Carol E Conrad

US Patent:

20070049641, Mar 1, 2007

Filed:

Aug 22, 2006

Appl. No.:

11/507706

Inventors:

Rabindra Tirouvanziam - Redwood City CA, US
Lenore Herzenberg - Stanford CA, US
Leonard Herzenberg - Stanford CA, US
Carol Conrad - Menlo Park CA, US
Richard Moss - Woodside CA, US

International Classification:

A61K 31/198

US Classification:

514562000

Abstract:

The present invention relates to pharmaceutical kits and methods to treat lung inflammation and redox imbalance in human cystic fibrosis patients using pharmaceutical compositions containing N-acetylcysteine (NAC), pharmaceutically acceptable salts of N-acetylcysteine, or N-acetylcysteine derivatives. In phase I studies, treatment with oral NAC at a dose of from about 1800 mg/day to about 3000 mg/day for a period of 4 weeks produced significant positive effects, namely, it decreased absolute numbers of white blood cells and neutrophils in the sputum and produced concomitant decreases in sputum neutrophil elastase specific activity and sputum interleukin-8 levels, suggesting an amelioration of lung inflammation in the patients. These effects were associated with an increased total GSH level in whole blood as well increased staining for reduced GSH in blood neutrophils, both of which reflect an amelioration of the redox imbalance in the patients. In ongoing phase II studies, oral NAC at a dose of about 2700 mg/day administered in double-blind manner for 12 weeks showed excellent safety and significantly decreased white blood cells in sputum as compared to placebo.