OUR NEW PROFILE IS: (NASDAQ: CRDL)
(TSX: CRDL) 🇨🇦
One person dies every 36 seconds in the United States from cardiovascular disease
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The Company brings together a wealth of research and development experience, advanced manufacturing capabilities, and a Management team, Board of Directors, and Scientific and Business Advisory Boards comprising business and thought leaders with extensive industry experience and expertise in commercializing proprietary drugs
Cardiol received clearance from the U.S. FDA for its Investigational New Drug (IND) application that is being investigated in a Phase II/III outcomes study (the LANCER Trial). A double-blind, placebo-controlled clinical trial investigating the efficacy and safety of its lead clinical product, 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 cardiovascular disease (CVD), and to investigate the influence CardiolRx has on key markers of inflammatory heart disease. CardiolRx™ is an oral cannabidiol formulation that is pharmaceutically manufactured under cGMP.
Cardiol also received clearance from the FDA for its IND application for a Phase II international trial that will investigate the anti-inflammatory and anti-fibrotic properties of CardiolRx in acute myocarditis, a condition caused by inflammation in heart tissue, 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.
The Company has research collaborations focused on developing a subcutaneous cannabidiol formulation for heart failure underway at international centers of excellence, including the Houston Methodist DeBakey Heart & Vascular Center, the University of Alberta, and TecSalud del Tecnológico de Monterrey, Mexico.
Cardiol Therapeutics Receives Clearance from the FDA and Regulatory Agencies in Brazil and Mexico for Important Protocol Amendments Designed to Expedite Patient Enrollment in the LANCER Trial
LANCER Trial expanded to include up to 20 Additional Clinical Research Centers
Oakville, Ontario, Mar 01, 2022 (Newsfile Corp via COMTEX) — Oakville, Ontario–(Newsfile Corp. – March 1, 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 anti-inflammatory therapies for the treatment of cardiovascular disease (“CVD”), today announced that it has received clearance from the FDA and regulatory agencies in Brazil and Mexico to modify the inclusion criteria for the LANCER trial to allow for, amongst other things, the enrollment of vaccinated patients. Commensurate with clearance to implement these important protocol amendments which will broaden the population of patients eligible for enrollment into LANCER, the Company also announced plans to expand the clinical trial infrastructure to include up to an additional 20 clinical research centers. LANCER is designed to evaluate the efficacy and safety of CardiolRx™ as a cardiopulmonary protective 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 impact of CardiolRx™ on symptom recovery and key biomarkers associated with inflammatory heart disease.
The Company expects the LANCER trial to achieve over 50% patient recruitment by the end of the first half of 2022 and to complete full patient enrollment during the second half of 2022. In addition to expanding site recruitment, the Company, in consultation with the LANCER Steering Committee, has amended the trial protocol in response to the evolving understanding of COVID-19 and the current standard of care. These updates are expected to remove key barriers to participation in LANCER as well as expand the eligible patient pool and include the following: (i) vaccinated people may be enrolled; (ii) use of therapies approved for treatment of COVID-19 under an emergency use authorization label is permitted; and (iii) a prior history of smoking or obesity, both CVD risk factors prevalent in younger patients, will allow entry into the trial. Furthermore, the Company expects Brazil to be a key contributor to patient enrollment given the country is approaching its winter season, the pace of vaccine booster administration is slow, and the pre-winter case rate is currently averaging approximately 100,000 per day.
“Given the compelling evidence demonstrating cannabidiol’s anti-inflammatory and cardiopulmonary protective properties, we believe CardiolRx™ has the potential to reduce a number of cardiopulmonary complications associated with COVID-19 infection. Interest in the LANCER trial remains strong, and Cardiol continues to activate new clinical research sites to accelerate patient recruitment,” stated Dr. Andrew Hamer, Chief Medical Officer of Cardiol Therapeutics. “The repeated waves of COVID-19 outbreaks coupled with inconsistent vaccine and vaccine booster uptake, underscore the need for therapeutics for high-risk patient populations, particularly those with significant CVD risk factors. Despite challenges resulting from ongoing changes to the standard of care, we are confident that the recently cleared protocol amendments will help ensure our LANCER patient enrollment targets are achieved.”
The LANCER trial was designed and is being overseen by an independent Steering Committee, consisting of international thought leaders in inflammatory heart disease. In addition to investigating the cardiopulmonary protective properties of CardiolRx™ in high-risk COVID-19 patients, the trial is expected to generate invaluable clinical data to further elucidate the therapeutic potential of CardiolRx™ in the treatment of other inflammatory cardiac disorders, including acute myocarditis and heart failure.
Patients with COVID-19 primarily present with respiratory symptoms which can progress to bilateral pneumonia and serious pulmonary complications. It is now recognized that the impact of the SARS-COV-2 virus that causes COVID-19 is not limited to the pulmonary system. Individuals with pre-existing CVD or who have CVD risk factors (such as diabetes, hypertension, obesity, smoking history, dyslipidemia, or age greater than 64) are at substantially greater risk for a more severe course and higher mortality. Moreover, people who have had COVID-19 have an increased risk and burden for adverse cardiovascular outcomes (such as acute myocardial infarction, dysrhythmias, pulmonary embolism, pericarditis, myocarditis, stroke, and heart failure) up to one year following their COVID-19 diagnosis. A therapeutic strategy to prevent or limit the number or severity of both pulmonary and cardiovascular complications will improve the socioeconomic burden of this disease.
4 Key Potential Milestones That Could Prove Cardiol Therapeutics’ That Warrant Your Attention
It’s coming for us all. There’s no doubt about it. Mortality is a real thing.
No matter how much we deny it, time is not on our side. But, how each of us arrive at that final destination remains to be seen.
That said, it would appear that in the United States, one major factor is putting the proverbial “nail in the coffin” for many Americans: heart disease.
According to the CDC, heart disease is the leading cause of death for men, women, and people of most racial and ethnic groups in the United States. (1)
In fact, the CDC shares: (1)
Fortunately for us all, one small under-the-radar company, Cardiol Therapeutics (Nasdaq:CRDL) (TSX:CRDL), is making tremendous progress on anti-inflammatory therapies for the treatment of cardiovascular disease.
And there might not be more of an important time than right now for Cardiol Therapeutics.
To The Rescue Comes Cardiol Therapeutics’ Lead Dr-ug Candidate: CardiolRx™(3)
How Cann-a-bidiol Protects the Heart in Models of Cardiovascular Disease
There is strong evidence supporting therapeutic potential in acute and chronic inflammatory heart disease.
Check it out:
Two Of Our Main Protagonists: CV-19 and CVD (2)
We’ve been under fire from a health crisis worldwide like we’ve never experienced in our lives. With CV-19 running rampant the last few years, it has put people with pre-existing health conditions in harm’s way.
It has been found that CV-19 is much more severe for those with cardiovascular disease (CVD) than for those without CVD. It’s estimated that 30 – 40% of patients who die from CV-19 do so from cardiovascular complications.
CV-19, a disease caused by the severe acute respiratory syndrome c-virus 2, is considered primarily a respiratory disease. However, an increasing number of reports indicate that CV-19 patients are at higher risk of developing cardiovascular complications, and CV-19 is found to be more deadly for those with cardiovascular disease (CVD) than for those without CVD.
Patients with CV-19 present primarily with respiratory symptoms which can progress to bilateral pneumonia and serious pulmonary complications. It is now recognized that the impact of CV-19 is not limited to the lungs. Individuals with pre-existing CVD or who have risk factors for CVD (such as diabetes, hypertension, obesity, abnormal serum lipids, or age greater than 64) are at significantly greater risk of developing serious disease from CV-19 and experience greater morbidity.
Moreover, such CV-19 patients are at significant risk of developing cardiovascular complications (such as acute myocardial infarction, cardiac arrhythmias, myocarditis, stroke, and heart failure) during the course of their illness, which are frequently fatal. A strategy to prevent or limit the number or severity of these cardiovascular complications is likely to considerably improve outcomes from this disease.
The rationale for the clinical program of cann-a-bidiol as a therapeutic approach to the treatment of CV-19 is based upon the reported anti-inflammatory effect of cann-a-bidiol. In addition, cann-a-bidiol has a cardio-protective effect and, therefore, it is anticipated that this cann-a-binoid may prevent CV-19-related cardiovascular complications thereby reducing morbidity and mortality.
Huge Potential Catalyst For Cardiol Therapeutics’: The LANCER Trial (4)
The company has received clearance from the U.S. Food and Dr-ug Administration for its Investigational New Dr-ug application to commence a Phase II/III, double-blind, placebo-controlled clinical trial investigating the efficacy and safety of its lead product, CardiolRx™.
The “LANCER Trial” Phase II/III Trial is designed to investigate the cardiorespiratory protective properties of CardiolRx™ in patients hospitalized with CV-19 who have a prior history of, or risk factors for, cardiovascular disease.
Primary Efficacy Endpoints*:
* Experience one of the following events during the first 28 days
Secondary Efficacy Endpoints:
422 Patients will be randomized 211 to CardiolRx™, 211 to placebo.
International Trial: U.S., Brazil, and Mexico clinical sites enrolling patients: clinical trial site initiation pending in Canada.
Treatment Oral Administration: Starting at 5mg/kg of body weight/day to a maximum of 15 mg/kg/day administered twice daily with food for 28 days.
Phase II/III LANCER Study Design
Just imagine if this dr-ug candidate/study receives highly positive results?
Those results could be game-changing for Cardiol Therapeutics (Nasdaq:CRDL) (TSX:CRDL).
Another Major Cardiol Therapeutics’ Focus: Acute Myocarditas (5)
Acute myocarditis is a significant cause of acute heart failure and death in younger individuals and remains a leading cause of sudden cardiac death in people under 35 years of age.
The most recent data from the ‘Global Burden of Disease Study’ suggests that the prevalence of myocarditis is approximately 22 per 100,000 population. In the United States, an orphan dr-ug designation is granted for pharmaceuticals being developed to treat medical conditions affecting fewer than 200,000 people. These conditions are referred to as orphan diseases. The assignment of orphan status to a disease and to dr-ugs developed to treat it is a matter of public policy in many countries and has yielded medical breakthroughs that might not otherwise have been achieved.
In the U.S. and the European Union, orphan dr-ugs are eligible for accelerated marketing approvals and companies developing orphan dr-ugs typically receive other incentives, including a prolonged period of market exclusivity that can extend over seven years, during which the dr-ug developer has sole rights to market the dr-ug.
Acute myocarditis is characterized by inflammation in the heart muscle (myocardium). It has many causes, but the most common is a viral infection. In most patients the immune system is effective in clearing the virus in five to seven days, inflammation subsides, and the individual makes a full recovery. In a proportion of patients, however, the inflammation in the heart persists – perhaps as an auto-immune process – and causes decreased heart function with symptoms and signs of heart failure. In some cases, this becomes progressive and leads to a chronic dilated cardiomyopathy which is the most common reason for heart transplantation.
Since people with acute myocarditis have impaired heart function, treatment is based on standard-of-care recommendations for heart failure. This includes diuretics, ACE inhibitors, angiotensin receptors blockers, beta blockers, and aldosterone inhibitors. For those with a severe and sudden onset presentation, intensive care is often required, with the use of inotropic medications (to increase the force of the heart muscle contraction) and occasionally, heart-lung bypass or ventricular assist devices. There is otherwise no specific treatment for acute myocarditis although some patients have responded to immuno-suppressive therapy (azathioprine) in combination with steroids, but the data are not conclusive enough for this to be the recommended therapy.
Based on the large body of experimental evidence of the anti-inflammatory activity of cann-a-bidiol in models of cardiovascular disease, Cardiol believes there is a significant opportunity to develop CardiolRx™ as a potential breakthrough therapy for acute myocarditis that would be eligible for designation as an orphan dr-ug. CardiolRx™ is a pharmaceutical cann-a-bidiol formulation that is manufactured under cGMP, and the same concentration (100mg/mL CB-D) as the first FDA-approved cann-a-bidiol therapy for use as an orphan dr-ug in rare forms of pediatric epilepsy.
Cann-a-bidiol Attenuates Myocarditis-induced Fibrosis (4)
Experimental Model of Autoimmune Myocarditis (EAM)
CardiolRx™ – Acute Myocarditis Clinical Development (4)
Cardiol Therapeutics Inc. IND application cleared by FDA for global Phase II trial.
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.
Three co-primary Endpoints*:
*Difference in means between active and placebo during the first 12 weeks
100 Patients will be randomized 50 to CardiolRx™, 50 to placebo.
Anticipate 25-30 sites U.S., Canada, and Europe. (Regulatory authorization to be obtained)
Treatment starting at 5mg/kg of body weight/day to a maximum of 20 mg/kg/day administered twice daily with food
Acute Myocarditis Study Design
But What About Straight Up Heart Failure? Cardiol Therapeutics Could Offer Significant Help Too (6)
Chronic Heart Failure (HF) is no joke.
Here’s a couple scary details to chew on: (4)
Subcutaneous Cann-a-bidiol Formulation
Cardiol is developing a proprietary subcutaneous formulation of cann-a-bidiol to achieve higher bioavailability. This subcutaneous formulation would be a new approach to the treatment of chronic heart failure based on the anti-inflammatory activity of cann-a-bidiol to treat inflamed heart tissue and the anti-fibrotic activity of cann-a-bidiol to treat fibrosis (scarring) in heart muscle.
Published third-party research has shown that cann-a-bidiol reduces inflammatory activation of the endothelial lining of blood vessels and aids endothelial vasorelaxation, resulting in improved blood flow. Cann-a-bidiol has also been shown to attenuate a number of measures of inflammation in models of diabetes, a common co-morbidity in heart failure patients, and to reduce myocardial fibrosis in a model of inflammatory heart disease.
Cardiol’s subcutaneous administration of cann-a-bidiol is designed to avoid first-pass metabolism, optimize and maintain blood levels of the dr-ug, and target inflammation and increased fibrosis in the heart. Cardiol believes that by enhancing the bioavailability will significantly broaden the therapeutic potential of this molecule.
Cardiol’s research shows cann-a-bidiol reduces the development of angiotensin-induced fibrosis: histopathologic analysis of heart tissue.
Cardiol Therapeutics’ Pipeline (6)
4 Key Potential Milestones That Could Prove Cardiol Therapeutics’ Stock To Be Undervalued At Current Levels (4)
Take a moment now and get Cardiol Therapeutics (Nasdaq:CRDL) (TSX:CRDL) on your radar.
Cardiol Therapeutics Appoints Thought Leaders in Cardiovascular Medicine to its Scientific Advisory Board
Cardiol Therapeutics Announces Closing of US$50 Million Public Offering
Cardiol Therapeutics Announces Pricing of Public Offering of Unit
Cardiol Therapeutics Files Preliminary Prospectus Supplement for Proposed Public Offering of Units
Cardiol Therapeutics Receives Health Canada Approval for Phase II Clinical Trial of CardiolRx(TM) for Acute Myocarditis
Cardiol Therapeutics Expands LANCER, a Phase II/III Trial of CardiolRx(TM), into Brazil, Mexico, and Canada
Cardiol Therapeutics to Participate in the 2021 Cantor Virtual Global Healthcare Conference
Cardiol Therapeutics Announces Acceleration of Expiry Date of Warrants Issued on June 4, 2020
Cardiol Therapeutics Appoints Michael J. Willner to Its Board of Directors
Cardiol Therapeutics Receives FDA Clearance of Investigational New Drug (IND) Application for Phase II Clinical Trial of CardiolRx(TM) for Acute Myocarditis
David Elsley, MBA
President and Chief Executive Officer
Mr. David Elsley is a business leader with a proven track record of developing, financing and managing all aspects of corporate development in biotechnology and high-growth organizations.
In 1990, Mr. Elsley founded Vasogen Inc., a biotechnology company focused on the research and commercial development of novel therapeutics for the treatment of heart failure and other inflammatory conditions. Mr. Elsley assembled a team of management, directors and scientific advisors comprising industry professionals and thought leaders from North America and Europe.… read more
Andrew Hamer, MB, ChB
Chief Medical Officer
Dr. Andrew Hamer brings 30 years of experience in the global life sciences industry, medical affairs, and cardiology practice to the Company. Most recently he served as Executive Director, Global Development-Cardiometabolic at California-based Amgen Inc., where he led the Global Development group for Repatha®, the LDL cholesterol lowering PCSK9 inhibitor evolocumab, which generated revenues of almost US $900 million in 2020.… read more
Chris Waddick, MBA, CPA, CMA
Chief Financial Officer
Mr. Chris Waddick has thirty years of experience in financial and executive roles in the biotechnology and energy industries, with substantial knowledge of public company management and corporate governance, and in designing, building, and managing financial processes, procedures, and infrastructure. Mr. Waddick most recently served as Executive Vice President and Chief Financial Officer for a private Ontario energy company where he was retained by the shareholders to refinance the company and establish a new strategic direction, as well as the appropriate financial infrastructure. During his tenure, he implemented two corporate restructurings, drove substantial earnings growth, and significantly reduced both cost of capital and debt levels.… read more
Bernard Lim, MIET, CEng (UK)
Chief Operating Officer
Bernard has a proven track record of over thirty years as a senior executive leading life sciences companies spanning biotechnology, diagnostics, medical devices, and high-technology companies in North America and Europe. He leads senior management teams through a sustained focus on strategy, rapid scale up and increasing talent depth to expand markets served. He was founder and CEO of a highly successful drug delivery company that he led from R&D through to commercialization and its eventual acquisition by Eli Lily.… read more
Andrea B. Parker, MSc, PhD
Senior Director of Clinical Operations
Dr. Parker is a senior executive with more than 30 years of experience in the execution of Phase I-IV research programs in the biomedical and medical device sectors. She was involved in the organization and execution of many large-scale international clinical trials, specializing in cardiovascular disease, pain management, and imaging techniques. She worked in academic settings, as well as for Contract Research Organisations and for Industry.… read more
Anne Tomalin, BA, BSc, RAC
Director of Regulatory and Quality
Ms Tomalin has a strong background in business, government, regulations, and reimbursement policies and has practiced exclusively in regulatory affairs since 1971. In September 2013, she founded TPIreg Inc., a Regulatory Affairs and Quality Assurance company providing consulting services for Canada and the United States to the healthcare industry. TPIreg Inc. was acquired by Innomar Strategies in 2019. Prior to TPIreg, in September 1996, Ms. Tomalin founded CanReg Inc. which became Canada’s largest Regulatory Affairs consulting firm with more than 100 staff, assisting clients with Health Canada, FDA, and EMA matters, before being acquired by United Health Inc. in December 2009. Prior to this, she was employed by Searle Canada for 20 years as Business Unit Director.… read more
Blagoja Ristevski, BSc, CHE
Director of Chemical Engineering and Manufacturing
Mr. Blagoja Ristevski graduated with a BSc in Chemical Engineering and Inorganic Chemistry from the University of Ss ‘Cyril and Methodius’, Skopje, Macedonia, and pursued postgraduate research on natural biopolymers as drug carriers at King’s College London, UK. For 20 years he was involved in the research and discovery of active drug molecules, drug delivery technologies, and manufacturing methodologies for finished drug products at several biopharmaceutical companies.… read more
Source 1: https://www.cdc.gov/heartdisease/facts.htm
Source 2: https://www.cardiolrx.com/our-focus/co-vid-19/
Source 3: https://www.cardiolrx.com/cardiolrx/cardiolrx-c-b-d/
Source 4: https://www.cardiolrx.com/wp-content/uploads/2022/02/Cardiol-Therapeutics-Corporate-Presentation-February-2022.pdf
Source 5: https://www.cardiolrx.com/our-focus/