Shares of ViaCell swiftly lost about a quarter of their value this morning after the biotech suspended an early-stage trial of its leading cancer treatment after several patients' immune systems rejected the therapy. Two out of eight patients in the trial experienced Grade IV acute graft-versus-host-disease, which can be fatal. Both patients recovered. The trial was focused on the use of CB001, stem cells harvested from umbilical cords that make new blood cells.
"Acute GVHD is a known side effect in transplantation," said Marc D. Beer, president and CEO of ViaCell. "The protocol's mandated stopping point for two cases of Grade IV aGVHD is intended as a standard type of safeguard for Phase I studies to allow us, along with the FDA and the sites, to assess the data. We are fully committed to working diligently with the FDA to find a path forward."
- read this report [1] from the AP for more
Links:
[1] http://www.forbes.com/business/healthcare/feeds/ap/2005/09/19/ap2231144.html