OPTIMIZATION OF A BIOARTIFICIAL LIVER-PHASE II

描述（改编自研究者摘要）：Algenix, Inc.正在采取

DESCRIPTION (Adapted from the Investigator's Abstract): 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.