Advanced Life Sciences Holdings’ cethromycin received Orphan Drug Designation for the prophylactic treatment of patients exposed to inhalation anthrax. “This designation will benefit us as we continue to build the cethromycin safety and efficacy database and will ultimately help position cethromycin as a potentially important antibiotic for the U.S. government's Strategic National Stockpile," says Michael T. Flavin, Ph.D., chairman and CEO.
The company’s cethromycin is a second-generation ketolide antibiotic. Cethromycin seems to have significant in vitro activity against over 30 anthrax (Bacillus anthracis) strains. Although it is still being tested in nonhuman primates to determine its potential efficacy as an inhalation anthrax prophylactic therapy, it is in late-stage evaluations for other indications. Cethromycin is in Phase III development for the treatment of respiratory tract infections and in pivotal Phase III trials for the treatment of mild-to-moderate community acquired pneumonia.