SBIR-STTR Award

Algenix, Inc. is taking a bioartificial liver (BAL) developed at the University of Minnesota through a Phase I clinical trial. This bioartificial liver is intended for providing a temporary support to liver failure patients awaiting transplantation. The BAL employs porcine hepatocytes entrapped in a collagen matrix within the lumens of a hollow-fiber bioreactor. The FDA has approved a Phase I Clinical Trial to be conducted at the University of Minnesota. A continuing major challenge in its development will be to maximize hepatocyte density in the reactor and to develop an acceptable protocol of "shelf- storage." This proposed research, in its Phase I, will investigate the feasibility of increasing the cell loading density and the possibility of developing a method of storing and shipping the BAL. In the Phase I research only limited number of variables will be investigated, including collagen cell concentration, and loading and storage temperature. The effects of the experimental variables will be evaluated by assessing the viability and liver specific activities of the hepatocytes in the BAL. A successful Phase I will lead to a Phase II Grant to develop a pilot manufacturing process of the improved bioartificial liver for use in further large animal pre-clinical trials and clinical applications. PROPOSED COMMERCIAL APPLICATION: The liver assist device is intended to address the clinical needs of patients suffering from acute liver failure and to provide a "bridge" to liver transplant. The BAL would also serve as a treatment for patients requiring detoxification and for trauma patients whose otherwise healthy liver has shut down.

Algenix, Inc. is taking a bioartificial liver (BAL) developed at the University of Minnesota through a Phase I clinical trial. This bioartificial liver is intended for providing a temporary support to liver failure patients awaiting transplantation. The BAL employs porcine hepatocytes entrapped in a collagen matrix within the lumens of a hollow-fiber bioreactor. A Phase I Clinical Trial is to be conducted at the University of Minnesota. A continuing major challenge in its development will be to develop an acceptable protocol of "shelf-storage" and to demonstrate the efficacy of such "shelf-stored" BAL in animal trials. In Phase I research the feasibility of using a hypothermic process to extend the life of BAL for shipping has been demonstrated. This proposed research, in its Phase II, will further optimize the hypothermic storage conditions using genomic research techniques, scale up the optimized process and perform animal trials to test the effectiveness of the hypothermically treated bioartificial liver. A successful Phase II research will facilitate the distribution of the bioartificial liver, hasten multi-center clinical trials and advance the application of this technology to treat needed patients. PROPOSED COMMERCIAL APPLICATION: Algenix Inc. plans to introduce the LIVE-Rx 2000 SYSTEM for the fulminant hepatic failure (FHF) indications (liver failure). The Company intends to market and sell machines and single-use treatment kit containing bioreactors, i.e., hemodialyzer cartridges containing hepatocytes embedded in collagen. The Company will initially focus on marketing LIVE-Rx 2000 SYSTEM into liver transplant centers. The initial sales focus for the Company will be the major liver transplant centers in the U.S. These are characteristically very sophisticated, multidiciplinary programs with surgeons, internal medicine, immunologists and other highly trained individuals working together in a tightly coordinated team. They will demand a high level of service, but because of their technical expertise can be expected to quickly master this new technology.