LONDON and MONTREAL, July 21, 2022 (GLOBE NEWSWIRE) -- DalCor Pharmaceuticals announced the results of the dal-GenE Phase 3 cardiovascular precision medicine outcomes trial with publication of Pharmacogenetics-guided dalcetrapib therapy after an acute coronary syndrome: the dal-GenE trial in the European Heart Journal.1
The dal-GenE (DAL-301) trial was initiated to determine the ability of dalcetrapib to reduce cardiovascular (CV) morbidity and mortality in a population experiencing an acute coronary syndrome (ACS) within 1-3 months before randomization (N=6147) and identified as carrying the AA genotype at variant rs1967309 in the adenylate cyclase type 9 (ADCY9) gene, as determined by the cobas ADCY9 genotype test. This AA genotype is carried by approximately 20% of the total population and up to 40% in people of African descent. Eligible patients were optimally treated for CV risk factors. The prespecified primary endpoint was time-to-first event for the composite of CV death, resuscitated cardiac arrest, non-fatal myocardial infarction (MI) or non-fatal stroke.
In the dal-GenE trial, treatment with dalcetrapib in the intent-to-treat (ITT) analysis did not demonstrate a statistically significant result, with the composite primary endpoint event occurring in 9.5% of the patients in the dalcetrapib group, as compared with 10.6% in the placebo group (hazard ratio (HR) 0.88; 95% CI 0.75-1.03; p=0.12).
However:
Pre-COVID-19, the clinical efficacy of dalcetrapib seen in the dal-GenE study was also consistent with that of the retrospective analysis conducted in patients with the rs1967309 AA genotype in the dal-OUTCOMES study3. The totality of these data validates the pharmacogenetic hypothesis that dalcetrapib can safely improve, beyond the current standard of care, the prognosis of ACS patients with the rs1967309 AA genotype. DalCor is working closely with Health Authorities to determine the path forward for the approval of dalcetrapib for the treatment of patients with the rs1967309 AA genotype following an ACS event.
About DalCorDalCor is a biopharmaceutical company with a focus on addressing cardiovascular disease, the greatest global healthcare burden. Our purpose is to deliver the first pharmacogenomic precision medicine in cardiovascular disease that specifically targets patients with the ADCY9 AA genotype. For more information, please visit dalcorpharma.com.
About dal-GenEdal-GenE was a double-blind, parallel-group, placebo-controlled, randomized trial comparing orally administered dalcetrapib 600 mg once daily with placebo in a 1:1 ratio in patients with an acute coronary syndrome within 1 to 3 months and the AA genotype at variant rs1967309 in the ADCY9 gene. A total of 6147 patients were randomly assigned to receive dalcetrapib 600 mg or placebo daily.
The primary endpoint was the time from randomization to first occurrence of cardiovascular death, resuscitated cardiac arrest, non-fatal myocardial infarction, or non-fatal stroke.
Participants were enrolled across 630 investigational sites located in North America, South America, Europe, Middle East, South Africa, Australia, and New Zealand. Patients were eligible if they were at least 45 years of age, recently hospitalized for an acute coronary syndrome within the previous 1 to 3 months, clinically stable, treated with guidelines-based management of LDL- cholesterol at a minimum to a target level less than 2.6 mmol/L, and confirmed in a central laboratory to have the AA genotype at variant rs1967309 in the ADCY9 gene.
About DalcetrapibDalcetrapib is potentially the first pharmacogenomic precision medicine in cardiovascular disease developed for patients with the ADCY9 AA genotype. A companion diagnostic test, developed in conjunction with Roche Molecular Systems, identifies patients with the ADCY9 AA genotype who may potentially benefit from dalcetrapib treatment. DalCor obtained global rights to develop, manufacture and commercialize dalcetrapib under a license and collaboration agreement with Roche.
References
Media Contact:Clare EvansIris Communication+1 403 888 6869clare.evans@iriscommunication.net
See the rest here:
dal-GenE Phase 3 Cardiovascular Precision Medicine Outcomes
- New gene offers hope for preventive medicine against fractures [Last Updated On: September 18th, 2012] [Originally Added On: September 18th, 2012]
- Colon Cancer Gene Database May Assist Research Efforts [Last Updated On: September 30th, 2012] [Originally Added On: September 30th, 2012]
- Researchers discover gene that causes deafness [Last Updated On: September 30th, 2012] [Originally Added On: September 30th, 2012]
- Gene Study Yields New Clues to Breast Cancer [Last Updated On: September 30th, 2012] [Originally Added On: September 30th, 2012]
- Gene key to chemotherapy efficacy [Last Updated On: September 30th, 2012] [Originally Added On: September 30th, 2012]
- Gene clues offer new hope for treating breast cancer [Last Updated On: September 30th, 2012] [Originally Added On: September 30th, 2012]
- Gene that causes deafness pinpointed [Last Updated On: October 1st, 2012] [Originally Added On: October 1st, 2012]
- Gene that causes a form of deafness discovered [Last Updated On: October 1st, 2012] [Originally Added On: October 1st, 2012]
- Novel gene associated with Usher syndrome identified [Last Updated On: October 2nd, 2012] [Originally Added On: October 2nd, 2012]
- Translational Regenerative Medicine: Market Prospects 2012-2022 [Last Updated On: October 2nd, 2012] [Originally Added On: October 2nd, 2012]
- Two-day test can spot gene diseases in newborns [Last Updated On: October 3rd, 2012] [Originally Added On: October 3rd, 2012]
- Fast Gene Screen May Help Sick Babies [Last Updated On: October 3rd, 2012] [Originally Added On: October 3rd, 2012]
- Gene therapies need new development models [Last Updated On: October 3rd, 2012] [Originally Added On: October 3rd, 2012]
- Rapid gene machines used to find cause of newborn illnesses [Last Updated On: October 3rd, 2012] [Originally Added On: October 3rd, 2012]
- Gene behind many spontaneous breast cancers identified [Last Updated On: October 3rd, 2012] [Originally Added On: October 3rd, 2012]
- Gene responsible for many spontaneous breast cancers identified [Last Updated On: October 3rd, 2012] [Originally Added On: October 3rd, 2012]
- Two-day test can spot gene diseases in newborns - Wed, 03 Oct 2012 PST [Last Updated On: October 3rd, 2012] [Originally Added On: October 3rd, 2012]
- Researchers Discover Gene Defect Linked to Deafness [Last Updated On: October 3rd, 2012] [Originally Added On: October 3rd, 2012]
- Gene diseases in newborns unveiled quicker [Last Updated On: October 4th, 2012] [Originally Added On: October 4th, 2012]
- Quicker gene test may help babies - Thu, 04 Oct 2012 PST [Last Updated On: October 4th, 2012] [Originally Added On: October 4th, 2012]
- Rapid gene-mapping test may diagnose disease in newborns [Last Updated On: October 5th, 2012] [Originally Added On: October 5th, 2012]
- 2-day test can spot gene diseases in newborns [Last Updated On: October 5th, 2012] [Originally Added On: October 5th, 2012]
- Gene diseases in newborns spotted with 2-day test [Last Updated On: October 5th, 2012] [Originally Added On: October 5th, 2012]
- Rare Gene Deletion Tied To Psychiatric Disease And Obesity [Last Updated On: October 10th, 2012] [Originally Added On: October 10th, 2012]
- Mount Sinai researchers discover gene signature that predicts prostate cancer survival [Last Updated On: October 10th, 2012] [Originally Added On: October 10th, 2012]
- Test Spots Newborn Gene Disease [Last Updated On: October 10th, 2012] [Originally Added On: October 10th, 2012]
- Gene signature predicts prostate cancer survival [Last Updated On: October 11th, 2012] [Originally Added On: October 11th, 2012]
- Researchers Discover Gene Signature that Predicts Prostate Cancer Survival [Last Updated On: October 11th, 2012] [Originally Added On: October 11th, 2012]
- Bioethics Panel Urges More Gene Privacy Protection [Last Updated On: October 11th, 2012] [Originally Added On: October 11th, 2012]
- High Levels of Blood-Based Protein Specific to Mesothelioma [Last Updated On: October 11th, 2012] [Originally Added On: October 11th, 2012]
- Gene clues to help tackle skin disease [Last Updated On: October 15th, 2012] [Originally Added On: October 15th, 2012]
- Additive effect of small gene variations can increase risk of autism spectrum disorders [Last Updated On: October 15th, 2012] [Originally Added On: October 15th, 2012]
- 2-gene test predicts which patients with heart failure respond best to beta-blocker drug [Last Updated On: October 16th, 2012] [Originally Added On: October 16th, 2012]
- Two-gene test predicts which patients with heart failure respond best to beta-blocker drug [Last Updated On: October 16th, 2012] [Originally Added On: October 16th, 2012]
- Gene Linked to Kidney Failure [Last Updated On: October 17th, 2012] [Originally Added On: October 17th, 2012]
- Nanoparticles seen as gene therapy advance [Last Updated On: October 17th, 2012] [Originally Added On: October 17th, 2012]
- Stem Cell Therapy for Sickle Cell Anemia - Video [Last Updated On: October 31st, 2012] [Originally Added On: October 31st, 2012]
- Sickle Cell Anemia: Stem Cell Gene Therapy - Donald Kohn - Video [Last Updated On: October 31st, 2012] [Originally Added On: October 31st, 2012]
- Finding A Cure For Cancer with Dr. Aaron Rapoport - Video [Last Updated On: October 31st, 2012] [Originally Added On: October 31st, 2012]
- First gene therapy to go on sale in Europe in 2013: company [Last Updated On: November 7th, 2012] [Originally Added On: November 7th, 2012]
- Nanomedicine: Infectious Diseases, Immunotherapy, Diagnostics, Antifibrotics, Toxicology And Gene Me - Video [Last Updated On: November 14th, 2012] [Originally Added On: November 14th, 2012]
- Stress gene linked to heart attack – Study [Last Updated On: December 20th, 2013] [Originally Added On: December 20th, 2013]
- Why not gift yourself with gene test this Christmas? [Last Updated On: December 20th, 2013] [Originally Added On: December 20th, 2013]
- "Stress gene" may raise heart attack risk in healthy people [Last Updated On: December 20th, 2013] [Originally Added On: December 20th, 2013]
- 'Stress Gene' Ups Heart Attack, Death Risk [Last Updated On: December 20th, 2013] [Originally Added On: December 20th, 2013]
- Common disorders: It's not the genes themselves, but how they are controlled [Last Updated On: December 20th, 2013] [Originally Added On: December 20th, 2013]
- What is a gene? - Genetics Home Reference [Last Updated On: December 20th, 2013] [Originally Added On: December 20th, 2013]
- Gene Medicine | Business Outline | About Us | TAKARA BIO INC. [Last Updated On: December 20th, 2013] [Originally Added On: December 20th, 2013]
- Gene Therapy Clinical Trials Worldwide [Last Updated On: December 20th, 2013] [Originally Added On: December 20th, 2013]
- Genentech - Official Site [Last Updated On: December 21st, 2013] [Originally Added On: December 21st, 2013]
- Gene Therapy - American Medical Association [Last Updated On: December 23rd, 2013] [Originally Added On: December 23rd, 2013]
- Researchers identify gene that influences the ability to remember faces [Last Updated On: December 24th, 2013] [Originally Added On: December 24th, 2013]
- Gene That Influences Bonding Also Found To Impact Facial Recognition [Last Updated On: December 24th, 2013] [Originally Added On: December 24th, 2013]
- Gene Therapy Method Targets Tumor Blood Vessels [Last Updated On: December 24th, 2013] [Originally Added On: December 24th, 2013]
- Latin Americans inherited diabetes gene risk from Neanderthals [Last Updated On: December 26th, 2013] [Originally Added On: December 26th, 2013]
- Gene that influences the ability to remember faces identified [Last Updated On: December 30th, 2013] [Originally Added On: December 30th, 2013]
- Study supports a causal role in narcolepsy for a common genetic variant [Last Updated On: January 2nd, 2014] [Originally Added On: January 2nd, 2014]
- Increasing Investments in Molecular Biology Research Drives the Market for DNA Gene Chips, According to a New Trend ... [Last Updated On: January 2nd, 2014] [Originally Added On: January 2nd, 2014]
- Loss of Function of a Single Gene Linked to Diabetes in Mice [Last Updated On: January 3rd, 2014] [Originally Added On: January 3rd, 2014]
- Gene Medicine and Health [Last Updated On: January 3rd, 2014] [Originally Added On: January 3rd, 2014]
- Gene Therapy - Nature [Last Updated On: January 5th, 2014] [Originally Added On: January 5th, 2014]
- KidsHealth for Parents - Gene Therapy and Children [Last Updated On: January 5th, 2014] [Originally Added On: January 5th, 2014]
- Gene Patent Case Fuels U.S. Court Test of Stem Cell Right [Last Updated On: January 6th, 2014] [Originally Added On: January 6th, 2014]
- Gene Mutation Increases Certain Health Risks For Blacks, Study Finds [Last Updated On: January 6th, 2014] [Originally Added On: January 6th, 2014]
- Single faulty gene causes major type 2 diabetes symptom in mice [Last Updated On: January 6th, 2014] [Originally Added On: January 6th, 2014]
- No 'brakes' -- Study finds mechanism for increased activity of oncogene in certain cancers [Last Updated On: January 6th, 2014] [Originally Added On: January 6th, 2014]
- AML score that combines genetic and epigenetic changes might help guide therapy [Last Updated On: January 9th, 2014] [Originally Added On: January 9th, 2014]
- Stem cell research identifies new gene targets in patients with Alzheimer's disease [Last Updated On: January 9th, 2014] [Originally Added On: January 9th, 2014]
- 14 new gene targets in Alzheimer’s identified [Last Updated On: January 10th, 2014] [Originally Added On: January 10th, 2014]
- Scientists uncover new target for brain cancer treatment [Last Updated On: January 11th, 2014] [Originally Added On: January 11th, 2014]
- Tweaking MRI to Track Creatine May Spot Heart Problems Earlier, Penn Medicine Study Suggests [Last Updated On: January 13th, 2014] [Originally Added On: January 13th, 2014]
- RSNA: Gene Variation Associated with Brain Atrophy in Mild Cognitive Impairment [Last Updated On: January 14th, 2014] [Originally Added On: January 14th, 2014]
- Keeping Stem Cells Pluripotent [Last Updated On: January 14th, 2014] [Originally Added On: January 14th, 2014]
- Gene variation associated with brain atrophy in mild cognitive impairment [Last Updated On: January 14th, 2014] [Originally Added On: January 14th, 2014]
- Genes: MedlinePlus Medical Encyclopedia - National Library of ... [Last Updated On: January 15th, 2014] [Originally Added On: January 15th, 2014]
- Gene Therapy May Restore Sight in People With Rare Blinding Disease [Last Updated On: January 16th, 2014] [Originally Added On: January 16th, 2014]
- Gene therapy treats blindness [Last Updated On: January 16th, 2014] [Originally Added On: January 16th, 2014]
- New Genetic Clue to Lupus Is Found [Last Updated On: January 17th, 2014] [Originally Added On: January 17th, 2014]
- New Gene Machine Could Mean More Accurate Diagnosis [Last Updated On: January 18th, 2014] [Originally Added On: January 18th, 2014]
- Same cell death pathway involved in three forms of blindness, study finds [Last Updated On: January 18th, 2014] [Originally Added On: January 18th, 2014]