
HepaLife’s Bioartificial Liver Exceeds Expectations
in New Tests Conducted Over Prolonged Periods of Time
HepaLife’s patented PICM-19 liver cells and artificial
liver device ‘bioreactor’ show ability to mimic important
human liver function with highest levels of liver-specific metabolic
activity over 14 day period; Traditional ‘primary’ cells
rapidly lose capabilities.
Boston, MA – May 12, 2008 – HepaLife
Technologies, Inc. (OTCBB: HPLF) (FWB: HL1) (WKN: 500625) today announced
that new tests of its bioartificial liver device demonstrate the
Company’s bioreactor system and patented PICM-19 cells inside
the device remain functional over prolonged periods time, far exceeding
the number of treatment hours referenced in published research studies
of human liver failure patients undergoing conventional liver support
therapies.
“Today’s news marks yet another favorable outcome from
a series of significant tests that researchers have recently conducted
on our bioartificial liver device, all designed to progressively
move us towards in vivo animal trials – a significant step
towards the commercialization of our technology,” explained
Mr. Frank Menzler, President and CEO of HepaLife Technologies, Inc.
“Previous tests have shown the ability of our liver cells
to consistently outperform other cell technologies, including the
world’s most widely used human liver cell line, HepG2. Importantly,
these newest test results now confirm that our patented PICM-19 liver
cells retain their functionality inside our liver device’s
bioreactor system for long periods of time. Moreover, the entire
system can function far longer than conventional treatment periods
for human liver failure patients, a key capability that could potentially
provide physicians and clinicians with a more flexible, longer-lasting
treatment option.”
Outcomes from new tests show that HepaLife’s bioartificial
liver device system is able to successfully retain the highest levels
of liver-specific metabolic activity -- mimicking the most important
functions of the human liver -- for 14 days, a substantially longer
period than the 6 to 48 hour conventional treatments described in
published research papers. Researchers anticipate that the ability
of HepaLife’s patented liver cells in combination with its
proprietary bioreactor system to remain functional for extended periods
of time may provide for more efficient and flexible patient treatment
options over prolonged periods of time, potentially improving patient
outcomes as a result.
HepaLife’s First-Of-Its-Kind Bioartificial Liver:
Results Prompt In-Vivo Animal Trials
In tests conducted over a 14 day period, researchers observed that
HepaLife’s patented PICM-19 cells maintained ‘differentiated
hepatocyte function’, the key to their ability to remain functional
as liver cells inside the Company’s bioartificial liver device.
Researchers have also conducted studies designed to model the environment
present when treating human liver failure patients, exposing the
Company’s liver cells to human blood plasma and toxic ammonia.
Notably, HepaLife’s PICM-19 cell line successfully removed
toxic ammonia, produced urea, and expressed CYP-450 enzymes - - all
leading indicators of liver function. While HepaLife’s PICM-19
cells maintained their differentiated hepatocyte function and CYP-450
activity in the presence of human plasma, CYP-450 activity was rapidly
lost in conventional cell technologies, including primary hepatocytes
and the world’s most widely-used human liver cell line, HepG2.
Exposure to human blood plasma did not affect the ability of HepaLife’s
PICM-19 cells to clear toxic ammonia. The clearance rate of ammonia
utilized per hour was similar to the rate observed for ammonia challenges
performed in culture medium. The conversion of ammonia to urea in
culture medium occurred at near-theoretical levels and the average
rate of ammonia clearance by the PICM-19 liver cells was equivalent
to rates obtained for primary porcine hepatocytes, thereby successfully
replicating the closest in vitro model of native liver function in
nature.
When challenged with high amounts of toxic ammonia, present in patients
with acute liver failure, HepaLife’s bioartificial liver reduced
ammonia levels by 75% within less than 24 hours. Published human
clinical data of systems utilizing liver cells other than HepaLife’s
patented PICM-19 cells, have only reported ammonia reduction levels
between 0 to 44%.
The primary mechanism for reducing toxic ammonia in the native liver
is by producing urea. The theoretical ratio of urea formed from ammonia
is 1:1. In recent tests of the Company’s liver cells, 85% of
the present ammonia was converted to urea. HepaLife’s PICM-19
liver cells are the only cell line known to have a complete urea
cycle producing significant amounts of urea.
Most importantly, scientists’ extrapolations based on the
calculated rate of ammonia clearance indicate that HepaLife’s
bioartificial liver has sufficient capacity to treat the targeted
acute liver failure animal model in HepaLife’s anticipated
initial in-vivo trials. In published studies of in-vivo clinical
data from liver support technologies utilizing conventional primary
porcine liver cells, the levels of reported ammonia reduction in
an animal model are significantly less than the ammonia reduction
observed in recent tests of HepaLife’s bioartificial liver
device by scientists. Researchers attribute the advanced performance
of HepaLife’s bioartificial liver to its unique use of the
Company’s patented PICM-19 liver cells in combination with
the novel design of the bioreactor system in which the cells are
housed.
Intended for the treatment of liver failure, the HepaLife™ Bioartificial
Liver device consists of three basic components: (1) a plasma filter,
separating the patient’s blood into blood plasma and blood
cells; (2) the bioreactor, a unit filled with the patented PICM-19
liver stem cell line which biologically mimics the liver’s
function; and (3), the HepaDrive™, a perfusion system for pumping
the patient's plasma through the bioreactor while controlling gas
supply and temperature for best possible performance of the cells.
ABOUT HEPALIFE TECHNOLOGIES, INC.
Based in Boston, Massachusetts, HepaLife Technologies, Inc. (OTCBB:
HPLF) (FWB: HL1) (WKN: 500625) is a developer of cell-based medical
technologies addressing prevalent human health concerns.
HepaLife is working towards the first-of-its-kind bioartificial
liver device for acute liver failure using the Company’s patented
PICM-19 liver stem cell line. The HepaLife™ bioartificial liver,
currently under development, is designed to serve as a supportive
device, either allowing the liver to regenerate upon acute liver
failure, or to bridge the patient's liver functions until a transplant
is available.
Utilizing its patented liver stem cell line PICM-19, HepaLife is
designing testing platforms to improve the pharmaceutical industry’s
capability to evaluate drug toxicity and possible side-effects before
pharmaceutical compounds are commercially distributed.
For additional information, please visit www.hepalife.com.
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http://www.hepalife.com/investor-alerts.php
To view the full HTML text of this release, please visit:
http://www.hepalife.com/press_releases/20080512.html.php
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