SAN DIEGO, Sept. 16 /PRNewswire/ -- 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.
About Vital Therapies, Inc.
Vital Therapies, Inc. (VTI) is based in San Diego, California, with a wholly owned subsidiary in Beijing, China. VTI is developing the first human liver cell-based Extracorporeal Liver Assist System (ELAD). ELAD could provide support for patients with severe liver failure by processing toxins and synthesizing proteins and metabolites that are key products of normal human liver function. ELAD is in investigational clinical trials and VTI completed a pivotal trial and filed for market approval in China in September 2007. For additional information visit www.vitaltherapies.com or contact Terry Winters, PhD, CEO, Vital Therapies at +1 858 673 6840. ELAD is a trademark of Vital Therapies, Inc.
About National Guard Hospital
King Fahad National Guard Hospital in Riyadh commenced its operations in May 1983. Since then, it has continued expanding, while providing services for a rapidly growing patient population in all of its catchment areas. Today, King Fahad National Guard Hospital has evolved to be part of the King Abdulaziz Medical City with many other prominent medical centers. Since its inauguration in February 2001; and within a short period, KAMC has been recognized as a distinguished healthcare provider.
KAMC is a JCI accredited healthcare provider and has been re-accredited recently in December 2009 with the JCI "Gold Seal of Approval" with excellent results. This is in recognition of KAMC's continual improvement in patient safety, quality care according to international standards, utilization of their education and consultation services, and an ability to match international benchmarks in patient health care.
The Arab Health Exhibition 2010 awarded KAMC "Excellence in Electronic Health Records Award" in recognition of their outstanding achievements in the development of quality medical care and high levels of health care services in the Middle East.
About ELAD and the SILVER Trial
The SILVER protocol enrolls subjects with chronic liver disease who have been hospitalized as a result of an event, such as an infection or an episode of bleeding, which has caused deterioration of their liver function (acute-on-chronic liver failure, ACLF). The trial is designed to explore whether the use of ELAD in this setting can prevent continued deterioration of liver function, called progression, and thus improve survival. The trial design uses a well-established measure of liver function called the MELD score to define the status of liver function. Treatment with ELAD, along with standard of care, is compared with standard of care alone. The time to either death or deterioration of liver function by a pre-specified amount is measured. It is postulated that the use of ELAD may extend the time to progression and improve survival in this rapidly progressing patient population.
ELAD is a biologic liver support system using a proprietary line of allogeneic human liver cells originally derived from a human liver tumor and refined by several leading cell experts. The cells are stable, immortal, can be grown in unlimited quantities and retain their hepatocyte (liver cell) characteristics. About one pound of cells is used for each treatment. The cells are grown in specially designed cartridges at VTI's plant in San Diego, transported to the hospital and used to treat the patient's plasma outside the body for up to ten days.
|SOURCE Vital Therapies, Inc.|
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