CHICAGO, April 21 Advanced Life Sciences Holdings, Inc. (OTC Bulletin Board: ADLS) today announced positive results from an in vitro study assessing the efficacy of Restanza(TM) (cethromycin), its novel oral antibiotic, against 30 strains of Burkholderia pseudomallei, a serious, life-threatening bacterial pathogen. 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 MIC90 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. In a separate study, Restanza also demonstrated in vitro activity against 30 strains of Burkholderia mallei with MIC values ranging from 0.06-1 ug/ml and MIC90 of 0.5 ug/ml, which are comparable to azithromycin.
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"These impressive data provide additional validation of Restanza's broad spectrum of antibacterial activity as a countermeasure for biodefense and highlight its ability to address serious bacterial infections that today are becoming untreatable due to the increasing public health threat of bacterial resistance to currently marketed antibiotics, especially in emerging markets," said Michael T. Flavin, Ph.D., chairman and chief executive officer of Advanced Life Sciences. "When these data are added to the substantial body of evidence from previously published studies showing Restanza's demonstrated potent activity in multi-drug resistant pneumonia, tuberculosis, malaria, Lyme disease and sexually transmitted diseases, such as gonorrhea, our belief in Restanza's breakthrough therapeutic potential is significantly strengthened."
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About Burkholderia pseudomallei and Burkholderia mallei
Burkholderia pseudomallei and Burkholderia mallei are Gram-negative, rod-shaped bacteria, and are the causative agents of the diseases melioidosis and glanders, respectively. These bacteria can be found in contaminated water, soil and on market produce. They cause 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 these diseases requires prolonged therapy with antibiotics. Few antibiotics are effective against these diseases, and there is currently no effective vaccine. The severe course of infection, high mortality, aerosol infectivity and worldwide presence of these pathogens have resulted in their inclusion as potential agents of biological warfare or bioterrorism, and are listed on the Centers for Disease Control list as Category B bioterrorism agents.
Restanza as a Biodefense Countermeasure
Advanced Life Sciences is developing Restanza as a broad spectrum medical countermeasure for biodefense to combat multiple high priority bioterror agents, such as Bacillus anthracis (anthrax), Fransicella tularensis (tularemia), Yersinia pestis (plague) and Burkholderia pseudomallei (melioidosis). FDA has designated Restanza as an orphan drug for the post-exposure prophylactic treatment of inhalation anthrax, plague and tularemia, but the FDA has not yet approved the drug for marketing in this or any other indication.
Restanza is being developed as a biodefense countermeasure by Advanced Life Sciences to fill the unmet need identified by the U.S. Government. In a report entitled "World at Risk: The Report of the Commission on the Prevention of WMD Proliferation and Terrorism," which was the result of a six-month study by the bipartisan Commission that Congress created pursuant to the recommendations of the 9/11 Commission, the Report states that a "potential gap in U.S. biological defenses is the threat of bioterrorist attacks with strains of anthrax that have been genetically modified to make them resistant to standard antibiotics. Given this potential threat, additional funding is needed for the National Institutes of Health and the private sector to develop new classes of antibiotics."
Advanced Life Sciences has received notice from the Biomedical Advanced Research and Development Authority (BARDA) of the U.S. Department of Health and Human Services that it has completed its initial technical evaluation of the Company's $15 million funding proposal for advanced development of Restanza as a biodefense countermeasure and identified it as a scientifically and technically sound proposal important to program goals and objectives that may require further development and may be recommended for acceptance subject to funds availability. The Company was invited to submit additional information to allow BARDA to make a final determination on the appropriateness of the proposal to enter into contract negotiations.
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 respiratory diseases. For more information, please visit us on the web at www.advancedlifesciences.com
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 Holdings, Inc.
