WOODRIDGE, Ill., Sept. 29 /PRNewswire-FirstCall/ -- Advanced Life Sciences Holdings, Inc. researchers presented, for the first time, data regarding the clinical safety and efficacy of cethromycin at the 46th Interscience Conference on Antimicrobial Agents and Chemotherapy. The presentations discussed the efficacy of cethromycin at varying doses in the treatment of community acquired pneumonia, acute bacterial exacerbation of chronic bronchitis and anthrax. Cethromycin, Advanced Life Sciences’ lead candidate, is a second-generation ketolide antibiotic with activity against clinically important Gram-positive bacteria, including many macrolide and penicillin resistant strains.
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Our researchers examined the efficacy of cethromycin in community acquired pneumonia in a poster titled “A Phase 2 Comparative Study of the Safety & Efficacy of Two Oral Doses of Cethromycin for the Treatment of Community Acquired Pneumonia (CAP).” In this study, approximately 180 subjects received either cethromycin 300 mg QD or cethromycin 600 mg QD. Although both doses were effective in a seven day regimen, the study supported the selection of 300 mg of QD cethromycin for the treatment of CAP, as fewer gastrointestinal adverse events were observed. Pivotal Phase III comparator trials using 300 mg QD cethromycin in CAP are currently in progress.
Another poster reviewing CAP clinical results was titled “A Phase 2/3 Comparative Study of the Safety & Efficacy of Two Oral Doses of Cethromycin for the Treatment of Community Acquired Pneumonia (CAP).” This study compared the safety and efficacy of a ten day course of therapy for cethromycin 150 mg QD versus cethromycin 150 mg BID in ambulatory subjects with CAP. Both cethromycin doses were safe and well tolerated. Equivalence in the clinical cure rates, overall bacteriological cure rates and pathogen eradication rates were demonstrated in the intent-to-treat population, however higher clinical cure rates in the clinically evaluable and clinically and bacteriologically evaluable populations were observed in the 150 mg QD treatment arm. Results from this study combined with PK/PD results from other studies support the dose selection of 300 mg QD of cethromycin in current CAP clinical studies.
In a poster titled “A Phase 2 Comparative Study of the Safety & Efficacy of Three Oral Doses of Cethromycin for the Treatment of Acute Bacterial Exacerbation of Chronic Bronchitis (ABECB),” researchers examined data from a double-blind, randomized, multicenter study in which patients received a cethromycin oral dose of either 150 mg QD, 300 mg QD or 600 mg QD for five days. All three treatments were effective in eradicating the target pathogens and in resolving symptoms of ABECB. However, the increased incidence of gastrointestinal adverse events at the 600 mg dose, as well as the lower efficacy observed at the 150 mg dose, may support the selection of a 300 mg QD dose in the treatment of ABECB in future clinical studies.
In a separate poster titled “A Phase 3 Comparative Study of Cethromycin 150 mg QD and Levofloxacin 500 mg QD for the Treatment of Acute Bacterial Exacerbation of Chronic Bronchitis (ABECB),” researchers compared a five day oral course of cethromycin 150 mg QD with a seven day oral course of levofloxacin 500 mg QD. The study was double-blind, randomized and multicenter, and approximately 500 patients were tested. The results indicated that cethromycin 150 mg QD and levofloxacin 500 mg QD were similar in resolving or improving clinical symptoms of ABECB in adults. While efficacy was similar between the two regimens, a 300 mg QD dose selection may be more appropriate in future comparator clinical studies of cethromycin versus standard of care therapy in ABECB.
In collaboration with the U.S. Army Medical Research Institute for Infectious Disease (USAMRIID), Advanced Life Sciences is exploring the efficacy of cethromycin against inhalation anthrax. Data from this research was presented at ICAAC for the first time. A slide session, “Susceptibility and Efficacy of Cethromycin in an Animal Model of Anthrax,” illustrated the efficacy of cethromycin in a mouse model. In the mouse model, cethromycin demonstrated efficacy against Bacillus anthracis when administered 24 hours post-exposure. This activity, combined with outstanding in vitro activity suggests that studies with additional animal models are in order. In July 2006, the Company initiated pre-NDA animal studies for the anthrax indication.
Finally, in vitro data will be presented at a poster session on Saturday, September 30, at 8:30 a.m. Pacific Daylight Time titled, “Antimicrobial Activity of Cethromycin, a Novel Ketolide, Tested Against Diverse Collections of Bacillus anthracis (BA) and Yersinia pestis (YP).”
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 second-generation ketolide antibiotic in pivotal phase III clinical studies currently enrolling patients at approximately 200 worldwide clinical sites for the treatment of community acquired pneumonia. To date, cethromycin has been tested against respiratory infections in 50 clinical studies involving 3,800 human subjects.
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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CONTACT: Investor Relations Contact, Edward P. Flavin of Advanced LifeSciences Holdings, Inc., +1-630-739-6744 Ext. 211
Web site: http://www.advancedlifesciences.com/
