ELAD(R) Liver Support System Study Initiated At Multiple U.S. Centers

Main Category: Liver Disease / Hepatitis
Also Included In: Clinical Trials / Drug Trials;  Medical Devices / Diagnostics
Article Date: 08 Jan 2009 - 0:00 PDT

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Vital Therapies, Inc. (VTI), a development stage company targeting liver disease, 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, Ph.D., 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 http://www.clinicaltrials.gov

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.

ELAD is a trademark of Vital Therapies, Inc.

Vital Therapies, Inc.
http://www.vitaltherapies.com