CHICAGO, Dec. 16 /PRNewswire-FirstCall/ -- Advanced Life Sciences Holdings, Inc. , 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."
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
FDA's "Animal Efficacy Rule" and the Use of Non-Human Primates
The non-human primates used in the study referenced above were used to help understand tularemia disease mechanisms and to assess novel approaches for the prophylactic treatment of inhaled tularemia in lieu of human efficacy testing pursuant to FDA's "Animal Efficacy Rule" (21 C.F.R. Section 314.600-650). The study referenced above was carried out in accordance with the Animal Welfare Act (AWA) under the supervision of an Institutional Animal Care and Use Committee (IACUC), which is responsible for enforcing the AWA.
Advanced Life Sciences is a biopharmaceutical company engaged in the discovery, development and commercialization of novel drugs in the therapeutic areas of infection, cancer and respiratory diseases. For more information, please visit us on the web at www.advancedlifesciences.com
(1) Journal of the American Medical Association (JAMA) Vol. 285 No. 21, June 6, 2001.
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