Drug appears to offer 'immunity' against anthrax toxin
By Steve Sternberg, USA TODAY
The government has approved the first human trial of a novel anthrax drug designed to fill a gap in the nation's defenses against biological attack, the drug's developer said Wednesday.
Called ABthrax, the drug appears to rid the blood of anthrax toxin, bacteria and spores entirely. "It provides sterilizing immunity," says William Haseltine, CEO of Human Genome Sciences Inc. of Rockville, Md., the drug's developer.
The drug, which also would be used against drug-resistant strains of anthrax, may represent a major advance over the antibiotics and vaccine now in use. Antibiotics can kill anthrax bacteria, but spores may survive long enough to produce deadly toxin. Antibiotics are powerless against anthrax toxin. And anthrax vaccine takes weeks to provide protection, too long for vaccine to guarantee protection in the event of an unexpected attack.
The human trial will involve several hundred volunteers. If the drug passes the test, it could be one of the first drugs eligible for purchase by the government under President Bush's proposed 10-year, $6 billion Project BioShield program, now moving through Congress. BioShield guarantees a market for anti-bioterror drugs by authorizing the government to buy them.
"I've seen the data, and it looks really promising," says Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases. "This is the kind of thing that might qualify for the BioShield approach."
ABthrax also represents a key test of new Food and Drug Administration guidelines for the approval of anti-bioterror drugs, which can't be tested for human effectiveness because volunteers would be exposed to lethal agents.
By Steve Sternberg, USA TODAY
The government has approved the first human trial of a novel anthrax drug designed to fill a gap in the nation's defenses against biological attack, the drug's developer said Wednesday.
Called ABthrax, the drug appears to rid the blood of anthrax toxin, bacteria and spores entirely. "It provides sterilizing immunity," says William Haseltine, CEO of Human Genome Sciences Inc. of Rockville, Md., the drug's developer.
The drug, which also would be used against drug-resistant strains of anthrax, may represent a major advance over the antibiotics and vaccine now in use. Antibiotics can kill anthrax bacteria, but spores may survive long enough to produce deadly toxin. Antibiotics are powerless against anthrax toxin. And anthrax vaccine takes weeks to provide protection, too long for vaccine to guarantee protection in the event of an unexpected attack.
The human trial will involve several hundred volunteers. If the drug passes the test, it could be one of the first drugs eligible for purchase by the government under President Bush's proposed 10-year, $6 billion Project BioShield program, now moving through Congress. BioShield guarantees a market for anti-bioterror drugs by authorizing the government to buy them.
"I've seen the data, and it looks really promising," says Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases. "This is the kind of thing that might qualify for the BioShield approach."
ABthrax also represents a key test of new Food and Drug Administration guidelines for the approval of anti-bioterror drugs, which can't be tested for human effectiveness because volunteers would be exposed to lethal agents.
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