The Montreal-based company reported in July that a death had occurred in the trial at a clinical site in Argentina. The trial was an international multi-center, randomized, placebo-controlled, double-blind study which had completed enrollment with 192 patients. Patients were to be administered once-weekly dosing of DAC:GRF for 12 weeks followed by a six-week follow-up. The patient received the 11th weekly dose on July 13, 2006 and, approximately two hours later, complained of chest discomfort. An ECG confirmed an acute myocardial infarction and death occurred approximately one hour later.
ConjuChem has pointed out that there is no evidence of any cardiotoxic effects of DAC:GRF in previous preclinical or clinical studies. According to the company, the attending physician stated that his most likely explanation for the event was that the patient had asymptomatic coronary artery disease with plaque rupture and occlusion.
ConjuChem also confirmed that it has terminated the phase II study and said that it is further evaluating the clinical development strategy of DAC: GRF.