Artificial Liver Device Improves Survival for Hepatitis B and C Patients with Decompensated Disease

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HIV and Hepatitis.com Coverage of the

61st Annual Meeting of the American Association for the Study of Liver Diseases

(AASLD 2010)

October 29 - November 2, 2010, Boston, MA

Artificial Liver Device Improves Survival for Hepatitis B and C Patients with

Decompensated Disease

SUMMARY: An artificial liver device known as ELAD -- which runs a patient's

blood through cartridges containing human liver cells -- conferred a significant

survival advantage for people with acute decompensated liver disease related to

chronic hepatitis B or C, according to a Chinese study presented at the recent

American Association for the Study of Liver Diseases " Liver Meeting " (AASLD

2010) in Boston. After 3 years, 44% of ELAD users were still alive without liver

transplants, compared with 18% in the standard therapy group.

Below is the text of a press release issued by ELAD developer Viral Therapies

describing the study and its findings.

Three-Year Follow-Up Data Confirm Safety and Survival Benefit In

Chinese Liver Failure Patients Treated With ELAD Bioartificial Liver

October 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.

The 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. 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.

Previously, 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.

Dr. 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. "

Dr. 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. "

In 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.

ELAD 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.

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 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.

12/14/10

Reference

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 1610.

Other Source

Vital 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.