MADISON, WIS —CeeTox and Cellular Dynamics International (CDI) today announced the introduction of a new, highly predictive cardiac safety screening service that utilizes human induced pluripotent stem (iPS) cell-derived cardiomyocytes. The Cardiac Arrhythmia Assessment Screen™ (CAAS) combines CeeTox’s expertise with in vitro toxicity screening and CDI’s iCell® Cardiomyocytes to provide a comprehensive profile of drug-induced cardiac toxicity early in the drug development cycle.
Cardiotoxicity is the leading cause for late-stage drug attrition and market withdrawal, and the FDA mandates cardiotoxic safety data on drug candidates prior to entering clinical development. Currently used animal models, non-cardiac cell lines transformed to mimic heart cells, and cadaveric cells do not truly recapitulate human response and are therefore more likely to miss adverse side effects. CDI's iCell Cardiomyocytes are highly pure, fully functional human cardiac cells derived from induced pluripotent stem cells (iPSCs). They are manufactured in reproducibly high quality and quantity to provide a more reliable, relevant and predictive in vitro model.
CeeTox's CAAS provides a fast, real-time assessment of drug-induced cardiac arrhythmias and biochemical cytotoxicity, thus enabling researchers to monitor both acute and longer-term effects, in contrast to the single time point results obtained with other assays.
Dr. James McKim, Chief Scientific Officer and CeeTox founder, said, "CeeTox's CAAS is an affordable addition to cardiac safety screening panels done during lead optimization, prior to candidate selection. More sensitive, predictable in vitro screens such as this that have direct implications for hazard identification and risk assessment can save drug developers valuable time and money."
"Increasingly researchers are publishing on the more predictive power of our iCell products in safety testing and discovery, and we're working closely with a number of pharma companies to develop assays that will become part of their standard screening platforms," said Chris Parker, Chief Commercial Office. "We're gratified to work with CeeTox as the first CRO to incorporate human iPSC-derived tissue cells as a standard human in vitro model into their screening services, thus reducing the use of animals in testing and providing a more predictive model of in vivo human response."
About CeeTox, Inc.
CeeTox, Inc. was founded in July of 2003 as a Contract Research Organization focused on in vitro toxicity screening of potential drug candidates and chemicals. CeeTox resides in 4,200-square-feet of state-of-the-art laboratory space in the Southwest Michigan Innovation Center (SMIC) (Kalamazoo, MI), a $13 million facility that serves as an incubator for new biotech companies in the Southwest Michigan area. The scientists at CeeTox have a collective experience of more than 100 years in areas of cell culture, biochemistry, and toxicology. The team has analyzed more than 4,000 new chemical entities and has repeatedly demonstrated the value of early in vitro toxicity data in the drug discovery process. See www.ceetox.com.
About Cellular Dynamics International, Inc.
Cellular Dynamics International, Inc. (CDI) is a leading developer of next-generation stem cell technologies for drug development, cell therapy, tissue engineering and organ regeneration. CDI harnesses its unique manufacturing technology to produce differentiated tissue cells from any individual’s stem cell line in industrial quality, quantity and purity. CDI is accelerating the adoption of pluripotent stem cell technology, adapting its methods to fit into standard clinical practice by the creation of individual stem cell lines from a standard blood draw. CDI was founded in 2004 by Dr. James Thomson, a pioneer in human pluripotent stem cell research at the University of Wisconsin-Madison. CDI’s facilities are located in Madison, Wisconsin. See www.cellulardynamics.com.