Tuesday, 5 October 2010

Human cardiomyocytes for predictive toxicity testing

GE Healthcare announces the availability of human cardiomyocytes, or heart muscle cells, that provide a more readily available and biologically-relevant alternative to current cell models and primary cells used in drug discovery and predictive toxicity testing.

Cardiotoxicity is one of the most common causes of drug safety liabilities, withdrawal of in-market drugs, and late-stage failure during drug development. Early detection, or prediction, of cardiotoxicity could significantly reduce overall drug development costs, and help minimize patient exposure to potentially harmful compounds.
Konstantin Fiedler, General Manager of Cell Technologies, GE Healthcare, said: “The development and commercialization of translational cellular assay products for our customers in the scientific community will help to support and speed up cutting-edge research, and ultimately help improve patient safety and health outcomes.”

GE Healthcare has used its cell technology and industrial-scale production expertise, along with its partnership with Geron Corporation (Nasdaq: GERN), to provide a consistent supply of well-characterized human cardiomyocytes for pharmaceutical safety screening, protected by Geron’s intellectual property portfolio, and which can be manufactured without genetic modification.

Stephen Minger, Research & Development Director, Cell Technologies, GE Healthcare, said: “These cardiomyocytes derived from an NIH-approved human stem cell line have physiological attributes analogous to their counterparts in the human body, and are a better and more reproducible tool for the accurate prediction of pharmacological characteristics of drug candidates than other currently used cell models or in vitro tests.”

David J. Earp, J D, PhD Geron’s senior vice president of business development and chief patent counsel, said: “This first product launch is a significant milestone in our partnership with GE Healthcare. It is the result of a close and productive collaboration between the scientific teams in our companies, and we are pleased that these cells will now be available to drug developers.”

GE Healthcare’s human embryonic stem cell (hESC)-derived cardiomyocytes have been highly characterized, in collaboration with ChanTest Corporation, through flow cytometry, subcellular imaging, and electrophysiology for both structural and functional markers, such as α-actinin and electrical activity. The cell supply is representative of a typical cardiac myocyte population, comprising ventricular, atrial and nodal cellular subtypes, the majority being ventricular myocytes.

Dr. Arthur “Buzz” Brown, Executive Chairman and Chief Scientific Officer, ChanTest Corporation, said: “The human cardiac action potential is the cellular basis for the electrocardiogram, which is central to the assessment of risk from non-cardiac drugs and the efficacy of anti-arrhythmic drugs. These hESC-derived cardiomyocytes enhance risk-benefit evaluation and could make the very expensive process of drug development more efficient.”

The cardiomyocytes are available in quantities to match a range of applications, from manual patch clamping to high-content screening, and are delivered cryopreserved for ease of use. They are ready to use on thawing and are viable for at least two weeks once recovered into culture, remaining viable for at least six months while cryopreserved. The source cell line, supplied through a global exclusive agreement with Geron, was derived from an approved human embryonic stem cell line listed on the US NIH Human Pluripotent Stem Cell Registry.

GE Healthcare