Advanced Life Sciences Announces Cethromycin Granted FDA Orphan Drug Designation for Anthrax
Advanced Life Sciences Holdings, Inc. announced that the United States food and Drug Administration (FDA) has granted Orphan Drug Designation to cethromycin for the prophylactic treatment of patients exposed to inhalation anthrax.
Advanced Life Sciences has established collaborations with U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) and the NIH's National Institute of Allergy and Infectious Disease (NIAID) for the research and development of cethromycin against anthrax and other biowarfare agents.
Cethromycin is a second generation ketolide antibiotic in Phase III clinical development for the treatment of respiratory tract infections. Cethromycin has been tested in over 4,400 human subjects and is currently in Pivotal Phase III trials for the treatment of mild-to-moderate community acquired pneumonia (CAP). Cethromycin has also been demonstrated to have significant in vitro activity against over 30 anthrax (Bacillus anthracis) strains. It is currently being tested in non- human primates to determine its potential efficacy for the prophylactic treatment of patients exposed to inhalation anthrax.
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