DalCor Randomizes First Patient in the DalGenE Phase 3 Cardiovascular Outcomes Trial

LONDON and MONTREAL, DalCor Pharmaceuticals today announced it has randomzied the first patient in the Phase 3 "dal-GenE" clinical trial, a cardiovascular outcomes study of dalcetrapib in patients with acute coronary syndrome (ACS) and the AA genotype in the ADCY9 gene. The worldwide clinical trial will be led by the Montreal Heart Institute.

The double-blind, randomized, placebo-controlled, multicenter Phase 3 clinical trial will enroll 5,000 patients recently hospitalized with ACS and who express the AA genotype at variant rs1967309 in the ADCY9 gene, determined by an investigational companion diagnostic test developed by Roche Molecular Systems (RMS). The primary endpoint of the study is the time to first occurrence of any component of the composite of cardiovascular death, myocardial infarction (heart attack) and stroke. The trial will be conducted at 1,000 sites in 33 countries.

Researchers at the Montreal Heart Institute (MHI), who will be leading the dal-GenE study, discovered the importance of the AA genotype in determining patients' clinical response to treatment with dalcetrapib. MHI's Biobank was also used in this pharmacogenomic research. Approximately 20 percent of the general population harbor the AA genotype.

Source: DalCor Pharmaceuticals