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Transave, Inc. Announces Positive Phase II Results For Once-Daily ARIKACE(TM) in the Treatment of Non-CF Bronchiectasis Patients Who Have Pseudomonas Lung Infections


9/14/2009 9:08:55 AM

MONMOUTH JUNCTION, N.J., Sept. 14 /PRNewswire/ -- Transave, Inc., today reported positive results from a Phase II clinical trial in non-cystic fibrosis (CF) bronchiectasis patients for its lead investigational drug, ARIKACE(TM) (liposomal amikacin for inhalation). The Phase II data indicated that ARIKACE, delivered once daily for 28 consecutive days, demonstrated superior clinical benefit compared to placebo as measured by patient and physician reported outcomes and reduction in Pseudomonas aeruginosa density. In addition, ARIKACE was well-tolerated with overall adverse events comparable to placebo. Results were presented today at the European Respiratory Society Meeting in Vienna, Austria by Anne E. O'Donnell, MD, Professor of Medicine and Chief of the Division of Pulmonary, Critical Care and Sleep Medicine, Georgetown University Hospital, and co-lead investigator of the study.

"The positive efficacy and tolerability profile demonstrated by ARIKACE in this study is encouraging for non-CF bronchiectasis patients that have pseudomonas lung infections and for physicians who treat them," said Dr. O'Donnell. "These successful results with ARIKACE are especially important since there is nothing currently approved to treat bronchiectasis patients with these types of infections."

Patients in the placebo arm of the study had a greater frequency of both hospitalizations and pulmonary exacerbations.

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 most frequent pathogens infecting bronchiectasis patients is Pseudomonas aeruginosa which is associated with increased sputum production, more extensive bronchiectasis, more hospitalizations, and reduced quality of life.

About ARIKACE(TM)

ARIKACE is a form of the antibiotic amikacin, which is enclosed in nanocapsules of lipid called liposomes. This advanced pulmonary liposome technology prolongs the release of amikacin in the lungs while minimizing systemic exposure. The treatment uses biocompatible lipids endogenous to the lung that are formulated into small (0.3 micron), neutrally-charged liposomes that enable penetration of the biofilm and are highly efficient, with a very low lipid-to-drug ratio (0.65). ARIKACE can be delivered through nebulization, which enables the small aerosol droplet size (1 to 5 microns) to facilitate more effective distribution in the lungs. In addition to this clinical study in non-CF bronchiectasis patients with Pseudomonas lung infections, clinical development is underway in CF patients with Pseudomonas lung infections, with positive Phase II results reported in June 2008. ARIKACE has been granted orphan drug status in the United States by the FDA, and has received an orphan drug designation in Europe by the European Medicines Agency for the treatment of Pseudomonas infections in patients with CF. ARIKACE has also been granted orphan drug status by the FDA for the treatment of bronchiectasis in patients with Pseudomonas or other susceptible pathogens.

About Transave, Inc.

Transave, Inc., is a biopharmaceutical company focused on the development of innovative inhaled pharmaceuticals for the site-specific treatment of chronic lung diseases. The company's major focus is on developing antibiotic therapy delivered via proprietary advanced pulmonary liposome technology in areas of high unmet need in lung diseases. The Transave team is dedicated to leveraging its development and commercialization expertise, along with its intellectual property, to bring life-extending and life-enhancing medicines to patients. For more information about Transave's technology and development programs, visit http://www.transaveinc.com/.

SOURCE Transave, Inc.

CONTACT: Jennifer Corrigan, +1-732-382-8898, jenn.corrigan@comcast.net

Web site: http://www.transaveinc.com/


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