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| |  Study Shows Intermittent Tobi Therapy Effective In Cystic Fibrosis Patients SEATTLE, WA -- Jan. 7, 1998 -- In two double-blind, placebo-controlled studies published in today's edition of The New England Journal of Medicine, chronic intermittent aerosolised antibiotic therapy with PathoGenesis Corp.’s Tobi(R) (tobramycin solution for inhalation) has demonstrated significant benefits in treating people with cystic fibrosis. In the largest studies of inhaled antibiotics to date, 300 milligrams of Tobi or an inhaled placebo was administered to 520 cystic fibrosis patients with Pseudomonas aeruginosa lung infections. Tobi or placebo was inhaled at home twice a day in repeated cycles of 28 days on drug, 28 days off drug, for three on-off cycles over 24 weeks. In both groups, patients were also allowed to receive standard treatment recommended for the management of cystic fibrosis, which may have included oral or intravenous antibiotics. "These are the first large-scale studies in cystic fibrosis patients to show such a sizeable average improvement in lung function and reduction in hospitalisation," said lead author Bonnie Ramsey, M.D., Cystic Fibrosis Center director at Children's Hospital and Regional Medical Center, Seattle, and professor of pediatrics, University of Washington School of Medicine. "Tobi has shown us that inhaled antibiotics work and that has tremendous implications for future treatment of cystic fibrosis." Results at week 20 (the end of the third period of drug administration) showed that patients treated with Tobi had an average increase in lung function of 10 percent, versus an average two percent decline in the placebo group. Pulmonary function is the best predictor of disease progression in people with cystic fibrosis. In addition, patients taking Tobi had decreased P. aeruginosa density in their sputum (phlegm) and were 26 percent less likely to be hospitalised than those in the placebo group. On average, Tobi-treated patients were hospitalised three fewer days than patients receiving standard cystic fibrosis therapy -- 5.1 days for Tobi patients, compared with 8.1 days for placebo patients. Tobi patients also were 36 percent less likely to require intravenous antipseudomonal antibiotics than patients taking placebo. Overall adverse events were comparable but less severe in the Tobi group than in the placebo group. Tinnitis (ringing in the ears) and voice alteration (for example, hoarseness) were the only adverse events reported by more patients in the Tobi group than in the placebo group. Tinnitis was reported by eight Tobi patients (3.1 percent) and by no placebo-treated patients. It was transient and appeared mild or moderate in severity. Voice alteration was reported by 33 Tobi patients (12.8 percent) and 17 placebo-treated patients (6.5 percent). Four patients in the placebo group and none in the Tobi group died during the studies. Additional data showed greatest benefit in teenagers and females. The New England Journal of Medicine article also reported that all patient subgroups experienced a benefit in lung function, as measured by forced expiratory volume at one second (FEV (1)). In particular, patients who were 13 to 17 years old or who were female demonstrated a significantly larger treatment effect than those in the other groups. Cystic fibrosis is a life-threatening inherited disease, affecting about 70,000 children and adults world-wide. In the U.S., intermittent exacerbations (flare-ups of pulmonary symptoms) of pseudomonal lung infections in cystic fibrosis patients have traditionally been treated with intravenous antibiotics in the hospital and/or at home for seven to 21 days. Despite frequent intravenous therapy, lung function continues to decline once the lungs are infected with P. aeruginosa and eventually 90 percent of such patients die of respiratory failure. Related Links: The New England Journal of Medicine, Tobi, PathoGenesis Corp.
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