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.
Instead, the Bioterror Act of 2002 gave the FDA the power to approve drugs based on their safety in humans and their effectiveness in two types of animals. ABthrax was tested in rabbits and non-human primates. All of the animals that received ABthrax, except for one primate, survived doses of anthrax toxin that killed all of the experiment's control animals.
ABthrax proved at least 90% effective, with only a 1-in-10,000 possibility that the finding could have occurred by chance, says David Stump, the firm's director of drug development.
Detailed results are to be released at scientific meetings this fall, he said.
Haseltine says his firm has so far poured its own money into ABthrax, adding that the company won't be able to carry on without government help. "Passage of BioShield or similar legislation is critical," he says," because there is no natural market."
BioShield is on hold in Congress, as members of a joint committee attempt to reconcile House and Senate versions of the legislation. In a speech Monday to BIO 2003, an annual meeting of biotech researchers, Bush urged Congress to send him a bill to sign "as soon as possible."
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.
Instead, the Bioterror Act of 2002 gave the FDA the power to approve drugs based on their safety in humans and their effectiveness in two types of animals. ABthrax was tested in rabbits and non-human primates. All of the animals that received ABthrax, except for one primate, survived doses of anthrax toxin that killed all of the experiment's control animals.
ABthrax proved at least 90% effective, with only a 1-in-10,000 possibility that the finding could have occurred by chance, says David Stump, the firm's director of drug development.
Detailed results are to be released at scientific meetings this fall, he said.
Haseltine says his firm has so far poured its own money into ABthrax, adding that the company won't be able to carry on without government help. "Passage of BioShield or similar legislation is critical," he says," because there is no natural market."
BioShield is on hold in Congress, as members of a joint committee attempt to reconcile House and Senate versions of the legislation. In a speech Monday to BIO 2003, an annual meeting of biotech researchers, Bush urged Congress to send him a bill to sign "as soon as possible."
