Adult Therapy Now Being Evaluated in Infants
Researchers at the University of North Carolina at Chapel Hill have begun enrolling infants in a clinical trial to test the effectiveness of inhaled hypertonic saline as a treatment for CF lung disease. The inhaled solution, which is currently being used by adults with CF, is salty saltwater — almost twice as salty as the Atlantic Ocean. The clinical trial, called "Infant Study of Inhaled Saline" or ISIS, is being funded by CFFT and is the first time inhaled saline will be tested in infants over an extended period of time. The study seeks to enroll 150 infants as young as four months at 15 sites in the United States, and one site in Canada. By inhaling a saltwater aerosol solution for 15 minutes twice a day, it is hoped the infants should be able to avoid a significant part of the damage the disease causes to their lungs. Click here for more information about participating in this clinical trial.
Second Phase 3 Denufosol Trial Commences
Inspire Pharmaceuticals, Inc. has initiated a second Phase 3 clinical trial evaluating denufosol tetrasodium inhalation solution for the treatment of CF. Denufosol enhances the hydration and clearance of mucus from the lungs by helping chloride move across cell membranes. This new trial, named TIGER-2 (Transport of Ions to Generate Epithelial Rehydration), is enrolling 350 people with CF aged 5 years and older in the United States and Canada and at additional international sites as the trial proceeds. The trial aims to demonstrate improved lung function and decreased pulmonary exacerbations, and measure the need for other CF medications and quality of life. TIGER-1, Inspire's first Phase 3 study of denufosol for CF, completed enrollment in October 2007 and trial results are expected in the next few months. Click here for more information about participating in this clinical trial.
CF Foundation "Goes Green" With AMRI
The Foundation recently initiated a four-year research collaboration with Albany Molecular Research, Inc. (AMRI) to explore natural products — substances taken from plants and bacteria — in an effort to increase the number and diversity of chemicals available that could improve the function of CFTR. In an agreement worth up to $23.7 million, AMRI will screen its natural products library, which contains approximately 285,000 plant and microorganism extracts, to find potential candidates that may correct the defective CFTR protein.