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October/November 2007                                                                                            Volume 13 - Number 1/2

    

 

Perspectives...

     

 


A Company’s Contribution to Biodefense
By Alicia Bandaranayake

The 2001 anthrax attacks in New York, Washington DC, and Florida turned the specter of bioterrorism on American soil into a reality.  An unknown assailant mailed letters containing anthrax spores to news media and senatorial offices in New York City, Boca Raton, and Washington DC.  More than 22 people developed anthrax infections, of which 11 developed the more life-threatening inhalation anthrax, while the others developed the less severe cutaneous anthrax.  Five people died of inhalation anthrax.  The Federal government realized that it would have to invest in Biodefense programs in order to safeguard the public from anthrax and other bioterrorism invaders.

The bacteria Bacillus anthracis causes anthrax infection by multiplying in the body and producing protective antigen and anthrax toxins.  Protective antigen facilitates the progression of anthrax infection by allowing anthrax toxins to enter and kill healthy cells in the human body.  While both a vaccine and antibiotics currently exist to prevent or treat anthrax infection, neither is ideal.  The anthrax vaccine takes several weeks after the initial injection to become effective and requires multiple injections over a period of eighteen months to fully confer immunity, as well as yearly booster injections to maintain immunity.  While antibiotics kill anthrax bacteria, they are not effective against anthrax toxins released into the blood.  

As a direct result of the 2001 anthrax attacks, Human Genome Sciences, Inc. (HGS) discovered and developed ABthrax, a human monoclonal antibody to Bacillus anthracis protective antigen.  ABthrax was the first investigational agent against anthrax infection to be evaluated in a clinical study.  It works by blocking protective antigen from binding to cells and preventing anthrax toxins from entering and killing cells.  Unlike the currently available anthrax vaccine, ABthrax provides protection immediately following the rapid achievement of appropriate blood levels of ABthrax.  Unlike antibiotics, Anthrax acts against anthrax toxins and may also prevent and treat infections by antibiotic-resistant strains of anthrax.  

While HGS developed ABthrax, the Federal government was also taking steps to increase biodefense spending.  In July 2004, the Project Bioshield Act was passed to accelerate the research, development, purchase, and availability of effective medical countermeasures against biological, chemical, radiological, and nuclear agents.  HGS has been a direct beneficiary of Project Bioshield and received a contract to develop ABthrax for government use in the event of an anthrax attack.  The first phase of the government contract was for HGS to supply ten grams of ABthrax to the U.S. Department of Health and Human Services (HHS) for comparative laboratory testing.  The second phase of the contract is for HGS to manufacture and deliver 20,000 treatment courses of ABthrax to the Strategic National Stockpile.  HGS will also complete the additional laboratory and clinical testing required to support the use of ABthrax in patients with inhalation anthrax disease in the event of an emergency prior to FDA licensure.  

President Bush stated at the signing of the Project Bioshield Act of 2004, “We refuse to remain idle when modern technology might be turned against us.  We will rally the great promise of American science and innovation to confront the greatest danger of our time.”  Project Bioshield creates partnerships between the government and industry to produce the medical countermeasures needed in case of an emergency.  HGS is just one of the companies working to lessen the fears associated with bioterrorism.  

For more information: http://www.hhs.gov/disasters/emergency/manmadedisasters/bioterorism/index.html