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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 -- HepaLife Technologies, Inc. (OTCBB OTCBB

See OTC Bulletin Board (OTCBB).
:HPLF) (FWB (Fixed Wireless Broadband) See fixed wireless. :HL1) (WKN WKN Wertpapier-Kenn-Nummer (identifying number assigned to securities traded in Germany)
WKN Warrior Knowledge Network (US Army) 
:500625) today announced that the Company's patented 'PBS-1' cells, under development for avian influenza avian influenza: see 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 (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board.  of HepaLife Technologies, Inc., a cell-based, biotechnology company developing: the first-of-its-kind artificial liver artificial liver Biotech A cartridge with cloned human liver cells, through which blood flows to facilitate removal of waste products. See Extracorporeal liver assist device, Liver dialysis.  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 Noun 1. Department of Health and Human Services - the United States federal department that administers all federal programs dealing with health and welfare; created in 1979
Health and Human Services, HHS
 reiterated earlier warnings of the avian avian /avi·an/ (a´ve-an) of or pertaining to birds.

a·vi·an
adj.
Of, relating to, or characteristic of birds.
 flu's pandemic pandemic /pan·dem·ic/ (pan-dem´ik)
1. a widespread epidemic of a disease.

2. widely epidemic.


pan·dem·ic
adj.
Epidemic over a wide geographic area.

n.
 threat, and among its response recommendations, has urged cell-culture based influenza vaccine influenza vaccine Flu vaccine A vaccine recommended for those at high risk for serious complications from influenza: > age 65; Pts with chronic diseases of heart, lung or kidneys, DM, immunosuppression, severe anemia, nursing home and other chronic-care  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.

"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 molecular biology, scientific study of the molecular basis of life processes, including cellular respiration, excretion, and reproduction. The term molecular biology was coined in 1938 by Warren Weaver, then director of the natural sciences program at the Rockefeller  and Molecular Virology Molecular Virology is the study of viruses at the molecular level. In particular, this includes the analysis of individual viral genes and gene products, and their interaction with host (human, plant or animal) cellular proteins. .

Last month, third-party analysis by the world's leading provider of integrated preclinical support services support services Psychology Non-health care-related ancillary services–eg, transportation, financial aid, support groups, homemaker services, respite services, and other services  confirmed that HepaLife's PBS-1 cells are free from exogenous Exogenous

Describes facts outside the control of the firm. Converse of endogenous.
 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 avian flu: see influenza. , 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 fer·til·ize  
v. fer·til·ized, fer·til·iz·ing, fer·til·iz·es

v.tr.
1. To cause the fertilization of (an ovum, for example).

2.
 chicken eggs. Over time, the virus is harvested from the eggs, eventually inactivated inactivated

rendered inactive; the activity is destroyed.


inactivated viruses
treated so that they are no longer able to produce evidence of growth or damaging effect on tissue.
 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 WWMT World Wide Message Tribe (band) , television news story about HepaLife's active cell-based vaccine research: www.hepalife.com/media)

ABOUT HEPALIFE TECHNOLOGIES, INC.

HepaLife Technologies, Inc. (OTCBB:HPLF) (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.

For additional information, please visit www.hepalife.com.

To receive future press releases via email, please visit:

http://www.hepalife.com/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 administrative costs,
n.pl the overhead expenses incurred in the operation of a dental benefits program, excluding costs of dental services provided.
, termination of contracts or agreements, technological obsolescence ob·so·les·cent  
adj.
1. Being in the process of passing out of use or usefulness; becoming obsolete.

2. Biology Gradually disappearing; imperfectly or only slightly developed.
 of the Company's products, technical problems with the Company's research and products, price increases for supplies and components, litigation An action brought in court to enforce a particular right. The act or process of bringing a lawsuit in and of itself; a judicial contest; any dispute.

When a person begins a civil lawsuit, the person enters into a process called 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 Form 10-Q

See 10-Q.
 and Form 10-K Form 10-K

A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information.


Form 10-K

See 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.
COPYRIGHT 2007 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2007, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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