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HEPALIFE COLLABORATES WITH USDA ON LIVER STORAGE RESULTS.


HepaLife Technologies, Inc. (OTCBB OTCBB

See OTC Bulletin Board (OTCBB).
: HPLF) (FWB (Fixed Wireless Broadband) See fixed wireless. : HL1), Vancouver British Columbia British Columbia, province (2001 pop. 3,907,738), 366,255 sq mi (948,600 sq km), including 6,976 sq mi (18,068 sq km) of water surface, W Canada. Geography
, a development stage biotechnology company focused on the identification, development and eventual commercialization of technologies and products for liver toxicity detection and the treatment of various forms of liver dysfunction and disease, has announced that its collaborating USDA USDA,
n.pr See United States Department of Agriculture.
 scientist, Dr. Ayesha Mahmood, presented important room temperature storage research results at a recent Biomedical Engineering Biomedical engineering

An interdisciplinary field in which the principles, laws, and techniques of engineering, physics, chemistry, and other physical sciences are applied to facilitate progress in medicine, biology, and other life sciences.
 Society Meeting,

Through a collaborative research effort, HepaLife Technologies has been working towards the optimization of culture conditions for the company's proprietary PICM-19H liver cell line; such optimization will enable these cells to grow faster, reach higher densities and have optimal function of key liver metabolic and 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.
 enzyme systems. Successful research outcomes will result in the incorporation of the PICM-19H cells in an 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 for use by patients suffering from chronic and acute liver disease Liver Disease Definition

Liver disease is a general term for any damage that reduces the functioning of the liver.
Description

The liver is a large, solid organ located in the upper right-hand side of the abdomen.
, as well as use in in-vitro toxicology and pre-clinical drug testing platforms.

In addition, the company's ongoing research has included the study of various factors that may improve and extend the length of time that the PICM-19H cells can be stored at room temperature instead of in heated incubators, which are designed to artificially mimic body temperature and are costly to transport around the country. Extended storage time in culture at room temperature could allow for easier long distance transportation of these cells. Moreover, the ability to place these cells in 'suspended animation' at room temperature will enable more efficient utilization of HepaLife's artificial liver device in its clinic or hospital setting.

"The benefits and cost savings of being able to ship the most important and perishable component of an artificial liver device - the cells - around the country without special incubator equipment would be tremendous," stated Arian Soheili, director of HepaLife Technologies, Inc. Soheili continued, "When it comes to developing a fully functional, therapeutically effective artificial liver device, the key is not in the hardware itself - rather, it's the biological component that goes inside.

"Our cell line, we believe, is what sets us apart from everyone else! As we progress and surpass each of our research objectives for our proprietary cell line - which, to-date has performed beyond our expectations - we move closer and closer to making the development of an artificial liver device a reality for the millions of individuals who suffer from liver disease.

"Equally important, I consider HepaLife's PICM-19H cell research of particular significance since it directly addresses the widely-held scientific opinion that the greatest hindrance in development of a therapeutically effective artificial liver device has been the lack of an appropriately defined liver cell line, able to provide the functions of an intact liver," Soheili concludes. Growing (culturing) or maintaining liver cells outside of the body (in vitro in vitro /in vi·tro/ (in ve´tro) [L.] within a glass; observable in a test tube; in an artificial environment.

in vi·tro
adj.
In an artificial environment outside a living organism.
), has proven difficult because once liver cells are removed from the body for culture, they soon lose their normal function. In contrast to HepaLife's PICM-19H, the cellular components of other artificial liver devices being developed to-date, have been based on freshly isolated porcine porcine /por·cine/ (por´sin) pertaining to swine.

porcine

pertaining to pig. See also hog (1), swine.


porcine circovirus 1
a nonpathogenic virus.
 hepatocytes, cell lines established from human liver tumors, stem-cell-like cells prepared from fresh human adult liver tissue, and human or pig liver cells 'transformed' or 'immortalized' by the addition of oncogenes oncogenes

1. genes carried by tumor viruses that are directly and solely responsible for the neoplastic transformation of host cells. Many oncogenes function after integration into the DNA of the host cell and some up-regulate normal downstream host cell genes to cause neoplasia.
 (i.e., genes associated with cancer) through genetic engineering. While immortalized liver cells retain a high capacity for growth, they often have reduced or altered 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.
 functions.

Unfortunately, most artificial liver systems being developed at other labs and companies have not lived up to initial expectations as a consequence of problems relating to their inability to grow liver cells quickly and safely, poor cell functionality, and inconsistent results from filtering or dialysis devices.

About Hepalife Technologies, Inc.

HepaLife Technologies, Inc. (OTCBB: HPLF) (FWB: HL1) is a development stage biotechnology company focused on the identification, 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. The company's research and development work is being conducted at two U.S. Department of Agriculture (USDA) laboratories, the Growth Biology Laboratory and the Biotechnology and Germplasm Laboratory, both located at the Beltsville Agricultural Research Center in Beltsville, Maryland.

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.
, and in collaboration with Dr. Neil C. Talbot and Dr. Thomas J. Caperna of the USDA, 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 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. .

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 cytochrome (sī`təkrōm'), protein containing heme (see coenzyme) that participates in the phase of biochemical respiration called oxidative phosphorylation.  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. At present, the company does not have commercial products intended to diagnose, treat, cure or prevent any disease. The statements contained in this press release regarding our ongoing research and development and the results attained by us to-date have not been evaluated by the Food and Drug Administration.

For additional information, visit http://www.hepalife.com or call 800/518-4879.
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Publication:Worldwide Biotech
Date:Nov 1, 2005
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