Promising drug fails to thwart fatal lung disease in large trial

DURHAM, N.C. -- A treatment that had shown early promise in alleviating symptoms and preventing the advance of the fatal lung disease pulmonary fibrosis failed to stall the disorder's progression in 162 patients, according to the results of an international clinical trial reported in the Jan. 8, 2004, issue of The New England Journal of Medicine.

Despite the treatment's failure to prevent scarring of the lungs -- a defining characteristic of the disease -- results of the trial did suggest that the drug, known as interferon gamma-1b, might extend the lives of select patients with mild to moderate symptoms, said pulmonologist David A. Schwartz, M.D., who led a portion of the trial at Duke University Medical Center.

"The bottom-line is that interferon gamma does not appear to be effective in slowing progression of pulmonary fibrosis (PF), but could potentially improve survival in patients if caught early in the disease process," Schwartz said.

The study was funded by InterMune Pharmaceuticals, Inc, Brisbane, CA, which manufactures interferon gamma-1b. Dr. Schwartz has been a paid consultant for InterMune since 2000.

PF is an inflammatory disease that results in scarring, or fibrosis, of the lungs. Over time, the fibrosis can progress such that the lungs can no longer deliver oxygen to the body's tissues. Although physicians often treat the disorder with a combination of anti-inflammatory and immunosuppressive therapies, the only clearly effective treatment is lung transplantation, Schwartz said. The median survival time for patients with the disease is two to three years.

PF has multiple causes including exposure to environmental contaminants, such as cigarette smoke and asbestos, and genetic predisposition. The prevalence of the disease is unknown according the National Institutes of Health, but estimates indicate the numbers are rising with as many as 15,000 new cases of idiopathic PF -- a form of the disease having unkno

Contact: Kendall Morgan
Duke University Medical Center

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