Interim safety data together with early signals of efficacy will be presented in oral presentation at The International Liver Congress™
Interim safety data together with early signals of efficacy will be presented in oral presentation at The International Liver Congress™
MONT-SAINT-GUIBERT, Belgium--(BUSINESS WIRE)-- 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.
About Promethera Biosciences
Promethera Biosciences is a global innovator in liver therapeutics whose mission is to bring life-saving treatments to reduce the need for liver transplantation. Our lead clinical program, derived from our patented cell technology platform HepaStem, is designed to benefit from its immune-modulatory and anti-fibrotic properties. In addition to our cell-based pipeline we develop antibody technologies, such as the anti-TNF-R1 antibody Atrosimab, to complement and diversify our therapeutic options. We are a team of international experts operating out of facilities in Mont-Saint-Guibert, Belgium, Durham, NC, USA, Tokyo, Japan and Basel, Switzerland.
Promethera®, HepaStem®, H2stem®, are all registered trademarks of the PROMETHERA group.
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Contacts
Promethera Biosciences SA For media:
Alexandra Schiettekatte
Alexandra.schiettekatte@promethera.com
Web: www.promethera.com
MacDougall
Mario Brkulj or Shai Biran, Ph.D.
+49 89 2420 9345
or +1 781-235-3060
promethera@macbiocom.com
Source: Promethera Biosciences