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Anthrax Monoclonal Antibody Valortim(tm) Demonstrates Therapeutic,Effect in New Primate Model of Established Anthrax Infection

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.

Findings of preclinical studies describing the activity of Valortim against anthrax infection were published in the October 2006 issue of the journal Infection and Immunity. An article abstract is available on the journal web site at http://iai.asm.org/cgi/content/abstract/74/10/5840.

In preclinical studies, Valortim both protected against infection and induced recovery and survival in animals exposed to lethal doses of inhalation anthrax spores. A study in non-human primates has demonstrated the potency of Valortim in this model using the potentially most clinically-useful intramuscular route of administration. In this study, the animals were challenged with a target aerosol dose of 200 times the median lethal dose of B. anthracis spores; 6 animals received no treatment, 6 animals received 1 mg/kg of Valortim intramuscularly, and 6 animals received 10 mg/kg of Valortim intramuscularly, all at the time of aerosol challenge. None of the animals were given antibiotics or other therapies. All control animals died within one week of the challenge; all treated animals in both dose groups were reported alive 60 days post-challenge. The effectiveness of doses even lower than 1.0 mg/kg may be studied in future preclinical research.

Valortim has also been administered intravenously and intramuscularly to healthy human volunteers in a completed phase I study, has been shown to be well tolerated at doses as high as 20 mg/kg (IV), and was not immunogenic. These study results were presented at the 2006 Infectious Diseases Society of America Annual Meeting. 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 neutral
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