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Advanced Life Sciences Announces Successful Thorough QT Study Of Cethromycin
Advanced Life Sciences
Holdings, Inc. (Nasdaq: ADLS), announced positive results from Trial
CL07-001, a thorough QT study of the Company's novel once-a-day oral
antibiotic, cethromycin. This study was conducted to evaluate the cardiac
safety of cethromycin and to enhance the safety database for the Company's
upcoming New Drug Application (NDA) submission for cethromycin to treat
community acquired pneumonia (CAP). The U.S. Food and Drug Administration
(FDA) requires thorough QT studies for all new chemical entities because
prolongation in QT interval (corrected for changes in heart rate, or QTc)
may signify an increased risk of developing cardiac arrhythmias.
Trial CL07-001 evaluated the potential of cethromycin to cause a
prolongation in electrocardiographic QT interval in accordance with FDA and
ICH E14 guidance. At the therapeutic and supratherapeutic doses,
cethromycin showed no signal of any electrocardiographic effects and,
hence, the study supported its favorable cardiac safety profile.
"We are extremely pleased with the outcome of this study. This was a
well-controlled, well-conducted study that provides additional evidence of
the favorable safety profile of cethromycin. We believe the results from
this trial further strengthen our anticipated NDA submission in CAP," said
Dr. Michael Flavin, chief executive officer of Advanced Life Sciences.
Trial CL07-001 was a double-blind, randomized, parallel study in which
cethromycin, given at a therapeutic dose (300 mg once-daily for 5 days) and
supratherapeutic dose (900 mg once daily for 5 days) was compared to
placebo and moxifloxacin in 238 healthy adult volunteers. Moxifloxacin is
an FDA approved anti-infective therapy that was used as a positive control
in this study because it has been previously established to cause an
increase in the QT interval.
The placebo-corrected QTc mean change from baseline (using the
individual correction method for heart rate, or QTcI) for the therapeutic
and supratherapeutic doses of cethromycin were -0.4 and 0.9 milliseconds,
respectively. Moxifloxacin demonstrated QT prolongation of 4.9
milliseconds, which is consistent with previous clinical experience and
thus validated the outcome of the study. In addition to the values for the
mean QTcI interval, none of the subjects in the cethromycin cohorts showed
increases in the QTcI of greater than 60 milliseconds, nor did any of the
cethromycin subjects display a QTcI that exceeded 480 milliseconds at any
time.
There were no deaths or serious adverse events reported in the trial in
either of the cethromycin cohorts. No hepatic-related adverse events were
reported for cethromycin subjects and liver function tests at the
therapeutic and supratherapeutic doses were consistent with those observed
in prior clinical trials with cethromycin. The most common adverse events
reported among cethromycin subjects were gastrointestinal and
mild-to-moderate in nature and were consistent with rates reported in prior
cethromycin clinical studies at the 300 mg dose level.
Cethromycin is not approved as a treatment for CAP, and data from this
analysis have not been reviewed by the FDA.
Cethromycin NDA/Regulatory Calendar:
The Company remains confident in its regulatory strategy for
cethromycin in the CAP indication. To gain further insight into the
evolving regulatory landscape for antibiotic drug development, members of
the management and scientific teams will be present at the upcoming FDA
Anti-Infectives Advisory Committee meeting discussing non-inferiority
margins in CAP clinical trials scheduled for April 1 and 2, 2008 in
Maryland. The Company will hold an investor conference call on April 3,
2008 after the completion of the FDA Anti-Infectives Advisory Committee to
provide management's viewpoints and reflections on the deliberations.
In an effort to re-confirm the regulatory pathway for cethromycin in
CAP after the Anti-Infectives Advisory Committee meeting is completed,
Advanced Life Sciences has requested and established a meeting on April 7,
2008 with the FDA to discuss the anticipated NDA submission in CAP. The
Company will conduct a conference call with investors on April 10, 2008 to
discuss the outcome of the April 7th meeting with the FDA.
About Community Acquired Pneumonia (CAP)
CAP is the sixth most common cause of death in the United States. CAP
and other respiratory tract infections are caused by pathogens such as
Streptococcus pneumoniae and Haemophilus influenzae. Approximately 5.6
million cases of CAP are diagnosed each year in the United States with 10
million physician visits, resulting in an estimated total annual
expenditure of $2 billion dollars for prescribed antibiotics to treat CAP .
CAP is potentially fatal if not treated properly, and the bacteria that
cause CAP are developing resistance to current standard of care treatments.
Macrolides and penicillins are currently the first-line treatments for
respiratory tract infections such as CAP. As macrolide and penicillin
resistance grows and has the potential to cause more clinical failures,
there is a need for new antibiotics with unique mechanisms of action that
can overcome this emerging resistance.
About Cethromycin
Cethromycin has shown higher in vitro potency and a broader range of
activity than macrolides against Gram-positive bacteria associated with
respiratory tract infections. In in vitro tests, cethromycin appears to be
effective against penicillin- and macrolide-resistant bacteria. Cethromycin
has a mechanism of action that may slow the onset of future bacterial
resistance.
In addition to its utility in CAP, cethromycin is also being
investigated for the prophylactic treatment of inhalation anthrax
post-exposure. The FDA has designated cethromycin as an orphan drug for the
prophylactic treatment of inhalation anthrax post-exposure, but the drug is
not yet approved for this 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 oral antibiotic in late-stage
development for the treatment of respiratory tract infections including
CAP. For more information, please visit us on the web at
http://www.advancedlifesciences.com.
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.
Advanced Life Sciences Holdings, Inc.
http://www.advancedlifesciences.com
Advanced ºtiinþele vieþii anunta de succes qt studiu aprofundat al Cethromycin - Advanced Life Sciences Announces Successful Thorough QT Study Of Cethromycin - articole medicale engleza - startsanatate