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Cethromycin Achieves All Endpoints in Second Pivotal Phase III Trial for Treatment of Pneumonia
Date:11/15/2007

) [-4.5, +5.1] (p>0.9999) PPc is

defined as subjects who have completed the minimum required study

medication, have confirmed clinical diagnosis of CAP supported by a

positive chest X-ray and appropriate clinical signs/symptoms of CAP,

and have had no other systemic antibacterial agents administered

during or prior to the study period. Based on the 94.0% clinical cure

rate for cethromycin being greater than 90%, a delta value of 10% or

less on the lower bound and greater than zero on the upper bound

[-4.5, +5.1] establishes non-inferiority. Under this analysis, the

study met the clinical cure rate endpoint in the PPc population.

Since p>0.05, there is not a statistically significant difference

between cethromycin and Biaxin, which supports non-inferiority.

-- Modified intent-to-treat clinical cure rate (mITT) -- cethromycin

83.1% (217 subjects/261 subjects) compared to Biaxin 81.1%

(206 subjects/254 subjects) [-4.8, +8.9] (p=0.5667). mITT is defined

as subjects who received at least one dose of study medication and had

a clinical diagnosis consistent with bacterial CAP confirmed by a

positive pre-treatment chest X-ray and appropriate signs/symptoms.

Based on the 83.1% clinical cure rate for cethromycin being between

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

greater than zero on the upper bound [-4.8, +8.9] establishes

non-inferiority. Under this analysis, the study met the clinical cure

rate endpoint in the mITT population. Since p>0.05, there is not a

statistically significant difference between cethromycin and Biaxin,

which supports non-inferiority.

-- Per protocol radiographic success rate -- cethromycin 92.7%

(202 subjects/218 subjects) compared to Biaxin 92.3% (192 subjects/208


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SOURCE Advanced Life Sciences Holdings, Inc.
Copyright©2007 PR Newswire.
All rights reserved

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