Advanced Life Sciences' Restanza Demonstrates Efficacy in Treating Anthrax... (espiratory distress is followed by shock...)

Advanced Life Sciences' Restanza Demonstrates Efficacy in Treating Anthrax Infection

Date:8/31/2009

espiratory distress is followed by shock and death, with close to 100% mortality.

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 (post-exposure prophylaxis before the onset of symptoms). 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.

Under the FDA's "Animal Efficacy Rule," drug sponsors must show that the treatment is effective in two animal species and must demonstrate safety in human clinical studies. The study results announced today will support the efficacy component of the Company's planned regulatory filing for marketing approval in anthrax. In addition, the safety database of over 5,000 human patients enrolled in over 50 clinical studies involving Restanza, which was validated in a positive 11-3 vote by a recent FDA advisory committee for the indication of community-acquired pneumonia, can support the safety component of the regulatory filing for marketing approval in anthrax.

"The successful outcome of this pivotal study, combined with our substantial data set showing the Restanza efficacy preventing anthrax infection post-exposure, provides strong validation of Restanza's broad utility as a life-saving treatment for anthrax and as a potent new biodefense agent," said Dr. Michael Flavin, Chairman and CEO of Advanced Life Sciences. "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. If these studies continue to
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SOURCE Advanced Life Sciences Holdings, Inc.
Copyright©2009 PR Newswire.
All rights reserved

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