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HepaLife’s Patented ‘PBS-1’ Cells for Avian Influenza Vaccine Achieve FDA’s Early Guidance Research Objective.
Independent third-party analysis by world's leading provider of integrated preclinical support services confirms HepaLife’s PBS-1 cells are free from exogenous agents, bacteria and fungi – important objectives.
Boston, MA – December 4, 2006– HepaLife Technologies, Inc. (OTCBB: HPLF) (FWB: HL1) (WKN: 500625) today announced confirmation that the Company’s patented ‘PBS-1’ cells, under development for avian influenza vaccines, are free of pathogens, diseases, bacteria, and potentially harmful viruses. Pathogen-free cells are critical for the rapid development of 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 very pleased that independent lab tests have confirmed our PBS-1 cells are pathogen-free. This is especially good news for HepaLife’s researchers, who can now confidently accelerate our vaccine development program forward,” explained Mr. Frank Menzler, President and CEO of HepaLife Technologies, Inc.
“Most importantly, our pathogen-free PBS-1 cells specifically addresses recently released recommendations in the US Food and Drug Administration’s (FDA) Draft Guidance for Industry for the safe and effective development of a new generation of cell-based vaccines.”
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.
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.
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.
(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 also 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 surveillance program.
In a US Government report issued last month, the Department of Health and Human Services (HHS) reiterated 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.
According to the HHS report (issued on November 13, 2006), “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 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
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