WOODRIDGE, Ill., Dec. 6 /PRNewswire-FirstCall/ -- Advanced Life Sciences Holdings, Inc. (Nasdaq: ADLS - News) today announced that the U.S. Food and Drug Administration (FDA) has reviewed and commented on the protocol for its pivotal phase 3 clinical trial of cethromycin, a novel ketolide antibiotic to treat Community Acquired Pneumonia (CAP).
Advanced Life Sciences submitted a Phase 3 clinical study protocol to the FDA in September of 2005 requesting that the Agency provide feedback to better enable the Company to conduct the study in accordance with what the FDA would expect for such a study. Although the FDA was not required to provide Advanced Life Sciences comments, the Company is pleased that the Agency reviewed the study protocol and provided helpful comments on various clinical and statistical issues. The FDA’s guidance will help minimize the possibility that the Agency will later criticize Advanced Life Sciences’ testing methodologies.
“Cethromycin is a ketolide antibiotic designed to overcome emerging bacterial resistance to macrolides and penicillins,” said Michael Flavin, Ph.D., chairman and chief executive officer of Advanced Life Sciences. “There is an increasing need for safe, novel therapies to treat respiratory tract infections such as CAP. The current products on the market are becoming less effective due to resistance. Cethromycin may offer CAP patients a convenient once-daily dosing regimen with the possibility of overcoming bacterial resistance that is emerging against currently marketed agents.”
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® (clarithromycin). Biaxin® 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. Dosing of the first patient in the trial is expected to occur in late December of 2005. Enrollment will take place over the ensuing twelve months with data availability anticipated in the fourth quarter of 2006.
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.
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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.
Source: Advanced Life Sciences
