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Vital Therapies commences enrollment in ELAD SILVER trial for acute-on-chronic liver failure

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http://www.news-medical.net/news/20100609/Vital-Therapies-commences-enrollment-i\

n-ELAD-SILVER-trial-for-acute-on-chronic-liver-failure.aspx

Vital Therapies commences enrollment in ELAD SILVER trial for acute-on-chronic

liver failure

9. June 2010 04:50

Vital Therapies, Inc., (VTI) is pleased to announce that the first two subjects

have been enrolled at King's College Hospital in London in the expansion of its

SILVER (Stabilization In LiVER failure) clinical trial in Europe. 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, randomized trial.

To date, 29 subjects have been enrolled at 11 U.S. sites and one U.K. site at

King's College Hospital, a major European centre for the treatment of complex

liver disease. Several other sites will soon be open for enrollment in the U.K.,

Denmark and Saudi Arabia. More than 20 sites should eventually enroll a total of

80 or more patients 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 Saudi Arabia. For a full listing of clinical trial sites

and further information on the trial, please go to www.clinicaltrials.gov.

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 prespecified 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.

At the recent European Association for the Study of the Liver (EASL) meeting in

Vienna a symposium sponsored in part by Vital Therapies addressed the use of

liver support systems in ACLF. Millis, M.D., Head of Liver

Transplantation at the University of Chicago presented results of earlier

clinical trials with ELAD including Phase I/II data in patients with acute liver

failure. He also presented results of a randomized, controlled trial of ELAD

carried out in China in 69 patients with ACLF. The China data confirmed

previously reported preliminary data in 60 patients, which showed that ELAD

significantly improved transplant free survival in subjects with ACLF compared

with standard of care alone, without unforeseen safety issues.

SOURCE Vital Therapies, Inc.

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http://www.news-medical.net/news/20100609/Vital-Therapies-commences-enrollment-i\

n-ELAD-SILVER-trial-for-acute-on-chronic-liver-failure.aspx

Vital Therapies commences enrollment in ELAD SILVER trial for acute-on-chronic

liver failure

9. June 2010 04:50

Vital Therapies, Inc., (VTI) is pleased to announce that the first two subjects

have been enrolled at King's College Hospital in London in the expansion of its

SILVER (Stabilization In LiVER failure) clinical trial in Europe. 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, randomized trial.

To date, 29 subjects have been enrolled at 11 U.S. sites and one U.K. site at

King's College Hospital, a major European centre for the treatment of complex

liver disease. Several other sites will soon be open for enrollment in the U.K.,

Denmark and Saudi Arabia. More than 20 sites should eventually enroll a total of

80 or more patients 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 Saudi Arabia. For a full listing of clinical trial sites

and further information on the trial, please go to www.clinicaltrials.gov.

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 prespecified 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.

At the recent European Association for the Study of the Liver (EASL) meeting in

Vienna a symposium sponsored in part by Vital Therapies addressed the use of

liver support systems in ACLF. Millis, M.D., Head of Liver

Transplantation at the University of Chicago presented results of earlier

clinical trials with ELAD including Phase I/II data in patients with acute liver

failure. He also presented results of a randomized, controlled trial of ELAD

carried out in China in 69 patients with ACLF. The China data confirmed

previously reported preliminary data in 60 patients, which showed that ELAD

significantly improved transplant free survival in subjects with ACLF compared

with standard of care alone, without unforeseen safety issues.

SOURCE Vital Therapies, Inc.

_________________________________________________________________

Hotmail is redefining busy with tools for the New Busy. Get more from your

inbox.

http://www.windowslive.com/campaign/thenewbusy?ocid=PID28326::T:WLMTAGL:ON:WL:en\

-US:WM_HMP:042010_2

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