Today, VistaGen
Therapeutics announced its membership in the Cardiac Research Safety
Consortium, a public-private partnership launched in 2006 through an FDA
Critical Path Initiative Memorandum of Understanding with Duke University. The
consortium aims to support research efforts that evaluate the cardiac safety of
medical products, drawing upon input from stakeholders from across industrial,
academic, and governmental sectors for data sharing and expertise.
VistaGen
Therapeutics is the creator of CardioSafe 3D™, a novel in vitro bioassay system
capable of predicting the cardiac effects, both toxic and non-toxic, of small
molecule drug candidates with greater speed and precision than alternative,
often-used safety models in drug development. That is inclusive of animal
models and cellular assays that use primary, immortalized, or transformed
cells. VistaGen Therapeutics incorporates use of mature, functional heart cells
differentiated from human pluripotent stem cells for its revolutionary in vitro
bioassay system.
The company’s
CardioSafe 3D™is the central component of the company’s groundbreaking stem
cell technology platform, Human Clinical Trials in a Test Tube™. With its
ability to detect unexpected heart and liver safety issues in drug candidates,
the stem cell technology is said to have tremendous potential for remedying
widespread drug discovery and development crises within the U.S. pharmaceutical
industry. VistaGen Therapeutics will be extending its expertise in cardiac
safety for advancement of research efforts in the consortium.
“We look forward to
partnering with the pharmaceutical, biotechnology, academic, and regulatory
members of the Cardiac Safety Research Consortium, and contributing our
expertise to support rapid advancement of our understanding of cardiac safety.
Cardiac safety, especially identifying proarrhythmic safety concerns of new
drug candidates prior to human studies, drives our internal efforts every day,
and we welcome the opportunity to participate in this innovative process with
the consortium,” said Ralph Snodgrass, Ph.D., VistaGen’s President and Chief
Scientific Officer.
“VistaGen shares our
commitment to improving cardiac safety of new medical products, and its
membership will strengthen CSRC,” commented Mitchell W. Krucoff, MD, FACC,
Professor of Medicine at Duke University and CSRC Co-Chairperson. “We look
forward to a productive, long-term relationship with VistaGen.”
For more information
about VistaGen Therapeutics and its biotechnological initiatives, please visit:
www.vistagen.com
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