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

SAN DIEGO, February 8, 2013 /PRNewswire/ --

Shire plc (LSE: SHP, NASDAQ: SHPG), today announced the initiation of a Phase 3 study designed to evaluate the efficacy and safety of ABH001, its dermal substitute therapy, for the treatment of non-healing wounds in patients with Epidermolysis Bullosa (EB), a group of rare genetic skin disorders that begin to manifest at birth or early childhood and occur in approximately 19 per 1 million live births in the US. [i]  

"People affected by EB suffer skin blisters and almost constant, acute pain and scarring," said the study's Principal Investigator, H. Alan Arbuckle , MD, Section Head Pediatric Dermatology Kaiser Permanente Colorado, Wound Care Consultant, Epidermolysis Bullosa Center of Excellence, The Children's Hospital, Aurora Colorado . "The current standard of care is daily wound care, bandaging and pain management. I am excited to be involved in testing the efficacy and safety of ABH001 as a potential treatment option for these patients."  

ABH001 for EB has been granted an orphan drug designation in the US and EU, and has also received Fast Track designation from the US Food and Drug Administration (FDA), which is aimed at facilitating the development and expediting the review of drugs and biologics that fill an unmet medical need. In addition, the European Medicines Agency's Pediatric Committee has agreed on a pediatric investigation plan for ABH001 for the treatment of EB.

The new Phase 3 study is a multi-site, prospective, randomized, open-label, intra-subject controlled trial evaluating the efficacy and safety of ABH001 to initiate healing and reduce the wound surface area of selected stalled, chronic cutaneous wounds associated with generalized EB. Approximately 20 subjects with generalized EB age
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SOURCE Shire plc
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