Cardiol Therapeutics Announces First Patient Enrolled in ARCHER, a Phase II Clinical Trial of CardiolRx for Treatment of Acute Myocarditis

Cardiol Therapeutics Announces First Patient Enrolled in ARCHER, a Phase II Clinical Trial of CardiolRx for Treatment of Acute Myocarditis

Multi-center, international, double-blind, randomized, placebo-controlled trial to enroll 100 patients

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 with acute myocarditis.

Myocarditis is an acute inflammatory condition of the heart muscle (myocardium) characterized by 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 under 35 years of age. In addition, some patients proceed to develop chronic dilated cardiomyopathy which continues to be the leading indication for cardiac transplantation. Although viral infection is the most common cause of myocarditis, the condition can also result from administration of therapies used to treat several common cancers, including chemo-therapeutic agents and immune checkpoint inhibitors. 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. Acute myocarditis should be managed with guideline directed therapies for heart failure, arrhythmia and conduction disturbances; however, there is no uniformly accepted treatment for the underlying inflammatory processes associated with this condition.

The Company believes there is a significant opportunity to develop an important new therapy for acute myocarditis that would also be eligible for designation as an orphan drug in the United States. The U.S. Orphan Drug Designation program was created to provide the sponsor of a drug significant incentives, including seven-year marketing exclusivity and exemptions from certain FDA fees, to develop treatments for diseases that affect fewer than 200,000 people in the U.S. (73,000 myocarditis cases are estimated in the U.S. annually). Products with Orphan Drug Designation also frequently qualify for accelerated regulatory review. The program was successfully utilized to support the first FDA approval of cannabidiol for the treatment of seizures associated with rare pediatric epilepsy syndromes. Cardiol believes there is a similar opportunity to develop its CardiolRx formulation as an orphan drug for the treatment of acute myocarditis.

About Cardiol Therapeutics

Cardiol Therapeutics Inc. (NASDAQ: CRDL) (TSX: CRDL) is 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 CVD. The Company's lead product candidate, CardiolRx™, is a pharmaceutically produced oral cannabidiol formulation that is being clinically developed for use in cardiovascular medicine. CardiolRx is currently being evaluated in a Phase II/III multi-national, 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 has also received IND authorization from the FDA to conduct clinical studies to evaluate the efficacy and safety of CardiolRx in two orphan drug indications: (i) the ARCHER trial, a Phase II multi-national, randomized, double-blind, placebo-controlled trial in acute myocarditis, an important cause of acute and fulminant heart failure in young adults and the leading cause of sudden cardiac death in people less than 35 years of age; and (ii) a Phase II multi-center 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, Cardiol is developing a subcutaneous formulation of cannabidiol for the treatment of 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 healthcare costs in the U.S. exceeding $30 billion annually.

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 the Company's focus on developing anti-inflammatory and anti-fibrotic therapies for the treatment of cardiovascular disease; the belief that cannabidiol has the potential to truly benefit patients with myocarditis; the Company's expectation of enrolling 100 patients at major cardiac centers in North America, Europe, Latin America, and Israel pursuant to the ARCHER study; the Company's belief that there is a significant opportunity to develop an important new therapy for acute myocarditis that would also be eligible for designation as an orphan drug in the United States; the Company's belief that there is an opportunity to develop its CardiolRx™ formulation as an orphan drug for the treatment of acute myocarditis. 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 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 23, 2022, 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

To view the source version of this press release, please visit https://www.newsfilecorp.com/release/132665

News Provided by Newsfile via QuoteMedia

CRDL:CA
Cardiol Therapeutics

Cardiol Therapeutics Investor Kit

  • Corporate info
  • Insights
  • Growth strategies
  • Upcoming projects

GET YOUR FREE INVESTOR KIT

The Conversation (0)
Cardiol Therapeutics (TSX:CRDL)

Cardiol Therapeutics


Keep reading...Show less
Cardiol Therapeutics Completes Patient Enrollment in its Phase II MAvERIC-Pilot Study Investigating CardiolRx for Recurrent Pericarditis

Cardiol Therapeutics Completes Patient Enrollment in its Phase II MAvERIC-Pilot Study Investigating CardiolRx for Recurrent Pericarditis

Topline Results Expected in Q2 2024

This is a Designated News Release.

News Provided by Newsfile via QuoteMedia

Keep reading...Show less
Cardiol Therapeutics Granted Orphan Drug Designation for its Lead Drug Candidate for the Treatment of Pericarditis

Cardiol Therapeutics Granted Orphan Drug Designation for its Lead Drug Candidate for the Treatment of Pericarditis

Designation Based on Pre-Clinical Data and Initial Clinical Data from the Company's MAvERIC-Pilot Phase II Study

This is a Designated News Release.

News Provided by Newsfile via QuoteMedia

Keep reading...Show less
Cardiol Therapeutics Announces it has Exceeded 50% Enrollment in its Phase II ARCHER Trial in Acute Myocarditis

Cardiol Therapeutics Announces it has Exceeded 50% Enrollment in its Phase II ARCHER Trial in Acute Myocarditis

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 anti-inflammatory and anti-fibrotic therapies for the treatment of heart disease, is pleased to announce that it has exceeded 50% patient enrollment for ARCHER, the Company's Phase II, multi-center, international, double-blind, randomized, placebo-controlled trial investigating the safety, tolerability, and impact of CardiolRx™ on myocardial recovery in patients presenting with acute myocarditis.

"Achieving this milestone reflects the commitment and interest demonstrated by our clinical collaborators and participating patients, and we thank them for their contribution to the progress being made in this important clinical trial," said David Elsley, Cardiol Therapeutics' President and Chief Executive Officer. "Acute myocarditis is an inflammatory heart disease that impairs heart function, is associated with symptoms that can seem like a heart attack, is an important cause of acute and fulminant heart failure and is a leading cause of sudden cardiac death in people under 35 years of age. Results from the ARCHER trial will assist in further understanding the therapeutic potential of CardiolRx™ and will complement the important clinical data from our ongoing MAvERIC-Pilot Phase II study in patients presenting with recurrent pericarditis."

News Provided by Newsfile via QuoteMedia

Keep reading...Show less
Cardiol Therapeutics Announces Massachusetts General Hospital, Largest Teaching Hospital of Harvard Medical School, as the 8th Major Medical Centre Participating in MAvERIC-Pilot

Cardiol Therapeutics Announces Massachusetts General Hospital, Largest Teaching Hospital of Harvard Medical School, as the 8th Major Medical Centre Participating in MAvERIC-Pilot

MAvERIC-Pilot is a Phase II Study in Recurrent Pericarditis and is Anticipated to Complete Patient Recruitment during Q1 2024

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 anti-inflammatory and anti-fibrotic therapies for the treatment of heart disease, is pleased to announce that Massachusetts General Hospital ("Mass General") has been initiated and is eligible to enroll patients in MAvERIC-Pilot, the Company'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.

News Provided by Newsfile via QuoteMedia

Keep reading...Show less
Cardiol Therapeutics Announces Study Results Presented at the 2023 Annual Meeting of the European Society of Cardiology Working Group on Myocardial and Pericardial Diseases

Cardiol Therapeutics Announces Study Results Presented at the 2023 Annual Meeting of the European Society of Cardiology Working Group on Myocardial and Pericardial Diseases

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 anti-inflammatory and anti-fibrotic therapies for the treatment of heart disease, announced today that study results demonstrated an experimental model of pericarditis induces mesothelial to mesenchymal transition ("MMT") and that this process is inhibited by cannabidiol treatment, the active pharmaceutical ingredient in CardiolRx™. An abstract summarizing these results was submitted by the Company's international research collaborators from the University of Virginia and Houston Methodist DeBakey Heart & Vascular Center to the 2023 Annual Meeting of the European Society of Cardiology Working Group on Myocardial and Pericardial Diseases ("MPD2023") held on November 15 and 16, 2023 in Belgrade, Serbia.

News Provided by Newsfile via QuoteMedia

Keep reading...Show less
Sirona Biochem Announces Plans for Commercial Launch of GlycoProteMim in Early 2025

Sirona Biochem Announces Plans for Commercial Launch of GlycoProteMim in Early 2025

Sirona Biochem Corp. (TSX-V: SBM) (FSE: ZSB) (US-OTC: SRBCF), also known as Sirona, is excited to share a new milestone in its journey. A recent exclusive video interview featuring Dr. Geraldine Deliencourt-Godefroy, Sirona's Chief Scientific Officer, has been released by the Investing News Network. In this interview, Dr. Deliencourt-Godefroy unveils Sirona's ambitious plans to introduce its innovative anti-aging product, GlycoProteMimTM, to the markets of North America and Europe in early 2025.

The interview provides an insightful look into the revolutionary potential of GlycoProteMim in the anti-aging sector. Viewers can access the full interview on the Investing News Network's website through this link: investingnews.com/sirona-biochem-eyes-2025-launch-of-new-anti-aging-product/

News Provided by GlobeNewswire via QuoteMedia

Keep reading...Show less

AMGEN TO HOST CONFERENCE CALL ON RARE DISEASE

Amgen (NASDAQ:AMGN) will host a webcasted call at 1:00 p.m. PT on Thursday, February 22, 2024 to discuss Rare Disease, its newly added fourth pillar of growth, and provide insights on its rare disease strategy and opportunities, including marketed products and pipeline. Murdo Gordon executive vice president of Global Commercial Operations at Amgen, Jay Bradner executive vice president of Research and Development and chief scientific officer at Amgen, Vikram Karnani executive vice president of Global Commercial Operations and Medical Affairs (Rare Disease) at Amgen, and Paul Burton senior vice president and chief medical officer at Amgen, will participate in the conference call. The webcast will be broadcast over the internet simultaneously and will be available to members of the news media, investors and the general public.

News Provided by PR Newswire via QuoteMedia

Keep reading...Show less
Sirona Biochem Provides Update on Loan

Sirona Biochem Provides Update on Loan

Sirona Biochem Corp . (TSX-V: SBM) (FSE: ZSB) (OTC: SRBCF) (" Sirona " or the " Company ") announce that, further to its news release on January 29, 2024, it has entered into an amendment to the demand grid promissory note dated September 22, 2023 (the " Amended Note ") with 0906462 B.C. Ltd. (the " Lender "). The Amended Note evidences a loan in the aggregate principal amount of up to $1,000,000 (the " Loan "). Pursuant to the terms and conditions of the Amended Note:

(a)   the Loan is repayable on demand by the Lender at any time following the one-year anniversary of the date of the applicable advance;

(b)   the Loan bears interest at a rate of 12% per annum, calculated yearly not in advance; and

(c)   the Company has agreed to, subject to TSX Venture Exchange approval (" TSXV Approval "), issue the Lender 450,000 common shares in the capital of the Company (" Bonus Shares ") at a price of $0.12 per Bonus Share, as consideration for the risks taken by the Lender in providing the Company the Loan.

News Provided by GlobeNewswire via QuoteMedia

Keep reading...Show less
Sirona Biochem Engages Global Beauty Consulting

Sirona Biochem Engages Global Beauty Consulting

Sirona Biochem Corp. (TSX-V: SBM) (FSE: ZSB) (OTC: SRBCF) (" Sirona " or the " Company ") has announced its partnership with Global Beauty Consulting Cosmetics Laboratory (GBC), under the leadership of CEO Gaël Boutry, a distinguished French formulator. GBC is currently developing an exclusive premium formulation for GlycoProteMim TM in anticipation of its launch in the first quarter of 2025.

GBC has a history of working with Sirona Biochem on the formulation of TFC-1067 for clinical development. This new venture is pivotal in building a brand and competitive product line that showcases GlycoProteMim's potent anti-aging benefits through its exclusive distribution brand Sirona Laboratories TM .

News Provided by GlobeNewswire via QuoteMedia

Keep reading...Show less
Sirona Biochem Eyes 2025 Launch of New Anti-aging Product

Sirona Biochem Eyes 2025 Launch of New Anti-aging Product

Following successful clinical trials for its groundbreaking anti-aging and anti-wrinkle molecule, TFC-1326, Sirona Biochem (TSXV:SBM) is pursuing a path to commercialization for a final cosmetic product, according to the company’s chief scientific officer, Géraldine Deliencourt-Godefroy.

“We are still pursuing a final compound to launch on the market, which is pretty good because it will allow us to have a better control on the final product. We can launch fast on the market, we can generate revenue earlier and also the level of revenue will be higher,” Deliencourt-Godefroy said.

Sirona has already trademarked its anti-aging skincare ingredient, GlycoProteMim, as one of the first steps for commercialization. In January of this year, the company also launched a new cosmetics subsidiary, Sirona Laboratories, which is dedicated to maximizing the commercial potential of GlycoProteMim.

Keep reading...Show less

AMGEN TO PRESENT AT THE 34TH ANNUAL OPPENHEIMER HEALTHCARE LIFE SCIENCES CONFERENCE

- Amgen (NASDAQ:AMGN) will present at the 34 th Annual Oppenheimer Healthcare Life Sciences Conference at 12:00 p.m. ET on Wednesday Feb. 14, 2024. Jay Bradner executive vice president of Research and Development and chief scientific officer at Amgen, Murdo Gordon executive vice president of Global Commerical Operations at Amgen, and Susan Sweeney senior vice president of Global Marketing, Access and Capabilities at Amgen, will present at the conference. The webcast will be broadcast over the internet simultaneously and will be available to members of the news media, investors and the general public.

The webcast, as with other selected presentations regarding developments in Amgen's business given by management at certain investor and medical conferences, can be found on Amgen's website, www.amgen.com , under Investors. Information regarding presentation times, webcast availability and webcast links are noted on Amgen's Investor Relations Events Calendar. The webcast will be archived and available for replay for at least 90 days after the event.

News Provided by PR Newswire via QuoteMedia

Keep reading...Show less
Cardiol Therapeutics

Cardiol Therapeutics Investor Kit

  • Corporate info
  • Insights
  • Growth strategies
  • Upcoming projects

GET YOUR FREE INVESTOR KIT

Latest Press Releases

Related News

×