14 Nov Cellular Dynamics International lands $500,000 SBIR grant
Madison, Wis. – Cellular Dynamics International, a Madison-based company co-founded by stem cell research pioneer James Thomson, has received a small business innovation research grant worth $499,796 from the National Institutes of Health to develop stem-cell derived heart cells for clinical studies.
The cells, called human cardiomyocytes or CMs, hold the promise of providing a more predictive model to determine cardio toxicity in the early stages of drug development. With the grant, CDI said it would use human pluripotent stem cells to derive pure populations of cardiomyocytes for development of preclinical models, and create the cells in quantities required for drug development.
It is the second SBIR grant awarded CDI this year, for a combined total of approximately $1 million. The company is using pluripotent stem cells, which have the ability to become any cell in the human body, to develop new tools for drug discovery, screening, and predictive toxicology.
The preclinical models would be conducted to more accurately predict cardiac toxicity in humans during the early stages of drug discovery, and allow for early detection of drug toxicity. In addition, the preclinical models would be conducted to improve safety by significantly reducing the chances of a cardio-toxic compound from reaching a clinical population.
Pharma issues
In the pharmaceutical industry, cardiac safety concerns have become one of the leading causes of drug failure, and the company believes that cardiac safety testing can best be accomplished using human cardiomyocytes. Detecting the potential toxicity of a compound “long before evaluating it in patients” is a clear priority for the pharmaceutical industry, according to CDI co-founder Craig January, a practicing cardiologist and professor in the University of Wisconsin-Madison, School of Medicine and Public Health.
To predict whether a drug will cause dangerous and possibly lethal side effects in people, the U.S. Food and Drug Administration mandates both preclinical and clinical cardiac safety studies for all new drugs in development. According to Cellular Dynamics, the problem with existing methods of cardio-toxicity prediction is that they rely on uncertain animal models that are non-cardiac in origin, which adds to the high cost of drug development.