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Advanced Life Sciences' Restanza Shows 100% Survival in Tularemia Pivotal Animal Study
Date:12/16/2009

ters for Disease Control as a Category A Bioterrorism Agent and is prioritized by the Department of Defense and Department of Health and Human Services as one( )of the most serious biological weapons, along with anthrax and plague.

The Working Group on Civilian Biodefense, an expert panel convened by the Center for Civilian Biodefense Studies at the Johns Hopkins Bloomberg School of Public Health, says that tularemia could pose serious consequences if aerosolized and used as a biological weapon and cites a World Health Organization study which projected estimates of 250,000 illnesses and 19,000 deaths in the event that a mass-casualty tularemia biological weapon were used against a modern city of 5 million people.(1)( ) Unlike anthrax, there is no FDA-approved vaccine available to protect against tularemia, and the only antibiotic treatments currently available for improving survival in the event of a tularemia outbreak are older agents, such as gentamicin and doxycycline.

Restanza as a Biodefense Countermeasure

Advanced Life Sciences is developing Restanza as a broad spectrum medical countermeasure for biodefense to combat multiple high priority bioterror agents, such as Bacillus anthracis (anthrax), Fransicella tularensis (tularemia), Yersinia pestis (plague) and Burkholderia pseudomallei (melioidosis) under a two-year, $3.8 million contract with the U.S. Department of Defense. The FDA has designated Restanza as an orphan drug for the post-exposure prophylactic treatment of inhalation anthrax, plague and tularemia, but the FDA has not yet approved the drug for marketing in this or any other indication.

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

The FDA's "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 becaus
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SOURCE Advanced Life Sciences Holdings, Inc.
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