Vital Therapies, Inc. ELAD Extracorporeal Liver Assist Device


	ELAD^® First human cell-based liver support therapy.


	The Rush To Test Drugs In China

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Vital Therapies, Inc. (VTI) is a new company formed in 2003 to continue the development of the ELAD^® (Extracorporeal Liver Assist Device) System, which augments the metabolic functions of a patient’s liver, thereby enabling a bridge to transplant or liver recovery. VTI acquired the assets and business of VitaGen/Hepatix.

ELAD^® cartridge

The sole therapy for serious liver disease is transplantation. In 2002, over 5,000 liver transplants were performed in the United States, restricted by available donor organs: another 17,000 patients are on the transplant waiting list. Many of the patients on the list die while waiting for a transplant.

In a market study done for VTI by Easton Associates in October 2003, they concluded that there were 21,290 patients eligible for ELAD^® therapy in the US in 2003 and that the theoretical market potential in the US is $1.08 Billion/year. Most of these patients are in the Fulminant Hepatic Failure (FHF), Acute Alcoholic Hepatitis, Sub-Fulminant and Acute-On-Chronic groups with the largest growth predicted in the latter due to incipient hepatitis. The ex-US market is larger due to hepatitis and cultural resistance to transplantation.

Baylor College of Medicine in Houston formed Hepatix in 1990 which developed the ELAD^® initial prototype used on 23 patients in two clinical trials with promising results. The product was then evaluated in Phase I and Phase II trials in a total of 44 patients (29 active and 15 controls) under an Investigational New Drug (IND) application, allowed by the Food and Drug Administration (FDA), at twelve centers in the United States and England. These trials demonstrated the safety of the ELAD^® System and the clinical data showed improvement over controls in bridge to transplant, survival and withdrawal of treatment as futile. ELAD^® is currently being evaluated in a pivotal clinical trial in China for acute-on-chronic liver failure.

The key employees from VitaGen in the area of clinical, manufacturing, quality control, process engineering and operations were retained and have a very strong commitment to successfully developing this product for liver therapy.

The manufacturing facility in San Diego consists of a class 10,000 clean room and all of the assets to produce ELAD^® cartridges for patient treatment to cGMP specifications. There is adequate capacity to produce cartridges for the clinical trials necessary for approval and also for the first year of commercial operations. All of the logistics necessary to transport the cartridges to the trial sites have been worked out.