Vital Therapies, Inc. (VTI) is targeting the treatment of liver failure with the development of
ELAD®, the first human-cell-based bioartificial liver. Seven clinical trials have been
conducted in the United States, Europe, and China, and a Phase III program in severe acute alcoholic hepatitis is underway in the United States and will be soon underway in Europe and Australia. In addition, a Phase III trial in fulminant liver failure will be initiated later this year.
VTI was formed in 2003 and is based in San Diego, California, USA. 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 have been developed to transport cartridges to point-of-care worldwide within 24 hours.
ELAD
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.
Prior Clinical Trials
Seven human studies have been completed in indications such as fulminant liver failure, acute-on-chronic hepatitis (including one which predominantly enrolled patients with acute flare of viral hepatitis B), and acute alcoholic hepatitis.
Upcoming Pivotal Program
VTI is in the process of finalizing a pivotal clinical trial program designed to support ELAD's potential approval in the United States, Europe, Australia and New Zealand. This program incorporates two randomized, controlled trials in severe acute alcoholic hepatitis and one randomized, controlled trial in fulminant hepatic failure. We expect to initiate this clinical program in Q1 2013.
China
A randomized, controlled pivotal trial was carried out to support the registration of ELAD in China and enrolled 49 patients with acute-on-chronic liver failure at two centers in Beijing. Roughly 70% of patients were suffering from acute flares of viral hepatitis B. The trial demonstrated a statistically significant improvement in transplant-free survival for patients treated with ELAD compared to the control group. 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.
Liver Disease
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.
