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| |  ALA/ATS MEETING: TOBI Shows Efficacy In Bronchietasis Patients SEATTLE, WA -- April 27, 1999 -- New clinical findings on TOBI® (tobramycin solution for inhalation) were presented yesterday (April 26) at the American Lung Association/American Thoracic Society (ALA/ATS) International Conference. TOBI is an aerosolized antibiotic developed and marketed by PathoGenesis Corp. Last year, PathoGenesis completed a double-blind, placebo-controlled, randomized Phase II clinical trial of TOBI in 74 patients with bronchiectasis, an irreversible condition of damaged, dilated airways that is usually complicated by persistent bacterial infections. "Bronchiectasis is a common but relatively unknown condition affecting up to 100,000 people in the United States,"said A. Bruce Montgomery, M.D., executive vice president of research and development. "Many patients with bronchiectasis cough up about 1/3 cup of sputum every morning." In PathoGenesis’ study, all subjects had Pseudomonas aeruginosa as the complicating infection. Patients took TOBI or an inhaled placebo for 28 days and were evaluated again 14 days later. Important findings included a more than 99.999 percent reduction on average in density of P. aeruginosa bacteria in the sputum (phlegm) at 14 and 28 days, as well as eradication of P. aeruginosa in the sputum in 32 percent of patients as of two weeks after stopping TOBI therapy. TOBI’s ability to reduce or eliminate pseudomonal bacteria in the sputum was correlated with improvement in the patients’ general health. More patients on TOBI than on placebo reported shortness of breath, wheezing and non-cardiac chest pain. These are symptoms that can be associated with bronchiectasis. "The dramatic reduction of bacterial organisms caused by aerosolized tobramycin has the potential to reduce episodes of acute respiratory infections in bronchiectasis patients," said Alan Barker, M.D., principal investigator and medical director of respiratory therapy at Oregon Health Sciences University, Portland, Ore. "In addition, this strategy of delivering medication by nebulizer may be safer than delivering high concentrations of medication intravenously." "Based on these promising results, PathoGenesis is actively moving forward on developing a Phase III protocol for testing TOBI in bronchiectasis patients, "Montgomery said. "We will consult our investigators at a meeting next month and sit down with the FDA this summer to discuss next steps. At about this same time, the investigators plan to submit an article to a respected peer-reviewed scientific journal." Using that article, PathoGenesis intends to promote TOBI for bronchiectasis to physicians under the provisions of the FDA Modernization Act. TOBI is currently approved in the U.S., Canada and Argentina for the management of cystic fibrosis patients with P. aeruginosa lung infections. Researchers also presented results of an 18-month study of TOBI in cystic fibrosis patients. Two-year study results are expected to be announced in June and October at upcoming scientific meetings. Bronchiectasis is a lung disease characterized by irreversible, abnormal dilation of the airways’ anatomical structure resulting from chronic infection and inflammation. Earlier episodes of bacterial or viral pneumonia, as well as other factors, can cause this lung damage. Clinically, bronchiectasis is characterized by chronic tissue-destroying airway infection. Cough and sputum production increase with intermittent exacerbations that may result in periodic hospitalizations. Related Links: TOBI, PathoGenesis Corp.
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