Advanced Life Sciences begins phase 3 cethromycin trial

By Lisa Kerner

Erie, Pa., Jan. 5 - Advanced Life Sciences Holdings, Inc. announced that enrollment is underway and the first patient dosing occurred in its phase 3 clinical trial to evaluate cethromycin in community-acquired pneumonia.

The randomized, double-blind trial will assess the efficacy and safety of cethromycin versus Biaxin (clarithromycin) in community-acquired pneumonia patients. Biaxin is an approved antibiotic currently indicated for the treatment of community-acquired pneumonia.

Cethromycin will be evaluated using a 300 mg once-daily dosing regimen over a seven day course of therapy. The clinical cure rate at the test-of-cure visit will be the primary endpoint for the trial. It is estimated that 250 will be enrolled in each arm of the study. In order to capture the community-acquired pneumonia seasons, enrollment will take place in the Northern and Southern Hemispheres.

"We are very pleased to get our pivotal trials underway," said Michael T. Flavin, chairman and chief executive officer of Advanced Life Sciences, in a news release. "The initiation of enrollment and first patient dosing in our phase 3 pivotal trial is a significant achievement for Advanced Life Sciences."

Community-acquired pneumonia is reportedly the sixth most common cause of death in the United States. It affects 5 million to 6 million patients in the United States each year, with 10 million physician visits, and 2 million hospitalizations occurring annually.

Although Cethromycin has been tested in approximately 3,800 subjects worldwide in 50 clinical trials to date, it is an investigational product that has not yet received Food and Drug Administration approval.

Advanced Life Sciences is a biopharmaceutical company based in Woodridge, Ill. The company works to develop and commercialize drugs used in the therapeutic areas of infection, cancer and inflammation.

© 2015 Prospect News.
All content on this website is protected by copyright law in the U.S. and elsewhere. For the use of the person downloading only.
Redistribution and copying are prohibited by law without written permission in advance from Prospect News.
Redistribution or copying includes e-mailing, printing multiple copies or any other form of reproduction.