Vital
Therapies Starts Phase 2 Trial of Artificial Liver Support System
Over
years or decades, chronic hepatitis B virus (HBV)
or hepatitis C virus (HCV) infection can lead
to advanced liver disease, including cirrhosis
and hepatocellular carcinoma.
Liver transplantation
is the only treatment for end-stage liver disease, but many patients die before
receiving a transplant due to the severe shortage of donor organs. Researchers,
therefore, have explored various liver assist technologies, or "artificial
livers," to keep patients alive while waiting for a transplant. Artificial
Liver Support System
 Below
is an edited excerpt from a recent press release from Vital Therapies, Inc. describing
progress in a clinical trial of one such device.
ELAD
Liver Support System Study Initiated at Multiple U.S. Centers Program
Expands on Successful Results from prior U.S., U.K. and China Trials
San
Diego, CA -- January 7, 2009 -- 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 CEO Terry
Winters, PhD, said, "With the continuing shortage of donor livers for transplantation
and the large number of patients unlisted for transplant, patients are dying who
do not have access to a donor liver or a living donor transplant. Our goal is
to get ELAD to market as soon as possible so patients with ALF may have another
treatment option."
VTI is currently enrolling
patients in three separate protocols:
Two are randomized,
controlled studies of patients with ACLF (Acute-on-Chronic Liver Failure) or FHF
(Fulminant Hepatic Failure). Continuous ELAD treatment is for a minimum of three
and a maximum of 30 days.
The third is an Expanded Access protocol with
cost recovery allowing emergency treatment of patients who do not qualify for
the first two protocols.
For more details on the protocols and study sites,
please go to www.clinicaltrials.gov [search for "ELAD"].
About
ELAD
ELAD is a bedside system whose central component is
four cartridges containing 440 grams of immortalized human liver cells and 32,000
hollow fibers. The patient's plasma flows inside of the hollow fibers to allow
two-way transfer of metabolites. During ELAD therapy the cells metabolize toxins
and synthesize proteins and other liver specific products essential for life.
The ELAD cell cartridges are produced at VTI's GMP-compliant facility in San Diego,
California.
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 Device (ELAD). ELAD could provide support for patients with severe
liver failure by processing toxins and 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 more information, visit www.vitaltherapies.com. |
1/20/09
Source Vital
Therapies, Inc. ELAD Liver Support System Study Initiated at Multiple U.S. Centers.
Press release. January 7, 2009.
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