, June 21
/PRNewswire/ -- In a head-to-head, Phase III clinical trial of Cayston delivered by the Altera Nebulizer System versus tobramycin inhalation solution in cystic fibrosis patients with Pseudomonas aeruginosa
, the co-primary endpoint of non-inferiority for mean percent change in forced expiratory volume in one second (FEV(1)) percent predicted after 28 days of treatment was achieved. Patients receiving Cayston had a mean increase in FEV(1) percent predicted from baseline to day 28 of 8.35 percent compared to 0.55 percent for patients receiving tobramycin inhalation solution, meeting the statistical definition of superiority for the Cayston and Altera combination. Safety results were similar across both arms of the study, with lower incidence of cough in patients receiving Cayston. This data was presented by Gilead Sciences during a late-breaker oral session on Friday at the 33rd European Cystic Fibrosis Conference (ECFC).
In the study, 268 patients were randomized to receive Cayston or tobramycin inhalation solution over a 24-week treatment period. Approximately 85 percent of patients in the study had received at least three courses of inhaled tobramycin in the 12 months prior to randomization. Final six-month study results will become available for presentation later this year.
"We are very pleased to see these encouraging results. Our goal is to improve therapies for respiratory care using our advanced aerosol delivery platforms, such as eFlow Technology. In addition to aerosol delivery expertise, PARI Pharma also contributed to the initial formulation of Cayston and optimized the formulation to the Altera Nebulizer System. As evidenced in multiple clinical trials, Altera delivers Cayston in two to three minutes a significant reduction in delivery time compared to other inhalation therapies," said Martin Knoch, president of PARI Pharma GmbH. "We are continuing to work with our pharmaceutical partners to create new drug-device combination therapies that give patients improved quality of life with shorter inhalation times."
Cayston is administered at a dose of 75 mg three times daily over a 28-day period and is delivered via the Altera Nebulizer System, a portable, drug-specific delivery device based on the eFlowTechnology platform. Cayston was approved and the Altera Nebulizer System was cleared by the U.S. Food and Drug Administration (FDA) in February 2010. Cayston received conditional marketing authorizations in the European Union and Canada in September 2009 and was approved in Australia in January 2010. For more information about Cayston, visit www.cayston.com or call 1-877-7CAYSTON. For more information on the Phase III study, please visit www.gilead.com.
About the Altera Nebulizer System and eFlow Technology
Cayston is administered by inhalation using the Altera Nebulizer System, an inhalation delivery device optimized specifically for use with Cayston. Cayston should only be administered with the Altera Nebulizer System. Cayston should not be mixed with any other drugs in the Altera Nebulizer Handset. Altera Nebulizer Systems are consistent with the specifications of the customized eFlow Nebulizer System used exclusively in all Cayston clinical trials. Altera is a drug-specific nebulizer system and its Instructions for Use specify that it is only to be used with Cayston. Altera is not an ultrasonic nebulizer and it is not a general purpose electronic aerosol generator nebulizer. No medication other than Cayston should be used in the Altera Nebulizer System.
The Altera Nebulizer System uses eFlow Technology to enable aerosolization of medication via a vibrating, perforated membrane that has thousands of small holes to produce the aerosol mist. The Altera Nebulizer System and eFlow Technology are proprietary to PARI Pharma.
About Cystic Fibrosis (CF)
CF is a chronic, debilitating genetic disease. A major characteristic of CF is production of abnormally thick, sticky mucus in the lungs, trapping bacteria and predisposing patients to lung infections, which continually damage their lungs. Chronic respiratory tract infection with P. aeruginosa contributes to the decline in pulmonary function, which is often associated with morbidity and mortality among CF patients. Currently there is no known cure for CF, and the goal of CF therapy is to control symptoms and prevent further lung damage.
About PARI Pharma
PARI Pharma focuses on the development of aerosol delivery devices and comprehensive inhalation drug development to advance aerosol therapies where drug and device can be optimized together. Based on PARI's 100-year history working with aerosols, PARI Pharma develops treatments for pulmonary and nasal administration customized with advanced delivery platforms, such as eFlow (lower respiratory) and Vibrent (upper respiratory) Technologies. PARI Pharma partners with pharmaceutical companies to develop new or improved therapies. PARI Pharma has several clinical development programs ongoing, either partnered or on its own, for cystic fibrosis, asthma, COPD, respiratory syncytial virus (RSV) infection, and treatments for lung transplant patients among other indications. PARI Pharma, a PARI Medical Holding company, is located near Munich, Germany with a major presence in the United States. Online at www.paripharma.com
SOURCE PARI Pharma