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Cardiol Therapeutics Inc
Symbol CRDL
Shares Issued 62,485,291
Close 2022-10-03 C$ 1.37
Market Cap C$ 85,604,849
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Cardiol says CardiolRx API inhibits cardiac fibrosis

2022-10-03 09:47 ET - News Release

Dr. Andrew Hamer reports

CARDIOL THERAPEUTICS ANNOUNCES PRE-CLINICAL STUDY RESULTS DEMONSTRATING CARDIOLRX INHIBITS AND ALSO PROMOTES REVERSAL OF MECHANISMS LEADING TO CARDIAC FIBROSIS

Cardiol Therapeutics Inc.'s study results have demonstrated the active pharmaceutical ingredient (API) in CardiolRx inhibits and also promotes the reversal of mechanisms known to play a role in the occurrence and development of fibrotic CVD (cardiovascular disease). The data were presented by its research collaborators from Houston Methodist DeBakey Heart & Vascular Center at the annual scientific meeting of the Heart Failure Society of America (HFSA2022).

The poster, entitled "Cannabidiol Inhibits Endothelial-to-Mesenchymal Transition and also Promotes the Reverse Process in vitro," was presented within the basic and translational science category of the HFSA2022 scientific program. The authors concluded that the API in CardiolRx protects cardiac function and exhibits an anti-fibrotic effect, possibly mediated by endothelial-to-mesenchymal transition (EndoMT).

"Our research collaborators from Houston Methodist DeBakey Heart & Vascular Center have previously shown that CardiolRx preserves cardiac function in a preclinical model of heart failure. The results of the present study provide further evidence of the cardioprotective properties of CardiolRx that suggest anti-fibrotic mechanisms with therapeutic potential in heart failure," stated Dr. Andrew Hamer, Cardiol Therapeutics' chief medical officer and head of research and development. "These results, together with previously reported preclinical in vivo data demonstrating anti-inflammatory activity, underpin our plan to advance the development of a novel subcutaneous formulation of CardiolRx for use in heart failure."

EndoMT is a complex biological process whereby an endothelial cell, the main cell type found in the inside lining of blood vessels, undergoes a series of molecular events that alter its characteristics toward a mesenchymal cell, such as a myofibroblast. Myofibroblast cells are the primary cells during wound healing and fibrosis. Mounting evidence indicates EndoMT is involved in adult CVD, and the mechanism has been described to contribute to myocardial fibrosis, an important part of heart remodelling that can lead to heart failure.

In the study, EndoMT was induced in HUVECs (human umbilical vein endothelial cells), a model system for studying human endothelial cell function, using a combination of agents (L-NAME and angiotensin-II). EndoMT was characterized through immunofluorescence (IF) for endothelial (CD31) and mesenchymal (Vimentin) markers. CardiolRx was added during the EndoMT induction process, and, on day 4 following induction, IF studies were performed. CardiolRx was shown to reduce the expression of the mesenchymal marker Vimentin in a dose-dependent manner. Separately, CardiolRx was added to EndoMT transitioned cells (after day 4 of EndoMT), and IF studies were performed on day 8. In this experiment, CardiolRx was shown to reduce Vimentin expression, suggesting reversal of EndoMT in vitro. This provides evidence that the cardioprotective properties of CardiolRx are due, in part, to the modulation of EndoMT.

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 cardiovascular diseases (CVDs). The company's lead product candidate, CardiolRx, is an oral pharmaceutical that is being clinically developed for use in CVDs.

Cardiol has received IND (investigational new drug) authorization from the U.S. Food and Drug Administration (FDA) to conduct clinical studies to evaluate the efficacy and safety of CardiolRx in two orphan drug indications: (i) a phase II multinational, randomized, double-blind, placebo-controlled trial (the Archer trial) in acute myocarditis, an important cause of acute and fulminant heart failure in young adults and a leading cause of sudden cardiac death in people less than 35 years of age; and (ii) a phase II multicentre open-label pilot study in recurrent pericarditis (inflammation of the pericardium), which is associated with symptoms including debilitating chest pain, shortness of breath and fatigue and results in physical limitations, reduced quality of life, emergency department visits and hospitalizations.

In addition, CardiolRx is being evaluated in a phase II/III multinational, randomized, double-blind, placebo-controlled study (the Lancer trial). Lancer is designed to evaluate the efficacy and safety of CardiolRx as a cardioprotective therapy to reduce major cardiovascular and respiratory events in patients hospitalized with COVID-19 who have a prior history of, or risk factors for, CVD and to investigate the influence CardiolRx has on key biomarkers associated with heart disease.

Cardiol is also developing a subcutaneous formulation of cannabidiol targeting the inflammation and fibrosis associated with the development and progression of heart failure -- a leading cause of death and hospitalization in the developed world, with associated health care costs in the United States exceeding $30-billion annually.

We seek Safe Harbor.

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