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Novel Valortim(R) Mechanism of Action Data Presented at the Keystone Symposia on Molecular and Cellular Biology
Date:3/31/2009

the anthrax Protective Antigen (PA) of the lethal toxin complex 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 also may 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. The Department of Health and Human Services has issued a requirement for up to 200,000 anthrax anti-toxin treatments to be included in the Strategic National Stockpile and PharmAthene believes that Valortim(R) is well positioned to address this need.

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 symptoms of inhalation anthrax infection may resemble a common cold. After several days, the symptoms may progress to severe breath
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SOURCE PharmAthene, Inc.
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