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

mycin 91.5% (205/224) compared to Biaxin(R) 95.9% (212/221) [-9.1, +0.3] p=0.0775). Based on the 95.9% 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 [-9.1, +0.3] establishes non-inferiority. Under this analysis, the Company met the non-inferiority endpoint of per protocol clinical cure rate. Since p>0.05, there is not a statistically significant difference between cethromycin and Biaxin(R), which supports non-inferiority.

Supplemental Data

The Company today confirmed supplemental efficacy data with its clinical research organization and announced results in the following endpoints:

    -- Modified intent-to-treat clinical cure rate -- cethromycin 82.9%

       (213/257) compared to Biaxin(R) 88.5% (224/253) [-11.9, +0.6]

       (p=0.0769).  Based on the 88.5% clinical cure rate for Biaxin(R) being

       between 80% and 90%, a delta value of 15% or less on the lower bound

       and greater than zero on the upper bound [-11.9, +0.6] establishes

       non-inferiority.  Under this analysis, the study met the endpoint of

       modified intent-to-treat clinical cure rate.  Since p>0.05, there is

       not a statistically significant difference between cethromycin and

       Biaxin(R), which supports non-inferiority.

    -- Per protocol radiographic success rate -- cethromycin 94.2% (211/224)

       compared to Biaxin(R) 95.9% (212/221) [-6.0, +2.5] (p=0.5130).  Based

       on the 95.9% 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 [-6.0, +2.5] establishes non-inferiority.  Under this

       analysis, the study met the endpoint of per protocol radiographic

       success rate.  Since p>0.05, there is not a statistically significant

       difference between cethromycin and Biaxin(R), which supports non-

       inferiority
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