Aerogen, Inc. has announced that a phase 2 multi-centre 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 programme, the company release said.

"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, VP 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 US. Of these, Aerogen estimates that greater than 50 per cent develop pneumonia while on a ventilator.

Aerogen's Investigational New Drug (IND) application was filed on October 26, 2004 with the Division of Anti-Infective Drug Products, Centre for Drug Evaluation and Research, United States Food and Drug Administration.

"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, 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.