Positive results announced for Restanza in treatment of inhaled tularemia

Positive top-line results have been announced by Advanced Life Sciences Holdings, Inc., for its once-a-day, oral antibiotic Restanza to treat inhaled lethal doses of tularemia.

A 14 day course of Restanza during a pivotal, non-human primate study achieved a 100 percent survival rate at the doses tested. In the study, all 10 animals receiving 16 mg/kg of Restanza once-a-day, the equivalent of a human dose of 300 mg, within 24 hours of exposure to a lethal dose of inhaled tularemia survived. Only of of the 10 animals that received a placebo survived.

"We believe that the impressive survival data in tularemia, combined with previously reported survival data in anthrax and plague, confirm the profile of Restanza as a potent, broad spectrum medical countermeasure for biodefense and underscore Restanza's impressive efficacy and safety against lethal pathogens which could represent significant threats to public health and safety," Michael T. Flavin, Ph.D., chairman and chief executive officer of Advanced Life Sciences said. "We believe that our company's biodefense strategy represents a promising commercial opportunity and we are excited about the scope and pace of our progress to date. One of Restanza's major differentiating advantages, and a key characteristic that has attracted US government interest, is its demonstrated breadth of activity against many lethal pathogens."

Tularemia, a bacterial disease, is transmitted to humans through contact with infected rodents or rabbits or through insects carrying Franciseela tularensis, the causative agent of tularemia. F. tularensis is classified by the Centers for Disease Control as a Category A Bioterrorism Agent and has been prioritized by the Department of Defense and Department of Health and Human Services as one of the most serious biological weapons.