WOODRIDGE, Ill., Jan. 5 /PRNewswire-FirstCall/ -- Advanced Life Sciences Holdings, Inc. today announced that enrollment is underway and the first patient dosing occurred in its pivotal phase 3 clinical trial to evaluate cethromycin in community acquired pneumonia (CAP).
(Logo: http://www.newscom.com/cgi-bin/prnh/20050428/CGTH039LOGO )
“We are very pleased to get our pivotal trials underway,” said Michael T. Flavin, Ph.D., chairman and chief executive officer of Advanced Life Sciences. “The initiation of enrollment and first patient dosing in our Phase 3 pivotal trial is a significant achievement for Advanced Life Sciences. Substantial resources, effort and commitment by our team and our collaborators have been dedicated to the successful commencement of this trial. We are delighted that patient dosing has now commenced.”
About the Trial
The trial is a pivotal phase 3 study intended to determine the safety and efficacy of cethromycin in CAP. Cethromycin is an investigational product and has not yet been approved by the FDA. The trial is a randomized, double- blind, multicenter, multinational, comparator trial to assess the efficacy and safety of cethromycin in CAP patients versus Biaxin(R) (clarithromycin). Biaxin(R) is an approved macrolide antibiotic currently indicated for the treatment of CAP. 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. The trial is powered to demonstrate non-inferiority at the 95% confidence interval. Approximately 250 patients are planned for enrollment in each arm of the study. Enrollment will occur in sites in the Northern and Southern Hemispheres to capture the CAP seasons in each geography and enable year-round enrollment.
About Cethromycin
Cethromycin has been tested in approximately 3,800 subjects worldwide in 50 clinical trials to date. Cethromycin has shown higher in vitro potency and a broader range of activity than macrolides against Gram-positive bacteria associated with respiratory tract infections.
In in vitro tests, it appears to be effective against penicillin- and macrolide-resistant bacteria. Cethromycin has a mechanism of action, unique to ketolides, that may slow the onset of future resistance. Cethromycin has shown in vitro evidence of extended post-antibiotic effects against pathogens commonly seen in respiratory tract infections.
About 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. CAP affects 5-6 million patients in the United States each year, with 10 million physician visits, and 2 million hospitalizations occurring annually.
About Advanced Life Sciences
Advanced Life Sciences is a biopharmaceutical company engaged in the discovery, development and commercialization of novel drugs in the therapeutic areas of infection, cancer and inflammation. The Company’s lead candidate, cethromycin, is a novel ketolide antibiotic in late-stage clinical development for the treatment of respiratory tract infections.
Visit us on the web at http://www.advancedlifesciences.com
Any statements contained in this presentation that relate to future plans, events or performance are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are subject to a number of risks and uncertainties that could cause actual results to differ materially from those described in the forward- looking statements. These risks and uncertainties include, among others, those relating to technology and product development, market acceptance, government regulation and regulatory approval processes, intellectual property rights and litigation, dependence on collaborative relationships, ability to obtain financing, competitive products, industry trends and other risks identified in Advanced Life Sciences’ filings with the Securities and Exchange Commission. Advanced Life Sciences undertakes no obligation to update or alter these forward-looking statements as a result of new information, future events or otherwise.
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CONTACT: Investor Relations, Edward P. Flavin of Advanced Life Sciences,+1-630-739-6744 Ex. 211
Web site: http://www.advancedlifesciences.com//
