Navigation Links
ELAD(R) 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, 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,

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:
(Date:11/26/2015)... -- Research and Markets ( ) has announced ... by Type (Dressings, Therapy Devices, Active Wound Care), Application ... and Geography - Global Forecast to 2020" report ... --> The purpose of this report is ... global advanced wound care market. It involves deep dive ...
(Date:11/26/2015)... India , November 26, 2015 ... --> adds ... Report" and "Investigation Report on China ... and 2021 forecasts data and information ... . ...
(Date:11/26/2015)... , Nov. 26, 2015 Research and ... of the "2016 Future Horizons and Growth ... Market: Supplier Shares, Country Segment Forecasts, Competitive Intelligence, ... --> --> ... of the Italian therapeutic drug monitoring market, including ...
Breaking Medicine Technology:
(Date:11/25/2015)... ... November 25, 2015 , ... ... the perfect dish and pleasing the palates of attendees is of the utmost ... dish to a seasonal get-together, give these recipes a try this holiday season. ...
(Date:11/25/2015)... , ... November 26, 2015 , ... ... Commission (AUC), European Union (EU), ANDI Pan African Centres of Excellence, and public ... in Nairobi (UNON) for the opening of the 5th African Network for Drugs ...
(Date:11/25/2015)... ... November 25, 2015 , ... Dental professionals who would like to become more ... to attend Dr. Mark Iacobelli’s Advanced Implant Mentoring (AIM) CE course. Courses will be ... As the co-founders of Advanced Implant Mentoring (AIM), Dr. Iacobelli and Dr. D’Orazio are ...
(Date:11/25/2015)... ... ... Smiles by Stevens is pleased to announce the addition of Botox® for the ... of the benefits of Botox® in the treatment of moderate facial wrinkling, few have ... pain as a result of Jaw Tension, TMJ (temporo-mandibular joint) disorder, and Bruxism (the ...
(Date:11/25/2015)... (PRWEB) , ... November 25, 2015 , ... “While riding ... an inventor, from Bronx, N.Y. “I thought there had to be a convenient and ... the PROTECTOR. , The PROTECTOR enables disabled individuals to safely travel during cold or ...
Breaking Medicine News(10 mins):