The USFDA has granted an Orphan Drug Designation to cethromycin for the prophylactic treatment of patients exposed to inhalation anthrax.
Cethromycin - a second generation ketolide antibiotic undergoing Phase III clinical trial for the treatment of respiratory tract infections – is Advanced Life Sciences' most advanced product candidate.
Proven for the treatment of mild-to-moderate community acquired pneumonia (CAP), cethromycin is currently being tested in non-human primates to determine its potential efficacy for the prophylactic treatment of patients exposed to inhalation anthrax.
According to Michael T. Flavin, Ph.D., chairman and chief executive officer of Advanced Life Sciences (Nasdaq: ADLS), commenting on the notice of designation:
"We are very pleased to receive this Orphan Drug designation and we believe that it represents the achievement of another important milestone in the development of cethromycin.
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."
Find more details from the press release.
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