Business
Cardiol Therapeutics Announces First Patient Enrolled in ARCHER, a Phase II Clinical Trial of CardiolRx(TM) for Treatment of Acute Myocarditis
Multi-center, international, double-blind, randomized, placebo-controlled trial to enroll 100 ...
About this update from Cardiol Therapeutics Inc. Class A
[{"type":"text","content":"Cardiol Therapeutics Announces First Patient Enrolled in ARCHER, a Phase II Clinical Trial of CardiolRx(TM) for Treatment of Acute MyocarditisMulti-center, international, double-blind, randomized, placebo-controlled trial to enroll 100 patientsOakville, Ontario--(Newsfile Corp. - August 3, 2022) - Cardiol Therapeutics Inc. (NASDAQ: CRDL) (TSX: CRDL) (\"Cardiol\" or the \"Company\"), a clinical-stage life sciences company focused on the research and clinical development of cannabidiol as an anti-inflammatory and anti-fibrotic therapy for the treatment of cardiovascular diseases (\"CVD\"), announced today that the first patient has been enrolled in ARCHER, the Company's Phase II, multi-center, international, double-blind, randomized, placebo-controlled trial designed to study the safety and tolerability of CardiolRx™, as well as its impact on myocardial recovery, in patients presenting with acute myocarditis. CardiolRx is a pharmaceutically produced oral cannabidiol formulation being developed for the treatment of acute and chronic inflammation associated with heart disease.Dennis McNamara, MD, MS, Professor of Medicine at the University of Pittsburgh, Director of the Center for Heart Failure Research at the University of Pittsburgh Medical Center, and Chair of the study steering committee commented, \"We have long suspected that it is the response to injury that needs to be addressed to improve outcomes in myocarditis. Given its impact limiting these inflammatory mechanisms, we believe cannabidiol has the potential to truly benefit patients with this condition. I am pleased this important milestone has now been achieved and the ARCHER study, designed to investigate CardiolRx's therapeutic potential in myocarditis, is formally underway.\" ARCHER has received regulatory clearance in multiple jurisdictions, including IND authorization from the FDA, and is expected to enroll 100 patients at major cardiac centers in North America, Europe, Latin America, and Israel. The primary endpoints of the trial, which will be evaluated after 12 weeks of double-blind therapy, consist of the following cardiac magnetic resonance imaging measures: left ventricular function (ejection fraction and longitudinal strain) and myocardial edema/fibrosis (extra-cellular volume), each of which has been shown to predict long-term prognosis of patients wi...