Interim safety data together with early signals of efficacy will be presented in oral presentation at The International Liver Congress™
MONT-SAINT-GUIBERT, Belgium, March 27th - Promethera Biosciences SA, a global innovator in cell-based medicines and liver diseases, today announced that clinical data from the ongoing phase 2a study of its lead product candidate HepaStem® in patients with Acute-on-Chronic Liver Failure (ACLF) or acute decompensation (AD) at risk of developing ACLF has been selected by the European Association for the Study of the Liver (EASL) for an oral presentation, by the principal investigator (Prof. F. Nevens, KULeuven, BE) during the plenary general session at The International Liver Congress™ (ILC) 2019 being held April 10-14, 2019, in Vienna, Austria.
HepaStem consists of liver stem cells that are obtained from ethically donated healthy human organs and expanded in GMP culture conditions. The product candidate is currently being evaluated in a Phase 2a clinical trial in acute on chronic liver failure (ACLF) and Acute decompensation (AD).
“We are very pleased with the interim data received from the HepaStem trial so far. We were able to obtain a safe dosing regimen in both ACLF and AD patients, and we continue to evaluate the safety of this ground-breaking treatment to achieve a thorough and robust safety profile,” said Etienne Sokal, M.D., Ph.D., Promethera’ s Chief Scientific & Medical Officer. “Promethera is pioneering the use of liver-derived stem cells for the treatment of ACLF and non-alcoholic fatty liver disease (NASH), and these preliminary safety results are very encouraging as we continue to advance HepaStem in the clinic.”
In the study, single and repeated infusions of HepaStem were shown safe in this AD/ACLF patient population. In addition, the Model for End Stage Liver Disease score (MELD), Child-Pugh score, and bilirubin levels, three indicators of liver disease severity, had decreased along the trial in treated patients, which is regarded as an encouraging sign of efficacy.
To download the abstract, please, click here.