DalCor Announces Expansion and Accelerated Enrollment of the dal-GenE Clinical Trial
Published: Apr 05, 2018
LONDON and MONTREAL, April 5, 2018 /PRNewswire/ -- DalCor today announced that the company will increase enrollment in its ongoing Phase 3 clinical trial of dalcetrapib from 5000 to 6000 patients. The decision for cohort expansion follows better than expected trial enrollment for dal-GenE, which has currently randomized a total of 4300 patients, an estimated 5 months ahead of enrollment projections.
"The success of the enrollment has provided the opportunity to reconsider initial assumptions to strengthen the trial design. As a result, the sample size of the dal-GenE study will be increased to 6000 patients while maintaining the originally projected recruitment timelines of year-end 2018," commented Dr. Jean-Claude Tardif, Chair of the dal-GenE Executive Committee. "The prospect of precision medicine for cardiovascular health has been embraced by our colleagues around the world. We're pleased that the great response from our investigators and study participants to the protocol has allowed us to enroll patients at a higher rate than originally anticipated. Expanding the number of patient events will increase the precision of the trial."
Dr. Robert McNeil, Chairman of DalCor added, "We are very pleased to be able to expand the clinical trial and still meet our projected timelines. Through the committed work of many collaborators, DalCor has been able to move quickly towards achieving our goal of developing dalcetrapib as a targeted therapy for cardiovascular disease patients."
About the dal-GenE Phase 3 Study
The double-blind, randomized, placebo-controlled, multicenter Phase 3 clinical trial will enroll 6000 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 is being conducted in over 700 sites in 33 countries.
DalCor is developing precision medicine by genetically targeting patients who will derive clinical benefits. By integrating clinical and genetic insights, DalCor intends to deliver superior clinical cardiovascular outcomes. The company's first development program, dalcetrapib, is intended to reduce cardiovascular events in a specific genetic subset of patients.
DalCor has a worldwide exclusive license for dalcetrapib together with rights to the genetic marker for use with dalcetrapib and is sponsoring the dal-GenE study. DalCor has offices in Montreal, San Mateo, Calif., Zug, Switzerland and Stockport, U.K. For more information, visit www.dalcorpharma.com.
Donald Black, M.D.
SOURCE DalCor Pharmaceuticals