• E-mail
• Print
• Comment
• Font Size
• Digg
• del.icio.us
• Discuss article

Critical Therapeutics Completes Clinical Trial of Intravenous Zileuton in Patients With Asthma; Preliminary Results to Be Reported By End of Third Quarter

Posted on: Tuesday, 25 July 2006, 09:00 CDT

Critical Therapeutics, Inc. (Nasdaq: CRTX) today announced that it has completed the double-blind, placebo-controlled, single-dose Phase I/II clinical trial of the intravenous (IV) formulation of zileuton in patients with asthma and is currently analyzing the data. Dosing was initiated in February 2006 and Critical Therapeutics expects to report preliminary results from this trial later this quarter. The Company is developing zileuton IV initially for use in 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.

The Phase I/II clinical trial of zileuton IV is designed to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy in 60 patients. Patients dosed in the study had a baseline lung function of 40%-80% of predicted normal, as measured by FEV1 (forced expiratory volume). This trial is the first time an IV formulation of a 5-lipoxygenase inhibitor has been tested in humans.

Patients enrolled in the study were randomized into four escalating dose groups, each receiving one infusion of either zileuton IV or placebo. Lung function measurements were taken prior to dosing and at additional times during the 24-hour period after the infusion. All patients participated in a three-day follow-up period post-infusion, primarily to assess the safety of zileuton IV.

About Zileuton

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 Safety Information

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.

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.

Forward-Looking Statements

Any statements in this press release about future expectations, plans and prospects for Critical Therapeutics, Inc., including, without limitation, statements regarding the progress and timing of our zileuton IV program; the expected results of our Phase I/II clinical trial of zileuton IV; the prospects, plans and objectives of management; 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: conducting clinical trials, including difficulties or delays in the completion of patient enrollment, data collection or data analysis; the results of preclinical studies and clinical trials with respect to our products under development and whether such results will be indicative of results obtained in later clinical trials; our ability to transition our management team effectively; our ability to successfully market and sell ZYFLO; our ability to maintain regulatory approvals to market and sell ZYFLO; our ability to develop and maintain the necessary sales, marketing, distribution 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; the timing and success of submission, acceptance and approval of our regulatory filings, including, without limitation, the NDA submission for the controlled-release (CR) formulation of zileuton; our heavy dependence on the commercial success of ZYFLO and zileuton CR; our ability to obtain the substantial additional funding required to conduct our research, development and commercialization activities; our dependence on our strategic collaboration with MedImmune, Inc.; 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 (SEC). 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.

ZYFLO(R) is a registered trademark of Critical Therapeutics, Inc.

Source: Business Wire

More News in this Category