Viewing the cell as the basic unit of life and therefore the first useful level of systems biology, Cellumen (www.cellumen.com) focuses on a cellular systems biology approach for drug discovery, development, and clinical trials.
“The day of the blockbuster drug is over or certainly limited,” says D. Lansing Taylor, Ph.D., CEO. “We now need to begin addressing the complexity and diversity of humans, and cells can be the surrogates of that complexity. Cell-based assays are the fastest growing sector of drug discovery and development.”
Cellumen is initially targeting hepatocytes in safety profiling since more than 50% of drug toxicities are liver based, says Dr. Taylor. The company assess both human and rat primary cells.
“Rat cells are included since the FDA mandates animal testing and primary rat cells can be used to filter compounds in the development pipeline. It’s important to do this early on in the process so we have a filter for selecting lead series and with fewer failures at later stages. Ultimately, the goal is to have a predictive tool for human toxicity.”
Cellumen scientists employed an 11-parameter, multiplex cytotoxicity panel in a recent study involving 130 compounds with safety data. “We measured three different time points in our model: one for an acute response, one hour; one for an early measure, 24 hours; and one as a chronic measurement, for example 72 hours, for compound treatments,” explains Dr. Taylor.
“The 11 parameters included mitochondrial function, oxidative stress, and cell cycle. The entire concept is that we look at a systemic readout of functional biomarkers. This generates a massive amount of data so we then couple this to informatics. The end result is that we can rank compounds and create a safety index for predicting hepatotoxicity during the investigational safety phase.”
In addition to their own programs, Cellumen offers custom profiling services, informatics, access to its databases, and safety assessments for clients who wish to outsource. The first panel of reagents and protocols for human hepatocyte profiling is available from Millipore in a comarketing arrangement.