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Data published in the New England Journal of Medicine support use of raxibacumab (ABthrax) for the treatment of inhalation anthrax
July 10, 2009Biologics License Application pending for first-in-class treatment for inhalation anthrax; HGS has delivered 20,000 doses of raxibacumab to the US Strategic National Stockpile for emergency use under a contract with BARDA
ROCKVILLE, Maryland - Human Genome Sciences, Inc. (Nasdaq: HGSI) today announced publication by the New England Journal of Medicine of the results of two pivotal animal efficacy studies, which showed the life-saving potential of the Company's human monoclonal antibody drug raxibacumab (ABthrax™), as well as the results of human safety studies, which supported the use of raxibacumab in the event of life-threatening inhalation anthrax disease.
"The results published today showed that a single dose of raxibacumab was highly effective as a treatment for inhalation anthrax in both rabbits and monkeys," said Sally D. Bolmer, Ph.D., R.A.C, lead author and Senior Vice President, Development and Regulatory Affairs, HGS. "Raxibacumab acted quickly to provide a significant survival benefit to animals showing clinical signs of disease caused by exposure to a dose of aerosolized anthrax spores that was approximately 200 times the median lethal dose. We also note that the safety profile shown in healthy human volunteers provides support for use of raxibacumab in the clinical setting of immediately life-threatening inhalation anthrax disease."
Raxibacumab represents a new way to address the anthrax threat. While antibiotics can kill the anthrax bacteria, they are not effective against the deadly toxins that the bacteria produce. Raxibacumab targets anthrax toxins after they are released by the bacteria into the blood and tissues. In an inhalation anthrax attack, people may not know they are infected with anthrax until the toxins already are circulating in their blood, and it may be too late for antibiotics alone to be effective.
"We are very proud that the importance of these data and the rigor and high quality of our scientists' work have led to publication in The New England Journal of Medicine," said David C. Stump, M.D., Executive Vice President, Research and Development, HGS. "Based on these results, we believe raxibacumab has the potential to be a significant step forward in the treatment of inhalation anthrax."
Edelman Public Relations
Raxibacumab represents a new way to address the anthrax threat. While antibiotics can kill the anthrax bacteria, they are not effective against the deadly toxins that the bacteria produce. Raxibacumab targets anthrax toxins after they are released by the bacteria into the blood and tissues. In an inhalation anthrax attack, people may not know they are infected with anthrax until the toxins already are circulating in their blood, and it may be too late for antibiotics alone to be effective.
"We are very proud that the importance of these data and the rigor and high quality of our scientists' work have led to publication in The New England Journal of Medicine," said David C. Stump, M.D., Executive Vice President, Research and Development, HGS. "Based on these results, we believe raxibacumab has the potential to be a significant step forward in the treatment of inhalation anthrax."
Edelman Public Relations
Anthrax Current Events and Anthrax News RSSMilestone biodefense publication by Elsevier journal Vaccine
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New explanation for nature's hardiest life form
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