13, 2010 -- Vital Therapies, Inc., (VTI) 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 bioartificial liver support system are maintained for
up to three years.
poster is titled "3-year follow-up of acute-on-chronic liver failure
(ACLF) subjects in randomized, controlled, multicenter trial of ELAD
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.
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.
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."
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."
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.
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.
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.
Investigator affiliations: Artificial Liver Treatment and Training Center,
Beijing, China; You'an Hospital of Capital Medical University, Beijing,
China; Department of Infectious Diseases, 302 Military Hospital of China,
Beijing, China; Transplant Center, Section of Transplantation, University
of Chicago, Chicago, IL.
Z Duan, S Xin, J Zhang, and others. 3-year follow up of acute-on-chronic
liver failure (ACLF) subjects in a randomized, controlled, multicenter
trial of the ELAD Bioartificial Liver Support System in 49 Chinese subjects
reveals significant transplant-free survival (TFS) benefit. 61st Annual
Meeting of the American Association for the Study of Liver Diseases
(AASLD 2010). Boston, October 29-November 2, 2010. Abstract
Therapies, Inc. Three-Year Follow-Up Data Confirm Safety And Survival
Benefit In Chinese Liver Failure Patients Treated With ELAD Bioartificial
Liver. Press release. October 13, 2010.