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Proprietary Liver Cell Line Performs Beyond Expectations.


VANCOUVER, British Columbia -- 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'

HepaLife Technologies, Inc. (OTCBB OTCBB

See OTC Bulletin Board (OTCBB).
:HPLF), 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 liver failure Clinical medicine Liver insufficiency that results in death, requires a liver transplant, or is characterized by recovery after encephalopathy, or while awaiting a transplant; also defined as a condition with ≥ 3 of following: albumin < 3. .

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 sub·pop·u·la·tion  
n.
A part or subdivision of a population, especially one originating from some other population: microbial subpopulations.

Noun 1.
 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 hepatocyte /hep·a·to·cyte/ (hep´ah-to-sit?) a hepatic cell.

hep·a·to·cyte
n.
A parenchymal liver cell.


Hepatocyte
A liver cell.
 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 Canaliculi
Also known as lacrimal ducts, these tube-like structures carry the tears from the eyes to the lacrimal sac.

Mentioned in: Dacryocystitis
 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. Arian Soheili, President of HepaLife. "While we have always been guardedly optimistic in our research pursuits, the performance of the cells as corroborated cor·rob·o·rate  
tr.v. cor·rob·o·rat·ed, cor·rob·o·rat·ing, cor·rob·o·rates
To strengthen or support with other evidence; make more certain. See Synonyms at confirm.
 by these favorable scientific outcomes achieves a significant precursory pre·cur·so·ry  
adj.
1. Preceding or preliminary; introductory: a precursory statement.

2. Suggesting or indicating something to follow.

Adj. 1.
 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 de·sir·ous  
adj.
Having or expressing desire; desiring: Both sides were desirous of finding a quick solution to the problem.



de·sir
 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 Detoxification Definition

Detoxification is one of the more widely used treatments and concepts in alternative medicine. It is based on the principle that illnesses can be caused by the accumulation of toxic substances (toxins) in the body.
 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 catabolism (kətăb`əlĭz'əm), subdivision of metabolism involving all degradative chemical reactions in the living cell.  of a number of nitrogen containing compounds.

HepaLife is continuing to actively conduct additional research, including the development of an experimental bioreactor bioreactor

a container in which living organisms carry out a biological reaction.
 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) 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 artificial liver Biotech A cartridge with cloned human liver cells, through which blood flows to facilitate removal of waste products. See Extracorporeal liver assist device, Liver dialysis.  device and developing proprietary in vitro toxicology In vitro toxicology is the scientific analysis of the effects of toxic chemical substances on cultured bacteria or mammalian cells. In vitro (literally 'in glass') testing methods are employed primarily to identify potentially hazardous chemicals and/or to confirm  and pre-clinical drug testing platforms.

Artificial Liver Device

Presently, through a Cooperative Research and Development Agreement “CRADA” redirects here. For other uses, see CRADA (disambiguation).

A Cooperative Research and Development Agreement (CRADA) is an agreement between a government agency and a private company to work together.
, 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 hepatotoxicity (hepˑ··tō·t , 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 FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
). 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 transferrin /trans·fer·rin/ (-fer´in) a glycoprotein mainly produced in the liver, binding and transporting iron, closely related to the apoferritin of the intestinal mucosa.

trans·fer·rin
n.
, 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.

Legal Notice Regarding Forward-Looking Statements

This release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 that are based upon current expectations or beliefs, as well as a number of assumptions about future events. Although the Company believes that the expectations reflected in the forward-looking statements and the assumptions upon which they are based are reasonable, it can give no assurance that such expectations and assumptions will prove to have been correct. The reader is cautioned not to put undue reliance on these forward-looking statements, as these statements are subject to numerous factors and uncertainties, including but not limited to adverse economic conditions, intense competition, lack of meaningful research results, entry of new competitors and products, adverse federal, state and local government regulation, inadequate capital, unexpected costs and operating deficits, increases in general and administrative costs, termination of contracts or agreements, technological obsolescence ob·so·les·cent  
adj.
1. Being in the process of passing out of use or usefulness; becoming obsolete.

2. Biology Gradually disappearing; imperfectly or only slightly developed.
 of the Company's products, technical problems with the Company's research and products, price increases for supplies and components, litigation An action brought in court to enforce a particular right. The act or process of bringing a lawsuit in and of itself; a judicial contest; any dispute.

When a person begins a civil lawsuit, the person enters into a process called litigation.
 and administrative proceedings involving the Company, the possible acquisition of new businesses or technologies that result in operating losses or that do not perform as anticipated, unanticipated losses, the possible fluctuation and volatility of the Company's operating results, financial condition and stock price, losses incurred in litigating and settling cases, dilution in the Company's ownership of its business, adverse publicity and news coverage, inability to carry out research, development and commercialization plans, loss or retirement of key executives and research scientists, changes in interest rates, inflationary factors, and other specific risks. In addition, other factors that could cause actual results to differ materially are discussed in the Company's most recent Form 10-QSB and Form 10-KSB filings with the Securities and Exchange Commission.
COPYRIGHT 2004 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2004, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Date:Sep 22, 2004
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