HepaPheresis™ System: Preclinical Results
HepaHope’s HepaPheresis™ System has already successfully undergone rigorous and extensive pre-clinical testing designed to demonstrate the efficacy, bio-compatibility, sustainability, and safety profile of its proprietary bioreactor. Utilizing non-human living models, these successful pre-clinical trials are a vital link to obtaining the regulatory approvals necessary to begin human testing.
The innovative technology at the heart of the HepaPheresis™ System is its unique bioreactor based on HepaHope’s proprietary hCD46 transgenic porcine liver slice technology, which functions as its primary bio-reactive component. In support of the efficacy of this technology in providing significant levels of liver-mimicking functionality, data from in vitro and/or in vivo studies were presented at the American Association for the Study of Liver Disease (AASLD) in 2006, 2007 and 2008; at the World Transplant Congress (WTC) in 2006; at the American Society for Artificial Internal Organs (ASAIO) in 2006, 2007, and 2008; and at the International Liver Congress (ILC) in 2006 and 2008. Clearance of ammonia, one of the many toxins that build up in the bloodstream of a liver failure patient, was demonstrated in the Company's in vitro and animal testing. Meanwhile, additional testing using dogs revealed no adverse health effects in healthy dogs treated with the HepaPheresis™ System; while, dogs with acute liver failure which were treated with the HepaPheresis™ system showed an improvement in biomarkers and enhanced survival benefits compared to dogs that were not treated.
Based on the success of these pre-clinical trials, the technology is currently being prepared for Phase I clinical trials in the USA and Mexico.