients with Epidermolysis Bullosa
Date:2/8/2013

d three years and older are planned to enroll in the trial, which is targeted to be conducted in 10 to 15 sites across the US, Europe and Canada. The study will comprise ABH001 applications sufficient to cover the surface area of the wound, applied topically every 4 weeks with protocol-specified dressings until healed or for up to 24 weeks.

"We are excited that Shire Regenerative Medicine has launched this trial," 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.  "While there is currently no cure for EB, I am encouraged that ABH001 is…targeting the chronic wounds that are the hallmark of this disease. I applaud Shire for pushing this forward and look forward to working closely with them as the trial progresses."  

"We are very eager to begin evaluating ABH001 as a potential wound treatment option for people with EB. We believe it has the potential to initiate and continue wound healing in this patient population," said Jeff Jonas , MD, President of Shire Regenerative Medicine. "We are committed to developing regenerative medicine solutions that enable people with life-altering conditions to lead better lives, and are encouraged by the fast track and orphan drug designations we have received to further develop this potential therapy for people, most often young children, suffering from this devastating condition."

Shire is also developing an intravenous protein replacement therapy for the treatment of dystrophic EB, which the company's Human Genetic Therapies business recently acquired from Lotus Tissue Repair, Inc. Initiation of this pivotal trial of ABH001 for patients with EB further demonstrates Shire's commitment to developing a portfolio of products targeted toward patients who suffer from this di
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SOURCE Shire plc
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