Critical Therapeutics to begin phase½ study of zileuton IV for asthma

By Angela McDaniels

Seattle, Dec. 19 - Critical Therapeutics Inc. said and it will begin a phase 1/2 study of zileuton IV in the United States in the first quarter of 2006 now that the 30-day waiting period for its Investigational New Drug Application for the intravenous formulation of zileuton for asthma.

The phase 1/2 study will assess the safety, tolerability, pharmacokinetics and exploratory efficacy of zileuton IV. The double-blind, placebo-controlled, single-dose, multi-center study will be conducted in 60 patients with asthma and baseline forced expiratory volume - a lung-function measure - of 40% to 80% of predicted normal.

"Acute asthma is ... responsible for approximately two million ER visits and nearly 500,000 hospital admissions in the United States annually. We believe that zileuton IV has the potential to benefit asthmatics who suffer from acute exacerbations," president and chief executive officer Paul Rubin said in a company press release.

"Clinical data demonstrates that oral zileuton's maximum effect on lung function correlates with blood drug concentration reaching peak level. As a result, we believe that the intravenous formulation may provide rapid onset of action because it could reach peak blood concentration rapidly following the time of injection."

Critical Therapeutics owns worldwide rights to the zileuton franchise, including Zyflo, a U.S. Food and Drug Administration-approved oral tablet formulation that the company markets in the United States for the prevention and chronic treatment of asthma in adults and children over 11 years of age.

Zileuton inhibits 5-lipoxygenase, the main enzyme responsible for the production of leukotrienes, a family of inflammatory mediators that can trigger asthma symptoms including inflammation, swelling, bronchoconstriction and mucus secretion, the company said.

Critical Therapeutics is a biopharmaceutical company based in Lexington, Mass., that develops products for respiratory, inflammatory and critical care diseases.

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