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 a phase I/II study in 20 pediatric patients suffering from inherited metabolic disorders.