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Advanced Life Sciences Announces Successful Thorough QT Study of Cethromycin
Date:2/19/2008

-Study Results Show Cethromycin Not Associated with QT Prolongation-

-Favorable Cardiac Safety Profile Strengthens NDA-

CHICAGO, Feb. 19 /PRNewswire-FirstCall/ -- Advanced Life Sciences Holdings, Inc. (Nasdaq: ADLS), today announced positive results from Trial CL07-001, a thorough QT study of the Company's novel once-a-day oral antibiotic, cethromycin. This study was conducted to evaluate the cardiac safety of cethromycin and to enhance the safety database for the Company's upcoming New Drug Application (NDA) submission for cethromycin to treat community acquired pneumonia (CAP). The U.S. Food and Drug Administration (FDA) requires thorough QT studies for all new chemical entities because prolongation in QT interval (corrected for changes in heart rate, or QTc) may signify an increased risk of developing cardiac arrhythmias.

(Logo: http://www.newscom.com/cgi-bin/prnh/20080218/ALSLOGO)

Trial CL07-001 evaluated the potential of cethromycin to cause a prolongation in electrocardiographic QT interval in accordance with FDA and ICH E14 guidance. At the therapeutic and supratherapeutic doses, cethromycin showed no signal of any electrocardiographic effects and, hence, the study supported its favorable cardiac safety profile.

"We are extremely pleased with the outcome of this study. This was a well-controlled, well-conducted study that provides additional evidence of the favorable safety profile of cethromycin. We believe the results from this trial further strengthen our anticipated NDA submission in CAP," said Dr. Michael Flavin, chief executive officer of Advanced Life Sciences.

Trial CL07-001 was a double-blind,
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SOURCE Advanced Life Sciences Holdings, Inc.
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