VANCOUVER, British Columbia, July 29, 2003 (PRIMEZONE) -- Under a Cooperative Research and Development Agreement (CRADA) with the USDA's Agricultural Research Service (ARS), the primary tool linking government and industry researchers, HepaLife Technologies, Inc. (OTCBB:HPLF) is collaborating towards optimizing the hepatic functions of the patented PICM-19 cell line. The patented application of the PICM-19 liver stem cells to an artificial liver device for support of human patients suffering liver failure is being tested.
The CRADA program, authorized under the Federal Technology Transfer Act of 1986, allows federal laboratories and businesses to form commercial partnerships that help move new technologies into the marketplace. Under a CRADA, ARS scientists work with private firms to help commercialize the technologies developed. A CRADA allows the collaborating company the first right to negotiate an exclusive license to any inventions that emerge under the agreement.
The overall objective of our research work is to optimize the culture conditions for the PICM-19 liver stem cell line so that the cells grow faster, reach higher densities, and have good function of key liver metabolic and detoxification enzyme systems. Concurrent with these cell biology efforts, bioengineering investigations on the cell culture hardware of the artificial liver device are ongoing.
Other specific research objectives are:
-- Develop cell culture system allowing the growth and differentiation of PICM-19 cells without STO feeder cell support.
-- Develop serum-free, defined or semi-defined medium cell culture system for growth and differentiation of PICM-19 cells.
-- Develop spheroid cultures of PICM-19 cells and test of rotating cell culture system (RCCS) for production and maintenance of spheroids.
-- Assay PICM-19 monolayer cultures and spheroid cultures for liver-specific functions; inducible P450 activity and content, y (gamma)-glutamyltranspeptidase activity, urea production, and ammonia clearance.
-- Assay PICM-19 liver-specific protein synthesis and secretion by electrophoretic and immunochemical techniques.
-- Assay liver-specific markers in PICM-19 by immunocytochemistry.
-- Document PICM-19 hepatocyte morphology by light and electron microscopy.
Ideally, further characterization and improvements required in the culture technology will result in the cell line not requiring feeder cell support and growth in a completely serum-free defined medium. These advancements would facilitate the objective of adapting and applying the optimized PICM-19 cell line technology to the development of an artificial liver device.
About HepaLife Technologies, Inc.
HepaLife Technologies, Inc. (OTCBB:HPLF) is a development stage biotechnology company focused on the research, development and eventual commercialization of technologies and products to treat various forms of liver dysfunction and disease.
Presently, through a Cooperative Research and Development Agreement, HepaLife Technologies is working towards optimizing the hepatic functionality of a patented cell line, whose hepatic characteristics have been demonstrated to have potential application in the production of an artificial liver device for use by human patients with liver failure.
The need for an artificial liver device able to remove toxins and improve immediate and long-term survival results for patients suffering from liver disease is more critical today than ever before.
Limited treatment options, a low number of donor organs, the high price of transplants and follow-up costs, a growing base of hepatitis, alcohol abuse, drug overdoses and other factors that result in liver disease, all clearly indicate that a strong need exists for an artificial liver device, now and into the foreseeable future.
Ongoing research and development work is being conducted at two laboratories, the Growth Biology Laboratory and the Biotechnology and Germplasm Laboratory, both located in Beltsville, Maryland.
For additional information, please visit www.hepalife.com.
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