Cardiol Therapeutics Inc. a clinical-stage biotechnology company focused on developing innovative anti-inflammatory therapies for the treatment of cardiovascular disease, is pleased to announce that it has received approval from Health Canada to proceed with the Company's Phase II, multi-center, double-blind, randomized, placebo-controlled trial designed to study the safety and tolerability of CardiolRx™ as well ...

Cardiol Therapeutics Inc. (NASDAQ: CRDL) (TSX: CRDL) ("Cardiol" or the "Company"), a clinical-stage biotechnology company focused on developing innovative anti-inflammatory therapies for the treatment of cardiovascular disease, is pleased to announce that it has received approval from Health Canada to proceed with the Company's Phase II, multi-center, 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. The approval follows the U.S. Food and Drug Administration (FDA) providing clearance to proceed with the Company's Investigational New Drug (IND) application to commence this trial, as announced by the Company on August 24th, 2021.

Myocarditis is an acute inflammatory condition of the myocardium, characterized by inflammation of the heart muscle, which may result in chest pain, impaired cardiac function, atrial and ventricular arrhythmias, and conduction disturbances. Although the symptoms are often mild, myocarditis remains an important cause of acute and fulminant heart failure and is a leading cause of sudden cardiac death in people less than 35 years old. In addition, some patients proceed to develop chronic dilated cardiomyopathy which continues to be the leading indication for cardiac transplantation. Although viral causes of myocarditis are the most common, myocarditis can result from a broad range of infections and can be caused by certain drugs, including chemo-therapeutic agents used to treat several common cancers. Myocarditis has also been described as a complication of COVID-19 and, more recently, has been reported as a rare complication associated with certain vaccines for COVID-19.

Cardiol's acute myocarditis study is expected to enroll 100 patients at clinical centers in the United States, Canada, and Europe. The primary endpoints of the trial, which will be evaluated after 12 weeks of double-blind therapy, consist of the following cardiac magnetic resonance measures: left ventricular function (ejection fraction and longitudinal strain) and myocardial edema (extra-cellular volume), each of which has been shown to predict long-term prognosis of patients with acute myocarditis.

The study has been designed by an independent steering committee comprising distinguished thought leaders in heart failure and myocarditis from international centers of excellence, including: the Cleveland Clinic, the Mayo Clinic, the Houston Methodist DeBakey Heart and Vascular Center, the University of Ottawa Heart Institute, McGill University Health Centre, University of Pittsburgh Medical Center, Charité Hospital Berlin, and the University of South Florida Health Morsani College of Medicine/Tampa General Hospital Heart and Vascular Institute.

Given the risk of significant heart failure associated with acute myocarditis, current intervention includes drugs commonly administered for heart failure. However, no generally accepted treatment exists for acute myocarditis. Some patients respond to immunosuppressive therapy in combination with steroids, or immune-modulation therapy using immune globulin. Nevertheless, the evidence for these therapies is insufficient to support their adoption as the standard of care and they carry high risk for significant adverse effects.

Based on the large body of experimental evidence of the anti-inflammatory and cardioprotective properties of cannabidiol in models of cardiovascular disease, the Company believes there is a significant opportunity to develop an important new therapy for acute myocarditis that would be eligible for designation as an orphan drug in the United States. The U.S. Orphan Drug Designation program was created to offer companies significant incentives, including accelerated regulatory review and approval, to develop treatments for diseases that affect fewer than 200,000 people in the U.S. The program was successfully utilized to support the first FDA approval of cannabidiol for the treatment of rare child-onset epilepsy syndromes. Cardiol believes there is a similar opportunity to develop its CardiolRx formulation as an orphan drug for the treatment of acute myocarditis, for which there is currently no accepted standard of care.

About Cardiol Therapeutics

Cardiol Therapeutics Inc. (NASDAQ: CRDL) (TSX: CRDL) 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). The LANCER trial is designed to evaluate the efficacy and safety of CardiolRx as a cardioprotective therapy to reduce mortality and major cardiovascular 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 markers of inflammatory heart disease.

Cardiol has also received clearance from the FDA for its investigational new drug ("IND") application for a Phase II international trial that will investigate the anti-inflammatory and anti-fibrotic properties of CardiolRx in patients with acute myocarditis, which remains a leading cause of sudden cardiac death in people under 35 years of age. In addition, Cardiol is developing a subcutaneous formulation of CardiolRx and other anti-inflammatory therapies for the treatment of chronic heart failure - a leading cause of death and hospitalization in North America, with associated annual healthcare costs in the U.S. alone exceeding $30 billion.

For more information about Cardiol Therapeutics, please visit cardiolrx.com.

Cautionary statement regarding forward-looking information:

This news release contains "forward-looking information" within the meaning of applicable securities laws. All statements, other than statements of historical fact, that address activities, events, or developments that Cardiol believes, expects, or anticipates will, may, could, or might occur in the future are "forward-looking information". Forward-looking information contained herein may include, but is not limited to, statements relating to a significant opportunity to develop an important new therapy for acute myocarditis that would be eligible for designation as an orphan drug, and the Company's focus on developing innovative anti-inflammatory therapies for the treatment of CVD. Forward-looking information contained herein reflects the current expectations or beliefs of Cardiol based on information currently available to it and is based on certain assumptions, including the assumption that, subject to positive outcomes of its clinical trials, the Company's CardiolRx™ formulation is eligible for designation as an orphan drug, and is also subject to a variety of known and unknown risks and uncertainties and other factors that could cause the actual events or results to differ materially from any future results, performance or achievements expressed or implied by the forward-looking information, and are not (and should not be considered to be) guarantees of future performance. These risks and uncertainties and other factors include the risks and uncertainties referred to in the Company's Annual Information Form dated March 31, 2021, as well as the risks and uncertainties associated with product commercialization and clinical studies. These assumptions, risks, uncertainties, and other factors should be considered carefully, and investors should not place undue reliance on the forward-looking information. Any forward-looking information speaks only as of the date on which it is made and, except as may be required by applicable securities laws, Cardiol disclaims any intent or obligation to update or revise such forward-looking information, whether as a result of new information, future events, or results, or otherwise.

For further information, please contact:

Trevor Burns, Investor Relations +1-289-910-0855
trevor.burns@cardiolrx.com

Anu Kher, Media Relations
cardiol@kcsa.com

To view the source version of this press release, please visit https://www.newsfilecorp.com/release/100691

News Provided by Newsfile via QuoteMedia

Cohen Milstein Files Class Action Complaint Against Bristol-Myers Squibb Company

Cohen Milstein Sellers & Toll PLLC ("Cohen Milstein") today announced that its ongoing investigation has led to the filing of a class action complaint against Bristol-Myers Squibb Company ("Bristol Myers") and several of its senior executives and directors. The case was filed in the United States District Court for the Southern District of New York, Case No. 21-cv-10351

The action was brought on behalf of all former Celgene Corporation ("Celgene") (CELG) shareholders that received Contingent Value Rights ("CVRs") in exchange for their Celgene shares pursuant to Bristol Myers' $74 billion acquisition of Celgene on November 20, 2019, and were damaged thereby, and all persons who purchased CVRs between November 20, 2019 and December 31, 2020 (the "Class Period"), and who were damaged thereby (the "Class").

Keep reading... Show less

BRISTOL MYERS 72 HOUR DEADLINE ALERT: Former Louisiana Attorney General and Kahn Swick & Foti, LLC Remind Investors With Losses in Excess of $100,000 of Deadline in Class Action Lawsuits Against Bristol-Myers Squibb Company - BMY

Kahn Swick & Foti, LLC ("KSF") and KSF partner, the former Attorney General of Louisiana, Charles C. Foti, Jr., remind investors that they have until December 6, 2021 to file lead plaintiff applications in securities class action lawsuits against Bristol-Myers Squibb Company ("BMS" or "the Company") (NYSE: BMY), if they received Contingent Value Rights ("CVRs") (NYSE: BMY.RT) in exchange for their shares of Celgene Corporation (NASDAQ: CELG) pursuant to BMS' acquisition of Celgene on November 20, 2019. These actions are pending in the United States District Court for the Southern District of New York.

What You May Do

Keep reading... Show less

AbbVie Provides Update on RINVOQ® for the Treatment of Rheumatoid Arthritis in the U.S.

ABBVie (NYSE: ABBV) today announced an update to the U.S. Prescribing Information and Medication Guide for RINVOQ ® (upadacitinib) for the treatment of adults with moderate to severe rheumatoid arthritis (RA). This update follows a Drug Safety Communication (DSC) issued on Sept. 1, 2021 by the U.S. Food and Drug Administration (FDA) following its final review of the post-marketing study, ORAL Surveillance, evaluating XELJANZ ® (tofacitinib) in patients with RA. 1 The results of this study showed a higher rate of major adverse cardiac events (MACE), malignancy, mortality and thrombosis in XELJANZ (a Janus kinase (JAK) inhibitor) versus TNF blockers. 1 The DSC and this label update apply to the class of systemically administered FDA-approved JAKs indicated for the treatment of RA and other inflammatory diseases. 1

Based on this class-wide update, the U.S. label for RINVOQ will now include additional information about the risks of malignancy and thrombosis, and the addition of mortality and MACE (defined as cardiovascular death, myocardial infarction and stroke) risks within the Boxed Warnings and Warnings and Precautions sections. 1 The indication has also been updated to the following: RINVOQ is indicated for the treatment of adults with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to one or more TNF blockers. 1

Keep reading... Show less

Amgen Announces 10% Increase In 2022 First Quarter Dividend

Amgen (NASDAQ:AMGN) today announced that its Board of Directors declared a $1.94 per share dividend for the first quarter of 2022. The dividend will be paid on March 8, 2022 to all stockholders of record as of the close of business on February 15, 2022 . This represents a 10% increase from that paid in each of the previous four quarters.

About Amgen
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Keep reading... Show less

U.S. Food and Drug Administration Accepts for Priority Review supplemental Biologics License Application for Reblozyl® in Adults with Non-Transfusion Dependent Beta Thalassemia

Submission based on results from Phase 2 BEYOND study of Reblozyl plus best supportive care in adults with NTD beta thalassemia

Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has accepted for priority review the supplemental Biologics License Application (sBLA) for Reblozyl ® (luspatercept-aamt), a first-in-class erythroid maturation agent, for the treatment of anemia in adults with non-transfusion dependent (NTD) beta thalassemia. The FDA has set a Prescription Drug User Fee Act (PDUFA) goal date of March 27, 2022. In addition, the European Medicines Agency has validated the Type II variation for Reblozyl in NTD beta thalassemia. Reblozyl is being co-developed and co-commercialized with Merck & Co., Inc., known as MSD outside the United States and Canada, following Merck's recent acquisition of Acceleron Pharma, Inc.

Keep reading... Show less

INVESTOR ALERT BY FORMER LOUISIANA ATTORNEY GENERAL: Class Action Lawsuits filed on behalf of BMY, LSPD, PTON, ZG Investors, Lead Plaintiff Deadlines Set

Kahn Swick & Foti, LLC ("KSF") and KSF partner, former Attorney General of Louisiana, Charles C. Foti, Jr., remind investors of pending deadlines in the following securities class action lawsuits:

Bristol-Myers Squibb Company (BMY)
Class: Investors who received Contingent Value Rights ("CVRs") (BMY.RT) in exchange for their shares of Celgene Corporation (CELG) pursuant to Bristol-Myers' acquisition of Celgene on November 20, 2019
Lead Plaintiff Motion Deadline: December 6, 2021
MISLEADING PROSPECTUS
To learn more, visit https://www.ksfcounsel.com/cases/nyse-bmy/

Keep reading... Show less

Top News

Related News