CHICAGO, Sept. 20 /PRNewswire-FirstCall/ -- Advanced Life Sciences Holdings, Inc. (Nasdaq: ADLS), presented further data in support of cethromycin, the Company's lead compound, at the 47th Interscience Conference on Antimicrobial Agents and Chemotherapy in Chicago, September 17 - 20. A total of seven poster presentations were made, some of which, in collaboration with Eurofins Medinet and Micromyx, discussed in vitro activity of cethromycin against key susceptible and resistant pathogens involved in community acquired pneumonia (CAP), while others reviewed safety data in certain special clinical populations. In addition, along with collaborators such as the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) and Battelle, the Company presented data demonstrating the potency of cethromycin against pathogens involved in bioterrorism.
The following poster presentations were made regarding the safety profile of cethromycin in certain special clinical populations:
"Evaluation of the Safety and Pharmacokinetics of Cethromycin Following Administration of Single and Multiple Doses to Subjects with Mild or Moderate Chronic Hepatic Insufficiency"
Cethromycin at 300 mg once daily for seven days was well tolerated by subjects with hepatic impairment and subjects with normal hepatic function. The results suggest that no dose adjustment is required when cethromycin is administered to subjects with mild or moderate hepatic impairment.
"Evaluation of the Safety and Pharmacokinetics of Cethromycin Following Administration of Multiple Doses to Subjects with Severe Renal Impairment"
Cethromycin at 300 mg QD for five days was well tolerated by both subjects with severe renal impairment and with normal renal function. Elevated drug exposure observed for subjects with severe renal impairment suggest that these patients should be monitored when taking cethromycin.
The following poster presentations discussed cethromycin as a potential treatment for CAP, particularly when resistance to other treatments is known:
"Assessment of In Vitro Activity of Cethromycin Against Telithromycin-resistant Strains of Streptococcus Pneumoniae"
All eight clinical Streptococcus pneumoniae isolates were resistant to erythromycin with MICs > 128 micron g/mL and had telithromycin MICs >/= 2 micron g/mL. For six of these isolates, the cethromycin MIC was at least 8-fold lower than the telithromycin MIC, for another isolate the MICs were the same, and for the other the telithromycin MIC was one doubling dilution lower than the cethromycin MIC.
Cethromycin maintained good in vitro potency against a collection of telithromycin-resistant S. pneumoniae isolates. This finding suggests that underlying resistance mechanisms that result in reduced telithromycin susceptibility do not affect cethromycin to the same extent. Therefore, cethromycin continues to represent a reasonable potential therapeutic option for S. pneumoniae of this phenotype.
"Assessment of In Vitro Activity of Cethromycin Against Strains of Streptococcus Pneumoniae"
Cethromycin demonstrated potent in vitro activity against all Streptococcus pneumoniae populations studied, regardless of their resistance phenotype. Based on MIC90 data collected, cethromycin was 2-4 times more potent than telithromycin and 10-12 times more potent than the macrolides studied. These findings demonstrate that cethromycin has the potential to be a potent therapeutic option for the treatment of CAP, even for infections caused by strains resistant to currently available drugs.
"Assessment of In Vitro Activity of Cethromycin Against Strains of Haemophilus Influenzae"
Cethromycin demonstrated potent in vitro activity against all Haemophius influenzae isolates studied regardless of beta-lactamase status. Based on the MIC data, cethromycin potency was comparable to telithromycin and azithromycin, and was superior to clarithromycin. These findings demonstrate that cethromycin has the potential to be a potent therapeutic option for the treatment of CAP caused by Haemophilus influenzae.
The following poster presentations demonstrated the potency of cethromycin as a potential treatment against bioterrorism pathogens:
"Efficacy of Cethromycin Against a Lethal Inhalation Anthrax Challenge in Rhesus Macaques"
All antibiotic treated animals maintained normal hematologic parameters and remained abacteremic throughout the treatment period. All cethromycin- treated animals survived, with only 1/10 demonstrating abnormal hematologic parameters following antibiotic cessation. One ciprofloxacin-treated animal demonstrated clinical signs of infection, bacteremia, alterations in hematologic and coagulation parameters, and died nine days after cessation of antibiotic treatments. All 10 control monkeys demonstrated a combination of clinical signs of anthrax, bacteremia, and/or alterations in hematologic and coagulation parameters post-challenge with five of ten succumbing to the infection. This study demonstrated that a thirty day course of oral cethromycin was 100% protective against a lethal dose of inhaled Bacillus anthracis Ames strain spores.
"Antimicrobial Activity of Cethromycin, a Novel Ketolide, Tested Against a Diverse Collection of Francisella Tularensis Strains"
Cethromycin was efficacious against 30 Francisella tularensis strains. Cethromycin had significant in vitro activity against Francisella tularensis. Cethromycin preferentially accumulates in the alveolar cells of the lungs, which may enhance efficacy when used as a postexposure prophylaxis for preventing pneumonic tularemia among individuals exposed to aerosolized Francisella tularensis. Thus, cethromycin appears promising as a therapy for tularemia infections.
The FDA has not approved cethromycin as a treatment for CAP or any other indication.
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 once-a-day antibiotic in late-stage clinical development for the treatment of respiratory tract infections including CAP. For more information, please visit us on the web at http://www.advancedlifesciences.com.
Advanced Life Sciences is developing cethromycin, a novel once-a-day antibiotic in response to the emerging bacterial resistance observed in the treatment of community acquired pneumonia (CAP). Cethromycin has been tested in approximately 5,000 human subjects during clinical trials.
The Company has conducted two, pivotal Phase III clinical trials of cethromycin for the treatment of mild-to-moderate CAP. In June of 2007, Advanced Life Sciences released positive results from the first of these two trials, Trial CL-06, which showed that cethromycin met primary and secondary clinical endpoints. Data from the second CAP pivotal trial is expected to be reported in the Fall. The Company believes that cethromycin, if approved, would build upon the growing market opportunity in the antibiotic marketplace and address the critical need for antibiotics that overcome bacterial resistance.
Any statements contained in this press release that relate to future plans, events or performance are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Except for historical information, the statements made in this press release are forward- looking statements about Advanced Life Sciences Holdings, Inc., including statements regarding the clinical trials and regulatory pathway of cethromycin. Forward-looking statements represent our management's judgment regarding future events and are accurate at the time they are made. The Company does not undertake any obligations to update any forward-looking statements whether as a result of new information, future events or otherwise. Our actual results could differ materially from those discussed herein due to several factors including the success and timing of our clinical trials and our ability to obtain and maintain regulatory approval and labeling of our product candidates; our plans to develop and commercialize our product candidates; the loss of key scientific or management personnel; the size and growth of potential markets for our product candidates and our ability to serve those markets; regulatory developments in the U.S. and foreign countries; the rate and degree of market acceptance of any future products; the accuracy of our estimates regarding expenses, capital requirements, and our ability to access capital through partnerships, stock offerings and future revenues; our ability to obtain and maintain intellectual property protection for our product candidates; the successful development of our sales and marketing capabilities; the success of competing drugs that become available; and the performance of third party collaborators and manufacturers. These and additional risks and uncertainties are detailed in the Company's filings with the Securities and Exchange Commission.
|SOURCE Advanced Life Sciences Holdings, Inc.|
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