ELAD® System Clinical Trials

The development of ELAD is focused on evaluating whether ELAD can provide clinical benefit in patients with Acute-on-Chronic Liver Failure and Fulminant Hepatic Failure. Six clinical trials have been completed. Two initial trials were completed under an IDE from the US FDA, one at Baylor College of Medicine and the other at Kings College in London.

Three trials were conducted under an IND from the US FDA at twelve different clinical sites in the US & UK.

The fifth of the six clinical trials, a registration trial for China, was conducted in Beijing, China under SFDA regulations. The China trial results, which will have to be confirmed in the US trials, demonstrated statistically significant improvement in transplant free survival for acute-on-chronic liver failure patients treated with ELAD compared to the control group. These patients were mostly suffering from hepatitis B infection. VTI filed for marketing approval with the China SFDA in September 2007 and the application is under review.

A total of 122 patients have been treated with the ELAD System. While the total number of patients treated with the product is relatively small the following observations can be made:

• The product appears to be well tolerated.
• Clinical endpoints suggest a difference in outcome between the treated and control patients.
• The investigators who participated remain interested in the potential of the ELAD System.

VTI also maintains a selective compassionate use program in USA under the FDA Expanded Access program. This program is structured so as not to interfere with the progress of clinical trials directed towards gaining marketing approval for ELAD in the United States.

For more information go to www.clinicaltrials.gov