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

d

to its existing bacteriologically evaluable patient database for

cethromycin.

-- Discontinuation rate -- from the modified intent-to-treat population,

discontinuation rate due to adverse events was 4.2% for cethromycin

and 2.8% for Biaxin.

Cethromycin demonstrated a favorable safety profile in Trial CL-05. The incidence of adverse events was not statistically different between cethromycin and Biaxin. The most common adverse events reported in patients receiving cethromycin were mild-to-moderate diarrhea (cethromycin 4.5%, Biaxin 4.1%), headache (cethromycin 2.4%, Biaxin 3.1%), nausea (cethromycin 4.5%, Biaxin 1.4%), vomiting (cethromycin 1.4%, Biaxin 1.0%), abdominal pain (cethromycin 1.4%, Biaxin 1.4%) and taste disturbance (cethromycin 7.6%, Biaxin 2.1%). No drug-related serious adverse events were observed in any study subject. Liver function tests and electrocardiogram monitoring in Trial CL-05 demonstrated no significant differences between subjects receiving cethromycin and subjects receiving Biaxin. This is consistent with the hepatic and cardiac side effect profile reported in previous cethromycin clinical trials.

Pivotal Phase III Clinical Program Results Summary:

Efficacy Trial CL-05 Trial CL-06 Pooled Results

Cethro- Biaxin Cethro- Biaxin Cethro- Biaxin Confidence

mycin mycin mycin Interval

Per

Protocol

Clinical

Cure Rate

(PPc) 94.0% 93.8% 91.5% 95.9% 92.8% 94.9%

(205/218)(195/208)(205/224)(212/221)(410/442)(407/429)[-5.4,+1.2]

Modified

Intent-To-

Treat

Clinical

Cure Rate

(mITT) 83.1% 81.1% 82.9% 88.5% 83.0% 84.8%

(217/261)(206/254)(213/257)(224/253)(430/518)(430/507)[-6.4,+2.8]

Bacterio-

logical

Cure Rate

(PPb) 95.9% 97.1% 89.1%
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SOURCE Advanced Life Sciences Holdings, Inc.
Copyright©2007 PR Newswire.
All rights reserved

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