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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