Aerogen Inc. Announces Initiation of a Phase 2 Multi-Center Study of Its Aerosolized Antibiotic for Treatment of Ventilator-Associated Pneumonia

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

administration.

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

Pneumonia.

"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

States.

Source: Aerogen, Inc.