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| |  ICFC: Tobi (Tobramycin) Improved Lung Function in Cystic Fibrosis Better Than Colomycin (Colistin) STOCKHOLM, SWEDEN -- June 7, 2000 -- After just one month on Tobi® (tobramycin solution for inhalation), cystic fibrosis patients in a clinical trial in the U.K. had improved lung function, compared with no improvement in patients who received standard treatment with inhaled colistin (Colomycin). The news was announced at the XIIIth International Cystic Fibrosis Congress in Stockholm, Sweden. Maintaining lung function is very important to people with cystic fibrosis, said the principal investigator, Professor Margaret Hodson of the Royal Brompton Hospital, London. "This is a life-threatening disease for young people," Professor Hodson said. "Life expectancy has increased, but if we can show we can stabilize patients and stop their decline in lung function, any treatment that will do this in the medium- to long-term is one we should be fighting for." The 28-day randomized clinical trial of 115 patients had two arms: 300 mg. of Tobi by inhalation twice a day in combination with standard cystic fibrosis care, or 80 mg. of Colomycin® 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. Colomycin is not approved for inhalation use in the U.S. The study's primary objective was to evaluate the relative change in pulmonary function from baseline, as defined by the percentage of predicted forced expiratory volume at one second (FEV1). At four weeks, "intent to treat" data showed a 6.7 percent improvement in FEV1 over baseline in Tobi patients, compared with a 0.37 percent improvement in Colomycin patients. Patients in both groups showed a reduction of bacterial density in sputum (phlegm). Tobi was approved in the U.K. last December for the long-term management of chronic pulmonary infection due to Pseudomonas aeruginosa in cystic fibrosis patients aged six years and older. The inhaled antibiotic is marketed in the U.K. by PathoGenesis Limited, a subsidiary of PathoGenesis Corp. Related Links: Tobi (tobramycin solution for inhalation) and PathoGenesis Corp.
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