
HepaLife’s Cells for Artificial Liver
Device Significantly Outperform Most-Widely Used Human Liver Cell
Line.
HepaLife’s cells mimic key liver responses,
vital to artificial liver device: synthesize 100% of ammonia; express
high levels of CYP-450 enzymes; only cells of their kind to produce
substantial amounts of urea, in in-vitro system.
Boston, MA – April 10, 2007 - HepaLife
Technologies, Inc. (OTCBB: HPLF) (FWB: HL1) (WKN: 500625) today announced
that the Company’s patented ‘PICM-19’ cells, under
development for use in artificial liver support and in-vitro toxicology
testing, have significantly outperformed the world’s most widely
used human liver cell line in important tests of liver-specific metabolic
functions.
“These tests clearly demonstrate our PICM-19
cell line’s superior performance in key, liver-specific functions
such as the essential ability to help safely excrete ammonia, a highly
toxic by-product which causes brain damage, coma, and even death,” explained
Mr. Frank Menzler, President and CEO of HepaLife Technologies, Inc. “This
ability is vital to successfully replicating the human liver’s
function in an artificial liver device.”
Scientists have long demonstrated that the HepaLife’s
patented PICM-19 cells have unique characteristics distinct from
other cells, and are able to successfully mimic the human liver's
response in several important ways. This functionality is crucial,
since according to researchers, the most vital component in an artificial
liver device is not the mechanical hardware, but rather, it is the
biological cells inside the device which are responsible for truly
replicating and performing the functions of the human liver.
The production of urea is a highly-important function
in the removal of toxic ammonia from the bloodstream, a unique capacity
consistently demonstrated by HepaLife’s PICM-19 liver cells. According
to results from HepaLife’s most recent lab tests, the Company’s
patented PICM-19 cells synthesized 100% of the ammonia present, nearly
four times more than HepG2-C3A, the world’s most widely-used
human liver cell line today.
HepaLife’s PICM-19 Cells Mimic Human
Liver’s Responses
A key function of the human liver is the detoxification
of ammonia, primarily through the synthesis of urea. Patients with
acute liver failure have compromised ammonia detoxification capabilities
which can result in brain damage. Likewise, patients with Urea-Cycle
Disorders (UCD), genetic liver diseases found in children and adults,
are unable to remove ammonia from the bloodstream, leading to brain
damage, coma, and death.
In
recent tests, HepaLife’s PICM-19 cells successfully synthesized
100% of the ammonia present, almost four times more than HepG2-C3A.
Most significantly, 36% of the ammonia was specifically synthesized
into urea by the PICM-19 cells as compared to 0% of the HepG2-C3A. Notably,
HepaLife's PICM-19 cell line is the only known, embryonic liver stem
cell line of its kind with the ability to produce substantial amounts
of urea, in an in vitro system.
Results from the same tests also demonstrated that
PICM-19 cells are able to express high levels of cytochrome P-450
enzymes, a key liver-related function in the detoxification of drugs
and xenobiotics. In contrast, HepG2-C3A showed very low, or
no detectable P450 activity at all.
In ongoing research, scientists have demonstrated
that HepaLife's PICM-19 cells have unique characteristics distinct
from other cells lines, and are able to mimic the human liver's response
in several important ways. PICM-19 cells:
- Do not develop tumors or become cancerous, despite years in
continuous culture
- Are the only cell line known to uniquely differentiate into
hepatocytes (liver cells) and/or bile duct epithelium
- Express high levels of inducible P450 and GGT; important
indicators of hepatocyte and bile duct functions, respectively
- Are able to remain in continuous culture, i.e., and undergo
repeated passage indefinitely while retaining hepatic function
and high density cell culture; these results demonstrate cell
line strength and function
- Express proteins and mRNA that are unique to the liver
- Exhibit in vivo-like response of the in-vitro produced ductules
to secretin and cAMP
- Detoxify high amounts of ammonia and synthesize urea and/or
glutamine, vital functions of the human liver
- Exhibit in vivo-like responses to common drugs and toxins (e.g.,
acetaminophen, rifampicin)
- Tolerate room temperature for prolonged periods of time while
retaining hepatic function which enables convenient handling
and shipping.
“Our PICM-19 cell line sets us apart from
anyone else, especially when considering how well we have outperformed
the HepG2-C3A cells, a cell line that has been traditionally sought-out
by researchers and industry for its liver-like functionality,” concluded
Mr. Frank Menzler.
“Above all, these research results clearly
underline the exciting potential of HepaLife’s patented PICM-19
cell technology platform, especially in artificial liver support.”
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.
The World Health Organization estimates that 10%
of the world’s population has chronic liver disease, including
25 million Americans. In China alone, half a million die of the disease
each year.
ABOUT HEPALIFE TECHNOLOGIES, INC.
HepaLife Technologies, Inc. (OTCBB: HPLF - News;
FWB: HL1) (WKN: 500625) is a biotechnology company focused on the
identification and development of cell-based technologies and products.
Current cell-based technologies under development
by HepaLife include 1) the first-of-its-kind artificial liver device,
2) proprietary in-vitro toxicology and pre-clinical drug testing
platforms, and 3) novel cell-culture based vaccine production to
protect against the spread of influenza viruses among humans, including
potentially the high pathogenicity H5N1 virus.
For additional information, please visit www.hepalife.com.
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visit:
http://www.hepalife.com/investor-alerts.php
To view the full HTML text of this release, please
visit:
http://www.hepalife.com/20070410-1.html.php
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