Pathogenesis Corp. Begins Patient Enrollment in TOBI Clinical Trial in The United Kingdom and Ireland
08:20 a.m. Apr 15, 1999 Eastern

LONDON, April 15 /PRNewswire/ -- PathoGenesis Ltd., a subsidiary of PathoGenesis Corp., has begun to enroll patients in an open-label, randomized clinical trial of TOBI(R) (tobramycin solution for inhalation) at 14 cystic fibrosis centers in the United Kingdom and Ireland. While the study is not required for regulatory approval of TOBI in Europe, it will give European clinicians hands-on experience with the drug, which is currently approved for sale in the U.S., Canada and Argentina.

PathoGenesis plans to enroll 120 patients age six and older who have been diagnosed with cystic fibrosis and Pseudomonas aeruginosa lung infections. The 28-day trial will have two arms: 300 mg. of TOBI by inhalation twice a day in combination with standard cystic fibrosis care, or 80 mg. of Colomycin(R) Injection (Pharmax) by inhalation twice a day in combination with standard care. Colomycin is a powdered intravenous antibiotic that is commonly dissolved in a sterile solution and aerosolized in the U.K.

The study's primary objective is to evaluate the relative change in pulmonary function from baseline, as defined by the percentage of predicted forced expiratory volume at one second (FEV1).

"This study is very important for patients with cystic fibrosis as it will examine the effects of tobramycin on lung function and quality of life," said Dr. Charles Gallagher, the principal investigator in Ireland and consultant respiratory physician at St. Vincent's Hospital, Dublin. "It is one of the first studies to examine the effects of treatment on quality of life in cystic fibrosis."

"We look forward to comparing tobramycin solution for inhalation with current practice in managing Pseudomonas aeruginosa infections in cystic fibrosis patients," said Professor Margaret Hodson, the principal U.K. investigator and honorary consultant physician at the Royal Brompton & Harefield NHS Trust, London.

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.

PathoGenesis Limited is the company's expanding European subsidiary, based outside London. In mid-August 1998, PathoGenesis Limited filed for regulatory approval of TOBI in Europe. The dossier was filed with the Medicines Control Agency in the U.K., which is the lead country for seeking regulatory approval of TOBI in the European Union.

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 Ltd.

Copyright 1999, PR Newswire

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