Cellumen, Inc. to Collaborate With the NCTR of the FDA to Apply Cellular Systems Biology (CSB(TM)) to Predictive Toxicology

PITTSBURGH, June 30 /PRNewswire/ -- Cellumen, Inc., the Cellular Systems Biology Company, announced today the initiation of a research collaboration with the National Center for Toxicology Research (NCTR), a research center of the Food and Drug Administration (FDA). Under the agreement, Cellumen will use its proprietary CellCiphr(R) toxicity risk assessment technology to profile blinded samples of known liver toxicity compounds including both failed and marketed drugs for the NCTR. The NCTR will incorporate the knowledge generated by Cellumen to develop a liver toxicity knowledge base. Cellumen will use the profiling data and compound safety data from the collaboration to further develop the diversity in the CellCiphr database and the types of cell panels, as well as to advance the classifier informatics tools.

"Failure to predict human toxicity among drug candidates early in the discovery/development process is a leading challenge for the pharmaceutical industry," stated D. Lansing Taylor, Ph.D., CEO of Cellumen. "Patients demand and deserve safe and effective drugs, while pharmaceutical companies are increasingly challenged to profitably meet that demand. Cellumen's vision is working toward the goal of replacing animal testing with a human in vitro system in order to facilitate the development of safer, more effective drugs," added Dr. Taylor.

By applying CellCiphr toxicity profiling early in the discovery and lead optimization phases, drug companies will accurately identify compounds with high human toxic liabilities. Actions can be taken to either de-prioritize high-risk compounds, or remove high-risk compounds from a lead series that ultimately would prove to be toxic. Cellumen is at the forefront of drug safety profiling services to aid in predicting drug toxicity early in the discovery/development process.

About Cellumen:

Cellumen is the leading innovator in cellular systems biology (CSB(TM)) solutions providing the most accurate predictions of drug efficacy and safety, thus reducing failure rates and cutting development costs. Cellumen's CSB solutions are driving "Discovery Toxicology" by addressing the full complexity of disease and safety. Leading global organizations such as the Mayo Clinic, Hamamatsu Photonics K.K., the EPA, NIH and top pharmaceutical companies partner with Cellumen.

About CellCiphr(R):

CellCiphr is the only cell-based assay solution combining tissue-specific cells, multiplexed functional biomarkers, advanced classifiers, and a compound reference library in order to allow drug developers to accurately identify drug candidates that have high efficacy and low toxicity. CellCiphr is capable of analyzing greater than 10 functional biomarkers per assay that are used as sentinels for analysis of mechanism of action and toxicity of new compounds applied to both rodent and human cells.

CONTACT: Donald P. Taylor, Senior Director, Marketing & Corporate
Development, Cellumen, Inc., +1-412-423-2284, don.taylor@cellumen.com

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