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Monday April 26, 8:09 am Eastern Time
Company Press Release
SOURCE: Pathogenesis Corp.
Strong Clinical Trial Results in Bronchietasis Patients Announced at ALA/ATS Meeting
SEATTLE, April 26 /PRNewswire/ -- Last night at the American Lung Association/American Thoracic Society (ALA/ATS) International Conference, pulmonologists heard new clinical findings on TOBI® (tobramycin solution for inhalation), an aerosolized antibiotic developed and marketed by PathoGenesis Corp. (Nasdaq: PGNS - news).
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. The pulmonologists at the ALA/ATS International Conference also heard presentations on 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.
Seattle-based PathoGenesis Corp. is a pharmaceutical company that develops drugs to treat chronic infectious diseases -- lung infections, in particular -- where there is a significant need for improved therapy. The company markets TOBI, an inhaled antibiotic, in the U.S. and other countries for management of P. aeruginosa infections in patients with cystic fibrosis. In addition, PathoGenesis is developing other drug candidates to treat serious chronic lung infections, including those common in cystic fibrosis, bronchiectasis and tuberculosis patients. PathoGenesis' stock is traded on the Nasdaq National Market System under the symbol PGNS. The company's Web site is located at www.pathogenesis.com.
Note: This news release contains ''forward-looking statements'' within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements are subject to known and unknown risks, uncertainties or other factors that may cause the company's actual results to be materially different from historical results or any results expressed or implied by such forward-looking statements. Factors that might cause such a difference include, but are not limited to, uncertainties related to the fact that PathoGenesis only began commercial operations in 1998, its dependence on TOBI, the degree of penetration of its markets and frequency of TOBI's use by patients, third party reimbursement and product pricing, drug development and clinical trials, competition and alternative therapies, and other factors described in PathoGenesis' filings with the Securities and Exchange Commission.
SOURCE: Pathogenesis Corp. |
