RESULTS OF PHASE I TRIAL OF ABTHRAX PUBLISHED

Human Genome Sciences reported that results published in the current issue of Clinical Infectious Diseases demonstrate that the first investigational agent against anthrax infection to be evaluated in a clinical study since the 2001 anthrax attacks in the U.S., is safe, well-tolerated and achieves the blood levels predicted by relevant animal models as necessary to afford significant protection from the lethal effects of the anthrax toxin.

Anthrax infection is caused by a spore-forming bacterium, Bacillus anthracis, which multiplies in the body and produces lethal toxins. Most anthrax fatalities are caused by the irreversible effects of anthrax toxins. Abthrax, which blocks the binding of protective antigen to cell surfaces and prevents the anthrax toxins from entering the cells, was studied in a randomized, single-blind, placebo- controlled, dose-escalation Phase I clinical trial. The trial was designed to evaluate the safety, pharmacokinetics and biological activity of Abthrax. The subjects received a single intramuscular injection or intravenous infusion of either Abthrax or placebo.

Results show that Abthrax was safe, well-tolerated and bioavailable after a single intramuscular or intravenous dose, with no dose-limiting adverse events. Only transient, mild-to-moderate adverse events were observed, with no statistically significant difference in adverse event profiles between active and placebo arms of the study.