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ELAD(R) Liver Support System Study Initiated at Multiple U.S. Centers
Date:1/6/2009

Program Expands on Successful Results from prior U.S., U.K. and China Trials

SAN DIEGO, Jan. 7 /PRNewswire/ -- Vital Therapies, Inc. (VTI), a development stage company targeting liver disease, today announced patient enrollment has begun for a randomized, controlled, multi-center, Phase 2 clinical trial that will study the Extracorporeal Liver Assist Device (ELAD) as a treatment for patients with Acute Liver Failure (ALF) under three protocols. The study is open for enrollment at seven U.S. sites, which will be expanded to 15 sites in the U.S. and Europe during the first half of 2009. Six patients have already been enrolled in the first protocol and four patients have been treated under the emergency use Expanded Access regulations.

This trial expands on prior results from phase 1 and 2 U.S. and U.K. trials and a pivotal, randomized, controlled clinical trial at two sites in China during 2006/2007. In that study, 69 patients with hepatitis B or C who had suffered ALF were treated with either ELAD or standard therapy. Thirty day transplant free survival rates were statistically significant in the ELAD group vs. concurrent controls. A marketing application was submitted to China's State Food and Drug Administration (SFDA) in September 2007 and is under review.

ALF afflicts more than 30,000 U.S. patients each year including people with chronic liver disease like hepatitis, or without chronic disease, such as individuals whose livers were harmed by taking too much acetaminophen pain medicine.

For ALF patients, liver transplantation is the only therapy proven to impact survival. However, it has a cost exceeding $350,000 and there is a worldwide shortage of livers for transplant. ELAD was designed to address both problems since it may support regeneration of a patient's native liver, or maintain sufficient liver function until a transplant organ is available.

VTI Chairman and CE
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SOURCE Vital Therapies, Inc.
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