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Advanced Life Sciences Announces Successful Thorough QT Study of Cethromycin
Date:2/19/2008

randomized, parallel study in which cethromycin, given at a therapeutic dose (300 mg once-daily for 5 days) and supratherapeutic dose (900 mg once daily for 5 days) was compared to placebo and moxifloxacin in 238 healthy adult volunteers. Moxifloxacin is an FDA approved anti-infective therapy that was used as a positive control in this study because it has been previously established to cause an increase in the QT interval.

The placebo-corrected QTc mean change from baseline (using the individual correction method for heart rate, or QTcI) for the therapeutic and supratherapeutic doses of cethromycin were -0.4 and 0.9 milliseconds, respectively. Moxifloxacin demonstrated QT prolongation of 4.9 milliseconds, which is consistent with previous clinical experience and thus validated the outcome of the study. In addition to the values for the mean QTcI interval, none of the subjects in the cethromycin cohorts showed increases in the QTcI of greater than 60 milliseconds, nor did any of the cethromycin subjects display a QTcI that exceeded 480 milliseconds at any time.

There were no deaths or serious adverse events reported in the trial in either of the cethromycin cohorts. No hepatic-related adverse events were reported for cethromycin subjects and liver function tests at the therapeutic and supratherapeutic doses were consistent with those observed in prior clinical trials with cethromycin. The most common adverse events reported among cethromycin subjects were gastrointestinal and mild-to-moderate in nature and were consistent with rates reported in prior cethromycin clinical studies at the 300 mg dose level.

Cethromycin is not approved as a treatment for CAP, and data from this analysis have not been reviewed by the FDA.

Cethromycin NDA/Regulatory Calendar:

The Company remains confident in its regulatory strategy for cethromycin in the CAP indication. To gain further insight into the evolving regulatory landscape for antibiotic drug de
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SOURCE Advanced Life Sciences Holdings, Inc.
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