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Amarantus Reports Preliminary 13-Year Longitudinal Follow-Up Human Patient Data for Engineered Skin Substitute Treatment of Congenital Giant Hairy Nevus
Amarantus Reports Preliminary 13-Year Longitudinal Follow-Up Human Patient Data for Engineered Skin Substitute Treatment of Congenital Giant Hairy Nevus.
About this update from Amarantus Bioscience Holdings, Inc.
[{"type":"text","content":"\n\n - Single ESS Treatment Provided Successful Skin Replacement on Infant Patient, Supporting Natural Skin Growth That Required no Additional Grafts or Reconstructive Surgery\n - Data Provides Translational Support for Multiple Pediatric Skin Conditions SAN FRANCISCO and GENEVA, Oct. 08, 2015 (GLOBE NEWSWIRE) --  Amarantus Bioscience Holdings, Inc. (OTCQX:AMBS), a biotechnology company developing therapeutic and diagnostic product candidates in orphan indications and neurology, reported on preliminary 13-year longitudinal follow-up data presented on Engineered Skin Substitute (ESS) for the treatment of pediatric severe burns and Congenital Giant Hair Nevus at the Tissue Products for Emergency Preparedness Symposium at the National Archives in Washington, DC in May 2015. Amarantus completed the acquisition of ESS in July 2015, and has focused the Company’s near-term execution strategy on the advancement of ESS in several therapeutic areas including Congenital Giant Hairy Nevus and pediatric severe burns, two rare pediatric diseases that the Company believes would be eligible for a Rare Pediatric Disease Designation (RPDD) by the US Food and Drug Administration (FDA). The Sponsor of a treatment approved under the RPDD pathway is eligible to receive a PRV that may be sold to other companies. Two PRVs have been sold in the last 6 months for an aggregate of $595 million to major pharmaceutical companies. The proceeds from the sale of a PRV are in addition to any potential revenues that could be generated from product sales. The Company intends to apply to the FDA for both orphan drug designation (ODD) and RPDD for ESS treatment of Congenital Giant Hairy Nevus in the fourth quarter of 2015. Congenital Giant Hairy Nevus is a rare pediatric disease defined by one or more, large, darkly pigmented and sometimes hairy patches with a projected adult diameter of over 40 cm with hypertrichosis. The condition is sometimes known as giant congenital melanocytic nevus. The estimated prevalence for the largest forms is 0.002% of births, affecting approximately 1 in 50,000 to 1 in 500,000 births annually. Melanocytic Nevi often grow proportionally to the body size as the child matures. As they mature, they often develop thickness, and become elevated, although these features can also be present from birth. Prominent terminal hairs often...