HepaLife™ Plans for Phase III Clinical Trial for HepaMate™ Bioartificial Liver System
News Feb 18, 2009
HepaLife Technologies, Inc., developing its cell-based bioartificial liver system, HepaMate™, as a potentially lifesaving treatment for liver failure patients, announced that it plans for a new pivotal Phase III clinical trial in the United States.
The HepaMate™ technology has previously been tested in clinical Phase I and pivotal Phase II/III studies involving more than 200 patients. Over 50 scientific papers and book chapters have been published on the technology.
A retrospective statistical analysis of the previous pivotal 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.
The inclusion of a subset of 24 patients who had undergone a prior, failed liver transplant negatively impacted the trial’s outcome. Such patients are known to have poor survival rates. Therefore, the previous Phase II/III trial was unable to achieve its primary 30-day survival endpoint in the overall study population.
Based on the 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.
“I treated 15 acute-liver failure patients with the technology in the previous pivotal clinical trial“, says University of California, San Francisco Liver Transplant Physician Philip Rosenthal, MD. “My experience was very good. The patients responded well to the bioartificial liver support therapy; some seriously ill patients even recovered without the need for a liver transplant. The HepaMate system has generated strong and favorable clinical data in acute liver failure patients. I am looking forward to seeing this much needed therapy utilized in the routine clinical setting helping patients with otherwise very limited treatment options.”