By a News Reporter-Staff News Editor at Heart Disease Weekly DalCor Pharmaceuticals announced it has exceeded its enrollment schedule with 50 percent of patients randomized in its Phase 3 "dal-GenE" clinical trial. More than 2,500 out of 5,000 expected patients with acute coronary syndrome (ACS) and the AA genotype at variant rs1967309 in the ADCY9 gene have entered into this cardiovascular outcomes study of dalcetrapib. In 2012, investigators at The Montreal Heart Institute observed a significant association of dalcetrapib in altering cardiovascular events (CV) for the AA genotype patients who had a 39 percent reduction in cardiovascular events when compared with placebo (see also DalCor Pharmaceuticals).
Approximately 1 in 5 people worldwide have the AA genotype at this single-nucleotide polymorphism (SNP), an important genetic marker that distinguishes which patients may be most likely to benefit from treatment by dalcetrapib and possibly similar drugs. DalCor is the first company to apply precision medicine to this field by studying dalcetrapib's promising effects on atherosclerosis in a specific genetically-defined population.
Dal-GenE is an international clinical trial led by the Montreal Health Innovations Coordinating Center (MHICC), the lead Academic Research Organization (ARO) and Medpace, a leading Clinical Research Organization (CRO). The patients have been accrued from over 700 centers in 31 countries, including the U.S., covering six continents.
"We are encouraged by recent developments in the industry that show positive trial results with cholesteryl ester transfer protein (CETP) inhibitors. While statins have earned a pivotal place as the standard of care for reducing some of the adverse consequences of elevated cholesterol, we believe, to continue this progress and address continuing unmet medical needs, new therapies targeting non-LDL mechanism will be needed," said Robert McNeil, CEO of DalCor. "There are now a number of studies that may indicate that dalcetrapib, through a 'CETP' mediated, non-LDL mechanism, may significantly reduce atherosclerosis in genetically defined patients who experienced an ACS event while treated with standard of care. The implications of these findings are that when employing genetically targeted medicines, such as dalcetrapib, to treat patients along with standard of care, they may experience marked clinical benefit compared to placebo. In this light, we are very excited to announce this enrollment milestone ahead of schedule."
"The rapid enrollment of patients may enable us to report topline data ahead of our timeline projections," Dr. McNeil added. "Importantly, we continue to target 2020 for dalcetrapib regulatory submissions."
Donald M. Black, Chief Medical Officer said, "We believe the peaked interest in this trial highlights the need for a therapeutic alternative, which we anticipate providing with our targeted compound, dalcetrapib. Our precise focus on a genetically-defined group is a first in cardiovascular medicine, and supports an individualized approach to treatment for better outcomes. We are motivated to make dal-GenE the first major test that uses precision medicine to improve prognosis following a recent acute coronary syndrome. We are looking forward to learning more about the other CETP inhibitor studies recently completed."
"Our clinical team has partnered with a strong network of investigators and other groups, such as ANMCO in Italy, Green Lane Coordinating Center in New Zealand and ECLA in Argentina and Chile, which enables us to significantly progress the study's recruitment rate," commented Dr. Therese Heinonen, the Global Project Director for the dal-GenE study speaking for the Montreal Health Innovations Coordinating Center (MHICC). "We expect to stay on this accelerated path toward meeting the worldwide demand for cardiovascular treatment with dalcetrapib."
Keywords for this news article include: DalCor Pharmaceuticals, Genetics, Cardiology, Heart Disease, Atherosclerosis, Arteriosclerosis, Clinical Research, Myocardial Ischemia, Acute Coronary Syndrome, Arterial Occlusive Diseases, Clinical Trials and Studies, Heart Disorders and Diseases, Cardiovascular Diseases and Conditions.
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