Cellumen's Rat Hepatocyte Early Safety Assessment Panel increases predictivity for human DILI

Nov 6 2009

Cellumen, Inc., a discovery and early safety assessment company, today announced that its in vitro Rat Hepatocyte Early Safety Assessment Panel provides increased predictivity for human drug induced liver injury (DILI) equivalent to that of a recently published panel comprised of human hepatocytes. The implications of this study have a significant impact on cost and throughput for in vitro human DILI predictive solutions.

As a result of these findings, less expensive, more reliable cells from a rat coupled with a 384-well assay format can result in reliable classification and risk-ranking of compounds for purposes of hit-to-lead prioritization and chemical class selection. In addition, the Cellumen in vitro rodent safety assessment panel provides robust dose- and time-dependent mechanistic profiles for each compound, allowing for de-risking compounds for specific mechanisms of toxicity.

The internal study, completed by Cellumen, focused on a set of 178 compounds spanning diverse chemical classes with published human DILI scores. Cellumen applied its proprietary Rat Hepatocyte Early Safety Assessment Panel consisting of freshly harvested hepatocytes, eight cellular features, three time points, and a 10 point dose response. The panel was analyzed on a high-content imaging platform and a classifier constructed to predict human DILI scores. Using this optimized Rodent Hepatocyte Panel, Cellumen achieved 100 percent specificity with nearly 50 percent sensitivity.

“We were excited by these findings, since we did not expect the concordance of human-to-human and rat-to-human DILI predictivity to be so strong,” says Don Taylor, Vice President of Corporate Development for Cellumen. “However, since Cellumen measured molecular mechanisms common to both species, these results may not be as surprising as initially thought.”

The results indicate that its in vitro Rat Hepatocyte Early Safety Assessment Panel can offer Cellumen customers higher throughput and lower cost solutions for human DILI predictivity than other options currently available.