Healthcare Industry News: Liver Assist Device
News Release - January 4, 2007
ELAD(R) Bioartificial Liver Trial in China Achieves Significance at Halfway PointSAN DIEGO and BEIJING, Jan. 4 (HSMN NewsFeed) -- Vital Therapies, Inc. (VTI) announced today that it has completed the interim analysis of the first 45 patients enrolled in its controlled, randomized, two-center, single-treatment trial in China for the ELADŽ (Extracorporeal Liver Assist Device) System. The trial is studying a bioartificial liver treatment in patients with chronic liver disease at Beijing Youan and 302 Military Hospitals in Beijing. The preliminary data indicate that ELAD has already achieved statistical significance in the endpoint of transplant-free survival.
"We have been very pleased with the clinical response we have seen in patients suffering from an acute exacerbation of chronic liver disease," said Duan Zhong-Ping, M.D., lead investigator and professor of Beijing Artificial Liver Treatment & Training Center and vice president, Beijing Youan Hospital. "Our center has treated a large number of patients with other mechanical and bioartificial liver treatments, and although the data with ELAD is preliminary, none has looked more promising than ELAD to impact a patient's long-term survival from a single treatment. The response of ELAD treated patients is best explained by regeneration of the liver since the improvement continues long after ELAD is discontinued."
ELAD augments the metabolic functions of a patient's liver, thereby enabling a bridge to transplant or liver recovery. The system differs from the mechanical filtration systems in development by using an immortalized line of human liver cells which, in addition to processing and removing blood toxins, can also supply to the patient metabolites synthesized by the liver, such as blood clotting proteins.
The statistics for the 42 evaluable patients showed that, at this point in time, the endpoint of transplant-free survival has already achieved statistical significance. The Kaplan Meier survival curves showed a p value for the difference between the treated and control groups of 0.03 (Wilcoxon basis). A p value of 0.05 and below is generally accepted as the standard for statistical significance in such a trial.
"While the p values will change as data continues to be generated, it is encouraging to be achieving these kinds of values halfway through the trial," added Dr. Duan.
Consistent with the recoveries that have been noted by the physicians among the patients in the trial, other measures also indicate the success of the trial to date, such as:
*8 of 14 (57 percent) controls have either died or had to be transplanted versus 7 of 28 (25 percent) treated patients.
*Biochemistry measures such as bilrubin, INR, Albumin and MELD scores, and clinical observations such as ascites, appetite and fatigue are also showing expected improvements in treated patients versus controls.
"VTI is grateful to its outstanding staff in San Diego and in China for the smooth implementation of the trial," said Terry E. Winters, Ph.D., VTI chairman and CEO. "We are also grateful to the tireless staff at the hospitals for treating the patients and to the Chinese authorities for their cooperation in importing ELAD into China to treat these very sick patients. We have received positive clinical response and strong support from our clinical trial physicians as well as our Clinical Advisory Board. Additionally, we are thrilled at the flawless scale up of manufacturing and the logistics of providing ELAD cartridges to China. This has given us the confidence to be able to provide commercial quantities of ELAD cartridges to China from our plant in San Diego starting with the planned market launch in late 2007."
These data were reviewed internally with the Vital Therapies Clinical Advisory Board (CAB), which includes eight prominent U.S. and European clinical experts in the field of hepatology and liver transplant surgery. CAB Chairman, J. Michael Millis, M.D., professor of Surgery and chief, Section of Transplantation University of Chicago, said: "This is clearly the most promising data on artificial livers ever generated. This experience in China and these data will provide the knowledge to enable the CAB to assist in developing an excellent protocol for the phase 3 U.S. FDA studies, which the company plans to begin in late 2007."
VTI is now seeking a Series C private equity financing in the United States and China for both the commercial launch in China as well as the implementation of phase 3 studies in the United States.
About the Study
This study is a controlled, randomized, two-center, single-treatment trial in China for the ELADŽ (Extracorporeal Liver Assist Device) System. The trial is being run at Beijing Youan and 302 Military Hospitals in Beijing and will continue enrolling until the planned 90 patient total is achieved. The first patient was enrolled in March, and the analysis covers the nine months through November 30. At that time, 26 of the 42 patients had either completed the 84 day trial, died or been transplanted. Patient enrollment criteria included seriously ill patients with acute on chronic liver failure who were estimated to have a 50 percent probability of mortality in 30 days.
There have been no significant safety issues attributable to ELAD. The sole serious adverse event was not attributed to ELAD. Thrombocytopenia, which was expected in this patient group, was handled with platelet transfusions. The live C3A cell cartridges for this trial have been grown at VTI's production facility in San Diego and shipped to China within a 24 hour window to treat each patient.
This trial has been conducted in China under an allowance from the State Food and Drug Administration (SFDA). At the conclusion of the trial, the results will be submitted to the SFDA and may also be submitted to regulatory authorities in other countries as part of the basis for allowance of pivotal trials.
About Liver Disease
According to the World Health Organization (WHO), severe liver disease annually affects approximately 12 million patients worldwide. In China, hepatitis is the third most prevalent disease, over 140 million people are infected with a hepatitis virus and 32 million people have active viral liver disease. In China, over 400,000 people die each year from liver disease. Official estimates suggest that China's yearly medical expenses for liver disease infections are more than $12 billion.
The ELADŽ system provides important metabolic support for patients with severe liver failure, thereby enabling a bridge to recovery or transplant depending on the type and severity of liver disease. The system consists of four cartridges containing cells that function like a normal human liver by metabolizing toxins and removing waste products while delivering essential proteins back into the plasma. These cartridges are incorporated into a blood pumping system at the patient's bedside and enable continuous patient treatment for up to 12 days. The key to the performance of ELAD is its utilization of a proprietary human hepatocyte cell line, C3A, an immortalized cell line that can be grown, stored and shipped worldwide.
About Vital Therapies, Inc.
Vital Therapies, Inc. (VTI) is a private San Diego-based liver therapy company. VTI is developing the first human-liver cell-based system, ELADŽ (Extracorporeal Liver Assist Device), which provides important metabolic support for patients with severe liver failure. For more information, please visit: www.vitaltherapies.com
Source: Vital Therapies
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