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
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.
Clinical Trials
Six human studies have been
completed
China
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.
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.
