Vital Therapies, Inc., (VTI) is pleased to announce 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®, can prevent deterioration of liver function and improve the survival of patients 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. For a full listing of clinical trial sites and further information on the trial, please see www.clinicaltrials.gov .
National Guard Hospital in Riyadh is one of the few hospitals in the Middle East to be recognized for the conduct of multi-center international clinical trials. The Hospital has participated in several multinational clinical trials in the past. The Principal Investigator in the trial, Dr. Ahmed Al Jabbary, said, "We are delighted to be a site for the SILVER clinical trial. Several of our nurses and physicians have been trained in the conduct of ELAD therapy at VTI's San Diego facility and are ready to assist in the subject treatments. The logistics of the shipment of the live human liver cells in the ELAD cartridges have been addressed and we expect to be treating each subject within 36 hours of shipment of the cartridges from VTI's plant in San Diego, California".
In addition to being a Expanded Access (compassionate use)SILVER trial site, National Guard Hospital is also part of VTI's program. One subject has already been treated in K.S.A. under this program.
The need for liver support therapies in K.S.A. and the Middle East should be substantial due to the high prevalence of hepatitis A, B and C infection and the low incidence of liver transplantation in the region. Including an investigational site in K.S.A. will enable the early submission of a local marketing application when the trial is completed.