Critical Therapeutics to Present Data on ZYFLO(R) at the 2006 International Conference of the American Thoracic Society.
One poster is based on a retrospective analysis of a randomized, placebo-controlled, double-blind, parallel-group study examining the safety and efficacy of two doses of ZYFLO. The study was conducted in 401 asthma patients randomized in to one of three treatment groups: zileuton 600 mg four times daily (the prescribed dose), zileuton 400 mg four times daily or placebo. None of the patients was on controller asthma treatment. The poster's lead author, Roger Menendez, M.D., of the Allergy and Asthma Center of El Paso, will present data from an analysis of patients on zileuton 600 mg or placebo stratified into two subgroups determined by baseline percent of predicted normal forced expiratory volume (FEV(1)), a measure of lung function. Quality of life scores increased in both subgroups for asthmatics on zileuton 600 mg. Quality of life was measured by the Asthma Quality of Life Questionnaire, a disease-specific health-related quality of life instrument developed by E. Juniper and colleagues that taps both physical and emotional impact of disease.
In the second poster, "A Role for the 5-LO Pathway in Allergen-Induced Airway Infiltration of Eosinophils and Neutrophils in a Murine Model of Asthma," lead author Lyn Libertine of Critical Therapeutics and her colleagues show that ZYFLO plays a key role in inhibiting the migration, aggregation and adhesion of eosinophils and neutrophils in response to leukotrienes, which play an important role in inflammation. Eosinophils and neutrophils are types of white blood cells that contribute to the symptoms of asthma.
Mice in the study were treated with montelukast, zileuton and a positive control dose of dexamethasone. While increased airway eosinophils were reduced by both drugs, zileuton demonstrated a more impressive reduction in the infiltration of polymorphonuclear neutrophils with the additional benefit of reducing systemic immunoglobulin E (IgE).
Both posters will be on display from 8:15 a.m. to 4:15 p.m. PT on Tuesday, May 23 in Area K (Sails Pavilion, upper level) of the San Diego Convention Center.
The ATS is an independently incorporated, international, educational and scientific society which focuses on respiratory and critical care medicine. The ATS 2006 International Conference, held May 19-24 in San Diego, is one the largest gatherings of pulmonary and critical care clinicians and researchers in the world.
About Critical Therapeutics
Critical Therapeutics, Inc. is a biopharmaceutical company focused on the discovery, development and commercialization of products for respiratory, inflammatory and critical care diseases. The Company owns worldwide rights to the asthma drug ZYFLO(R) (zileuton tablets), as well as other formulations of zileuton. ZYFLO is the only 5-lipoxygenase inhibitor approved for marketing by the U.S. Food and Drug Administration. The Company's commercialization efforts for ZYFLO are carried out by its specialty sales force. Critical Therapeutics also is developing treatments directed toward the severe inflammatory response in acute diseases and conditions that lead to admission to the emergency room or intensive care unit, and acute exacerbations of other chronic diseases that frequently lead to hospitalization. For more information, please visit www.crtx.com.
ZYFLO is indicated for the prevention and chronic treatment of asthma in adults and children 12 years of age and older. ZYFLO, which contains the active ingredient zileuton, blocks the formation of leukotrienes that may contribute to asthma symptoms. Zileuton is an orally active inhibitor of 5-lipoxygenase, the enzyme that catalyzes the formation of leukotrienes from arachidonic acid. The recommended dose is one 600 mg tablet four times a day. ZYFLO is not indicated for use in the reversal of bronchospasm in acute asthma attacks, including status asthmaticus. Therapy with ZYFLO can be continued during acute exacerbations of asthma. ZYFLO should be taken regularly, even during symptom-free periods.
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.
ZYFLO(R) is a registered trademark of Critical Therapeutics, Inc.
Any statements in this press release about future expectations, plans and prospects for Critical Therapeutics, Inc., including, without limitation, possible therapeutic benefits and market acceptance of ZYFLO and all other statements that are not purely historical in nature, constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Without limiting the foregoing, the words "anticipate," "believe," "could," "estimate," "expect," "intend," "may," "plan," "project," "should," "will," "would" and similar expressions are intended to identify forward-looking statements. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including risks and uncertainties relating to: the extent of market acceptance of ZYFLO; our heavy dependence on the commercial success of ZYFLO and the controlled-release formulation of zileuton; our ability to develop and maintain the necessary sales, marketing and manufacturing capabilities to commercialize ZYFLO; patient, physician and third-payer acceptance of ZYFLO as a safe and effective therapeutic product; adverse side effects experienced by patients taking ZYFLO, our ability to obtain the substantial additional funding required to conduct our research, development and commercialization activities; and our ability to obtain, maintain and enforce patent and other intellectual property protection for ZYFLO, our drug candidates and our discoveries. These and other risks are described in greater detail in the "Risk Factors" section of our most recent Quarterly Report on Form 10-Q and other filings that we make with the Securities and Exchange Commission. If one or more of these factors materialize, or if any underlying assumptions prove incorrect, our actual results, performance or achievements may vary materially from any future results, performance or achievements expressed or implied by these forward-looking statements.
In addition, the statements in this release reflect our expectations and beliefs as of the date of this release. We anticipate that subsequent events and developments will cause our expectations and beliefs to change. However, while we may elect to update these forward-looking statements publicly at some point in the future, we specifically disclaim any obligation to do so, whether as a result of new information, future events or otherwise. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this release.
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|Date:||May 23, 2006|
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