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Emergency Medicine Specialist at Front Lines of Adverse Drug Reactions & Acute Liver Failure Joins HepaLife to Assist Ongoing Development of Artificial Liver Device & Hepatotoxicity Testing Platform.


VANCOUVER, British Columbia -- HepaLife Technologies, Inc. (OTCBB OTCBB

See OTC Bulletin Board (OTCBB).
:HPLF), 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, today announced the addition of Dr. Darryl J. Fleishman to the Company's Scientific Advisory Board.

Dr. Fleishman brings over a decade of direct medical experience with emergency-room patients suffering from 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.
 and acute liver failure Acute liver failure is the appearance of severe complications rapidly after the first signs of liver disease (such as jaundice), and indicates that the liver has sustained severe damage (loss of function of 80-90% of liver cells).  as well as those injured by adverse drug effects to the liver.

Drug-induced liver damage, also known as hepatotoxicity hepatotoxicity (hepˑ··tō·t , has become increasingly frequent and is now the leading cause of acute liver failure in the United States (National Institute of Diabetes and Digestive Kidney Diseases).

According to the National Institutes of Health, up to 5% of the nation's 100 million-plus hospital admissions can be attributed to adverse drug reactions. Each year, approximately 1.5 million Americans are hospitalized due to adverse drug reactions according to a long-standing study published in the Journal of American Medical Association American Medical Association (AMA), professional physicians' organization (founded 1847). Its goals are to protect the interests of American physicians, advance public health, and support the growth of medical science.  (JAMA JAMA
abbr.
Journal of the American Medical Association
), and an additional 770,000-plus develop drug reactions once they are hospitalized.

In all, over 2.2 million Americans per year -- more than 6,000 patients each day -- suffer adverse drug reactions in hospitals. Sadly, nearly 80,000 children are admitted to hospitals as a consequence of such adverse drug reactions with almost 40% of such cases classified as 'life-threatening'.

Emergency Medicine Specialist Joins HepaLife Scientific Advisory Board

A Board Certified board certified,
adj the status of a dental specialist such as an orthodontist who has become a board diplomate by successfully completing the certification program of the recognized certification board in that area of practice.
 Emergency Medicine Specialist, Dr. Darryl J. Fleishman is a graduate of Boston University School of Medicine Boston University School of Medicine (BUSM) is one of the graduate schools of Boston University. It is an American medical school located in the South End neighborhood of Boston, Massachusetts.  (BUSM BUSM Boston University School of Medicine ), established in 1848 and today ranked among America's top five largest independent universities. With over 1,000 clinical trials and 575 funded research programs, BUSM is a distinct leader in clinical medical research.

Having completed his Emergency Medicine Residency Program at Wayne State University Wayne State University, at Detroit, Mich.; state supported; coeducational; established 1956 as a successor to Wayne Univ. (formed 1934 by a merger of five city colleges).  in Detroit, Michigan, Dr. Fleishman is currently in active emergency-medicine practice at Illinois' St. Francis Hospital St. Francis Hospital may refer to:
  • St. Francis Hospital — Wilmington, Delaware
  • St. Francis Hospital — Columbus, Georgia
  • St. Francis Hospital — Greenville, South Carolina
  • St. Francis Hospital — Memphis, Tennessee
  • St.
 & Health Center, established 100 years ago and notably reputed as the state's only hospital of its kind to be ranked among America's top 100 cardiovascular hospitals five times.

Among numerous appointments at Level 1 trauma centers and emergency treatment centers, Dr. Fleishman has tenured ten·ured  
adj.
Having tenure: tenured civil servants; tenured faculty.

Adj. 1. tenured
 at several of Greater Chicago's most respected healthcare institutions, including: Advocate Christ Medical Center, Mt. Sinai Hospital, Holy Cross Hospital Holy Cross Hospital may refer to:

In the United Kingdom:
  • Holy Cross Hospital — Haslemere, Surrey, England
In the United States:
  • Holy Cross Hospital — Nogales, Arizona
  • Holy Cross Hospital — Fort Lauderdale, Florida
, Ingalls Memorial Hospital Ingalls Memorial Hospital is a general medical and surgical hospital located in Harvey, Illinois, a south suburb of Chicago, Illinois. Ingalls is a secular establishment and has no parent affiliation. , and others.

"As our research team continues to advance the critical science behind our proprietary 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 toxicology testing platforms, it is increasingly important for us to leverage the kind of hands-on experience and end-user insight that Dr. Fleishman brings to our Scientific Advisory Board, especially with his years of experience in dealing with liver damage, its side effects Side effects

Effects of a proposed project on other parts of the firm.
 and related symptoms in an emergency room setting," commented HepaLife Chairman, Mr. Harmel Rayat.

"I'm honored to accept this appointment and join the HepaLife team in its fight against liver disease, especially through development of the Company's artificial liver device which I hope will someday be able to help the thousands of Americans awaiting transplants and suffering with the consequences of 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. ," stated Dr. Darryl Fleishman.

"Recently, I had the opportunity to visit the research labs in Maryland and see first-hand how HepaLife's research team is making inroads inroads
Noun, pl

make inroads into to start affecting or reducing: my gambling has made great inroads into my savings

inroads npl to make inroads into [+
 in this area," continued Dr. Fleishman. "It's particularly exciting to see the potential implications of the Company's PICM-19H cells for use in toxicity testing.

"The need to more efficiently, accurately and cost-effectively pre-screen drugs and chemical compounds for toxicity to the liver cannot be overstated. A toxicity testing platform of this kind may well help reduce the number of patients our hospitals treat for drug-induced liver damage, especially in light of America's increasing use of pharmaceutical products and rising reliance on everyday drugs."

Surprisingly, the most commonly cited pharmaceutical agent responsible for drug-induced liver damage is acetaminophen acetaminophen (əsēt'əmĭn`əfĭn), an analgesic and fever-reducing medicine similar in effect to aspirin. It is an active ingredient in many over-the-counter medicines, including Tylenol and Midol. , implicated im·pli·cate  
tr.v. im·pli·cat·ed, im·pli·cat·ing, im·pli·cates
1. To involve or connect intimately or incriminatingly: evidence that implicates others in the plot.

2.
 in nearly 50% of all acute liver failure in America and ranked as the most frequently administered class of drug during emergency room visits.

Acetaminophen is found in more than 100 products and is the most widely used pharmaceutical analgesic analgesic (ăn'əljē`zĭk), any of a diverse group of drugs used to relieve pain. Analgesic drugs include the nonsteroidal anti-inflammatory drugs (NSAIDs) such as the salicylates, narcotic drugs such as morphine, and synthetic drugs  and antipyretic antipyretic /an·ti·py·ret·ic/ (-pi-ret´ik)
1. relieving or reducing fever.

2. an agent that so acts.


an·ti·py·ret·ic
n.
An agent that reduces or prevents fever.
 agent, worldwide. As one of the most common pharmaceuticals associated with both intentional and accidental poisoning, acetaminophen related liver toxicity is the leading cause of hepatic failure requiring liver transplantation in Great Britain and the second most common cause of liver failure requiring transplantation in the United States.

In response to the growing number of individuals suffering from liver disease as a result of drug overdoses or interactions, rampant alcohol abuse and the worldwide hepatitis epidemic, HepaLife Technologies is developing the first of its kind artificial liver device incorporating the PICM-19H cell line, which has now been in continuous culture for over two years 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.

Most recently, as reported in the Company's April 11, 2005, press release, HepaLife successfully surpassed it's primary research objectives related to the optimization of the PICM-19H cell line. (HepaLife's April 11, 2005 press release can be viewed at: http://www.hepalife.com/Investor/PressReleases/20050411-1.html)

To-date, the overall objective of HepaLife's collaborative research work has been, and continues to be, the optimization of culture conditions for the Company's proprietary PICM-19H 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 incorporation of the PICM-19H cells in an artificial liver device, as well as use in in-vitro toxicology and pre-clinical drug testing platforms. Concurrent with these efforts, bioengineering investigations on the cell culture hardware of HepaLife's artificial liver device are also actively underway.

About HepaLife Technologies, Inc.

HepaLife Technologies, Inc. (OTCBB:HPLF) 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.

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, 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.

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, please visit www.hepalife.com

To receive future press releases via email, please visit http://www.hepalife.com/Alerts-Index.asp

To view the full HTML text of this release, please visit http://www.hepalife.com/Investor/PressReleases/20050524-1.html

Legal Notice Regarding Forward-Looking Statements

No statement herein should be considered an offer or a solicitation of an offer for the purchase or sale of any securities. 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. We currently have no commercial products intended to diagnose, treat, prevent or cure any disease. The statements contained in this press release regarding our on going research and development and the results attained by us to-date have not been evaluated by the Food and Drug Administration. There can be no assurance that further research and development, and /or whether clinical trial results, if any, will validate and support the results of our preliminary research and studies. Further, there can be no assurance that the necessary regulatory approvals will be obtained or that HepaLife will be able to develop commercially viable products on the basis of its technologies. 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. The Company undertakes no obligation to publicly release the results of any revisions to these forward looking statements that may be made to reflect the events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
COPYRIGHT 2005 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2005, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Date:May 24, 2005
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