Aerogen Inc has completed plans for, and will soon initiate a Phase 2 clinical trial in France to evaluate pulmonary delivery of the antibiotic amikacin using their next generation Aeroneb Professional Nebulizer System (Aeroneb Pro Optimized). Upon successful completion of the amikacin program, the Company intends to market the drug, which will be delivered from a proprietary ampoule designed for use only with the Aeroneb Pro Optimized. This next generation nebulizer has already been CE marked for use in clinical investigations.

The Aeroneb Professional Nebulizer System (Aeroneb Pro) was launched worldwide in June of 2002. The product was designed specifically to provide efficient aerosol drug therapy for patients on mechanical ventilation in need of respiratory therapy. The Aeroneb Pro Optimized incorporates additional features that further improve efficiency of drug deposition in the lungs, making it uniquely suitable for delivery of expensive or other specialty drugs.

The Phase 2 amikacin study will compare the relative efficiency of pulmonary delivery of amikacin via both the Aeroneb Pro and the Aeroneb Pro Optimized, and via the Airlife Misty Neb nebulizer (Allegiance).

"For years, clinicians have been looking for ways to efficiently deliver aerosolized antibiotics to aid in the treatment of patients on mechanical ventilators who have serious lung infections. Their efforts have been hampered by lack of suitable delivery systems. The Aeroneb Pro Optimized enables high-efficiency delivery of antibiotics, which is expected to improve outcomes for these severely ill patients," said Robert Fishman, Vice President of Scientific Affairs at Aerogen.

"Amikacin is a member of the aminoglycoside class of antibiotics and is typically delivered to patients intravenously. Although amikacin is commonly used to treat infections in the critical care setting, systemic delivery can result in severe side effects. By delivering amikacin via our Aeroneb Pro Optimized we are able to administer the drug directly to the lung, minimizing systemic toxicity," continued Dr. Fishman.