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PharmAthene Submits Proposal to BARDA in Response to Broad Agency Announcement for Advanced Research and Development for Valortim(R)
Date:6/2/2009

tional anthrax, the most lethal form of illness in humans caused by the Bacillus anthracis bacterium. The investigational antibody is designed to target a protein component known as the anthrax Protective Antigen (PA) of the lethal and edema toxin complexes produced by the bacterium. Preclinical studies suggest that Valortim(R) has the potential to provide significant protection against anthrax infection when administered prophylactically post-exposure (i.e., prior to the emergence of symptoms of anthrax infection) and to increase survival when administered therapeutically (i.e., once symptoms become evident).

As previously presented, Valortim(R) has been administered intravenously and intramuscularly to healthy human volunteers in a completed Phase 1 study, was well tolerated at doses as high as 20 mg/kg (IV), and was not immunogenic. Pharmacokinetic analysis suggested that doses as low as 1 mg/kg resulted in circulating levels of antibody after a month, with a similar potency for neutralizing anthrax toxin in vitro as was seen with serum obtained from subjects who had been vaccinated with anthrax vaccine.

Anti-toxins such as Valortim(R) are a key element in combating and treating anthrax infection, in addition to vaccines and antibiotics, and are an essential requirement for the Strategic National Stockpile. PharmAthene believes that Valortim(R) is well positioned for procurement consideration in the civilian biomedical stockpile.

About Anthrax

According to the Centers for Disease Control and Prevention, anthrax is an acute infectious disease caused by the spore-forming bacterium Bacillus anthracis. Anthrax most commonly occurs in hoofed mammals and can also infect humans. Symptoms of disease vary depending on how the disease is contracted, but usually occur within seven days after exposure. The serious forms of human anthrax are inhalation anthrax, cutaneous anthrax, and intestinal anthrax. Initial
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