VitaGen Announces Enrollment for Phase II Trial Of Elad(R)
Bioartificial Liver Support Therapy-First Human Cell-Based
Bioartificial Liver System Designed To Increase the Liver's Ability
to Regenerate And Recover
SAN DIEGO, Mar 14, 2002 -- VitaGen Incorporated announced today that
it is currently enrolling patients with fulminant hepatic failure
(FHF) in a multicenter Phase II clinical trial. These patients
represent a similar patient population to those studied in the
successfully completed Phase I/II trial, but include patients at
earlier stages of liver disease progression.
"This trial is designed to demonstrate an improvement
in 'transplantation-free survival' compared to current standard of
care ... a highly relevant clinical outcome," commented Patrick
Maguire, M.D., Ph.D., Vice President of Medical Affairs and New
Technologies for VitaGen. Dr. Maguire continued to say, "It will
also provide the opportunity to measure economic and quality of life
benefits of the treatment." The ELAD(R) Phase II trial will be
conducted at several major hospitals and transplant centers across
the United States.
VitaGen Incorporated completed a randomized, open-label Phase I/II
clinical trial in critically ill patients with late-stage FHF or
primary graft non-function in the third quarter of 2000. Patients
were enrolled at six transplant centers with the goal of evaluating
the safety and effectiveness of the ELAD(R) system in bridging
patients to either transplantation or recovery. Despite the severity
of the patients' disease progression when enrolled in this trial,
initial outcomes comparing ELAD(R)- treated patients to control
patients showed 12 of 15 (80%) ELAD(R)-treated patients successfully
bridged to transplant or recovery, compared to 5 of 9 (56%) in the
control group. In a subset of the trial including only those
patients who were listed for transplant, 11 of 12 (92%) of the ELAD
(R)-treated patients were successfully bridged to transplant or
recovery versus 3 of 7 (43%) of the listed controls.
The ELAD(R) bioartificial liver support system is designed to
combine the unique and potentially powerful benefits of cell therapy
with a reliable medical device similar to that used in kidney
dialysis treatment. As a cell therapeutic, the ELAD(R) system is
believed to perform many essential biological liver functions,
including metabolizing toxins and producing beneficial proteins.
VitaGen's proprietary C3A immortalized hepatic cells allow the ELAD
(R) system to provide extended continuous treatment (more than seven
days in recent clinical studies).
VitaGen is the first to develop a human cell-based bioartificial
liver support system. The Company has plans to pursue additional
clinical trials designed to (i) gain efficacy data regarding the
liver's ability to regenerate and recover as a result of ELAD(R)
therapy and (ii) demonstrate ELAD(R)'s broad applicability in the
treatment of multiple liver disease states.
VitaGen Incorporated is a privately held biotechnology company with
headquarters and laboratory facilities located in La Jolla,
California, and a GMP manufacturing facility in Rancho Bernardo,
California. For additional information about this trial, please
contact Dr. Patrick Maguire at 1-877-VITAGEN or by email at
pmaguire@...
SOURCE VitaGen Incorporated
CONTACT: Aron Stern, CFO of VitaGen Incorporated, +1-858-552-1522