Cethromycin Achieves All Endpoints in Second Pivotal Phase III Trial for Treatment of...(umococci is a growing challenge when it ...),Health

Date:11/15/2007

umococci, is a growing challenge when it comes to serious infections like CAP," said Dr. Donald Low, Head of the Division of Microbiology in the Department of Laboratory Medicine and Pathobiology at the University of Toronto in Toronto, Ontario. "Cethromycin, a new antibiotic, may be the solution to this important public health problem, as it has demonstrated a broad spectrum of antibacterial activity and an ability to overcome pneumococcal resistance in clinical trials."

Program Design

The Phase III CAP pivotal development program was comprised of two double-blind, randomized, well controlled, multi-center, multi-national, comparator trials designed to assess the safety and effectiveness of cethromycin in CAP patients compared to Biaxin. Trial CL-06 enrolled patients from clinics in Europe, South America and Israel and Trial CL-05 enrolled patients from the United States, Canada and South Africa. In both trials, cethromycin was evaluated using a 300 mg once-daily oral dosing regimen compared to 250 mg twice-daily dosing for Biaxin, both over a seven-day course of therapy. Biaxin is an FDA-approved standard of care antibiotic currently indicated for the treatment of CAP.

The primary endpoint for both trials was the clinical cure rate at the test-of-cure visit (Day 14-21 post-initiation of dosing). The eligibility of patients for each trial was based on clinical signs and symptoms as well as chest X-ray results as evaluated by an independent radiologist. Extensive electrocardiogram and liver function test monitoring were incorporated into the study design in order to examine safety in these areas and add to the safety database established in previous cethromycin clinical trials.

Results of Trial CL-05

In Trial CL-05, cethromycin met all efficacy endpoints and demonstrated a favorable safety profile as outlined below:

-- Per protocol clinical cure rate (PPc) -- cethromycin 94.0% (205/218)

compared to Biaxin 93.8% (195/208
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SOURCE Advanced Life Sciences Holdings, Inc. Copyright©2007 PR Newswire. All rights reserved

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