Critical Therapeutics Announces Results of Phase I/II Trial of Intravenous Formulation of Zileuton
Wednesday August 23, 8:00 am ET
Zileuton IV Well Tolerated at All Dose Levels and Positive Impact on Lung Function Measurements Noted
LEXINGTON, Mass.--(BUSINESS WIRE)--Aug. 23, 2006--Critical Therapeutics, Inc. (Nasdaq: CRTX - News) today announced the results of its Phase I/II clinical trial designed to evaluate safety, tolerability and pharmacokinetics of the intravenous formulation of zileuton (zileuton IV) in patients with asthma. In addition, the trial included measurements to detect evidence of improvement in lung function. The double-blind, placebo-controlled trial enrolled 60 patients at 10 clinical sites in the United States. Patients enrolled in the trial had a mean FEV(1) (forced expiratory volume in one second) of 63 percent of predicted normal at baseline and a mean age of 40 years. Patients enrolled in the trial were randomized into four escalating dose groups (75 mg, 150 mg, 300 mg, and 600 mg), each receiving one infusion of either zileuton IV or placebo. Each of the four dose groups enrolled 15 patients, of whom 12 received zileuton IV and three received placebo. All 60 patients who were randomized completed the trial.
Patients in each of the four zileuton IV cohorts showed a greater mean percentage improvement in FEV(1) than patients in the placebo group when measured at 10, 30 and 60 minute intervals after dosing. The 300 mg dose was predicted to approximate the currently approved oral dose of ZYFLO®(zileuton tablets). In this trial, the 300 mg dose group showed a mean improvement in FEV(1) from baseline of 13.7 percent at 60 minutes after dosing. In addition, zileuton IV was well tolerated at all doses tested with no serious adverse events reported in the trial.
Critical Therapeutics is developing zileuton IV initially for use in emergency room or urgent care centers for patients who suffer acute exacerbations of asthma. According to the Centers for Disease Control and Prevention's National Center for Health Statistics, asthma resulted in approximately 1.8 million emergency room visits in the United States in 2003.
Lyndon Mansfield, M.D., Principal Investigator and Director of Western Sky Medical Research in El Paso, Texas, stated, "I believe that the results from this Phase I/II trial are promising and support the further development of the drug for patients suffering acute exacerbations of asthma. I am particularly encouraged about the opportunities for zileuton IV in emergency and urgent care settings where there has not been a new treatment paradigm in a number of years."
"The onset of action of bronchodilation with oral zileuton correlates with peak blood concentrations," stated Walter Newman, Chief Scientific Officer of Critical Therapeutics. "If this is also true with zileuton IV, it could improve current emergency room management of this difficult-to-treat asthma patient population."
Frank Thomas, President of Critical Therapeutics, stated "We are pleased with the results that we have seen from this trial to date and will be examining the pharmacokinetic data when it becomes available next month. Following completion of the full analysis, we will determine the next development step for this program, including the appropriate doses for further examination. Our focus continues to be on advancing the programs we believe will provide the greatest value to patients and our shareholders."
About Zileuton / ZYFLO® (Zileuton tablets)
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, swelling, bronchoconstriction and mucus secretion.
ZYFLO is indicated for the prevention and chronic treatment of asthma in adults and children 12 years of age and older. ZYFLO is the only 5-LO inhibitor approved for marketing by the U.S. Food and Drug Administration.
ZYFLO is not indicated for use in the reversal of bronchospasm in acute asthma attacks, including status asthmaticus. Mild to moderate side effects associated with the use of ZYFLO are abdominal pain, upset stomach and nausea. A small percentage of patients treated with ZYFLO show an increased release of a liver enzyme known as ALT. As a result, the level of liver enzymes in patients treated with ZYFLO should be measured by a simple blood test. It is recommended that physicians perform this test before administering ZYFLO and repeat the test on a regular basis while patients are on the medication. ZYFLO is contraindicated in patients with active liver disease or transaminase elevations greater than or equal to three times the upper limit of normal. For full prescribing information, please visit www.crtx.com/pat_pi.html or call the Company's toll free telephone number 1-866-835-8216 to request medical information. |
