Cethromycin: Treatment For Anthrax And Other High-Priority Biodefense Agents

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High-Priority Biodefense Agents

National Institute of Allergy and Infectious Diseases will conduct studies to evaluate cethromycin, the late-stage antibiotic, as a treatment for anthrax and other high-priority biodefense agents.

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This collaboration is part of the U.S. Government's effort to accelerate the research and development of medical countermeasures through the crucial phase of drug development between basic research and acquisition of final products under Project BioShield.

Project BioShield provides the Department of Health and Human Services with the authority and funding to procure promising countermeasures for addition to the Strategic National Stockpile, which is the Center for Disease Control and Prevention's store of medical supplies to protect the American public in the event of a public health emergency. Project BioShield provides the NIAID, part of the National Institutes of Health, with the authority to support development of countermeasures toward possible future procurement with Project BioShield funds.

"We are very excited about our partnership with the NIAID as it allows us to leverage the financial and scientific resources of the U.S. Government's premier research institute to develop cethromycin as a broad spectrum medical countermeasure," said Dr. Michael T. Flavin, Chief Executive Officer. "With the threat of growing resistance to currently available therapies, the U.S. Government is focused on procuring next-generation products with a broad spectrum of activity to complement currently-held medical countermeasures in the Strategic National Stockpile. This partnership with NIAID will expand the data on cethromycin as a biodefense application, and we expect the results to strengthen our efforts in positioning cethromycin for purchase by the U.S. Government."

In May, Advanced Life Sciences announced positive data from a study that showed cethromycin to be effective in preventing inhalation anthrax infection in primates. The study, involving a 30-day course of oral dosing, demonstrated that cethromycin was 100% protective against a lethal dose of inhaled anthrax as compared to the current standard of care, Cipro(R) (ciprofloxacin), which demonstrated 90% protection. The FDA has designated cethromycin as an orphan drug for the prophylactic treatment of inhalation anthrax post-exposure, however the FDA has not yet approved the drug for marketing in this or any other indication.

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