Cardiac Safety Evaluation
NEXEL’s NeXST Cardiac Safety Service helps researchers make informed decisions during drug development. While current safety guidelines have addressed hERG-related risks, concerns remain about the assay’s accuracy. hERG inhibition doesn’t always lead to QT prolongation in patients. Other ion channels, calcium handling, and contractility factors, not assessed by hERG assays, can also impact cardiac safety. NEXEL, a member of the HESI CiPA working group, is involved in revising ICH guidelines to mandate novel assays, including iPS-Cardiomyocytes, in preclinical toxicity testing.
GV Research Platform (GVRP), in collaboration with Nexel will provide Nexel’s proprietary NeXST and associated cardiac safety services in India, bringing advanced technology to the forefront of research and development in the region.
Cardiac Safety (Predicting proarrhythmic risk of investigational drugs)
Evaluating the impact of drugs on multiple ion channels within cardiomyocytes, NeXST, ISO 17025 certified, is enhancing Cardiomyocyte Viability by providing precise predictions of proarrhythmic risk (TdP, Torsade de Pointes) for investigational drugs. This aligns with the CiPA-initiated assessment method outlined in the new ICH Guideline.
Applications
* Proarrhythmic risk screening at early drug discovery (hit to lead).
* Optimal dose screening for preclinical study.
* Cardiac safety pharmacology study for IND filing of investigational drugs (after adoption of new ICH E14/S7B).
