Critical Therapeutics Initiates Phase II Clinical Study of CTI-01; Receives CTI-01 U.S. Patent.

LEXINGTON, Mass. -- Study to Assess Safety and Efficacy in Patients Undergoing Major Cardiac Surgery with Cardiopulmonary Bypass;

Company Receives U.S. Patent Relating to Use of CTI-01 for the Treatment of Ischemia and Reperfusion Injury 

Critical Therapeutics, Inc. (Nasdaq: CRTX), a biopharmaceutical company focused on the discovery, development and commercialization of products for respiratory, inflammatory and critical care diseases, today announced that it has initiated a Phase II clinical trial of CTI-01, an anti-inflammatory compound that it is developing for the treatment of certain critical care conditions.

This study is a double-blind, randomized, placebo-controlled, parallel-group clinical study to determine the safety and efficacy of CTI-01 in the prevention of organ damage in patients undergoing major cardiac surgery involving the use of cardiopulmonary bypass (CPB), such as coronary artery bypass graft and/or valve replacement or repair. The company expects the study will enroll up to 150 patients at multiple clinical sites. Patients will receive a total of six doses, administered intravenously just prior to and after surgery.

"According to the Centers for Disease Control and Prevention, there were more than 500,000 procedures performed in the United States in 2002 using CPB. We estimate that the incidence of post-operative organ dysfunction occurs in up to 30 percent of patients undergoing cardiac surgery with CPB, and may be caused by an exaggerated inflammatory response to surgical trauma and the CPB machine," said Walter Newman, Ph.D., Critical Therapeutics' chief scientific officer. "Our study is designed to assess the benefit of CTI-01 in reducing these responses and thereby potentially improving patient outcome following surgery with CPB. Protecting high-risk cardiac surgery patients from complications is of significant interest to the medical community."

Previous Phase I clinical trials conducted in the United Kingdom and the United States demonstrated that CTI-01 can be administered safely at concentrations greater than those shown to be effective in animal models of organ dysfunction.

CTI-01 is a small molecule that has demonstrated potent anti-inflammatory and tissue protection activity in multiple animal models of disease including pancreatitis, ischemia-reperfusion injury, sepsis, renal injury and endotoxemia. In in vivo and in vitro scientific research, CTI-01 inhibited the systemic release of cytokines, such as TNF-alpha and HMGB1, which promote the body's inflammatory response. The over-expression of these cytokines has been linked to diseases that occur in critical care settings, such as severe organ damage following CPB and post-operative ileus following abdominal surgery.

Company Receives CTI-01 Patent

Critical Therapeutics also announced that it has been awarded U.S. patent No. 6,846,842 B2, entitled, "Pyruvate Ester Composition and Method of Use for Resuscitation After Events of Ischemia and Reperfusion." The patent encompasses broad methods of use of CTI-01, and/or other related compounds, to counteract ischemia and reperfusion injury resulting from a variety of conditions.

"This patent provides Critical Therapeutics with important intellectual property protection for our CTI-01 program and highlights the commercialization opportunities for small-molecule treatments based on this technology," Dr. Newman said.

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 is developing a sales and marketing infrastructure in connection with its in-licensed product, ZYFLO(R) Filmtab(R) (zileuton tablets). 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.

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ZYFLO(R) is a registered trademark of Critical Therapeutics, Inc. Filmtab(R) is a registered trademark of the Abbott Group of Companies.