CDI and VivoMedica launch pharmaceutical industry consortium

Cellular Dynamics International (CDI) and VivoMedica plc announce the launch of CARDIOTOX - a pharmaceutical industry consortium to validate a human cell model and analysis system for preclinical cardiotoxicity testing of pharmaceutical candidate compounds. The consortium will be formally launched at the Safety Pharmacology Society 9th Annual Meeting in Strasbourg, France, on Sept. 15-18, 2009, during a workshop sponsored by CDI and VivoMedica at 12:30p.m. CET on Sept. 17.

Pharmaceutical companies are invited to participate in the consortium, which aims to provide the industry with a human cardiomyocyte-based solution to predict pro-arrhythmic effects of new chemical entities (NCEs). Human cardiomyocytes, or heart cells, express the relevant cardiac proteins and are thought to be more predictive of a drug compound's effect than animal cell-based technologies. The consortium will validate the testing system using CDI's revolutionary iCell(TM) Cardiomyocytes and VivoMedica's DrugPrint(R) analysis system. Extracellular micro-electrode array (MEA) recordings from CDI's fully functional induced pluripotent stem (iPS) cell-derived human cardiomyocytes will be analyzed using VivoMedica's proprietary electrical waveform analysis technology. This approach will identify drug-induced changes that indicate the arrhythmogenic potential of NCEs under investigation. These technologies, combined into an integrated test, will provide the industry with a validated pro-arrhythmia reference database for comprehensive early assessment of NCE's arrhythmogenic potential, the end result being greater predictive power, reduced reliance on animal testing, reduced cost, and an overall increase in efficiency in the drug discovery and development process.

"Adverse cardiac effects have resulted in the withdrawal or blackbox warnings of multiple high profile drugs in recent years. Even now it's estimated that 25-40% of all drugs in pre-clinical testing show some adverse drug-induced cardiotoxicity," said Julian Demmon, CEO of VivoMedica. "The challenge for the industry is how to reliably predict clinical cardiotoxicity earlier in the pipeline and thus to target drug development funding more effectively. We believe that iCell Cardiomyocytes in the DrugPrint system will help the pharmaceutical industry overcome this challenge."

"Maintaining a normal cardiac rhythm requires the complex coordination of dozens of proteins. Disruption of this interplay, even for a few minutes, can have severe consequences and even death," said Craig T. January, M.D., Ph.D., F.A.C.C., director and founder of CDI. "Incorporating human cells into toxicology testing is an important goal in the pharmaceutical industry, as human-based models are more likely to recapitulate relevant in vivo biology."

"Mimicking drug toxicity that would manifest itself in clinical trials is a key component of improving the efficiency of drug development," said Chris Kendrick-Parker, chief commercialization officer of CDI. "We have been able to reliably and consistently generate large numbers of human cardiomyocytes for use in pharmaceutical drug development using our iPS cell technologies. Incorporating iCell Cardiomyocytes into VivoMedica's DrugPrint platform will enable our customers to access a reliable human cardiomyocyte cell model in a highly effective testing system."