New Artificial Liver Tests: HepaLife's 'PICM-19' Demonstrate
Advantages Over Today's Best-Available Liver Cells
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© Business Wire 2008
2008-04-28 18:29:12 -
- HepaLife Technologies, Inc. Mr. Frank Menzler, President, 800-518-
4879 HepaLife Technologies, Inc. (OTCBB:HPLF) (FWB:HL1) (WKN:500625)
today announced that results from new tests of the Company's patented
PICM-19 liver cells show the highest levels of important liver-
specific metabolic activity key to mimicking human liver function,
and further demonstrate the PICM-19's ability to perform equivalent
to freshly harvested adult porcine hepatocytes, traditionally
regarded the best available liver cell source for bioartificial liver
support. HepaLife's PICM-19 liver cells also significantly outperform
the world's most widely used human liver cell line.
In ongoing tests, scientists have compared HepaLife's PICM-19 cells
against the world's leading human liver cell line (HepG2-C3A) and
against freshly-harvested liver cells (hepatocytes) from pigs,
recognized as the closest animal species for mimicking human liver
function. Of concern, the HepG2-C3A human liver cell line is tumor-
derived, created by extracting cells from a human hepatoblastoma, a
very rare cancer tumor mainly occurring in infants and children.
Freshly harvested pig liver cells pose other risks, such as the
potential for infecting human patients with animal diseases carried
by individual donor pigs.
Unlike freshly harvested liver cells from animals and tumor-derived
human cell lines, HepaLife's PICM-19 liver cells are disease free and
genetically consistent, and are neither cancer derived nor vulnerable
to the medical history of the donor source - all important
considerations for integration of liver cells inside an artificial
liver device for acute liver failure in humans.
According to researchers, new tests have shown that HepaLife's PICM-
19 cells exhibit the highest levels of Phase 2 conjugation activity,
an important mechanism of the liver to excrete toxic substances. In
contrast, freshly harvested adult pig hepatocytes, showed levels of
Phase 2 activity that was either identical or slightly lower than the
PICM-19. In comparison, the human liver cell line showed very low
Phase 2 activity.
The data also demonstrates that HepaLife's 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,
the HepG2-C3A human liver cell line showed very low or no detectable
P450 activity at all.
"Yet again, these results clearly demonstrate our PICM-19 cell line's
superior performance in key, liver-specific functions such as the
essential ability to metabolize and excrete toxic the same substances
present in liver failure patients," explained Mr. Frank Menzler,
President and CEO of HepaLife Technologies, Inc. "Our ability to
outperform existing human cell lines and successfully compete against
primary liver cells sets us apart from anyone else, and is vital to
effectively replicating the human liver's function in our
bioartificial liver device."
The central role played by the liver is the clearance and
transformation of toxins and drugs. Drug metabolism is usually
divided into two phases: Phase 1 in which cytochrome P-450 enzymes
metabolize and activate many toxicologically important substrates to
prepare a drug for Phase 2. In this second phase, activated drugs are
made water-soluble to be actively transported and excreted via bile
or plasma.
Another 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. In test results announced today,
HepaLife's PICM-19 cells successfully removed identical high levels
compared to adult pig hepatocytes and almost four times more than
HepG2-C3A. Most significantly, ammonia was synthesized into urea by
the PICM-19 cells. The HepG2-C3A cells lack this important
functionality. Notably, HepaLife's PICM-19 cell line is the only
known liver stem cell line of its kind with the ability to produce
substantial amounts of urea.
Intended for the treatment of liver failure, the HepaLife(TM)
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(TM)
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-
device for acute liver failure using the Company's patented PICM-19
liver stem cell line. The HepaLife(TM) 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.
To receive future press releases via email, please visit:
www.hepalife.
To view the full HTML text of this release, please visit:
hepalife.com/
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,
ate," "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 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.
HepaLife's patented cells show highest levels of liver-specific
metabolic activity - key to mimicking liver behavior in artificial
liver device; Unlike freshly harvested liver cells, PICM-19 are
disease free, genetically consistent, and not vulnerable to donor's
medical history.
http://www.pr-
r561019.htm
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StemCells subscribers may also be interested in these sites:
Children's Neurobiological Solutions
http://www.CNSfoundation.org/
Cord Blood Registry
http://www.CordBlood.com/at.cgi?a=150123
The CNS Healing Group
http://groups.yahoo.com/group/CNS_Healing
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