FDAnews
www.fdanews.com/articles/82961-advanced-life-sciences-to-begin-cap-drug-study

ADVANCED LIFE SCIENCES TO BEGIN CAP DRUG STUDY

December 7, 2005

Advanced Life Sciences will soon launch a pivotal Phase III clinical trial of cethromycin, a novel ketolide antibiotic to treat community-acquired pneumonia (CAP). The trial is intended to determine the safety and efficacy of cethromycin in CAP.

The trial is a randomized, double- blind, multicenter, multinational, comparator trial to assess the efficacy and safety of cethromycin in CAP patients versus Biaxin (clarithromycin). Biaxin is a macrolide antibiotic currently indicated for the treatment of CAP. Cethromycin will be evaluated using a 300 mg once-daily dosing regimen over a seven-day course of therapy.