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Cethromycin Achieves Primary Endpoint in Pivotal Phase 3 Pneumonia,Clinical Trial

CHICAGO, June 21, 2007 /PRNewswire-FirstCall/ -- Advanced Life Sciences Holdings, Inc. , today announced positive results from Trial CL-06, the first of two pivotal Phase 3 clinical trials designed to assess the safety and effectiveness of cethromycin, a novel once-a-day antibiotic, for the treatment of community acquired pneumonia (CAP). In the study, cethromycin achieved non-inferiority in its primary endpoint of per protocol clinical cure rate compared to Biaxin(R) (clarithromycin) in CAP. Cethromycin was evaluated using a 300 mg once-daily dosing regimen compared to 250 mg twice-daily dosing for Biaxin(R), both over a seven-day course of therapy. Cethromycin also demonstrated safety results that were similar to those seen with Biaxin(R).

(http://www.newscom.com/cgi-bin/prnh/20050428/CGTH039LOGO)

"We are pleased with the positive results from Trial CL-06 and we believe the strong clinical cure rates coupled with the favorable safety profile seen with cethromycin in this study validate our dosing strategy and will allow us to continue on our current regulatory and commercial partnering pathway," said Dr. Michael T. Flavin, chief executive officer. "Non-inferiority was achieved despite the unusually high clinical cure rate observed with the comparator drug." Dr. Flavin added, "We are currently compiling the results from Trial CL-05, our second Phase 3 trial, and we will report top-line results when they are available."

Study Details

Trial CL-06 was a multi-center, multi-national, double-blind, randomized, comparator Phase 3 clinical study in which cethromycin was compared to Biaxin(R) in treating mild-to-moderate CAP. In the study, 522 adult patients were enrolled from clinics in Europe, South America and Israel.

In the study, cethromycin achieved non-inferiority in its primary endpoint of
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