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PharmAthene and Medarex Announce Additional $0.8 Million U.S. Government Appropriation for Continued Development of Anthrax Therapeutic Valortim(TM)
Date:11/6/2007

person, and then is believed to facilitate the entry of additional destructive toxins into the cells. Valortim is designed to target anthrax protective antigen and protect the cells from damage by the anthrax toxins.

Valortim has been administered intravenously and intramuscularly to 46 healthy human volunteers in a completed phase I study, was well tolerated at doses as high as 20 mg/kg (IV), and was not immunogenic. The Phase I data showed that Valortim was safe and well-tolerated. No drug-related Grade 2-4 or serious adverse events were reported. Grade 1 adverse events were reported in 16 of the volunteers overall, with the most common being pain/burning at the injection site for those being dosed intramuscularly (6 subjects). There were also a few mild headaches (3 subjects overall). 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. These study results were presented at the 2006 Annual Meeting of the Infectious Diseases Society of America.

Preclinical 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 the potential to be administered therapeutically (once symptoms become evident).

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 inhalatio
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SOURCE PharmAthene, Inc.
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