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U.S. Officials Warn of ‘Pandemic’ Avian Influenza & Urgent Need for Cell-Based Vaccines, HepaLife’s Primary Target.
Boston, MA – November 20, 2006 - HepaLife Technologies, Inc. (OTCBB: HPLF) (FWB: HL1) (WKN: 500625) today announced that a US Government report issued last week by the Department of Health and Human Services (HHS) has 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.
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.
Currently, vaccine production involves injecting a small amount of a targeted virus into fertilized chicken eggs, where the virus multiplies. After the virus is harvested from the eggs, chemicals inactivate and purify the virus, which is then blended into a vaccine and bottled in vials. This production method takes at least six months. It is unlikely that current egg-based vaccines will be produced fast enough to meet expected demand due to the lengthy production time, in the event of a flu pandemic.
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.”
“The HHS report is a stark reminder of the urgent need for action, and it clearly reinforces our contention that a cell-based vaccine production system is essential to successfully fighting the influenza threat,” explained HepaLife President and CEO, Mr. Frank Menzler.
“This report comes on the heels of the U.S. Food and Drug Administration’s (FDA) major push to modernize and speed the production of vaccines in response to pandemic influenza and other emerging threats,” continued Mr. Menzler. “Only six weeks ago, the FDA issued its industry guidance on how to safely and effectively develop new cell-based vaccines. I fully expect our research and development to follow these recommendations in order to work towards the fastest possible approval for our influenza products.”
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.
According to a report authored by the National Governor’s Association, avian influenza is “one of the most deadly human diseases ever reported” and is projected to infect as many as 90 million Americans, or one-third of the population in severe pandemic conditions.
About AVIAN FLU
The H5N1 strain of avian flu can be transmitted from birds to humans. From 2003 to November 13, 2006 the World Health Organization has confirmed 258 human cases, including 153 deaths. There is currently no vaccine available to protect humans from H5N1.
The Centers for Disease Control states, “There is little pre-existing natural immunity to H5N1 infection in the human population. If these H5N1 viruses gain the ability for efficient and sustained transmission among humans, an influenza pandemic could result, with potentially high rates of illness and death.” In May, the White House issued a report saying that a disease outbreak could lead to the deaths of 200,000 to 2 million in the U.S. alone.
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.
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