Critical Therapeutics Completes Dosing of First Patient in Clinical Trial of Intravenous Zileuton
LEXINGTON, Mass.--(BUSINESS WIRE)--Feb. 15, 2006--Critical Therapeutics, Inc. (Nasdaq: CRTX - News) today announced that it has enrolled and dosed the first patient in its Phase I/II clinical trial of intravenous (IV) zileuton in patients with asthma. The double-blind, placebo-controlled, single-dose trial is being conducted at multiple centers in the United States.
The Phase I/II clinical trial is designed to evaluate the IV formulation's safety, tolerability, pharmacokinetics and preliminary efficacy in 60 patients, pre-screened for response to oral zileuton, whose baseline lung function is 40%-80% of predicted normal, as measured by FEV1 (forced expiratory volume). It is the first time an IV formulation of a 5-lipoxygenase inhibitor has been tested in humans. By initiating the clinical trial in patients, the Company should be able to gain insights into the drug's effect on lung function. As an oral drug, zileuton has been studied in clinical trials involving more than 5,000 asthma patients. In October 2005, Critical Therapeutics began marketing ZYFLO®, a four-times-per-day tablet formulation of zileuton, in the United States for the prevention and chronic treatment of asthma in patients 12 years of age and older.
This study is designed to enroll patients into four escalating dose groups, with each patient receiving one infusion of either IV zileuton or placebo. Lung function measurements will be taken prior to dosing and at additional times during the 24-hour period after the infusion. All patients will be followed for up to three days post-infusion, primarily to assess the safety of zileuton IV.
"This trial is our first clinical step toward developing IV zileuton as an additional therapy for emergency room management of acute asthma - an area that has not had any new treatment options in a number of years," said Paul Rubin, M.D., president and chief executive officer of Critical Therapeutics. "According to the American Lung Association, acute asthma attacks result in nearly two million emergency room visits in the United States each year, and about 25 percent of those patients end up hospitalized. Oral zileuton's rapid onset of action is well established. Based on the drug's pharmacological profile, the IV formulation has the ability to achieve peak blood concentration within minutes, providing the potential to become part of a new treatment regimen in the acute care setting." |
