A U.S. biotechnology company announced today that it has received Food and Drug Administration approval to begin human testing of a new drug that has been found to both prevent and treat anthrax (see GSN, March 18).

Human Genome Sciences is now set to begin enrolling adult volunteers into a Phase 1 placebo-controlled clinical trial to evaluate the safety and tolerability of its new drug, ABthrax.  Adults enrolled into the study will be administered different dose levels of intramuscularly and intravenously administered ABthrax, the company said in a press release.  Under the Bioterrorism Act of 2002, the company can use the results of animal testing to demonstrate the drug efficacy for the purposes of licensing and marketing approval, the company said.

“We are pleased to be able to proceed with a clinical trial to evaluate the safety, tolerability and pharmacology of ABthrax in healthy adults,” Human Genome Sciences Senior Vice President David Stump said in a statement.  “Positive results from such a human study, along with our preclinical proof of efficacy data, would support the further development of ABthrax as a new means to prevent and treat anthrax infections,” Stump said.

ABthrax is a human monoclonal antibody that works by countering protective antigen — a toxin released by the anthrax bacterium.  Animal testing has found that a single dose of the drug can protect against anthrax infection once an appropriate level of the antibody is built up in the blood, the company said.  The drug also works against the toxins produced by anthrax bacterium, making it suitable as a treatment.

Large-scale production of ABthrax is dependent on government funding, which could be provided through the pending “Project Bioshield” legislation, the company said (see GSN, June 24; Human Genome Sciences release, June 25).

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