Investigators Present Long-Term TOBI Data at Cystic Fibrosis Conference; Lung Function Improvements Were Maintained
07:15 a.m. Oct 16, 1998 Eastern

MONTREAL, Oct. 16 /PRNewswire/ -- Investigators today reported 18-month clinical trial data on TOBI(R) (tobramycin solution for inhalation) at the North American Cystic Fibrosis Conference. Marketed by PathoGenesis Corp. (Nasdaq:PGNS), TOBI is approved in the U.S. for management of cystic fibrosis patients with Pseudomonas aeruginosa.

Among the important findings of the TOBI 18-month data:

-- Cystic fibrosis patients continued to maintain improved lung function

above baseline values after 18 months of the chronic intermittent TOBI

treatment regimen -- 28 days on drug, 28 days off drug. After 18

months, previously published literature suggests that these patients

might otherwise have lost, on average, about 6 percent of lung

function relative to baseline had they not been taking TOBI.

-- Delay of TOBI therapy led to irreversible loss of lung function.

Patients who were in the placebo group for six months before beginning

TOBI therapy never achieved absolute lung function values comparable

to those achieved by patients who were treated with TOBI throughout

the 18-month study.

"Our 18-month clinical trials of TOBI establish that proactive treatment is superior to symptomatic therapy," said A. Bruce Montgomery, M.D., executive vice president of research and development. "The 18-month data show that treatment efficacy is maintained -- and that waiting to treat often leads to irreversible loss in lung function."

At the North American Cystic Fibrosis conference, PathoGenesis also released preclinical data on another aerosolized drug candidate, PA-1420 (polymyxin E1). This is PathoGenesis' second entry in a planned portfolio of aerosolized antibiotics to treat a number of chronic lung infections, including those common in cystic fibrosis, bronchiectasis, ventilator- dependent and immunocompromised patients.

Each ready-to-use ampule of TOBI contains 300 milligrams of tobramycin in a 5 milliliter solution. TOBI is aerosolized and administered using a PARI LC PLUS(TM) reusable nebulizer and a DeVilbiss Pulmo-Aide(R) compressor. It is inhaled twice daily and requires about 15 minutes per treatment. The TOBI treatment regimen consists of repeated cycles of 28 days on drug, followed by 28 days off drug. TOBI is approved for sale in the U.S., and regulatory applications are pending in other countries.

Seattle-based PathoGenesis Corp. is a pharmaceutical company that develops and markets drugs to treat chronic infectious diseases where there is a significant need for improved therapy. The company currently focuses on 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 may contain "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 Corporation

Copyright 1998, PR Newswire 

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