Chiron Corporation and Nektar Therapeutics announced data from the final study report of a phase I clinical trial of tobramycin powder for inhalation (TPI) presented by Chiron at the 18th Annual North American Cystic Fibrosis Conference in St. Louis, October 14-17.

TPI, an inhaled antibiotic, is being developed for the treatment of cystic fibrosis (CF) patients with infections caused by Pseudomonas aeruginosa. The trial data, presented in four abstracts and an oral presentation at the conference, suggest that TPI, a formulation of tobramycin, a drug with a proven efficacy and safety profile, may significantly reduce the treatment burden for cystic fibrosis (CF) patients by offering a short administration time and full portability.

"Chiron is working to protect the health of CF patients, and TPI has the potential to be a revolutionary approach to treating common lung infections associated with CF," said Stephen Dilly, M.D., chief medical officer, Chiron BioPharmaceuticals. "TPI represents the first dry-powder, high-payload delivery of an antibiotic directly to the airways. Phase I clinical data show that it may be a well-tolerated, more convenient alternative to existing therapies. We believe TPI could potentially improve patient compliance and are committed to demonstrating this through further clinical studies."

"Getting an anti-infective drug like tobramycin quickly, directly and deep into an infected lung is a logical way to improve treatment for CF patients," said John Patton, Ph.D., Nektar co-founder and chief scientific officer. "Our formulation and pulmonary drug delivery technologies enable development of innovative therapeutics like this next generation of inhaled tobramycin."

TPI is used with a capsule-based hand-held inhaler, developed in collaboration with Nektar Therapeutics, that provides a fully portable, quick and convenient system for CF patients. The phase I trial, which included 90 patients at 15 study centers in the United States, compared the safety, pharmacokinetics and delivery time of TPI administered via the novel hand-held device to Chiron's TOBI tobramycin solution for inhalation administered via nebulizer. Based on positive phase I data, Chiron plans to initiate two large phase III clinical trials for further study of TPI.