Critical Therapeutics Announces Decision to Discontinue Clinical Trial of CTI-01
Wednesday March 15, 9:50 am ET
LEXINGTON, Mass.--(BUSINESS WIRE)--March 15, 2006--Critical Therapeutics, Inc. (Nasdaq: CRTX - News), a biopharmaceutical company focused on the discovery, development and commercialization of products for respiratory, inflammatory and critical care diseases, today announced it has decided to discontinue the Phase II clinical trial of CTI-01, an anti-inflammatory compound.
The decision to discontinue the trial was based on stability issues that potentially could affect the integrity of clinical drug supplies currently at sites. The Company is undertaking an evaluation of those issues. No significant safety concerns have been identified in the trial to date.
Of the 150 planned patients, 102 patients have received study medication. The Company will analyze the safety and efficacy data from these patients and expects to report results later this year. Once the Company completes its analyses of the safety and efficacy data, as well as its evaluation of the stability issues, it will determine what steps will be taken with regard to future clinical trials of CTI-01.
"We believe that with 102 patients enrolled, we can still gain valuable information about the activity of the compound in a high risk patient population that will enable us to determine appropriate next development steps," said Walter Newman, Senior Vice President of Research and Development.
The double-blind, randomized, placebo-controlled, parallel-group clinical trial was designed to determine the safety and efficacy of CTI-01 in patients at risk of complications, including organ damage, while undergoing cardiac surgery involving the use of the cardiopulmonary bypass machine. |
