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According to Advanced Life Sciences, the results of the placebo-controlled non-human primate study showed that a 14-day course of Restanza achieved up to a 60% survival rate when administered after animals demonstrated clinical symptoms of anthrax infection as a result of an inhaled dose of aerosolized anthrax spores that was 200 times the median lethal dose of anthrax. None of the animals that received placebo survived.
Due to the extreme lethality of anthrax infection once symptoms appear, Restanza's ability to achieve a 60% survival rate is clinically and statistically significant.
The study was supported by the National Institute of Allergy and Infectious Diseases (NIAID), an institute of the National Institutes of Health (NIH), which is a component of the Department of Health and Human Services (HHS), an agency of the US government.
The results of this pivotal study complement previously reported efficacy results from two non-human primate studies showing that Restanza is highly effective in protecting animals from death after being infected with inhalation anthrax. In those studies, Restanza achieved a 100% survival rate against an inhaled lethal dose of anthrax when treatment was initiated within 24 hours of challenge compared to 0% survival rate in placebo-treated animals.
Michael Flavin, chairman and CEO of Advanced Life Sciences, said: "We believe that the government continues to be pleased with our progress and we anticipate achieving important milestones in our biodefense program in the near-term. We expect key data to be available and reported from our ongoing pivotal studies in plague and tularemia by the end of 2009."
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