Dr. Andrew Hamer reports
CARDIOL THERAPEUTICS ANNOUNCES MASSACHUSETTS GENERAL HOSPITAL, LARGEST TEACHING HOSPITAL OF HARVARD MEDICAL SCHOOL, AS THE 8TH MAJOR MEDICAL CENTRE PARTICIPATING IN MAVERIC-PILOT
Massachusetts General Hospital (Mass General) has been initiated and is eligible to enroll patients in MAvERIC-pilot, Cardiol Therapeutics Inc.'s phase II open-label pilot study, investigating the safety, tolerability and efficacy of CardiolRx in patients with recurrent pericarditis. In addition to standard safety assessments, the study is designed to evaluate improvement in objective measures of this rare disease, and during an extension period, assess the feasibility of weaning concomitant background therapy, including corticosteroids, while taking CardiolRx and to assess freedom from pericarditis recurrence.
"We are delighted to have the world-renowned Massachusetts General Hospital contributing to our MAvERIC-pilot study enrolment," commented Dr. Andrew Hamer, Cardiol Therapeutics' chief medical officer and head of research and development. "Mass General has been consistently ranked as a top hospital in the United States and has the largest hospital-based research program in the country. We look forward to the support of Mass General's clinicians and participating patients towards reaching full enrollment in this groundbreaking study."
MAvERIc-pilot is enrolling 25 patients at eight prominent medical research centres in the United States that specialize in pericarditis care. The study recently surpassed 50 per cent of its enrolment objective and is anticipated to complete patient recruitment during Q1 2024. The study chairman is Dr. Allan L. Klein, MD, director of the Center of Pericardial Diseases and professor of medicine, Heart and Vascular Institute, at the Cleveland Clinic. The primary efficacy end point is the change, from baseline to eight weeks, in patient-reported pericarditis pain using an 11-point numeric rating scale (NRS). The NRS is a validated clinical tool employed across multiple conditions with acute and chronic pain, including previous studies of recurrent pericarditis. Secondary end points include the NRS score after 26 weeks of treatment, and changes in circulating levels of C-reactive protein, a commonly used clinical marker of inflammation.
About recurrent pericarditis
Recurrent pericarditis refers to inflammation of the pericardium (the membrane or sac that surrounds the heart) that follows an initial episode (frequently resulting from a viral infection). Patients may have multiple recurrences. Symptoms include debilitating chest pain, shortness of breath and fatigue, resulting in physical limitations, reduced quality of life, emergency department visits and hospitalizations. Significant accumulation of pericardial fluid and scarring can progress to life-threatening constriction of the heart. The only Food and Drug Administration approved therapy for recurrent pericarditis, launched in 2021, is costly and is primarily used as a third-line intervention. The number of patients seeking and receiving treatment for recurrent pericarditis annually in the United States is estimated at 38,000. Hospitalization due to recurrent pericarditis is often associated with a six-to-eight-day length of stay and cost per stay is estimated to range between $20,000 and $30,000 in the United States.
About Cardiol Therapeutics Inc.
Cardiol Therapeutics is a clinical-stage life sciences company focused on the research and clinical development of anti-inflammatory and anti-fibrotic therapies for the treatment of heart disease. The company's lead small-molecule drug candidate, CardiolRx (cannabidiol) oral solution, is pharmaceutically manufactured and in clinical development for use in the treatment of heart disease. It is recognized that cannabidiol inhibits activation of the inflammasome pathway, an intracellular process known to play an important role in the development and progression of inflammation and fibrosis associated with myocarditis, pericarditis, and heart failure.
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