Three-Year Follow-Up Data Confirm Safety and Survival Benefit in Chinese Liver Failure Patients Treated With ELAD(R) Bioartificial Liver

By Vital Therapies Inc., PRNE
Tuesday, October 12, 2010

Poster presentation scheduled at AASLD November 2nd

SAN DIEGO, October 14, 2010 - Vital Therapies, Inc., (VTI) today announced that a poster is being
presented at the American Association for the Study of Liver Diseases (AASLD)
meeting in Boston on Tuesday, November 2nd. It confirms that previously
reported findings of improved transplant free survival (TFS) in Chinese
subjects with acute-on-chronic liver failure (ACLF) treated with the ELAD(R)
bioartificial liver support system are maintained for up to three years.

The poster is titled "3-year follow-up of acute-on-chronic liver failure
(ACLF) subjects in randomized, controlled, multicenter trial of ELAD(R)
bioartificial liver support system in 49 Chinese subjects reveals significant
transplant-free survival (TFS) benefit." It is being presented by Dr. Michael
Millis
, Professor of Surgery, University of Chicago, and is coauthored by
Drs. Zhongping Duan and Jing Zhang, Beijing You'an Hospital, and Shaojie Xin
and Shaoli You, 302 Military Hospital, Beijing.

Previously, it was reported that 84-day follow-up of ACLF subjects
enrolled at two liver treatment centers in China showed statistically
significant improvements in TFS for ELAD treatment compared with standard of
care (SOC). At least three years following enrollment, survivors were
consented and underwent a cancer screen and physical exam in accord with a
questionnaire.

Of 49 subjects enrolled, 84-day TFS was 21/32 (65.6%) in the ELAD group
vs. 7/17 (41.1%) in controls. Three-year TFS was 14/32 (43.8%) in the ELAD
group vs. 3/12 (25%) in controls. Of 84-day survivors, 2/21 (9.5%) ELAD and
2/7 (28.6%) controls died, 1/21 (4.8%) ELAD and 0/7 controls were
transplanted and 4/21 (19.0%) ELAD and 2/7 (28.6%) controls were lost to
follow-up. Survival analysis reveals a statistically significant improvement
in TFS (p=0.045, log-rank analysis) for the ELAD treated subjects compared
with SOC. Median survival of controls was 37 days, whereas median survival of
ELAD treated subjects was at least 3 years. There was no evidence of tumor
development in either group.

Dr. Millis commented, "This is the first time that a long term survival
benefit has been demonstrated in subjects who recovered following treatment
with ELAD. It is highly encouraging to note that those subjects that survive
in the short term are able to go on to extended survival without any apparent
increase in mortality or morbidity compared with subjects administered
standard of care."

Dr. Duan, who served as a principal investigator for the study,
commented, "China has about 95 million HBV carriers and chronic hepatitis B
patients, and 38 million hepatitis C patients. It is estimated that 0.1%-0.5%
of these patients will experience severe hepatitis due to acute
hepatocellular necrosis or hypofunction, which results in hepatic
insufficiency and hepatic failure. Mortality from this condition still
remains around 50%-70% even with comprehensive internal medicine treatment,
leading to as many as 400,000 deaths per year in China from acute liver
failure. When approved for commercial sale in China, ELAD will be the first
bioartificial liver support system proven to improve survival in this
population."

In order to confirm these findings from China, VTI is conducting the
SILVER (Stabilization In LiVER Failure) trial in the United States, Europe
and Saudi Arabia which has achieved 50% of its targeted enrollment. Should
this study yield positive findings, these results, along with data from other
studies, will form the basis of regulatory filings for future marketing
authorization.

About ELAD and the SILVER Trial

The SILVER protocol enrolls subjects with chronic liver disease who have
been hospitalized as a result of an event, such as an infection or an episode
of bleeding, which has caused deterioration of their liver function
(acute-on-chronic liver failure, ACLF). The trial is designed to explore
whether the use of ELAD in this setting can prevent continued deterioration
of liver function, called progression, and thus improve survival. The trial
design uses a well-established measure of liver function called the MELD
score to define the status of liver function. Treatment with ELAD, along with
standard of care, is compared with standard of care alone. The time to either
death or deterioration of liver function by a pre-specified amount is
measured. It is postulated that the use of ELAD may extend the time to
progression and improve survival in this rapidly progressing patient
population.

ELAD is a biologic liver support system using a proprietary line of
allogeneic human liver cells refined by several leading cell experts. The
cells are stable, immortal, can be grown in unlimited quantities and retain
their hepatocyte (liver cell) characteristics. About one pound of cells is
used for each treatment. The cells are grown in specially designed cartridges
at VTI's cell culture facility and used to treat the patient for up to ten
days.

About Vital Therapies, Inc.

Vital Therapies, Inc. (VTI) is based in San Diego, California, with a
wholly owned subsidiary in Beijing, China. VTI is developing the first human
liver cell-based Extracorporeal Liver Assist System (ELAD). ELAD could
provide support for patients with severe liver failure by processing toxins
and also synthesizing proteins and metabolites that are key products of
normal human liver function. ELAD is in investigational clinical trials and
VTI completed a pivotal trial and filed for market approval in China in
September 2007. For additional information visit
www.vitaltherapies.com or contact Terry Winters, PhD, CEO, Vital
Therapies
at +1-858-673-6840.

ELAD is a trademark of Vital Therapies, Inc.

Terry Winters, PhD, CEO of Vital Therapies, +1-858-673-6840

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