
HepaMate™,
previously known as 'HepatAssist', was clinically evaluated in a
successful Phase I clinical trial. Following these results a pivotal
Phase II/III prospective, randomized, controlled trial in 171 patients
with fulminant/subfulminant hepatic failure and primary non-function
following a failed liver transplant (86 control and 85 treated) in
11 U.S. and 9 European medical centers was conducted. The clinical
trial was seen as a landmark in the area of liver support.
The inclusion of a subset of 24 patients who had undergone a prior,
failed liver transplant negatively impacted the previous trial’s
outcome. Such patients are known to have poor survival outcomes.
Therefore, the previous pivotal Phase II/III trial was unable to
achieve its primary 30-day survival endpoint in the overall study
population. Based on a retrospective statistical analysis of the
clinical trial data, HepaLife expects a new Phase III clinical trial
without the inclusion of failed liver transplant patients to be successful.
A retrospective statistical analysis of the Phase II/III clinical
trial data, adjusted for the impact of liver transplantation on patient
survival, revealed a statistically significant survival advantage
for patients with fulminant and subfulminant hepatic failure when
treated with HepaMate™ compared to controls receiving standard medical
care alone. HepaMate™ treatment demonstrated a reduction of the risk
of pre-transplant death by 47% in fulminant hepatic failure patients
(n=121; p<0.043) relative to controls and by 67% in fulminant
hepatic failure patients with drug or chemical induced toxicity (n=53;
p=0.014). At the same time that bioartificial liver therapy improved
outcomes for treated patients, it provided patients with a trend
towards additional time for a liver transplant to become available
(median of 2 days for all patients). HepaMate™ demonstrated clinical
activity for a large majority of the enrolled patients (147 out of
171). The FDA previously approved to use identical statistical methodology
employed for the retrospective analysis in any subsequent clinical
trial and also previously approved to increase the liver cell dose
for HepaMate™.
Pivotal
Phase II/III Clinical Trial Data
| Journal: |
Annals of Surgery, Volume 239, Number 5, 2004 |
| Title: |
Prospective, randomized, multicenter, controlled trial of a
bioartificial liver in treating acute liver failure |
| Authors: |
Demetriou AA, Brown RS Jr, Busuttil RW, Fair J, McGuire BM,
Rosenthal P, Am Esch JS 2nd, Lerut J, Nyberg SL, Salizzoni M,
Fagan EA, de Hemptinne B, Broelsch CE, Muraca M, Salmeron JM,
Rabkin JM, Metselaar HJ, Pratt D, De La Mata M, McChesney LP,
Everson GT, Lavin PT, Stevens AC, Pitkin Z, Solomon BA |
Phase
I Clinical Trial Data
| Journal: |
Annals of Surgery, Volume 225, Number 5, 1997 |
| Title: |
Clinical experience with a bioartificial liver (BAL) in the
treatment of severe liver failure:
A phase I clinical trial |
| Authors: |
Watanabe F, Mullon C J-P, Hewitt WR, Arkadopoulos N, Kahaku
E, Eguchi S, Khalili T, Arnaout W, Shackleton CR, Rozga J, Solomon
B, Demetriou AA |
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*
- Demonstrated survival without a transplant
- Reduced risk
of pre-transplant death in fulminant hepatic failure patients
- Helped in keeping liver failure patients alive and neurologically
intact before, during and immediately after transplantation
- Improved survival in fulminant hepatic failure
patients with drug-induced liver toxicity
* Data from retrospective analysis |
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