Vital Therapies, Inc. (VTI) is targeting the treatment of liver disease and is developing the first human liver cell-based ELAD® which is in investigational clinical trials in USA and China.
VTI was formed in 2003 and is based in San Diego, California, USA, with a subsidiary in Beijing, China. ELAD manufacturing is carried out in San Diego in a GMP compliant facility. Manufacturing capacity was expanded during 2008 to produce cartridges for both clinical trials and potential commercialization. Systems to transport cartridges to point of care worldwide within 24 hours have been developed.
ELAD has been designed to stabilize liver function in patients with life-threatening, acute liver failure by processing toxins and synthesizing proteins that are key products of normal human liver function, possibly enabling a bridge to transplant or liver recovery.
Six human studies have been completed
The pivotal China trial enrolled 49 patients and was carried out to support the registration of ELAD in China. It demonstrated statistically significant improvement in transplant free survival for acute-on-chronic liver failure patients treated with ELAD compared to the control group. These were mostly hepatitis B patients. VTI filed an application for marketing approval with the China SFDA in September 2007 and this application remains under review. These results remain to be confirmed in studies outside China.
The World Health Organization recognizes liver disease as a significant health problem. Liver transplantation is the only therapy proven to extend survival in liver failure patients, but the waiting list for liver transplants is extensive and many on the list will not receive an organ due to a shortage of donors. Many more patients do not qualify for transplantation. By stabilizing liver function in patients during the acute phase of liver failure ELAD has the potential to improve survival, quality of life and the cost of care for patients with a broad spectrum of severe liver disease.