Pharmathene Announces Publication of Phase I Study Results for Anthrax Anti-toxin Valortim

PharmAthene, Inc. PIP today announced that results from a Phase I clinical study of Valortim® were published in the December issue of Clinical and Vaccine Immunology. The American Society for Microbiology peer-reviewed journal describes clinical data supporting the potential use of Valortim®, a fully human monoclonal antibody, as both a post-exposure prophylaxis and therapeutic treatment for anthrax infection. "There is a strong need for additional therapeutic options for inhalational anthrax disease as current therapies, specifically antibiotics and aggressive supportive care, are not optimally effective in individuals with active, symptomatic anthrax infection. Anti-toxin therapies like Valortim® could potentially provide important protection in the event of a bioterrorism attack with anthrax," remarked Dr. Thomas Fuerst, Executive Vice President and Chief Scientific Officer. "Our Phase I results demonstrate that a single dose of Valortim® can provide levels of antibodies in humans that correspond to protective levels in animal models and is well tolerated. Based on the accumulating human safety and animal efficacy data for Valortim®, we believe that it could represent an important addition to the nation's anthrax armamentarium." Preclinical studies suggest that Valortim® has the potential to provide significant 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). In these studies, Valortim® has been shown to protect both rabbits and monkeys against the lethal effects of anthrax infection when administered at the time of exposure, at doses as low as 1.0 mg/kg. When administered to rabbits after the development of symptoms, Valortim® also improved survival as late as 48 hours post-exposure as compared to controls.