OPTIMIZATION OF A BIOARTIFICIAL LIVER-PHASE II

描述(改编自《调查者摘要》)：Algenix，Inc. 明尼苏达大学通过一种 I期临床试验。这种生物人工肝旨在提供一种 为等待移植的肝功能衰竭患者提供临时支持。BAL 利用猪肝细胞被包裹在胶原基质中的腔内 一种中空纤维生物反应器。一期临床试验将在 明尼苏达大学。它发展中的一个持续的重大挑战将是 制定一个可接受的“货架储存”协议，并证明 这种“搁置储存”的BAL在动物试验中的有效性。在第一阶段研究 采用低温工艺延长BAL使用寿命的可行性 航运已经得到了演示。这项拟议的研究在其第二阶段将 利用基因组研究进一步优化低温贮藏条件 技术，扩大优化过程，并进行动物试验以测试 低温处理的生物人工肝的有效性。一个 成功的第二阶段研究将有助于分发 生物人工肝，加快多中心临床试验，推进 应用这项技术来治疗有需要的病人。 建议的商业应用： Algenix Inc.计划推出针对暴发性肝脏的Live-Rx 2000系统 衰竭(FHF)指征(肝功能衰竭)。该公司打算营销和销售机器和 一次性使用治疗包，内含生物反应器，即含有肝细胞的血液透析器盒 嵌在胶原蛋白里。该公司最初将专注于将LIVE-Rx 2000系统推向 肝脏移植中心。 该公司最初的销售重点将是美国的主要肝脏移植中心。 这些都是典型的非常复杂的，多学科的项目，有外科医生，内部 医学、免疫学家和其他训练有素的个人在紧密协调下共同工作 一队。他们将要求高水平的服务，但由于他们的技术专长，可以 预计很快就能掌握这项新技术。

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.