
HepaLife Surpasses Major Milestone
in Cell-Based Vaccine Development for Avian Influenza
HepaLife’s patented PBS-1 cells successfully
replicate targeted human influenza viruses, the most important
step in development of cell-based vaccines to treat infected patients.
Boston, MA – January 22, 2007 -
HepaLife Technologies, Inc. (OTCBB: HPLF) (FWB: HL1) (WKN: 500625)
today announced that the Company’s patented ‘PBS-1’ cells,
under development for avian influenza vaccines, have actively grown
and replicated several human influenza virus types, including H1N1,
H3N2 and type B. The most important step towards the production
of a cell-culture based vaccine against a targeted virus is the ability
to efficiently grow the same virus in a cell substrate.
“This discovery marks a critical success milestone
for HepaLife’s vaccine development program,” stated Mr.
Frank Menzler, President and CEO of HepaLife Technologies, Inc.,
a cell-based, biotechnology company developing: the first-of-its-kind
artificial liver device; in-vitro toxicology and drug testing platforms;
and cell-culture based vaccines to protect against the spread of
influenza viruses among humans, including potentially the high pathogenicity
H5N1 virus.
“I’m very pleased by how well our patented
PBS-1 cells have been able to grow and replicate several human influenza
virus types,” explained Mr. Menzler. “Growing a
particular virus inside a cell line is the key to successfully producing
a vaccine against the same virus, using cell-culture.”
Cell-culture based vaccine production with the ability
to quickly address prospective mutations in the avian influenza virus
is a promising replacement of cumbersome, time-consuming, and costly
vaccine production processes which currently rely on chicken eggs.
A US Government report issued by the Department of Health and Human
Services reiterated earlier warnings of the avian flu's pandemic
threat, and among its response recommendations, has urged cell-culture
based influenza vaccine production, HepaLife's primary application
for its patented 'PBS-1' cell line.
The most important step towards the production of
a cell-culture based vaccine against a targeted virus is the ability
to efficiently grow the same virus in a cell substrate. The
picture below shows influenza type B virus growth on HepaLife’s
PBS-1 cells, four days after the infection. The colored stains (marked
by arrows) indicate where PBS-1 cells have been successfully infected
and are actively producing the human influenza virus.
(View HepaLife's PBS-1 cells growing human virus:
http://www.hepalife.com/vaccine-1.html.php)
“What
is especially encouraging is the rapid and vigorous growth of strains
that had not been previously adapted to cell culture growth. These
strains are usually only grown in embryonated chicken eggs or on
primary, non-immortalized chicken cells,” emphasized Dr. Paul
Coussens, a HepaLife Scientific Advisory Board Member and Professor
of Molecular Biology and Molecular Virology.
Last month, third-party analysis by the world's
leading provider of integrated preclinical support services confirmed
that HepaLife's PBS-1 cells are free from exogenous agents, fungi,
bacteria, diseases, and potentially harmful viruses. Pathogen-free
PBS-1 cells specifically address recently released recommendations
in the US Food and Drug Administration's Draft Guidance for Industry
for the safe and effective development of a new generation of cell-based
vaccines.
(View HepaLife's December 4, 2006 research update
on pathogen-free PBS-1 cells: http://www.hepalife.com/20061204-1.html.php)
“These positive results are important to our
next vaccine development steps, which include the growth of other
human influenza strains, already provided to us by the Centers for
Disease Control. In addition, we plan to investigate several
strains of avian influenza, including the highly pathogenic H5N1
avian flu, using our patented PBS-1 cell line,” concluded
Mr. Frank Menzler.
HepaLife’s non-mammalian PBS-1 cell line is
derived from an immortalized chicken embryo cell, and is being developed
for more flexible cell-culture based vaccine production with the
ability to quickly address prospective mutations in the avian influenza
virus.
Protected by five issued patents, including US patent
5,989,805 ("Immortal Avian Cell Line to Grow Avian and Animal
Viruses to Produce Vaccines"), HepaLife is developing production
methods to make flu vaccines faster, safer and at less cost by means
of the Company’s patented PBS-1 line of cells.
Currently, vaccine production involves injecting
a small amount of a targeted virus into fertilized chicken eggs. Over
time, the virus is harvested from the eggs, eventually inactivated
and purified, and finally blended into a vaccine and bottled in vials. This
egg-based production method takes at least six months, and in the
event of a flu pandemic, it is unlikely to produce vaccines fast
enough to meet expected demand.
(View a CBS-affiliate, WWMT, television news story
about HepaLife’s active cell-based vaccine research: www.hepalife.com/media)
ABOUT HEPALIFE TECHNOLOGIES, INC.
HepaLife Technologies, Inc. (OTCBB: HPLF - News;
FWB: HL1) (WKN: 500625) is a development stage biotechnology company
focused on the identification, development and eventual commercialization
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) cell-culture based vaccines to protect against
the spread of influenza viruses among humans, including potentially
the high pathogenic H5N1 virus.
For additional information, please visit www.hepalife.com
To receive future press releases via email,
please visit http://www.hepalife.com/investor-alerts.php
To view the full HTML text of this release,
please visit http://www.hepalife.com/20070122-1.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.
|