CHICAGO, IL, November 15, 2007, 2007/PRNewswire/: -- 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 (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.
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 year, will form the core of our New Drug Application (NDA) submission and positions us well with prospective commercial partners, said Dr. Michael Flavin, Chairman and CEO of Advanced Life Sciences.
Trial CL-05 was a double-blind, randomized, multi-center, multi-national, comparator phase III clinical study in which cethromycin was compared to Biaxin, an approved antibiotic, in treating mild-to-moderate CAP. The trial design called for a seven-day course of therapy in which cethromycin was evaluated using a 300 mg once-daily dosing regimen compared to a 250 mg twice-daily dosing regimen of Biaxin. In the study, 584 adult patients were enrolled from
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