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Promethera® Biosciences Provides Update on HepaStem NASH-Fibrosis Program with Late-Breaking Preclinical Data at 2016 AASLD Meeting


HepaStem™ reduces liver inflammation and improves fibrosis symptoms in a NASH mouse model.

Mont-Saint-Guibert, Belgium, November 14, 2016 – Promethera® Biosciences SA, a world-leading cell therapy and regenerative medicine company targeting liver diseases, today announced the presentation of new preclinical NASH-Fibrosis data from its proprietary HepaStem™ program, demonstrating a beneficial effect of HepaStem™ in a nonalcoholic steatohepatitis (NASH) mouse model and confirming Hepastem™’s unique and multifaceted mode of action. The results were presented on Sunday, November 13th by the Promethera® R&D and Medical Affairs team, in a late-breaking poster presentation titled, “Clinical-grade human liver mesenchymal stem cells for the treatment of NASH-Fibrosis through immunomodulation” at The Liver Meeting 2016, the 67th Annual Meeting of the American Association for the Study of Liver Disease (AASLD), currently being held in Boston, Massachusetts.

In the study, HepaStem™ was administered in a single and repeated dose setting with or without immunosuppression in a NASH STAMTM cell mouse model. HepaStem™ significantly reduced inflammation and Nonalcoholic Fatty Liver Diseases (NAFLD) Activity score (NAS), as well as fibrotic collagen deposition in liver sections at 9 weeks of age. In addition, Promethera®’s in-house R&D could further elucidate the underlying  immunomodulatory effect of HepaStem™ cells. In in vitro co-culturing systems with T-lymphocytes or dendritic cells, HepaStem™ was shown to decrease T-cell activation and dendridic cell generation and activation in vitro. HepaStem™ cells were also shown to secrete high levels of HGF (Hepatocyte Growth Factor), a growth factor known to inhibit stellate cells, the key in-situ players in liver fibrosis development.

“These first data support that HepaStem™ has the strong potential to modulate and decrease inflammation and fibrosis, opening the route to promising clinical trials in NASH and other severe inflammatory conditions of the liver,” said Prof Dr Etienne Sokal, Founder and CI and CSO of Promethera® Biosciences. He added that Promethera® is further investigating preclinical studies in various liver inflammatory and fibrotic models.

“Promethera® is in the process of building on results such as these that firmly support our expansion to the larger indications of NASH, liver inflammation and fibrosis,” said Dr John Tchelingerian, CEO of Promethera® Biosciences“With the good safety profile shown in the pediatric patients from our initial clinical studies, HepaStem™ cells offer a unique product profile which we believe will differentiate Promethera®’s approach as a novel and impactful cell therapy platform in a highly-competitive environment as our industry seeks therapies for devastating liver diseases.”

HepaStem™ is a cell suspension constituted of heterologous human adult liver-derived mesenchymal stem cells isolated from ethically donated healthy adult human liver tissue. HepaStem™ treatment has been shown to be safe in phase I/II study in 20 pediatric patients suffering from inherited metabolic disorders.

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