Cethromycin Achieves All Endpoints in Second Pivotal Phase III Trial for Treatment of...( - Trial CL-05 Results Showed Cethr...),Health

- Trial CL-05 Results Showed Cethromycin had 94.0% Clinical Cure Rate Compared to 93.8% Clinical Cure Rate for Biaxin(R), a Current Standard of

Care Treatment - - Trial CL-05 and Trial CL-06 to Form the Core of New Drug Application -

CHICAGO, Nov. 15 /PRNewswire-FirstCall/ -- Advanced Life Sciences Holdings, Inc. (Nasdaq: ADLS), today announced positive results from Trial CL-05, the second of two pivotal phase III clinical trials designed to assess the safety and effectiveness of cethromycin, a novel once-a-day oral antibiotic for the treatment of mild-to-moderate community acquired pneumonia (CAP), the sixth leading cause of death in the United States. The primary efficacy endpoint of statistical non-inferiority in the clinical cure rate at the test-of-cure visit was achieved. The study results showed that cethromycin cured 94.0% of patients with CAP, compared to Biaxin(R) (clarithromycin), a current standard of care treatment for CAP, which cured 93.8% of studied patients in the per protocol population. In the modified intent to treat population, cethromycin cured 83.1% of patients and Biaxin cured 81.1%. Cethromycin also demonstrated favorable safety results, with reported side effects similar to or less than those seen with Biaxin.

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

"We are very excited to have met all of our endpoints in Trial CL-05, and we are pleased to have successfully completed the clinical development program of cethromycin. The results attained in this trial, along with the positive results achieved in Trial CL-06 reported in June of this y
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