Cardiol Therapeutics enrolls first patient in LANCER Phase II/III trial of CardiolRx on coronavirus patients

Cardiol Therapeutics Inc (TSE:CRDL) (OTCQX:CRTPF) announced that the first patient has been randomized in the LANCER Phase II/III trial of its oral cannabidiol formulation CardiolRx. The trial is a randomized, double-blind, placebo-controlled study that will test the efficacy and safety of CardiolRx in preventing cardiovascular complications in 422 hospitalized patients who have a confirmed coronavirus (COVID-19) diagnosis and pre-existing (or at risk for) cardiovascular disease. Cardiol’s chief medical officer Dr Andrew Hamer told investors that there is “compelling evidence” that inflammation plays a role in the development and progression of heart disease. READ: Cardiol Therapeutics says CardiolRx safe and well tolerated in Phase I study of oral cannabidiol formulation "I am excited to see the initiation of the LANCER trial which will provide a unique opportunity to explore the anti-inflammatory and cardioprotective properties of CardiolRx in COVID-19 patients who are at high risk for major cardiovascular complications,” Hamer said in a statement. LANCER is being run in major hospitals across the US. The study’s primary endpoint will be the difference between the active and placebo groups in the percentage of patients who develop one or more outcomes – cardiovascular complications, ICU admission rates, ventilatory support – during the first 28 days following randomization and the first dose of study medication. The trial is expected to be completed during 2021 and will support an emergency use authorization for the treatment of COVID-19 patients who would have qualified for enrollment in LANCER, according to Cardiol, which added that successful trial results may also be used to support a new drug application. LANCER should also generate “invaluable” clinical data about the potential of CardiolRx to treat of other cardiac inflammatory disorders, including acute myocarditis and heart failure, the company added. COVID-19 can significantly impact individuals with cardiovascular disease or who are at risk for developing heart problems. Evidence also shows that patients infected with COVID-19 can go on to develop heart complications during the course of their illness. Cardiol told shareholders that “a therapeutic strategy to prevent or limit the number or severity of these cardiovascular complications is likely to considerably improve outcomes from this disease.” Oakville, Ontario-based Cardiol is a clinical-stage biotechnology company focused on the research and clinical development of innovative anti-inflammatory therapies for the treatment of cardiovascular disease. Contact Angela at angela@proactiveinvestors.com Follow her on Twitter @AHarmantas