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

96.8% 92.7% 97.0%

(70/73) (67/69) (57/64) (61/63) (127/137)(128/132) NA

Safety Trial CL-05 Trial CL-06 Pooled Results

Cethromycin Biaxin Cethromycin Biaxin Cethromycin Biaxin

Diarrhea 4.5% 4.1% 5.0% 4.7% 4.7% 4.4%

(13/288) (12/291) (13/260) (12/257) (26/548) (24/548)

Headache 2.4% 3.1% 3.1% 6.2% 2.7% 4.6%

(7/288) (9/291) (8/260) (16/257) (15/548) (25/548)

Nausea 4.5% 1.4% 2.7% 3.9% 3.6% 2.6%

(13/288) (4/291) (7/260) (10/257) (20/548) (14/548)

Vomiting 1.4% 1.0% 2.7% 1.6% 2.0% 1.3%

(4/288) (3/291) (7/260) (4/257) 11/548) (7/548)

Abdominal Pain 1.4% 1.4% 1.5% 3.1% 1.5% 2.2%

(4/288) (4/291) (4/260) (8/257) (8/548) (12/548)

Taste

Disturbance 7.6% 2.1% 11.2% 6.2% 9.3% 4.0%

(22/288) (6/291) (29/260) (16/257) (51/548) (22/548)

AE

Discontinuations 4.2% 2.8% 1.6% 2.8% 2.9% 2.8%

(11/261) (7/254) (4/257) (7/253) (15/518) (14/507)

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

"We would like to thank all the patients and principal investigators who participated in the cethromycin pivotal clinical trial program," said Dr. Flavin. "We would also like to thank our contract research organizations, Quintiles, Covance Clinical Laboratories, Covance Cardiac Safety Services and ClinPhone for their work in conducting our clinical program."

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SOURCE Advanced Life Sciences Holdings, Inc.
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