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Tuesday, July 12, 2016 News

Promethera Biosciences appoints world-class Scientific and Medical Advisory Board

• Six independent, renowned and international key opinion leaders in hepatology/liver research on advisory board
• Strengthens Promethera’s relationship to the international clinical and academic liver disease community to receive broader strategic, scientific and    medical advice.

Promethera Biosciences SA, a Belgian biopharmaceutical company with U.S. operations developing a variety of cell therapies for the treatment of inborn liver metabolic disorders (ILMD) and acquired liver diseases with high unmet medical needs, today announces the establishment of a Scientific and Medical Advisory Board (SMAB) and its ongoing responsibilities. Six independent, renowned and international key opinion leaders have been appointed.

The opinion leaders appointed are Massimo Pinzani, MD, PhD, FRCP, FAASLD, Anil Dhawan, MD, FRCPCH, Sanjeev Gupta, MBBS, MD, FRCP, FACP, FAASLD, Michael Ott, MD, Andreas Nuessler, PhD and Patrice Cani, RD, MSc, PhD. In addition, Promethera has appointed Professor Massimo Pinzani as the Chairman of the SMAB.

The Advisory Board will work closely with Promethera to support its management team and board of directors, providing strategic, scientific and medical advice. It is currently scheduled to meet on a bi-annual basis. Primary key aspects to be addressed by the SMAB include the application of Promethera’s cell therapy technologies to clinical benefits in a broad range of liver diseases, cell engraftment, cell encapsulation, editing or re-programming of cells, maintenance and expansion of specific cells, clinical translation of certain features of Promethera’s cells to treat liver diseases and the development of relevant small and large animal models.

"Promethera has developed very quickly in 2016, acquiring key assets of Cytonet, and considerably expanding its pipeline with pre-commercial products. As a result, it is critical to select and appoint world leading experts in genetic and acquired liver disease to support Promethera as it develops its three cell technologies Heparesc®, HepaStem and H2Stem," said Prof Etienne Sokal, founder and Chief Innovation and Scientific Officer of Promethera Biosciences. "The formation of the SMAB provides an additional scientific and clinical commitment from Promethera to find the best route to market for the products created by its unique regenerative medicine technological platforms and its positioning in the liver space. In addition, Promethera will be able to establish and strengthen relationships with the academic centers of its SMAB members and their international clinical sites of excellence that are already treating a broad range of liver disorders.”

Prof. Massimo Pinzani, Chairman of the SMAB adds: “Promethera has accomplished exciting and rapid achievements, especially in its transition in the last 12 months, to position itself to develop a more ambitious pipeline and expanded technological platforms. As chair and member of the Scientific Medical Advisory Board, I am ideally placed to further support Promethera in a range of strategic and scientific aspects. I look forward to contributing to promising developments that could potentially result in creating new and effective products for the underserved market of liver diseases.”

Massimo Pinzani, MD, PhD, FRCP is a Professor of Medicine, clinical hepatologist, Director of the UCL Institute for Liver and Digestive Health and the Sheila Sherlock Chair of Hepatology at University College of London, UK. He has served in the governing and scientific boards of major international organizations in the areas of hepatology and gastroenterology, and as Associate Editor of top peer reviewed international journals in the area of medicine.

Anil Dhawan, MD, FRCPCH is a Professor of Paediatric Hepatology, Director of the Paediatric Liver, GI and Nutrition Centre and Clinical Director for Child Health at King’s College Hospital, London, UK. He is Joint Clinical Academic Group (CAG) Leader for Child Health for King’s Health Partners and Director of the Cell Therapy Unit which has pioneered the use of human hepatocytes for the treatment of metabolic liver diseases and acute liver failure.

Sanjeev Gupta, MBBS, MD, FRCP, FACP, FAASLD, is a Professor of Medicine and Pathology and holds the Eleazar and Feige Reicher Chair in Translational Medicine at Albert Einstein College of Medicine in the Bronx, NY, USA. He is a member of several NIH-funded Scientific Centers and Institutes at Albert Einstein College of Medicine. He has served extensively as a keynote speaker in international conferences, is a pioneer of mechanisms to restore the liver by cell transplantation, and has contributed seminal insights in engraftment, proliferation and function of transplanted cells, including stem cell-derived cells, in the liver.

Michael Ott, MD, is Associate Professor for Experimental Hepatology at the Hannover Medical School, Germany which is recognized worldwide as one of the leading centers for transplantation medicine. He specializes in cell and gene therapies for liver diseases, stem cell research, microRNAs and in vitro and in vivo re-programming of somatic cells.

Andreas Nuessler, PhD, is a Professor and Head of Experimental Medicine and Head of the Siegfried Weller Institute within the department of Traumatology at the Eberhard Karls University Tuebingen. He is part-time lecturer in surgery and traumatology. His specific area of research involves various pathways leading to inflammatory reactions in the liver by using isolated liver cells and whole livers. He developed standard culture methods to isolate various fractions of human liver cells for routine use to study specific aspects of drug metabolism in 2D and 3D cultures.

Patrice Cani, RD, MSc, PhD, is a Professor at the Université catholique de Louvain (UCL), Brussels, Belgium, researcher from FRS-FNRS and group leader in the Metabolism and Nutrition lab at the Louvain Drug Research Institute from the UCL. He is WELBIO investigator and co-director of the European Associated Laboratory: “NeuroMicrobiota” (INSERM, Toulouse, France/UCL, Brussels, Belgium).

About Promethera Biosciences
Promethera is a clinical stage biopharmaceutical company and the global leader and most advanced cell therapy and regenerative medicine company for the treatment of inborn and acquired liver diseases with no effective therapeutic cure. Promethera uses allogeneic progenitor cells, stem cells and mature hepatocytes harvested and purified from non-transplantable, healthy human livers (Heterologous Human Adult Liver-derived Progenitor Cells, HHALPC and Heterologous Human Liver Cells, HHLivC). Using its three different cell products, Heparesc® (mature hepatocytes), HepaStem and H2Stem (progenitor/stem cells), Promethera develops therapeutic options for the treatment of a broad variety of liver diseases ranging from orphan indications, such as rare inborn metabolic diseases including urea cycle disorders (UCD) or inherited diseases such a1at deficiency (α1-antitrypsin) and hemophilia to large indications such as acute on chronic liver failure (ACLF), fibrosis, nonalcoholic steatohepatits (NASH). Heparesc® is a pre-commercial product candidate that has been studied in two open multi-center clinical trials to evaluate the safety and efficacy in children with neonatal urea cycle defects. The Company is preparing for a new drug submission (NDS) for Heparesc® with Health Canada and a potential commercial launch of Heparesc® in selected countries. HepaStem successfully completed a phase I/II clinical study in UCD and Crigler-Najjar syndrome (CNS) and is currently in phase II clinical study in UCD patients under 12 years old. Further, HepaStem will be positioned based on its mesenchymal cell (MSC) features in acquired liver diseases by end of 2016 for a phase II safety clinical trial in ACLF. H2Stem, a follow-on progenitor/ stem cell with hepato-biliary features will enter the clinical stage in 2017 and targets inborn metabolic diseases or inherited diseases such as a1at deficiency.

Promethera Biosciences is a spin-off of the Walloon Region-based Université catholique de Louvain (UCL) and was founded in 2009 by Prof. Etienne Sokal and Sopartec, the tech transfer office (TTO) of UCL. With headquarters located in Mont-Saint-Guibert in the Walloon Region, Belgium and a U.S. based GMP compliant manufacturing facility in Durham, NC, US. Promethera Biosciences currently has approximately 56 employees led by an experienced and international management team.