PharmAthene, Inc. announced that the United States Food and Drug Administration (FDA) has provided formal consent for PharmAthene to reinitiate clinical testing of its anthrax anti-toxin, Valortim, after lifting the partial clinical hold placed on the programme in late 2009.

“We're very pleased to resume clinical testing of Valortim,” remarked Dr. Thomas Fuerst, senior vice president and chief scientific officer. “The accumulating data suggest that Valortim may have unique characteristics, which could position it as a leading candidate for future procurement in the nation's bio-defence stockpile. A presumed different mechanism of action, relative to other anthrax monoclonal antibodies and encouraging efficacy data in animal studies at low doses, suggest that Valortim may offer important advantages in the treatment of symptomatic anthrax infection.”

Dr Fuerst continued, “We have proposed moving forward with a Phase I intravenous dose-escalation study of Valortim, which is expected to commence in the next several weeks. We look forward to resuming clinical testing of this important anthrax anti-toxin candidate, which we hope one day will offer improved protection for our nation's citizens, both at home and on the battlefield.”

Valortim is a fully human anti-toxin monoclonal antibody being developed for the prevention and treatment of inhalational anthrax. Animal studies suggest that Valortim has the potential to provide protection against anthrax infection when administered prophylactically (prior to the emergence of symptoms of anthrax infection) and also may increase survival when administered therapeutically (once symptoms become evident).

The Valortim project has been funded in whole or in part with Federal funds from the National Institute of Allergy and Infectious Disease, National Institutes of Health and the Biomedical Advanced Research and Development Authority, Department of Health and Human Services, under Contract No. HHSN272200700033C.

PharmAthene was formed to meet the critical needs of the United States and its allies by developing and commercializing medical countermeasures against biological and chemical weapons.