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Advanced Life Sciences Announces Supplemental Efficacy Data from,First Pivotal Phase 3 Pneumonia Clinical Trial

. -- Modified intent-to-treat radiographic success rate -- cethromycin 88.3% (227/257) compared to Biaxin(R) 91.7% (232/253) [-8.8, +2.0] (p=0.2383). Based on the 91.7% clinical cure rate for Biaxin(R) being 90% or greater, a delta value of 10% or less on the lower bound and greater than zero on the upper bound [-8.8, +2.0] establishes non-inferiority. Under this analysis, the study met the endpoint of modified intent-to-treat radiographic success rate. Since p>0.05, there is not a statistically significant difference between cethromycin and Biaxin(R), which supports non-inferiority. -- Bacteriological cure rate -- cethromycin 89.1% (57/64) compared to Biaxin(R) 96.8% (61/63). The bacteriologically evaluable population for each arm of the trial was not powered to demonstrate statistical non-inferiority at a 95% confidence interval. -- Percent of bacteriologically evaluable patients -- approximately 28% of subjects in the per protocol population were bacteriologically evaluable. The Company believes that this percentage of bacteriologically evaluable patients is in-line with rates observed in precedent successful antibiotic drug approvals and will add to its overall bacteriologically evaluable patient database. -- Discontinuation rate -- from the modified intent-to-treat population, discontinuation rate due to adverse events was 1.6% for cethromycin and 2.8% for Biaxin(R). Total discontinuation rate (due to adverse events, clinical failure, exclusion criteria and withdrawal of consent) was 7.0% for cethromycin and 7.9% for Biaxin(R). Both cethromycin and Biaxin(R) were well tolerated with discontinuation rates similar to those observed in prior clinical trials.

Cethromycin was evaluated using a 300 mg once-daily dosing regimen compared to 250 mg twice-daily
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