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| |  CF CONFERENCE: TOBI Provides Long-Term Improvements SEATTLE, WA -- October 8, 1999 -- TOBI® (tobramycin solution for inhalation), the first and only inhaled antibiotic approved for people with cystic fibrosis (CF), continues to help these patients live better, breathe better and enjoy improved nutritional status after two years on drug. "Chronic intermittent therapy with TOBI has proven remarkable in its ability to improve patients’ quality of life," said Frank Accurso, professor of pediatrics at the University of Colorado School of Medicine. "TOBI helps them breathe better, reduces the time they spend in the hospital and promotes weight gain in our most difficult-to-treat patients, the teenagers. In addition, it’s quite reassuring to see TOBI’s strong safety profile after a full two years." The TOBI data were announced at a seminar at the North American CF Conference that was sponsored by PathoGenesis Corp., which markets TOBI in North America. Among the key findings presented: - In every season, TOBI reduced the number of days patients were hospitalized. TOBI produced the largest effect during the fall season, the time of year when CF patients are most frequently hospitalized for exacerbations or flare-ups of pulmonary symptoms. Study results showed a 62 percent reduction in the number of days patients on TOBI (versus placebo) were hospitalized in October, November and December. - Patients inhaled TOBI in repeated cycles of 28 days on drug, 28 days off drug for up to two years. At the end of the last on-drug cycle (after 92 weeks), average lung function remained nearly 5 percent above baseline (at week 0) -- a significant achievement considering that most CF patients typically lose lung function over the course of a year. An estimated 95 percent eventually die of respiratory failure. - Adolescents (ages 13 to 17) had the largest improvement in their ability to breathe when compared with the other age groups, showing a treatment effect of about 14 percent in lung function improvement above baseline at the end of the last on-drug cycle. The typical teenager loses lung function more rapidly than an older or younger person with CF. - Patients treated with TOBI have been shown to have an improved nutritional status. Teenagers in the TOBI clinical trial dramatically demonstrated the benefits of improved infection control. After six months of TOBI therapy, adolescent patients had a mean weight gain of about five pounds, while placebo patients only gained about two pounds. After 18 months of TOBI therapy, adolescent patients had a mean weight gain of nearly 10 pounds above baseline. No weight differential was seen in younger or older patients when comparing the TOBI and placebo groups. Weight gain is an important indicator of nutritional status and is associated with improved prognosis in CF patients. "Better nutritional status allows these patients to be more like ‘regular’ teens than ‘sick’ teens," said Wilbur H. Gantz, chairman and CEO of PathoGenesis. "Many are now able to participate in sports and other activities, just like others their age." TOBI was shown to be safe for long-term treatment. In the six-month placebo-controlled portion of the study, voice alteration (e.g., hoarseness) and tinnitus (ringing in the ears) were the only adverse experiences reported by significantly more TOBI patients than placebo patients. In the two-year follow-on studies, most adverse events declined with increased TOBI exposure.
Related Links: TOBI and PathoGenesis Corp.
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