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Critical Therapeutics Announces Enrollment in Phase III Trial of Zileuton in Patients With Acute Exacerbations of COPD

Posted on: Monday, 15 October 2007, 09:00 CDT

Critical Therapeutics (Nasdaq: CRTX) today announced the start of patient enrollment in the LEUKO study, a randomized, double-blind, placebo-controlled efficacy trial to examine the effects of ZYFLO® (zileuton tablets) used in the treatment of adults with Chronic Obstructive Pulmonary Disease (COPD). The purpose of this trial is to examine the effectiveness of ZYFLO at reducing the length of a hospital stay for adults who are hospitalized for a COPD exacerbation, or a worsening of their COPD symptoms. Secondary outcomes will include lung function improvement, "treatment failure" at 30 days (defined as intubation, hospital re-admission or urgent visit for COPD symptoms, or intensification of therapy), health-related quality of life and urinary leukotriene levels.

This clinical trial is being sponsored and funded by the National Heart, Lung and Blood Institute (NHLBI), part of the National Institutes of Health (NIH), and is being conducted by the COPD Clinical Research Network (CRN).

Enrollment of 520 patients is planned for 19 inpatient hospitals at 10 academic centers in the United States. Eligible patients will have been admitted to the hospital with acute exacerbations of COPD, have at least 10 pack years of smoking and have a forced expiratory volume in one second (FEV1) of less than 60 percent of predicted level. Patients will be randomized to receive either oral placebo or zileuton (600 mg QID) for 14 days.

Prescott Woodruff, M.D., pulmonologist and critical care specialist at the University of California at San Francisco Medical Center and Principal Investigator of the NIH clinical trial, said, "Exacerbations of COPD impose a considerable burden with regard to morbidity, mortality, and health care cost, and therapeutic approaches to COPD exacerbations have not changed in many years. We are excited to study this novel approach in the context of the NIH NHLBI COPD Clinical Research Network."

About COPD

Primarily caused by smoking1, COPD is a disease in which the lung airways are partly damaged and obstructed, making it difficult to breathe. Symptoms include coughing, excess mucus production, shortness of breath, wheezing, and chest tightness. Treatment usually includes inhaled bronchodilator or steroid medications that work by relaxing the muscles around the lung airways and reducing inflammation. COPD is the fourth leading cause of death in the United States. In 2002, the disease claimed approximately 120,000 lives2, accounted for more than 700,000 hospitalizations and resulted in 1.5 million emergency room visits3.

About ZYFLO CR and ZYFLO

ZYFLO CRTM (zileuton) extended-release tablets and ZYFLO are the only FDA-approved leukotriene synthesis inhibitors for the prophylaxis and chronic treatment of asthma in adults and children 12 years of age and older. ZYFLO CR and ZYFLO are not indicated for use in the reversal of bronchospasm in acute asthma attacks. Therapy with ZYFLO CR and ZYFLO can be continued during acute exacerbations of asthma.

The recommended dose of ZYFLO CR is two 600 mg extended-release tablets twice daily, within one hour after morning and evening meals, for a total daily dose of 2400 mg. The recommended dose of ZYFLO is one 600 mg immediate-release tablet four times a day for a total daily dose of 2400 mg.

ZYFLO CR and ZYFLO are contraindicated in patients with active liver disease or transaminase elevations greater than or equal to three times the upper limit of normal. A small percentage of patients treated with ZYFLO CR (2.5%) and ZYFLO (1.9%) in placebo-controlled trials showed an increased release of a liver enzyme known as ALT and bilirubin (an orange or yellowish pigment in bile). As a result, the level of liver enzymes in patients treated with ZYFLO CR and ZYFLO should be measured by a simple blood test. It is recommended that physicians perform this test before administering ZYFLO CR and ZYFLO and repeat the test on a regular basis while patients are on the medication. Patients taking ZYFLO CR and theophylline should reduce the theophylline dose by 50%. Patients taking ZYFLO CR and propranolol or warfarin should be monitored and doses adjusted as appropriate. Most common side effects associated with the use of ZYFLO CR and ZYFLO are sinusitis, nausea and pharyngolaryngeal pain and abdominal pain, upset stomach and nausea, respectively.

For full prescribing information for ZYFLO CR, please visit www.zyflocr.com or call the Company's toll free telephone number 1-866-835-8216 to request medical information.

For full prescribing information for ZYFLO, please visit www.zyflo.com or call the Company's toll free telephone number 1-866-835-8216 to request medical information.

About Critical Therapeutics

Critical Therapeutics, Inc. is developing and commercializing innovative products for respiratory, inflammatory and critical care diseases. The Company owns worldwide rights to two FDA-approved drugs for the prevention and chronic treatment of asthma in patients 12 years of age and older: twice-daily ZYFLO CR™ (zileuton) extended-release tablets and ZYFLO® (zileuton tablets). Critical Therapeutics is developing products for acute asthma attacks that lead patients to the emergency room and other urgent care settings. The Company also is developing therapies directed toward the body's inflammatory response. Critical Therapeutics is located in Lexington, Mass. 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 anticipated timing, status and results of the COPD clinical trial of ZYFLO, and possible therapeutic benefits, safety and future development of ZYFLO CR and ZYFLO, including with respect to the design and outcome of the COPD clinical trial, 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; whether the COPD clinical trial will demonstrate effectiveness of ZYFLO in treating COPD, including whether the results of prior clinical trials and preclinical studies will be indicative of results obtained in this clinical trial; our ability to successfully market and sell ZYFLO CR and ZYFLO, including the success of our co-promotion arrangement with Dey, L.P. (DEY); our ability to develop and maintain the necessary sales, marketing, distribution and manufacturing capabilities to commercialize ZYFLO CR and ZYFLO; patient, physician and third-party payor acceptance of ZYFLO CR and ZYFLO as safe and effective therapeutic products; adverse side effects experienced by patients taking ZYFLO CR or ZYFLO; our heavy dependence on the commercial success of ZYFLO CR; our ability to maintain regulatory approvals to market and sell ZYFLO CR and ZYFLO; our ability to successfully enter into additional strategic co-promotion, collaboration or licensing transactions on favorable terms, if at all; 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 CR and ZYFLO, our discoveries and our drug candidates. 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 press 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. Our forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, business development transactions, joint ventures or investments we may make. 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® is a registered trademark of Critical Therapeutics, Inc.

ZYFLO CRTM is a trademark of Critical Therapeutics, Inc.

1 U.S. Department of Health and Human Services. The Health Consequences of Smoking. A Report of the Surgeon General, 2004

2 National Center for Health Statistics. Report of Final Mortality Statistics, 2002

3 Centers for Disease Control and Prevention, Facts About Chronic Obstructive Pulmonary Disease, August 2003

Source: Business Wire

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