CHICAGO, Feb. 19 Advanced Life SciencesHoldings, Inc. (Nasdaq: ADLS), today announced positive results from TrialCL07-001, a thorough QT study of the Company's novel once-a-day oralantibiotic, cethromycin. This study was conducted to evaluate the cardiacsafety of cethromycin and to enhance the safety database for the Company'supcoming New Drug Application (NDA) submission for cethromycin to treatcommunity acquired pneumonia (CAP). The U.S. Food and Drug Administration(FDA) requires thorough QT studies for all new chemical entities becauseprolongation in QT interval (corrected for changes in heart rate, or QTc) maysignify an increased risk of developing cardiac arrhythmias.
Trial CL07-001 evaluated the potential of cethromycin to cause aprolongation in electrocardiographic QT interval in accordance with FDA andICH E14 guidance. At the therapeutic and supratherapeutic doses, cethromycinshowed no signal of any electrocardiographic effects and, hence, the studysupported its favorable cardiac safety profile.
"We are extremely pleased with the outcome of this study. This was awell-controlled, well-conducted study that provides additional evidence of thefavorable safety profile of cethromycin. We believe the results from thistrial further strengthen our anticipated NDA submission in CAP," said Dr.Michael Flavin, chief executive officer of Advanced Life Sciences.
Trial CL07-001 was a double-blind, randomized, parallel study in whichcethromycin, given at a therapeutic dose (300 mg once-daily for 5 days) andsupratherapeutic dose (900 mg once daily for 5 days) was compared to placeboand moxifloxacin in 238 healthy adult volunteers. Moxifloxacin is an FDAapproved anti-infective therapy that was used as a positive control in thisstudy because it has been previously established to cause an increase in theQT interval.
The placebo-corrected QTc mean change from baseline (using the individualcorrection method for heart rate, or QTcI) for the therapeutic andsupratherapeutic 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 theoutcome 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 QTcIof greater than 60 milliseconds, nor did any of the cethromycin subjectsdisplay a QTcI that exceeded 480 milliseconds at any time.
There were no deaths or serious adverse events reported in the trial ineither of the cethromycin cohorts. No hepatic-related adverse events werereported for cethromycin subjects and liver function tests at the therapeuticand supratherapeutic doses were consistent with those observed in priorclinical trials with cethromycin. The most common adverse events reportedamong cethromycin subjects were gastrointestinal and mild-to-moderate innature and were consistent with rates reported in prior cethromycin clinicalstudies at the 300 mg dose level.
Cethromycin is not approved as a treatment for CAP, and data from thisanalysis have not been reviewed by the FDA.
Cethromycin NDA/Regulatory Calendar:
The Company remains confident in its regulatory strategy for cethromycinin the CAP indication. To gain further insight into the evolving regulatorylandscape for antibiotic drug development, members of the management andscientific teams will be present at the upcoming FDA Anti-Infectives AdvisoryCommittee meeting discussing non-inferiority margins in CAP clinical trialsscheduled for April 1 and 2, 2008 in Maryland. The Company will hold aninvestor conference call on April 3, 2008 after the completion of the FDAAnti-Infectives Advisory Committee to provide management's viewpoints andreflections on the deliberat