Vital Therapies, Inc. (VTI), announced today data from two studies of the company's ELAD(R) (Extracorporeal Liver Assist Device) System were presented at the 2007 American Association for the Study of Liver Diseases (AASLD) Annual Meeting, which was held November 2-6 in Boston, Mass.
-- Abstract (#91), "Interim results of Randomized Controlled Trial of
ELAD(R) in Acute on Chronic Liver Disease," was presented in a
parallel session on Monday, November 5th. This controlled, randomized
(2:1) clinical trial enrolled 69 patients with acute-on-chronic liver
failure in two protocols at two centers in Beijing, China. The first
49 patient protocol resulted in a 30 day transplant-free survival rate
of 50% in the controls and 87% in the treated group (p<0.01). The
second protocol, which had a shorter ELAD(R) treatment time, did not
reach statistical significance. Initial conclusions from this trial
demonstrated ELAD(R) is safe and effective in this patient population
when used with the longer treatment time.
-- Abstract (#855), "ELAD(R) Cellular and System Performance
Improvements," was a poster presentation detailing the metabolic
characteristics of the ELAD(R) cartridges in order to optimize
performance.
Terry Winters, Ph.D., Chairman and CEO said, "These data are consistent with our previous research and experience. ELAD is helping patients and the technology continues to be refined for optimum benefit. These are positive developments as we apply for marketing approval in China and advance our U.S. clinical program."
To date, only liver transplantation has been shown to increase survival. However, demand for liver transplantation far exceeds the supply of donor livers, creating a need for an alternative, lifesaving therapy such as ELAD(R). In China alone, an estimated 160 million people suffer from chronic liver infections such as Hepatitis B and C.
About ELAD(R) (Extracorporeal Liver Assist Device)
The ELAD(R) system provides important metabolic support for patients with liver failure, enabling a bridge-to-transplant or recovery, depending on the type and severity of liver disease. The system consists of four cartridges containing cells that function like normal human liver hepatocytes. The cells metabolize toxins and remove waste products while delivering essential proteins into the plasma. These cartridges are incorporated into a blood pumping system at the patient's bedside and enable continuous treatment for up to 12 days. The key to ELAD's(R) performance is a proprietary human hepatocyte cell line that can be grown, stored and shipped worldwide.
About Vital Therapies. Inc.
Vital Therapies, Inc. is a private San Diego-based liver therapy company that was founded in 2003. It is developing the first human liver cell-based system which provides important metabolic support for patients with severe liver failure. The company's manufacturing facility meets cGMP specifications to produce ELAD cartridges for patient treatment.
For more information, please visit VTI's Website at http://www.vitaltherapies.com/
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