- Cardiol Therapeutics (CRDL) is expanding its LANCER trial to include Brazil, Mexico, and Canada
- LANCER is a phase II/III randomized, double-blind, placebo-controlled trial designed to assess the efficacy of CardiolRx™ in preventing cardiovascular complications in COVID-19 patients
- The LANCER trial is currently enrolling patients at hospital centers in the United States under an Investigational New Drug (IND) application cleared by the USFDA
- Clinical site activation is underway in Brazil, Canada and Mexico and the first hospital centers are initiating patient enrollment
- Cardiol Therapeutics is a clinical-stage biotechnology company focused on developing treatments for cardiovascular disease
- Cardiol Therapeutics Inc. (CRDL) opened trading at C$4.85 per share
Cardiol Therapeutics (CRDL) is expanding its LANCER trial to include several hospital centers in Brazil, Mexico, and Canada.
LANCER is a phase II/III randomized, double-blind, placebo-controlled trial designed to assess the efficacy and safety of CardiolRx™ in preventing cardiovascular complications in hospitalized patients with a confirmed diagnosis of COVID-19 who have pre-existing, or significant risk factors for, cardiovascular disease (CVD).
The LANCER trial is currently enrolling patients at hospital centers in the United States under an Investigational New Drug (IND) application cleared by the U.S. Food and Drug Administration (FDA).
Cardiol has now received requisite government approvals from health regulators in Brazil, Mexico, and Canada to initiate several additional hospital centers in these countries. Clinical site activation is underway in Brazil and Mexico and the first hospital centers are initiating patient enrollment. Clinical site selection is also in progress 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,” stated Dr. Guillermo Torre-Amione, Chairman of Cardiol Therapeutics.
“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.”
The primary goal of the LANCER trial is to determine the percentage of patients who develop one or more of several common outcomes, during the first 28 days following randomization and the first dose of study medication. These include all-cause mortality, the requirement for ICU admission and/or ventilatory support, as well as cardiovascular complications, including heart failure, acute myocardial infarction, myocarditis, stroke, or new sustained or symptomatic arrhythmia.
Patients with COVID-19 present with respiratory symptoms which can progress to bilateral pneumonia and serious pulmonary complications. It is now recognized that the impact of COVID-19 is not limited to the pulmonary system. Individuals with pre-existing CVD or who have risk factors for CVD (such as diabetes, hypertension, obesity, abnormal serum lipids, or age greater than 64) are at significantly greater risk of developing serious disease from COVID-19 and experience greater morbidity. Moreover, such COVID-19 patients are at significant risk of developing cardiovascular complications during the course of their illness, which are frequently fatal.
A therapeutic strategy to prevent or limit the severity of both pulmonary and cardiovascular complications is likely to improve outcomes from this disease.
The LANCER trial is being overseen by an independent steering committee, consisting of international thought leaders in inflammatory heart disease. In addition to investigating the pulmonary and cardioprotective properties of CardiolRx in high-risk COVID-19 patients, the trial is expected to generate invaluable clinical data with respect to the therapeutic potential of CardiolRx in the treatment of other inflammatory cardiac disorders, including acute myocarditis and heart failure.
Cardiol Therapeutics is a clinical-stage biotechnology company focused on the research and clinical development of innovative anti-inflammatory therapies for the treatment of cardiovascular disease (“CVD”). The company’s lead product, CardiolRx™, is a pharmaceutically produced oral cannabidiol formulation that is being investigated in a phase II/III outcomes study (the LANCER trial).
Cardiol Therapeutics Inc. (CRDL) opened trading at C$4.85 per share.
