Transave Completes Enrollment in Arikace(TM) Phase II Bronchiect...( Presently No Approved Treatments ...),Health

Presently No Approved Treatments

MONMOUTH JUNCTION, N.J., April 21 /PRNewswire/ -- Transave, Inc., today reported completion of patient enrollment in a Phase II study evaluating the safety and efficacy of Arikace(TM) (liposomal amikacin for inhalation) in non-cystic fibrosis (CF) bronchiectasis patients. The results, which are expected to be available by mid-year, will shed new light on how this patient population responds to treatment. Presently, there are no approved treatments for the disease.

"Today's announcement marks the achievement of yet another important milestone in the development of Arikace for chronic lung infections," said Tim Whitten, Transave's Chief Executive Officer. "We believe Arikace has the potential to be an important new treatment for non-CF patients with bronchiectasis. We look forward to seeing the Phase II results in June and moving to Phase III as soon as possible."

The double-blind, placebo-controlled study is designed to evaluate Arikace in non-CF patients who have bronchiectasis with Pseudomonas lung infections. In the trial, 64 adult patients were randomized 2:1 to Arikace - either a 280 mg or a 560 mg dose - or placebo for 28 days, followed by a 28-day off-treatment observation period. Arikace and placebo are administered once daily using an Investigational eFlow(R) Nebulizer System (PARI Pharma GmbH), a novel, highly efficient, portable aerosol delivery system. Sixteen clinical sites throughout Europe and India are participating in the study.

Bronchiectasis is characterized by localized, irreversible enlargement of the bronchial tubes. Involved bronchi are dilated, inflamed, and easily collapsible, resulting in airflow obstruction and impaired clearance of secretions. The accumulation of mucus in the bronchi leads to frequent infections, which further reduce lung function in these patients. One of the m
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