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Battelle Life Sciences Research CRO+ Today

Battelle Life Sciences Research CRO+ Today

August 2016 - Issue 8

Microscopic view of anthrax

ANTHIM Research Papers Accepted for Publication

Researchers at Battelle contributed to two new papers detailing results from animal efficacy studies of a new treatment for inhalational anthrax. The papers have been accepted for publication by the journal Antimicrobial Agents and Chemotherapy.

The papers describe results of animal efficacy studies conducted by Battelle under the FDA animal rule for licensure of Elusys Therapeutics’ ANTHIM (obiltoxaximab) Injection, which received FDA approval in March 2016. ANTHIM acts as a treatment or prophylactic for inhalational anthrax. It neutralizes the effect of the anthrax toxin, preventing spread of the toxin throughout the body and the resulting tissue damage, which usually leads to death without treatment. It is expected to be an important addition to the Strategic National Stockpile (SNS), which stores large quantities of medicines, therapies and vaccines to protect the public in the case of an epidemic, natural disaster or terrorist attack.

Battelle scientists Drs. Daniel Sanford, Lisa N. Henning and Gregory V. Stark contributed to both the research and the papers. The first, “Obiltoxaximab for Inhalational Anthrax: Efficacy Projection Across a Range of Disease Severity,” focuses on the efficacy of obiltoxaximab for treatment of inhalational anthrax. The second, “Obiltoxaximab Prevents Disseminated Bacillus anthracis Infection and Improves Survival during Pre- and Post-Exposure Prophylaxis in Animal Models of Inhalational Anthrax,” focuses on the prophylactic efficacy of the drug, both pre-exposure and post-exposure. Both studies used animal models under the FDA Animal Rule, which provides an alternative licensure pathway for products that cannot be practically or ethically tested in humans.