CRITICAL THERAPEUTICS ANNOUNCES NIH STUDY OF ZYFLO

Critical Therapeutics has announced that the NIH will sponsor and fund a clinical trial to evaluate whether using Zyflo (zileuton tablets) to treat patients admitted to the hospital with acute exacerbations of chronic obstructive pulmonary disease (COPD) will shorten their hospital stay. The clinical trial is scheduled to begin in the first quarter of 2007 and is being conducted by the COPD Clinical Research Network in 10 U.S. centers. The trial is expected to enroll 520 patients.

The Phase III, double-blind, placebo-controlled clinical trial was designed by the Steering Committee of the COPD Clinical Research Network. Patients who have been admitted to the hospital with acute exacerbations of COPD will be randomized to receive either oral placebo or zileuton for 14 days. The primary endpoint for this trial is the length of hospital stay for patients admitted with acute exacerbations of COPD. Additional clinical and biological endpoints will also be measured.

Zileuton inhibits 5-lipoxygenase (5-LO), an enzyme that catalyzes the formation of leukotrienes from arachidonic acid. 5-LO is the main enzyme responsible for the production of leukotrienes, a family of inflammatory mediators that can trigger asthma symptoms including inflammation, airway swelling, bronchoconstriction and mucus secretion.

Zyflo, the immediate-release tablet formulation of zileuton, blocks the formation of leukotrienes. It is indicated for the prevention and chronic treatment of asthma in adults and children 12 and older.