LONDON, UK & MONTREAL, QC — DalCor Pharmaceuticals reports it is ahead of its enrollment schedule with the randomization of over 1,000 of the planned 5,000 patients that will take part in the company’s Phase 3 “dal-GenE” clinical trial.
“We are pleased and gratified that recruitment goals are ahead of schedule,” said Dr. Jean-Claude Tardif, director of the Research Center at the Montreal Heart Institute and professor of medicine at the Université de Montréal, and principal investigator for dal-GenE. “This is a testament to the need for precision medicine in this critically important sector of medicine; the DalCor approach is the first for cardiovascular medicine. Furthermore, it clearly shows the interest in the study and the necessity for a new therapeutic alternative for patients.”
In 2012, investigators at the Montreal Heart Institute led by Dr. Tardif and Marie-Pierre Dubé found a significant association between the effects of dalcetrapib in altering CV events and the polymorphism at the rs1967309 location in the adenylate cyclase type 9 (ADCY9) gene. Patients with the AA genotype had a 39 per cent reduction in CV events when treated with dalcetrapib compared to placebo, while GG patients had a 27 per cent increase and AG patients had a neutral effect. This analysis was conducted in 5749 patients. A prospective analysis of the dal-Plaque 2 study data has also demonstrated reduced atherosclerosis in the AA population when treated with dalcetrapib, but an increase in atherosclerosis in the GG population.
The dal-GenE Phase 3 trial is a cardiovascular outcome study of dalcetrapib in patients with acute coronary syndrome (ACS) and the AA genotype in the ADCY9 gene. Approximately one in five people harbor the AA genotype.
Patients have been recruited at 642 hospitals in 30 countries, including the U.S., and on six continents. The worldwide clinical trial is led by the Montreal Health Innovations Coordinating Center (MHICC), the Lead Academic Research Organization (ARO) and Clinical Research Organization (CRO) Medpace .
The company says that Dalcetrapib is the first precision medicine in the cardiovascular space to have reached full-scale development with the Phase 3 clinical study. Over 17,000 patients have participated in dalcetrapib clinical trials to date.