Cardiol Therapeutics (TSX:CRDL, NASDAQ:CRDL) Inc announced it is expanding its LANCER clinical trial to Brazil, Mexico, and Canada.
LANCER is a Phase II/III randomized, double-blind, placebo-controlled safety and efficacy trial of the company’s lead drug CardiolRx in patients with coronavirus (COVID-19) who are at risk of, or dealing with, cardiovascular disease.
Up until now, the trial was being run exclusively in the US. The company has received government approvals from health authorities in Brazil, Mexico, and Canada to expand the trial in hospitals in the three countries.
READ: Cardiol Therapeutics enrolls first patient in LANCER Phase II/III trial of CardiolRx on coronavirus patients
Cardiol told investors that clinical site activation is underway in Brazil and Mexico, with hospitals already starting to enroll patients. Site selection is underway in Canada.
"COVID-19 remains an international crisis and there remains an urgent need to develop new therapeutics to address the immune-mediated inflammation that results from the virus, particularly in high-risk patients with cardiovascular disease," Cardiol’s chairman Guillermo Torre-Amione said in a statement.
"With the expansion of the LANCER trial to include prominent clinical research centers in Brazil, Mexico, and Canada, we are now positioned to accelerate patient recruitment into the trial and expedite the path towards our goal of determining the cardioprotective properties of CardiolRx in COVID patients with pre-existing, or significant risk factors for, cardiovascular disease."
LANCER’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.
COVID-19 can significantly impact individuals with cardiovascular disease or who are at risk of 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.
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.
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