Proprietary Liver Cell Line Performs Beyond Expectations

Results from improved cell line continue to surpass initial expectations; Key enzyme systems indicate highly favorable results; PICM-19P cells now indexed as 'PICM-19H'

VANCOUVER, British Columbia--(BUSINESS WIRE)--Sept. 22, 2004-- HepaLife Technologies, Inc. (OTCBB:HPLF - News), a development stage biotechnology company focused on the research, development and eventual commercialization of technologies and products for liver toxicity detection and the treatment of various forms of liver dysfunction and disease, is pleased to announce that ongoing results from research into its proprietary cell line -- PICM-19H -- have surpassed Management's initial expectations for potential application towards the development of a bio-artificial liver device for use by human patients with liver failure.

Ongoing research and testing has been actively conducted to specifically observe cell growth and assess particular hepatic functions of the PICM-19H cell line, previously referenced as 'PICM-19P' and developed as a subpopulation of the original, patented PICM-19 liver cell line.

Most notably, PICM-19H has now been in continuous culture for over 22 months without presenting any detectable changes in hepatocyte morphology and function, a significant achievement. During this time, the cells have been repeatedly passaged (split and cultured) more than 30 times and have consistently retained their ability to differentiate into hepatocytes with excellent morphology and function. Also, test cultures of PICM-19H have been maintained for as long as 5 months without passage. Key functional, hepatocyte-specific, morphological features such as biliary canaliculi were maintained in the cells over this extended time period.

"These research results mark a definitive step forward for the PICM-19 liver cell family," explained Mr. Harmel Rayat, President of HepaLife. "While we have always been guardedly optimistic in our research pursuits, the performance of the cells as corroborated by these favorable scientific outcomes achieves a significant precursory milestone towards development of the bio-artificial liver device."

As early as January 2004, the PICM-19H cells first recorded growth of 2-3 times the cell density of the original PICM-19 cell line, a highly beneficial attribute, particularly desirous for use in a bio-artificial liver device. In addition to measuring cell growth and densities, determinations of inducible P-450, ammonia removal, and urea production were also conducted and similarly yielded markedly positive results.

While the liver is responsible for detoxifying numerous substances, these positive P-450 tests are of particular importance; the P-450 enzyme systems are key components in the overall hepatic detoxification pathway of drugs and other xenobiotics. Likewise, ureagenesis is another important hepatic function since urea production is required for the detoxification of ammonia derived from the catabolism of a number of nitrogen containing compounds.

HepaLife is continuing to actively conduct additional research, including the development of an experimental bioreactor that will be the prototype of a bio-artificial liver device. PICM-19H cells will be seeded into the bioreactor for tests of growth, differentiation, and hepatic function in a flow through system.

About HepaLife Technologies, Inc. HepaLife Technologies, Inc. (OTCBB:HPLF - News) is a development stage biotechnology company focused on the research, development and eventual commercialization of technologies and products for liver toxicity detection and the treatment of various forms of liver dysfunction and disease.

Currently, HepaLife is concentrating its efforts on creating the first-of-its-kind artificial liver device and developing proprietary in vitro toxicology and pre-clinical drug testing platforms.

Artificial Liver Device Presently, through a Cooperative Research and Development Agreement, HepaLife Technologies is working towards optimizing the hepatic functionality of the patented PICM-19 cell line. The hepatic characteristics of the PICM-19 cell line have been demonstrated to have potential application in the production of an artificial liver device for use by human patients with liver failure.

With 25 million Americans suffering from liver disease, the need for an artificial liver device able to remove toxins and improve immediate and long-term survival results 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 a strong need for an artificial liver device.

In Vitro Toxicology Testing Hepatotoxicity, or liver damage caused by medications and other chemical compounds, is the single most common reason leading to drug withdrawal or refusal of drug approval by the Food and Drug Administration (FDA). In fact, about one third of all drugs fail pre-clinical or clinical trials due to the toxic nature of the compounds being tested, costing pharmaceutical companies around $2 billion annually on such toxicity-related drug failures.

With the cost to develop an FDA approved drug approaching $1 billion and taking 10 to 15 years, a 10% improvement in predicting failures before clinical trials could save $100 million in development costs per drug. Despite efforts to develop better methods, most of the tools used for toxicology and human safety testing are decades old.

The PICM-19 cells grown in vitro synthesize liver specific proteins such as albumin and transferrin, and display enhanced liver-specific functions such as ureagenesis and cytochrome P450 activity. As a result, HepaLife, using the patented PICM-19 cell line, plans to develop proprietary in vitro toxicological and pre-clinical drug testing platforms that will more accurately determine the potential toxicity and metabolism of new pharmacological compounds in the liver.

For additional information, please visit hepalife.com

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