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Cethromycin Achieves Primary Endpoint in Pivotal Phase 3 Pneumonia,Clinical Trial

of cethromycin in CAP patients compared to Biaxin(R). Trial CL-06 enrolled patients from clinics in Europe, South America and Israel and Trial CL-05 has enrolled patients from North America and South Africa. Cethromycin was evaluated using a 300 mg once-daily dosing regimen compared to 250 mg twice-daily dosing for Biaxin(R), both over a seven-day course of therapy. Biaxin(R) is an FDA-approved macrolide antibiotic currently indicated for the treatment of CAP.

The primary endpoint for both trials is 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 and chest X-ray as evaluated by an independent radiologist. Extensive electrocardiogram and liver function test monitoring were incorporated into the study design to examine safety in these areas, and to build on the safety database established in previous cethromycin clinical trials.

Each trial was powered to demonstrate non-inferiority at the 95% confidence interval. To achieve non-inferiority a drug must show that it does not statistically perform any worse than the comparator treatment.

About Community Acquired Pneumonia (CAP)

CAP is the sixth most common cause of death in the United States. CAP and other respiratory tract infections are caused by pathogens such as Streptococcus pneumoniae and Haemophilus influenzae. CAP affects 5-6 million patients in the United States each year, with 10 million physician visits and 2 million hospitalizations occurring annually.

Macrolides and penicillins are currently the first-line treatments for respiratory tract infections such as CAP. As macrolide and penicillin resistance grows and has the potential to cause more clinical failures, there is a need for new antibiotics with unique mechanisms of action, which can overcome this emerging resistance.

About Cethromycin

Cethromycin has shown higher in vitro potency a
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