Vital Therapies Expands SILVER Trial to Saudi Arabia
Bioartificial Liver Trial Now at Halfway Point
Vital Therapies, Inc., (VTI) announced that the first subject has been enrolled at National Guard Hospital in Riyadh, Kingdom of Saudi Arabia( K.S.A.) in the further expansion of its silver (Stabilization In LiVER Failure) clinical trial to the Middle East. The trial is evaluating whether VTI's biological cellular therapy product, ELAD(R), can prevent deterioration of liver function and improve the survival of subjects with acute-on-chronic liver failure (ACLF).
The SILVER trial is an open label, multi center, controlled and randomized trial. To date, 40 subjects have been enrolled at 14 clinical sites in U.S. (11), U.K. (2) and K.S.A. More than 20 sites should eventually enroll a total of 80 or more subjects in a 1:1 treated- to-control ratio. If successful, the resulting data will provide the basis for a Biological License Application (BLA) in the U.S., a Marketing Approval Application (MAA) in Europe, and a marketing approval application in K.S.A.
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