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news.HepaLife Technologies, a biotechnology company, has announced that it plans for a new pivotal Phase III clinical trial of its cell-based bioartificial liver system, HepaMate, as a potentially lifesaving treatment for liver failure patients in the US.
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The HepaMate technology has previously been tested in clinical Phase I and pivotal Phase II/III studies involving more than 200 patients.
According to the company, 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, the company said.
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.
Philip Rosenthal, liver transplant physician at University of California, San Francisco, said: “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.”