
Favorable Research Outcomes Prompt
Expansion of HepaLife’s Influenza Vaccine Initiative.
Boston, MA – December
18, 2006– HepaLife Technologies, Inc. (OTCBB: HPLF)
(FWB: HL1) (WKN: 500625) today announced plans to expand its influenza
vaccine development initiative following favorable research outcomes
related to the Company’s ‘PBS-1’ cell line. HepaLife’s
patented PBS-1 cell line is being developed for application in
novel, cell-culture based vaccine production to help protect against
the spread of influenza viruses among humans, including potentially
the high pathogenicity H5N1 avian flu virus.
“I’m proud to announce that we are actively
expanding HepaLife’s vaccine development program based on encouraging
results from our PBS-1 cell line research, including important outcomes
announced earlier this month, which indicate that our cells have
successfully achieved a critical milestone related to the FDA’s
draft guidelines”, explained HepaLife President and CEO, Mr.
Frank Menzler.
(View HepaLife's December 4, 2006 research update
on pathogen-free PBS-1 cells: http://www.hepalife.com/20061204-1.html.php)
Among key findings, the Company announced that independent
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Administration’s (FDA) Draft Guidance for Industry for the
safe and effective development of a new generation of cell-based
vaccines.
Last month, a US Government report issued by the Department of
Health and Human Services (HHS) reiterated earlier warnings of the
Avian Flu’s pandemic threat, and among its response recommendations,
urged cell-culture based influenza vaccine production, HepaLife’s
primary application for its patented ‘PBS-1’ cell line.
“Especially exciting are the implications of developing our
PBS-1 cell technology for more flexible cell-culture based vaccine
production with the ability to quickly address prospective mutations
in the avian influenza virus, and replace cumbersome, time-consuming,
and costly vaccine production processes which currently rely on chicken
eggs.”
Current vaccine production methods involve 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.
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 and at less cost by means of the Company’s
patented PBS-1 line of cells.
(View a CBS-affiliate, WWMT, television news story about
HepaLife’s active cell-based vaccine research: www.hepalife.com/media)
HepaLife’s cell-based vaccine production would eliminate
problems created by allergies to egg albumin, and potentially replace
expensive influenza diagnostics for avian flu by reducing the time
to detection and cost of analysis, critical factors in a large
scale influenza surveillance program.
According to the Department of Health and Human Services, “There
is no way to know how lethal an H5N1 avian influenza outbreak could
be, but a catastrophic scenario — a pandemic of 1918 severity — could
cause nearly two million deaths in the United States, and tens, perhaps
hundreds, of millions of deaths worldwide.”
An earlier report authored by the National Governor’s
Association considers avian influenza “one of the most deadly
human diseases ever reported,” projected to infect as many
as 90 million Americans or one-third of the population in severe
pandemic conditions.
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 pathogenicity H5N1 virus.
At present, HepaLife 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.
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/20061218-1.html.php
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