Vital
Therapies, Inc. (VTI) is targeting the treatment of liver
disease and is developing the first human liver
cell-based Extracorporeal
Liver Assist Device (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 subsidary in
Beijing, China. ELAD manufacturing is carried out in San
Diego in a GMP compliant facility. Manufacturing capacity
has been 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 could provide metabolic support for
patients with severe 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 Trails
Five human studies have been
completed and a phase 2 trial began enrollment in the USA
in September 2008.
China
The China trial enrolled 69 patients and was
run for registration purposes 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 the USA study.
Liver Disease
The World Health Organization
recognizes liver disease as a significant health problem.
Liver transplantation is the only therapy proven to extend
survival 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. ELAD has the potential to
improve survival, quality of life and the cost of care in
both chronic and fulminant patients who experience liver
failure.
