( a collected todate we believe that Ce...)Cethromycin Shown Effective Against Anthrax in Study,Health

a collected to date, we believe that Cethromycin could address this need and be considered for purchase by the U.S. Government under Project BioShield and the Strategic National Stockpile to provide protection to the American public in the event of an anthrax attack."

Primate Study Findings

In the study, 30 naive non-human primates were randomized into 3 groups of 10 animals and were aerosol challenged with Ames strain anthrax spores at a target dose of 50 LD50. Beginning 24 hours post-challenge, 10 primates were treated with 16 mg/kg (the human equivalent of 300 mg) Cethromycin once daily, 10 primates were treated with 16 mg/kg ciprofloxacin twice daily, and 10 primates received water for injection (2 ml/kg) once daily. All antibiotic treatments were by oral gavage for 30 days.

The study results showed that all ten Cethromycin-treated animals survived, with one of the ten demonstrating abnormal hematologic parameters following antibiotic cessation, which were then normalized. One of the ten ciprofloxacin-treated animals died nine days following cessation of ciprofloxacin treatments after demonstrating clinical signs of infection, bacteremia and alterations in hematologic and coagulation parameters. All ten control primates demonstrated a combination of clinical signs of anthrax, bacteremia, and alterations in hematologic and coagulation parameters post-challenge with five of ten succumbing to the infection.

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

Advanced Life Sciences is developing Cethromycin for the prophylactic treatment of inhalation anthrax to ultimately help protect against human infection from anthrax. The primates used in the study referenced above were used to help understand anthrax disease mechanisms and to assess novel ways to treat anthrax 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 wi
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