Advanced Life Sciences Participates In Key Infectious Disease Conference
As an exhibitor at this year's conference, Advanced Life Sciences was successful in updating and interacting with more than 10,000 physicians, researchers and other healthcare professionals from around the globe who have gathered at the 50th ICAAC to focus on solutions to the problem of infectious disease. Data on the Company's lead product, Restanza™ (cethromycin), its novel once-daily oral antibiotic, was presented showing the drug's efficacy against 30 strains of Burkholderia pseudomallei, a serious, life-threatening bacterial pathogen that is also a potential agent of biological warfare or bioterrorism, and is listed on the Centers for Disease Control list as a Category B bioterrorism agent. Restanza showed significant in vitro activity against clinical and environmental strains of B. pseudomallei as measured by minimal inhibitory concentration (MIC), the lowest concentration of an antimicrobial that will inhibit the visible growth of a microorganism after 24 hours of incubation. Restanza demonstrated antibacterial activity with MIC values ranging from 0.5 - 8 ug/ml and an MIC90 value of 4 ug/ml. Most notably, Restanza also demonstrated positive activity against strains that were resistant to a commonly used antibiotic, azithromycin, for which MIC values were all greater than 64 ug/ml.
Restanza is a novel oral once-a-day antibiotic that is in late stage development for the treatment of community acquired bacterial pneumonia (CABP) and biodefense pathogens. It has shown higher in vitro potency and a broader range of activity than macrolides against Gram-positive bacteria including CA-MRSA and pathogens associated with respiratory tract infections and appears to be effective against penicillin-, macrolide- and fluoroquinolone-resistant bacteria. Restanza's demonstrated potency and ability to overcome bacterial resistance may be due to its mechanism of action resulting in specificity for its bacterial target. In addition to its utility in CABP, Restanza is also being investigated for the prophylactic treatment of inhalation anthrax post-exposure and other high priority biodefense pathogens, including plague and tularemia. The FDA has designated Restanza as an orphan drug for the prophylactic treatment of inhalation anthrax post exposure, as well as for use in treating plague and tularemia, but the drug is not yet approved for these or any other indications.
Advanced Life Science recently announced that it has reached agreement with the United States Food and Drug Administration (FDA), under the Special Protocol Assessment (SPA) process, on the design of its planned Phase 3 study of Restanza to treat CABP.
About Burkholderia pseudomallei
Burkholderia pseudomallei is a Gram-negative, rod-shaped bacteria, and is the causative agent of the disease melioidosis. This bacterium can be found in contaminated water, soil and on market produce. It causes deadly infectious diseases endemic to Southeast Asia and northern Australia, and which may occur in other tropical and subtropical regions. Transmission to humans and animals occurs through direct contact with the organism via ingestion, inhalation, or through open wounds and skin abrasions. Treatment of this disease requires prolonged therapy with antibiotics. Few antibiotics are effective against this disease, and there is currently no effective vaccine. The severe course of infection, high mortality, aerosol infectivity and worldwide presence of this pathogen has resulted in its inclusion as potential agent of biological warfare or bioterrorism, and is listed on the Centers for Disease Control list as a Category B bioterrorism agent.
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. Forward-looking statements represent our management's judgment regarding future events. 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, future revenues and capital requirements; our ability to obtain financing on terms acceptable to us; 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