Advanced Life Sciences Holdings' Restanza promising against tularemia

Advanced Life Sciences Holdings, Inc. (OTC Bulletin Board: ADLS), today announced positive top-line results from a pivotal, non-human primate study of its novel, once-a-day, oral antibiotic Restanza(TM) (cethromycin) against an inhaled lethal dose of tularemia. A 14-day course of Restanza achieved a 100% survival rate at the doses tested. All of the ten animals in the study that received 16 mg/kg once-a-day of Restanza (approximate to a human dose of 300 mg) within 24 hours after exposure to a lethal dose of inhaled tularemia survived while only one of the ten animals that received 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," said Michael T. Flavin, Ph.D., chairman and chief executive officer of Advanced Life Sciences. "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 is a bacterial disease commonly transmitted to humans through contact with infected rodents or rabbits or through insects that carry Francisella tularensis, the causative agent of tularemia, which is classified by the Centers 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. 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.

SOURCE Advanced Life Sciences Holdings, Inc.