Pathogenesis Corp. Reports Results of Phase II Trial of TOBI In Bronchiectasis Patients
08:18 a.m. Dec 21, 1998 Eastern

SEATTLE, Dec. 21 /PRNewswire/ -- PathoGenesis Corp. today reported the primary endpoint results of a double-blind, placebo-controlled, randomized Phase II clinical trial of TOBI(R) (tobramycin solution for inhalation) in patients with bronchiectasis, a form of severe chronic bronchitis.

PathoGenesis enrolled 74 subjects age 18 or older who had been diagnosed with bronchiectasis and Pseudomonas aeruginosa airway infections. The 28-day trial was conducted in 15 medical centers in the U.S. The principal endpoint was microbiological response, as measured by changes in observed bacterial levels in the sputum (phlegm). This endpoint was chosen because the most clinically important symptoms, cough and sputum production, are principally due to the ongoing airway infection.

Bacterial levels in the sputum decreased more than 99.999 percent on average in the TOBI treatment group at 28 days, compared to no change on average in the placebo group. This difference was statistically significant. The percent of patients with at least one adverse experience was comparable between the two treatment groups. The TOBI and placebo groups were comparable at baseline in respect to age, gender, and disease severity.

"These results are encouraging. The antimicrobial activity in this trial was about 10,000-fold greater than the average reduction in bacterial counts achieved by TOBI after 28 days in the cystic fibrosis clinical trials," said A. Bruce Montgomery, M.D., executive vice president of research and development. "We intend to do further analysis of this data, and look forward to the presentation of the full study in April 1999 at the American Lung Association/American Thoracic Society meeting. We will be having further discussions with the FDA on next steps."

Bronchiectasis is a lung disease defined by irreversible, abnormal dilation of the airways' anatomical structure. Earlier episodes of bacterial or viral pneumonia, as well as other factors, can cause this lung damage. Clinically, bronchiectasis is characterized by chronic necrotizing airway infection, which causes cough and sputum production, associated with intermittent exacerbations that may result in periodic hospitalizations. An estimated 100,000 people have bronchiectasis in the U.S., most of whom are age 50 or older.

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. 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 began commercial operations only recently, its dependence on TOBI, third party reimbursement and product pricing, government regulation, 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.

Copyright 1998, PR Newswire

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