VitaGen:PhaseII Trial Bioartificial Liver Support

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Thursday March 14, 5:01 am Eastern Time

Press Release

SOURCE: VitaGen Incorporated



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, March 14 /PRNewswire/ -- 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® 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® 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®- treated patients to control patients showed 12 of 15 (80%) ELAD®-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®-treated patients were successfully bridged to transplant or recovery versus 3 of 7 (43%) of the listed controls.



The ELAD® 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® 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® 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® therapy and (ii) demonstrate ELAD®'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 [email protected].



SOURCE: VitaGen Incorporated