Advanced Life Sciences Holdings, Inc. (Nasdaq: ADLS), Chicago, has
announced the commencement of its collaboration with the National
Institute of Allergy and Infectious Diseases (NIAID), the lead
governmental institute supporting biodefense research, under which the
NIAID will conduct studies to evaluate cethromycin, the company's
late-stage antibiotic, as a treatment for anthrax and other
high-priority biodefense agents. This collaboration is part of the U.S.
Government's effort to accelerate the research and development of
medical countermeasures through the crucial phase of drug development
under Project BioShield. All studies conducted under this partnership
will be funded by the NIAID and will be performed by its contract
testing laboratories.
Project BioShield provides the Department of Health and Human
Services with the authority and funding to procure promising
countermeasures for addition to the Strategic National Stockpile, which
is the Center for Disease Control and Prevention's store of medical
supplies to protect the American public in the event of a public health
emergency. Project BioShield provides the NIAID, part of the National
Institutes of Health, with the authority to support development of
countermeasures toward possible future procurement with Project
BioShield funds.
"We are very excited about our partnership with the NIAID as
it allows us to leverage the financial and scientific resources of the
U.S. Government's premier research institute to develop cethromycin
as a broad spectrum medical countermeasure," said Dr. Michael T.
Flavin, CEO. "With the threat of growing resistance to currently
available therapies, the U.S. Government is focused on procuring
next-generation products with a broad spectrum of activity to complement
currently-held medical countermeasures in the Strategic National
Stockpile. This partnership with NIAID will expand the data on
cethromycin as a biodefense application, and we expect the results to
strengthen our efforts in positioning cethromycin for purchase by the
U.S. Government."
In May, Advanced Life Sciences announced positive data from a
primate study that showed cethromycin to be effective in preventing
inhalation anthrax infection. The study, involving a 30-day course of
oral dosing, demonstrated that cethromycin was 100% protective against a
lethal dose of inhaled anthrax as compared to the current standard of
care, Cipro(r) (ciprofloxacin), which demonstrated 90% protection. The
FDA has designated cethromycin as an orphan drug for the prophylactic
treatment of inhalation anthrax post exposure, but the FDA has not yet
approved the drug for marketing in this or any other indication.
About Project BioShield
The Project BioShield Act of 2004 (Public Law 108-276) is aimed at
accelerating the research and development of medical countermeasures by
instituting a secure funding source ($5.6 Billion over 10 years) for the
purchase of critical medical countermeasures, such as vaccines,
therapeutics and diagnostics. Project BioShield also grants the NIAID
authority to expedite and simplify the solicitation, review, and award
of grants and contracts for the development of critical medical
countermeasures. Finally, Project BioShield establishes the Emergency
Use Authorization (EUA) to provide access to the best available medical
countermeasures following a Declaration of Emergency by the Secretary of
Health and Human Services.
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 community acquired pneumonia
(CAP).
For more information, call 312/546-3508 or visit
http://www.advancedlifesciences.com.
About Cethromycin
Advanced Life Sciences is developing cethromycin, a novel
once-a-day antibiotic in response to the emerging bacterial resistance
observed in the treatment of CAP. In addition to its utility in CAP,
cethromycin was also recently shown to be effective in preventing
inhalation anthrax (Bacillus anthracis) infection post-exposure in a
primate study.
Cethromycin has been tested in approximately 5,000 human subjects
during clinical trials. 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.
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