Navigation Links
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 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 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.


'/>"/>
SOURCE Vital Therapies, Inc.
Copyright©2009 PR Newswire.
All rights reserved

Related medicine technology :

1. Vital Therapies Announces Presentation of ELAD(R) Artificial Liver Data at American Association for the Study of Liver Diseases 2007 Annual Meeting
2. Tibotec Presents Interim Findings for TMC435, an Investigational Genotype 1 Hepatitis C Treatment, at the AASLD Liver Meeting 2008
3. GSK Believes There Is No Liver Safety Issue With AVANDIA; Responds to Public Citizen Petition
4. Jennerex Completes the Treatment of First Patient Cohort in Phase 1 Trial With Intravenous Delivery of JX-594 Oncolytic Virus
5. Experts Assert That Varian Technologies Deliver Speed and Clinical Accuracy in Treating Cancer Patients
6. CEL-SCI Expects to Take Delivery of New Manufacturing Facility on October 8, 2008
7. Oramed Pharmaceuticals Launches GLP1-Analog Program, Based on its Proprietary Drug Delivery Platform
8. New Data Support Earlier Suggested Guidance for Levels of Cell-Mediated Immunity in Pediatric Liver Transplant Patients
9. Bayer and Onyx Begin Enrollment in STORM Trial Studying Nexavar as Adjuvant Therapy for Patients With Liver Cancer
10. The New England Journal of Medicine Publishes Nexavar(R) Study Demonstrating Significant Improvement in Overall Survival in Patients With Liver Cancer
11. Jennerex Publishes Clinical Trial Data With Lead Product JX-594 Demonstrating Efficacy Against Liver Cancer and Associated Hepatitis B Virus
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/11/2017)... , July 11, 2017  Bayer has awarded grants totaling ... as part of its prestigious Bayer Hemophilia Awards Program (BHAP). ... Philadelphia and Uniformed Services University of ... among the winners. Grant recipients were announced last night during ... (ISTH) 2017 Congress, Berlin, Germany . ...
(Date:7/11/2017)... of Echenberg Institute, is announcing a new safe and effective at-home VuVa ... other painful pelvic pain conditions such as pelvic floor dysfunction, vulvodynia, vulvar ... ... VuVa ... company, VuVatech LLC, fills a void in the women,s wellness market because ...
(Date:7/10/2017)... 2017 The Institute for In Vitro Sciences ... recipient of a VITROCELL® inhalation exposure system thanks to ... The device, which is designed to replace animals in ... cells to airborne test materials in an environment that ... system for testing combustible tobacco products, as well as ...
Breaking Medicine Technology:
(Date:7/27/2017)... ... July 27, 2017 , ... ... from 2012-2016, will keynote Day 2 of the HIMSS Healthcare Security Forum, the ... at the Sheraton Boston Hotel, Sept. 11-13, 2017. , Daniel will deliver his ...
(Date:7/26/2017)... ... July 26, 2017 , ... Capillus, LLC has announced ... hair loss. The new Flexible Fitting Design offers a more comfortable, adaptable fit and ... delighted with the improvements to the home-use laser therapy caps intended to improve both ...
(Date:7/26/2017)... , ... July 26, 2017 , ... Six greater Bay Area roller derby leagues are ... ‘em Bleed,” the most widely attended series of blood drives in California, beginning July 29. ... over the past 4 years -- enough to have helped to save up to 2700 ...
(Date:7/26/2017)... , ... July 26, 2017 , ... A major challenge ... Inconsistent results freeze drying samples and a lengthy freeze dry cycle are a few ... discuss freeze drying techniques, as well as new accessories and advancements in laboratory freeze ...
(Date:7/26/2017)... ... 2017 , ... “We are dentists and we thought there could be an ... we invented the MAGNETIC/ LOCK BRACKETS.” , The patent-pending MAGNETIC/ LOCK BRACKETS provides an ... it offers an effective alternative to traditional braces. As a result, it enhances comfort ...
Breaking Medicine News(10 mins):