
HepaLife's Liver Cells Detect Acetaminophen Poisoning, A Leading
Cause of Liver Failure.
Successfully detecting dangerous compounds in new and existing
drugs is critical to the development of new toxicology testing
platforms.
Vancouver, BC - June 13, 2006 - HepaLife Technologies Inc.
(OTCBB: HPLF) (FWB: HL1), today announced that its PICM-19 embryonic
liver stem cells have successfully demonstrated acetaminophen toxicity,
a critical step for the integration of these cells into proprietary
toxicology testing platforms being developed by HepaLife to identify
chemicals and compounds which cause damage to the liver.
Acetaminophen is a popular over-the-counter and prescription painkiller
found in many medications. Although commonly thought to be safe,
acetaminophen can become toxic and cause serious damage to the liver
when consumed in high doses, or in combination with other drugs or
alcohol.
"Acetaminophen can be a potent dose-dependent poison for the
liver; if you take too much, it can result in liver failure and death,"states
Mr. Harmel S. Rayat, President and CEO of HepaLife. "In addition
to our other research findings, the response of our PICM-19 cells
to acetaminophen provides further scientific validation of our belief
that these cells possess the metabolic functionality of true liver
cells. Displaying enhanced liver-specific functions and expression
of liver specific proteins, we believe the PICM-19 cells have the
potential to identify drugs which are toxic to the liver, ideally
before these drugs enter the marketplace."
Researchers have demonstrated the ability of HepaLife's PICM-19
cells to mimic the human liver cell's natural response to acetaminophen
poisoning, a response enhanced through exposure to alcohol in recent
experiments.
Acetaminophen, contained in dozens of over-the-counter cold and
flu preparations, is one of the most widely used non-prescription
painkillers in the United States. Unfortunately, individuals often
ingest too much acetaminophen for fever or pain, not realizing the
potential for liver damage, especially when combined with alcohol.
Acetaminophen overdose is now the leading cause of acute liver failure
in the United States, accounting for 50,000 emergency room visits
and 42% of liver failures.
"Acetaminophen overdoses are the most common cause of acute
liver failure in the United States. 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'," continued
Mr. Rayat. "The safety benefits of detecting this kind of toxicity
are especially important to consumers when considering that over
the last 25 years, hepatotoxicity has been attributed to one-fifth
of all drugs withdrawn from the market following FDA approval."
Liver damage, or 'hepatotoxicity', caused by medications and other
chemical compounds, is the single most common reason leading to drug
withdrawal or refusal of drug approval by the 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. HepaLife,
using the patented PICM-19 cell line, is developing 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.
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.
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
In 2003 alone, the inability to accurately predict toxicity early
in drug development cost the pharmaceutical industry a record $8
billion. In particular, 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 FDA. In fact, about one third of all potential drugs fail pre-clinical
or clinical trials due to the toxic nature of the compounds being
tested, accounting for an estimated $70 million (20%) of total research
and development costs per drug.
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.
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 hepalife.com
To receive future press releases via email, please visit http://hepalife.com/alerts.php
To view the full HTML text of thisrelease, please visit http://hepalife.com/20060613-1.html.php
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 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. Forward-looking
statements, which involve assumptions and describe our future plans,
strategies, and expectations, are generally identifiable by use of
the words "may," "will," "should," "could,""expect," "anticipate," "estimate," "believe," "intend," or "project" or
the negative of these words or other variations on these words or
comparable terminology. 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 of the Company's products,
technical problems with the Company's research and products, price
increases for supplies and components, 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-Q and Form 10-K filings with the
Securities and Exchange Commission. These reports and filings may
be inspected and copied at the Public Reference Room maintained by
the U.S. Securities & Exchange Commission at 100 F Street, N.E.,
Washington, D.C. 20549. You can obtain information about operation
of the Public Reference Room by calling the U.S. Securities & Exchange
Commission at 1-800-SEC-0330.The U.S. Securities& Exchange Commission
also maintains an Internet site that contains reports, proxy and
information statements, and other information regarding issuers that
file electronically with the U.S.Securities & Exchange Commission
at http://www.sec.gov. 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. |