Cytel's MI Drug Disappoints In Phase II

Cytel has announced the termination of a Phase II clinical study with its carbohydrate-based cell adhesion blocker, Cylexin. The study was designed to evaluate the effect of the drug on myocardial salvage in patients with acute myocardial infarction treated with primary angioplasty.

Cytel stopped the study on the recommendation of the independent Data and Safety Monitoring Board, which decided the drug was safe but, based upon the primary endpoint of myocardial salvage, there was no benefit in patients treated with Cylexin over those patients who received placebo.

Cytel said it "will pursue detailed analyses of all efficacy and safety data from this trial, including those on approximately 30 additional patients from whom data have not yet been collected," before deciding on the future of the compound in this indication. Because the drug does not appear to do any harm, the 100 or so patients who have already received the drug will continue do so in an open-label phase, which will allow some useful data to be generated. None of the secondary endpoints have been analysed to date.