Critical Therapeutics Initiates Phase II Clinical Study of CTI-01

Critical Therapeutics 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, 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.