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Phase 3 Trial Initiated To Evaluate Tobramycin Inhalation Powder in Cystic Fibrosis Patients
"TIP therapy is designed to provide the first dry-powder, high-payload delivery of an antibiotic directly to the airways," said Stephen Dilly, M.D., chief medical officer, Chiron BioPharmaceuticals. "The speed and convenience of TIP therapy could be an important advance in treating common lung infections associated with CF, and the ASPIRE trials underscore Chiron's ongoing commitment to and investment in exploring new treatment options for patients living with CF."
"Delivering an anti-infective drug like tobramycin quickly and directly into an infected lung is a logical way to treat CF patients," said John Patton, Ph.D., Nektar co-founder and chief scientific officer. "Our unique powder formulation and advanced inhaleable technologies may enable innovative therapeutics, such as TIP, to target local lung infections."
TIP is used with a pocket-size, capsule-based inhaler, developed in collaboration with Nektar Therapeutics, that is designed to provide a fully portable, quick and convenient inhalation system. Clinical data from a Phase I trial of TIP suggests that TIP may significantly reduce the treatment burden for CF patients by offering a short administration time and full portability.
About the ASPIRE Trials
The ASPIRE trials are two Phase III clinical trials intended to determine the efficacy and safety of tobramycin inhalation powder (TIP). TIP is an investigational product and has not yet been approved by the U.S. Food and Drug Administration (FDA). TIP is being evaluated for the management of cystic fibrosis (CF) patients with Pseudomonas aeruginosa lung infection. ASPIRE I is a randomized, double-blind, multicenter, multinational, placebo-controlled trial to assess the efficacy and safety of TIP in CF patients. During the first 28 days only, subjects will be randomized to either the investigational drug or placebo. This will be followed by two treatment cycles with the active drug. The ASPIRE I trial began in October 2005. ASPIRE II is a randomized, open-label, multicenter, multinational trial to assess the safety of TIP versus TOBI® (tobramycin inhalation solution, USP) in CF patients. The ASPIRE II trial is expected to begin in 2006. TOBI is an approved antibiotic, which is inhaled directly into the lungs and is used to treat Pseudomonas aeruginosa lung infections in CF patients. For more information, please visit www.aspire-trials.com.
About Cystic Fibrosis
Cystic fibrosis (CF) is a genetic disease that primarily affects people of Caucasian origin. About 30,000 people in the United States and about 70,000 people worldwide have CF. Patients with CF have abnormal movement of salt in and out of the cells lining their lungs, which leads to secretion of thick, sticky mucus that supports bacteria growth. Pseudomonas aeruginosa (Pa) is the most common bacterium causing lung infections in people with CF. By the age of 17, nearly 70 percent of people with CF have Pa in their lungs. Pa infections cause lung inflammation and -- through cycles of inflammation, obstruction and infection -- deterioration of lung function, at an estimated average rate of 1.4 percent to 4 percent per year. Treatment of CF lung disease is aimed at controlling infection, reducing lung obstruction and decreasing inflammation.
Source: Chiron Corporation and Nektar Therapeutics