Eurostars programme:
A novel in vitro Screening system for the prediction of Drug Induced Liver Injury (DILI-Screen)

a collaboration of

Drug-induced hepatotoxicity is the leading cause of acute and chronic liver failure and the most common adverse event causing drug non-approval and withdrawal by the European Medicine Agency (EMEA) and the U.S. Food and Drug Administration (FDA). Approximately 40% of new drug candidates fail in clinical trials because of serious toxic events that remained unrecognized in preclinical studies.

The current gold standard for the prediction of human hepatotoxicity is still animal studies that are largely hampered by high cost, bad predictive value and a common ethical problem. While 85% of cardiovascular, 88% of gastrointestinal and 90% of hematological toxicity can be predicted by animal toxicity tests, hepatotoxicity prediction still suffers from less than a 50% accuracy and is therefore recognized as inappropriate for drug screening campaigns.

There is clear need for reliable in vitro tools with good predictive power, human relevance, fast turnaround times, and broader, more rapid accessibility. Goal of the present project is to fill this vacancy by the DILI-Screen, a novel in vitro screening system for the prediction of Drug Induced Liver Injury by using cryopreserved human hepatocytes (CryoHeps), single or pooled, and multiple toxicity endpoint measurements. The two participating SME’s, KaLy-Cell (Illkirch, France) and Pharmacelsus (Saarbrücken, Germany) will bundle their expertise in human hepatocyte culture and preclinical testing to develop a first working prototype of the DILI-Screen within the realm of this project.

Further information on the Eurostars programme: www.eurostars-eureka.eu