WOODRIDGE, Ill., Oct. 13 /PRNewswire/ -- Advanced Life Sciences Holdings, Inc. presented, for the first time, clinical results comparing the safety and efficacy of cethromycin at varying doses for the treatment of acute bacterial sinusitis (ABS) at the 44th Annual Meeting of the Infectious Diseases Society of America (IDSA). This year's meeting took place in Toronto, Ontario.
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The first poster presented "A Phase 2 Comparative Study of the Safety & Efficacy of Three Oral Doses of Cethromycin for the Treatment of Acute Bacterial Sinusitis (ABS)," and detailed a double-blind, randomized, parallel- group, multi-center study comparing cethromycin 150 mg QD, cethromycin 300 mg QD and cethromycin 600 mg QD, all for ten days, for the treatment of ABS. The clinical and bacteriological cure rates were generally greater in the 300 mg QD group than in both the 150 mg and 600 mg QD groups. Approximately 300 subjects were enrolled, and the study found that clinical and radiographic response rates were generally lower for subjects taking 600 mg of cethromycin QD, possibly because they exhibited a statistically significant increase in the number of gastrointestinal adverse events, making subjects somewhat less compliant with their treatment regimen. As a result, the overall pathogen cure rate was higher with statistical significance (p<0.05) in the 300 mg QD group than in the 600 mg QD group. The results support use of cethromycin at 300 mg QD for the treatment of ABS in further studies.
The second poster, titled "A Phase 2/3 Comparative Study of the Safety & Efficacy of Cethromycin 150 mg QD vs. Cethromycin 150 mg BID for the Treatment of Acute Bacterial Sinusitis (ABS)," compared the safety and efficacy of a ten day course of cethromycin given either 150 mg QD or 150 mg BID in subjects with ABS. The study enrolled over 600 patients and demonstrated that both treatment regimens were effective in resolving or improving clinical signs and symptoms of ABS and eradicating the target pathogens in adult subjects. This study, combined with previous clinical trials for community acquired pneumonia and acute bacterial exacerbation of chronic bronchitis, supports the selection of a 300 mg QD dosing regimen in further studies of cethromycin in treating ABS.
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.
Forward-Looking Statements
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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Web site: http://www.advancedlifesciences.com/
