
HepaLife Achieves Major Cell Biology Objective in Artificial
Liver Device Research
HepaLife's liver cells demonstrate ability to function and survive
without feeder cell support, following successful room temperature
and human plasma survival outcomes; findings crucial to artificial
liver device.
Vancouver, BC - May 30, 2006 - HepaLife Technologies, Inc.
(OTCBB: HPLF) (FWB: HL1) today announced that the Company's patented
liver stem cells have demonstrated the ability to survive and function
without feeder cell support, a significant cell biology objective
in the research and development of HepaLife's artificial liver device
for human patients suffering from acute liver failure.
"There are an estimated 25 million Americans with liver disease,
with tens of thousands worldwide dying each year as a consequence
of acute liver failure.For these patients, the immediate need for
an artificial liver device is critically urgent," explained
Mr. Harmel S. Rayat, President and CEO of HepaLife.
"Key to the development a fully functional, therapeutically
effective artificial liver device is not the mechanical hardware
itself, but rather, the biological component that goes inside and
mimics the behavior of the human liver," continued Mr. Rayat. "This
is where HepaLife's PICM-19 liver cells are critical - they have
repeatedly shown the ability to survive and grow in multiple environments,
emulating the functions of the human liver."
In ongoing research, HepaLife's 'PICM-19H' liver stem cells have
demonstrated the crucial ability to not only survive, but also remain
functional without feeder cell support. PICM-19H cell culture without
the aid of STO feeder cells will allow for a more defined cell culture
system, an active research and application goal of the Company.
A defined PICM-19H cell culture system (i.e., one free of feeder
cells and undefined cell culture medium constituents) may also be
important for potential FDA approval of HepaLife's artificial liver
device, currently under development and expected to incorporate the
PICM-19H cells as a key component.
"We believe our cell line is what sets us apart from the competition.
As we advance and surpass each of our research objectives, we move
closer than ever to the development of an artificial liver device," stated
Mr. Rayat.
Scientists have long-considered that the greatest hindrance to the
development of a completely functional artificial liver device is
the lack of an appropriately defined normal (i.e., non-tumor or cancer
gene associated) cell line that has normal liver cell form and function.Unlike
other cells, HepaLife's liver cells remain fully functional and do
not become tumorigenic or cancerous, despite years in continuous
culture.
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.
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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
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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
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