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MOUNTAIN VIEW, Calif. -- Aerogen, Inc. announces that a Phase 2 multi-center study evaluating an aerosolized antibiotic for treatment of ventilator-associated pneumonia (VAP) in the critical care setting is underway. This study involves aerosolized
delivery of amikacin, an aminoglycoside antibiotic, by means of Aerogen's
proprietary aerosol delivery system. A study using an earlier version of this
delivery system resulted in highly efficient delivery of amikacin to the lungs
of ventilated patients.
This Phase 2 study, to be conducted in the intensive care units (ICUs) of
both United States and European hospitals, is a randomized, double-blind,
placebo-controlled, parallel group study. Approximately 108 patients with VAP
will be enrolled in the study and will be allocated to one of three groups.
Patients in all three groups will receive intravenous antibiotics and will
also receive either aerosolized amikacin in one of two dosing regimens or an
aerosolized placebo. The study is designed to optimize the dosing regimen for
amikacin, evaluate safety and tolerability of repeat dosing, and to provide
preliminary evidence of efficacy. It is anticipated that the results of this
study will be available in the third quarter of 2005, and that a positive
outcome to this study will be sufficient to support moving directly into the
Phase 3 program.
"To date, systemic toxicity (renal damage and hearing impairment) and the
relatively low penetration into the lungs associated with standard intravenous
(IV) administration of amikacin have limited its use for treatment of VAP
despite its ideal antimicrobial properties. We anticipate that efficient
delivery of amikacin directly to the lung can minimize systemic toxicity while
optimizing the drug's efficacy, and that this drug-device combination product
will improve outcomes for these seriously ill patients," said Robert S.
Fishman, MD, vice president of scientific affairs at Aerogen.
The current study follows completion of an earlier Phase 2 study in which
the delivery of amikacin via aerosol was shown to result in antibiotic
concentrations in tracheal aspirates that averaged more than 100-fold greater
than those achieved following IV administration of the drug, while systemic
exposure to the drug was substantially less than that associated with IV
There are approximately 300,000 patients that develop hospital-acquired
pneumonia each year in the U.S. Of these, Aerogen estimates that greater than
50 percent develop pneumonia while on a ventilator. VAP has been reported to
increase a patient's risk of death by 20 percent to 30 percent over that of the underlying
disease alone. In addition, VAP increases treatment expenses by an average of
$40,000 per patient primarily due to the extended time (average increase of 9
days) a patient is required to stay on a ventilator.
Aerogen's Investigational New Drug (IND) application was filed on Oct.
26, 2004 with the Division of Anti-Infective Drug Products, Center for Drug
Evaluation and Research, Food and Drug Administration (FDA).
The submission incorporated results of Aerogen-sponsored toxicity studies in
rats and dogs that the FDA has indicated are adequate to support the
submission of a New Drug Application for aerosolized delivery of amikacin, and
the results of the earlier Phase 2 study. The clinical protocol included in
the IND was developed with significant input from Aerogen's board of advisors
and prospective investigators. The principal investigator in this study is
Dr. Michael Niederman of Winthrop University Hospital in Mineola, N.Y., who
recently co-chaired the ATS-IDSA Consensus Committee on Hospital-Acquired
"I expect this study to be an important contribution to the VAP
literature," said Niederman. "With Aerogen's high-efficiency delivery
system, we expect to achieve higher concentrations of amikacin in the lung
than were previously achievable by the aerosol route, while keeping systemic
exposure low as compared with IV administration of the drug. With this new
delivery system in-hand, the addition of aerosolized amikacin to standard IV
therapy has a good chance of better treating resistant bacteria, reducing the
emergence of resistant bacteria in individual patients, and eventually
allowing shorter courses of antibiotic treatment-an important objective for
minimizing antibiotic resistance in intensive care units.
"This is truly a pivotal milestone for our company, for positive results
from this aerosol delivery study will validate our technology and will lead to
the possibility of new treatment options for patients with serious respiratory
disorders in the critical care setting," said Jane E. Shaw, PhD, Aerogen
chairman and CEO.
Aerogen intends to commercialize this product in the United States and is
actively seeking a partner to commercialize the product outside the United
Source: Aerogen, Inc.