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Amarantus and Lonza Walkersville, Inc. Provide Update on cGMP Manufacturing Readiness for the Engineered Skin Substitute (ESS) Program
Amarantus and Lonza Walkersville, Inc. Provide Update on cGMP Manufacturing Readiness for the Engineered Skin Substitute (ESS) Program.
About this update from Amarantus Bioscience Holdings, Inc.
[{"type":"text","content":"\n\n\n\nAmarantus and Lonza Walkersville, Inc. Provide Update on cGMP Manufacturing Readiness for the Engineered Skin Substitute (ESS) Program\n\n\n\n\n\nAmarantus and Lonza Walkersville, Inc. Provide Update on cGMP Manufacturing Readiness for the Engineered Skin Substitute (ESS) Program\nPR Newswire\nSAN FRANCISCO, February 22, 2016\n\n\n\nSAN FRANCISCO, February 22, 2016 /PRNewswire/ --\n\nAmarantus BioScience Holdings, Inc. (OTCQB: AMBS), a biotechnology company focused on developing products for Regenerative Medicine, Neurology and Orphan Diseases, today updated the status of its cGMP manufacturing technical transfer for producing ESS at Lonza Walkersville, Inc., a premier contract manufacturer  providing cell and tissue-based products for clinical development.\n\nAmarantus announced that it has successfully completed the growth and testing components of its confirmatory engineering run as previously anticipated, and is now finalizing the documentation, sterilization validation, and auditing that is required to complete the technical transfer. Once technical transfer is finished, which is expected to be in the first quarter of 2016, Amarantus will be operationally ready to supply ESS for the planned Phase 2 clinical study for the treatment of full thickness thermal burns covering over 50% of the body with the US Army.  The 10-patient trial will be conducted under a Collaborative Research & Development Agreement (CRADA) with the U.S. Army's Institute for Surgical Research (ISR) at Fort Sam Houston in Texas. Two additional civilian sites will be opened to accelerate enrollment of the study.\n\nCompletion of the confirmatory engineering run is a highly significant milestone, as this is a demonstration that the ESS investigational product can be grown from adult (rather than only from pediatric) donor tissue using a scalable and fully cGMP-compliant process.\n\n\"In October 2015, the Company decided to focus the majority of its available resources on the ESS program, due largely to the incredible need for this product in the marketplace - evidenced by the US Army's financial support and strong desire to open enrollment for the upcoming Phase 2 clinical study to treat U.S. soldiers who have been critically burned serving their country,\" said Gerald E. Commissiong, President & CEO of Amarantus. \"Today's announc...