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Advanced Life Sciences' Restanza(TM) Shows 100% Survival In Confirmatory Anthrax Study
Date:6/23/2009

protect against human infection from anthrax. In studies conducted by the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID), Restanza was shown to be highly active in vitro against 30 strains of anthrax. In May 2007, a non-human primate study showed that a 30-day course of oral Restanza was 100% protective against a lethal dose of inhaled anthrax as compared to the standard of care, Cipro(R) (ciprofloxacin), which demonstrated 90% protection. The FDA has designated Restanza as an orphan drug for the post-exposure prophylactic treatment of inhalation anthrax, but the FDA has not yet approved the drug for marketing in this or any other indication.

In addition to its development in anthrax, Restanza is also being developed to combat other high priority bioterror agents such as Fransicella tularensis (tularemia), Yersinia pestis (plague) and Burkholderia pseudomallei (melioidosis) under a two year, $3.8 million contract with the Defense Threat Reduction Agency (DTRA) of the U.S. Department of Defense.

FDA's "Animal Efficacy Rule" and the Use of Non-Human Primates

The "Animal Efficacy Rule" allows for approval of new drug products based on animal data when adequate and well-controlled efficacy studies in humans cannot be ethically conducted because the studies would involve administering a potentially lethal or permanently disabling toxic substance or organism to healthy human volunteers. Approval of a drug under the "Animal Efficacy Rule" is subject to certain post-approval commitments, including the submission of a plan for conducting post-marketing studies, post-marketing restrictions to ensure safe use (if deemed necessary), and product labeling information intended for patient advising that, among other things, indicates the product's approval was based on efficacy studies conducted in animals alone.

The non-human primates use
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SOURCE Advanced Life Sciences Holdings, Inc.
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