FDA CLEARS HUMAN TRIALS OF ANTHRAX TREATMENT
25 Jun 2003
Source: Wall Street Journal, June 25, 2003
FDA Clears Human Trials Of Anthrax Treatment
DOW JONES NEWSWIRES
ROCKVILLE, Md. -- Human Genome Sciences Inc. said the Food and Drug Administration cleared a new-drug application to start human trials of ABthrax, an experimental drug for the prevention and treatment of anthrax infections.
Human Genome, the first biopharmaceutical company to bring an anthrax drug to trial, is hoping for government help to develop ABthrax as part of the war on terrorism.
"Large-scale development and manufacture of ABthrax is dependent on government funding either under existing authority or under proposed Project Bioshield legislation," the company said Wednesday, referring to proposals put forward by President Bush for defenses against biological weapons.
The FDA cleared the drug for human trials based on data indicating the human monoclonal antibody was effective in protecting against infection from inhaled anthrax in rabbits and monkeys.
The company will now proceed with a phase-one trial of the safety and tolerability of the drug in humans, but the researchers will not test the effectiveness of the antibody in the subjects because that would require exposing humans to a bioagent.
Under the bioterrorism act of 2002, the FDA will consider successful studies in relevant animal models as sufficient to establish the efficacy of a drug for licensing and marketing approval.
Human Genome will begin enrolling healthy adult volunteers into a trial to test the safety and dosage of the antibody administered intramuscularly and intravenously.
The company will seek approval for the drug as both a preventive measure and a treatment for infection by the bacillus anthracic toxin.
The only currently available options for protecting humans against anthrax infections are a vaccine and antibiotics. The vaccine requires continued injections over about 18 months, with annual boosters. Antibiotics will kill anthrax bacteria, but are not effective against the toxins once they have reached the blood.
Human Genome said it has discovered a third mechanism of defense against anthrax . The ABthrax antibody would protect a subject with a single dose and may prevent and treat infections by antibiotic-resistant strains of anthrax , the company said.
ABthrax could be ready for emergency use as early as the end of 2004, the company said, but only if the government provides funding and commits to purchasing the product upon approval.
Human Genome said it will report the full results of the animal trials at the annual convention of Biotechnology Industry Organizations in Washington D.C. later Wednesday.
Shares of Human Genome Sciences closed Tuesday on the Nasdaq Market at $12.64, up nine cents, or 0.7%.