CHICAGO, Sept. 15 /PRNewswire/ -- Advanced Life
Sciences Holdings, Inc. (OTC Bulletin Board: ADLS), a
biopharmaceutical company engaged in the discovery, development and
commercialization of novel drugs in the therapeutic areas of
infection, oncology and respiratory diseases, today participated in
the 50th Interscience Conference on Antimicrobial Agents and
Chemotherapy (www.icaac.org). The International conference is
being held in Boston,
Massachusetts this week.
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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.
About Restanza
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.
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. The Company's lead candidate, Restanza, is a novel
once-a-day oral antibiotic in late-stage development for the
treatment of respiratory tract infections including CABP and
biodefense pathogens including anthrax, plague and tularemia. For
more information, please visit us on the web at
www.advancedlifesciences.com or follow us on twitter at
http://twitter.com/advancedlifesci.
Forward-Looking Statements
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.
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