Favorable Research Outcomes Prompt Expansion of HepaLife's Influenza Vaccine Initiative.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 plans to expand its 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 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 (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. 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 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 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 FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) Draft Guidance for Industry for the safe and effective development of a new generation of cell-based vaccines.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 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 (HHS HHS Department of Health and Human Services. ) reiterated earlier warnings of the avian 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, 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 avian influenza: see 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 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. 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 WWMT World Wide Message Tribe (band) , 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 egg albumin n. The white of an egg. Also called ovalbumin. , 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) (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 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, 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/Alerts-Index.asp. To view the full HTML text of this release, please visit: http://www.hepalife.com/20061218-1.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 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. |
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