12yearplan
4 years ago
Cardiol Therapeutics Receives FDA Approval for Investigational New Drug (IND) Application for Phase II/III COVID-19 Trial
1 hour ago
Trial will take place at major U.S. centers and examine the cardioprotective properties of CardiolRx(TM) in patients hospitalized with COVID-19 who have a prior history of, or risk factors for, cardiovascular disease (CVD)
Oakville, Ontario--(Newsfile Corp. - September 25, 2020) - Cardiol Therapeutics Inc. (TSX: CRDL) (OTCQX: CRTPF) ("Cardiol" or the "Company"), a clinical-stage biotechnology company focused on developing innovative therapies for inflammatory heart disease, is pleased to announce that the U.S. Food and Drug Administration (FDA) has approved the Company's Investigational New Drug (IND) application to commence a Phase II/III, double-blind, placebo-controlled clinical trial investigating the efficacy and safety of CardiolRx™, a pharmaceutically produced extra strength cannabidiol formulation, in 422 hospitalized COVID-19 patients with a prior history of, or risk factors for, cardiovascular disease (CVD). The trial will take place at major centers in the United States, where the prevalence of COVID-19 remains high.
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 COVID-19 is not limited to the pulmonary system. 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 COVID-19 and experience greater morbidity. Moreover, such COVID-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, and which are frequently fatal, with an estimated 30 - 40% of patients who die from COVID-19 doing so from cardiovascular complications. A strategy to prevent or limit the number or severity of these cardiovascular complications is likely to considerably improve outcomes from this disease.
Cardiol's Phase II/III trial has been designed to assess the efficacy, safety, and tolerability of CardiolRx™ in preventing cardiovascular complications in hospitalized patients, with a confirmed diagnosis of COVID-19 within the previous 24 hours, and who have pre-existing CVD and/or significant risk factors for CVD. The composite primary efficacy endpoint will be the difference between the active and placebo groups in the percentage of patients who develop, during the first twenty-eight days following randomization and first dose of study medication, a composite endpoint consisting of one or more of several common outcomes in this patient population, including all-cause mortality, requirement for ICU admission and/or ventilatory support, as well as cardiovascular complications, including the development of heart failure, acute myocardial infarction, myocarditis, stroke, or new sustained or symptomatic arrhythmia.
The study was designed and will be overseen by an independent Steering Committee, consisting of international thought leaders in inflammatory heart disease: Dr. Dennis McNamara (Chair), Professor of Medicine and Director of the Center for Heart Failure Research, University of Pittsburgh; Dr. Leslie Cooper (Co-Chair), Chair of the Mayo Clinic Enterprise Department of Cardiovascular Medicine and Chair of the Department of Cardiovascular Medicine, Mayo Clinic; Dr. Arvind Bhimaraj, Medical Director, Advanced Heart Failure, Mechanical Circulatory Support and Heart Transplant Programs, Houston Methodist Hospital; Dr. Barry Trachtenberg, Director, Cardio-Oncology and Cardiac Amyloid Programs, Associate Director, Mechanical Circulatory Support Program, Houston Methodist Hospital; Dr. Wilson Tang, Director of the Center for Clinical Genomics, Research Director, and staff cardiologist in the Section of Heart Failure and Cardiac Transplantation Medicine, Cleveland Clinic; Dr. Peter Liu, Chief Scientific Officer and Vice President of Research, University of Ottawa Heart Institute; Dr. Carsten Tschöpe, Vice Director of the Dept. of Cardiology, Charité University Medicine Berlin, Germany; and Dr. Matthias Friedrich, Professor of Medicine and Chief, Cardiovascular Imaging, McGill University Health Centre.
Dr. Dennis McNamara, Chair of the Steering Committee for the trial commented: "As a Steering Committee, we are excited about the potential for this study to contribute valuable new information about the role of anti-inflammatory agents in the management of COVID-19. Now that approval from the FDA has been granted, we are anxious to get underway so that we can investigate the impact of CardiolRx in this very important disease process."
"Receiving approval from the FDA for our IND application to initiate a clinical program in COVID-19 patients represents a major milestone for Cardiol Therapeutics and provides the opportunity to significantly accelerate the commercial development of CardiolRx," said David Elsley, President and CEO of Cardiol Therapeutics. "The COVID-19 pandemic is providing our Company with a unique opportunity to rapidly study the cardioprotective properties of CardiolRx in patients who have a prior history of, or risk factors for, cardiovascular disease and are most vulnerable to the virus. Subject to study outcomes, our discussions with the FDA indicated that the design and scope of our Phase II/III trial may be used as a registration study in support of a New Drug Application."
The rationale for using cannabidiol to treat patients with COVID-19 is based on extensive pre-clinical investigations by Cardiol and others in models of cardiovascular inflammation which have demonstrated that CBD has impressive anti-inflammatory and anti-fibrotic activity, as well as anti-ischemic, and anti-arrhythmic action, and that it improves myocardial function in models of heart failure. In pre-clinical models of cardiac injury, cannabidiol was shown to be cardio-protective by reducing cardiac hypertrophy, fibrosis, and the production of certain re-modelling markers, such as cardiac B-type Natriuretic Peptide (BNP), which is typically elevated in patients with heart failure. These data were accepted for presentation at the American College of Cardiology's 69th Annual Scientific Session held virtually on March 28 - 30, 2020.
About Cardiol Therapeutics
Cardiol Therapeutics Inc. (TSX: CRDL) (OTCQX: CRTPF) is a clinical-stage biotechnology company focused on developing innovative therapies for inflammatory heart disease. The Company recently received approval from the U.S. FDA for its Investigational New Drug (IND) application to commence a Phase II/III, double-blind, placebo-controlled clinical trial investigating the efficacy and safety of its lead product, CardiolRx™, in hospitalized COVID-19 patients with a prior history of, or risk factors for, cardiovascular disease (CVD). CardiolRx™ is an ultra-pure, high concentration cannabidiol oral formulation that is pharmaceutically produced, manufactured under cGMP, and THC free (<5 ppm).
Cardiol is also planning a Phase II international trial of CardiolRx™ in acute myocarditis, a condition caused by inflammation in heart tissue, which remains the most common cause of sudden cardiac death in people less than 35 years of age, and developing proprietary cannabidiol formulations for the treatment of chronic heart failure. Chronic heart failure is the leading cause of death and hospitalization in North America, with associated annual healthcare costs in the U.S. alone exceeding $30 billion. For further information about Cardiol Therapeutics, please visit cardiolrx.com.
For further information, please contact:
David Elsley, President & CEO +1-289-910-0850
david.elsley@cardiolrx.com
Trevor Burns, Investor Relations +1-289-910-0855
trevor.burns@cardiolrx.com
12yearplan
4 years ago
Long awaited news: Cardiol Therapeutics Signs Supplier Agreement with Medical Cannabis by Shoppers, a Subsidiary of Shoppers Drug Mart Inc.
Oakville, Ontario--(Newsfile Corp. - March 18, 2020) - Cardiol Therapeutics Inc. (TSX: CRDL) (OTCQX: CRTPF) ("Cardiol" or the "Company"), a leader in the production of pharmaceutical cannabidiol (CBD) and the development of innovative cannabidiol products for heart disease, is pleased to announce that it has signed a supplier agreement to offer its pharmaceutically produced cannabidiol to Medical Cannabis by Shoppers ("Shoppers"), a subsidiary of Shoppers Drug Mart Inc.
Shoppers will be the exclusive retailer of Cardiol's CardiolRx™ brand of cannabidiol products in Canada. Under the terms of the agreement, Cardiol's exclusive manufacturing partner, Dalton Pharma Services Inc., will supply Cardiol's pharmaceutical cannabidiol products to Shoppers for resale in all provinces and territories in Canada through Shoppers' online store. Manufactured under cGMP and THC free (<5 ppm), Cardiol's products are designed to be the safest and most consistent pharmaceutical cannabidiol formulations available and will be sold initially in three dosage formats: 100mg/mL, 50mg/mL, and 25mg/mL. Shoppers also has the right to resell all future products available from Cardiol's product line, subject to any and all regulations.
There is a growing demand from paediatricians for a cannabidiol formulation that does not contain THC. The Canadian Paediatric Society and The College of Physicians and Surgeons of Ontario recommend that physicians not expose young people under the age of 25 to THC, as its effects on brain development are unknown. For elderly patients, THC exposure can lead to unfavourable drug interactions, delirium, instability, and other effects of intoxication. People over the age of 65 represent the fastest growing segment for medicinal cannabinoids in Canada.
"Shoppers Drug Mart is a trusted brand in Canada and we are delighted that Medical Cannabis by Shoppers has agreed to carry Cardiol's pharmaceutical cannabidiol on an exclusive basis," said David Elsley, President and CEO of Cardiol Therapeutics. "The signing of this important distribution agreement has now positioned our Company to meet the growing demand for medical cannabidiol products that are free from the psychotropic effects of THC, while setting the highest industry standards for purity, stability, safety, and consistency for patients and healthcare providers."
12yearplan
4 years ago
Oakville, Ontario--(Newsfile Corp. - March 5, 2020) - Cardiol Therapeutics Inc. (TSX: CRDL) (OTCQX: CRTPF) ("Cardiol" or the "Company"), a leader in the production of pharmaceutical cannabidiol (CBD) and the development of innovative cannabidiol medicines for heart diseases, has received a No Objection Letter from Health Canada to conduct a Phase 1 study of the Company's pharmaceutically produced (cGMP), high concentration, pure cannabidiol formulation that is THC free (<5ppm). The Company plans to initiate the study in Q2, 2020.
Cardiol's Phase 1 study is designed to measure the pharmacokinetics (blood levels of drug) following single and multiple doses of the Company's extra strength 100mg/mL concentration pharmaceutical cannabidiol formulation in up to up to 55 healthy subjects, both in the fasting and fed states. The study will also measure standard safety parameters at escalating doses to help select the optimal dosing levels for the Company's planned international Phase 2 study in acute myocarditis, an inflammatory form of heart failure that represents a leading cause of sudden cardiac death in children and young adults.
"Receiving Health Canada's No Objection Letter to conduct a Phase 1 study is an important development for Cardiol, as this will be the first study designed to investigate safety and dosing levels of our high concentration cannabidiol formulation developed for patients who should not be exposed to THC," said David Elsley, President and CEO of Cardiol Therapeutics. "The study is expected to provide important data to support the commercial and clinical development of this unique THC free (<5ppm) product which contains the same cannabidiol concentration as the medicine approved by the FDA for rare forms of paediatric epilepsy."
There is a growing demand for a cannabidiol formulation that does not contain THC. Both the College of Physicians and Surgeons of Ontario and the Canadian Paediatric Society recommend that physicians do not expose young people under the age of 25 to THC, as its effects on brain development are unknown. For elderly patients, THC exposure can lead to unfavourable drug interactions and adverse effects of intoxication. Cardiol plans to enter the Canadian medicinal cannabinoid market (estimated at $1.2 billion annually) imminently and to address the market's largest segments - people under 25 and adults over 65 years of age - by offering what the Company believes to be the purest form of cannabidiol in the world.
Cardiol's ultra-pure cannabidiol formulation is pharmaceutically produced specifically for medical purposes and is manufactured under the most stringent quality standards set by the pharmaceutical industry. It is free from the psychotropic effects of THC and is produced using controlled processes in a cGMP, Health Canada approved, FDA registered and inspected pharmaceutical facility. This allows for consistent quality and purity from batch to batch, resulting in a THC free (<5 ppm) cannabidiol oil - ideal for patients who should not be exposed to THC.
About Cardiol Therapeutics
Cardiol Therapeutics Inc. (TSX: CRDL) (OTCQX: CRTPF) is focused on producing pharmaceutical cannabidiol (CBD) products and developing innovative therapies for heart diseases, including acute myocarditis and other causes of heart failure. The Company's lead product, CardiolRx™, is formulated to be the most consistent cannabidiol formulation on the market. CardiolRx is pharmaceutically produced, manufactured under cGMP, and is THC free (<5 ppm). The Company also plans to commercialize CardiolRx in the billion-dollar market for medicinal cannabinoids in Canada and is pursuing distribution opportunities in Europe and Latin America.
In heart failure, Cardiol is planning an international clinical study of CardiolRx in acute myocarditis, a condition caused by inflammation in heart tissue, which remains the most common cause of sudden cardiac death in people less than 35 years of age. The Company is also developing proprietary nanotechnology to uniquely deliver pharmaceutical cannabidiol and other anti-inflammatory drugs directly to sites of inflammation in the heart associated with heart failure. Heart failure is the leading cause of death and hospitalization in North America with associated annual healthcare costs in the U.S. alone exceeding $30 billion. For further information about Cardiol Therapeutics, please visit cardiolrx.com.
For further information, please contact:
David Elsley, President & CEO +1-289-910-0850
david.elsley@cardiolrx.com
Trevor Burns, Investor Relations +1-289-910-0855
trevor.burns@cardiolrx.com
12yearplan
4 years ago
Globe and Mail Jan 24, 2020
Cardiol Therapeutics Inc. (CRDL-T) is “on a catalyst-studded path that could see investors realizing significant upside in the near-term,” said Raymond James analyst Rahul Sarugaser.
In a research report released Friday, Mr. Sarugaser initiated coverage of the Oakville, Ont.-based company with an "outperform" rating.
“Cardiol Therapeutics (CRDL) is a biopharmaceutical company,” he said. "What CRDL is not: a cannabis company. The cause for confusion? CRDL focuses its therapeutic strategy around the active pharmaceutical ingredient (API) cannabidiol (CBD): a molecule that occurs naturally in the cannabis plant. The key differentiator: CRDL formulates its products using pharmaceutical manufacturing quality standards, deriving its CBD by chemical synthesis and directing its products toward sensitive, underserved—i.e., paediatric and geriatric—patient populations that most need their source of CBD to be THC-free (THC is the psychoactive component of cannabis). We appreciate that even modest penetration of these patient populations with pharmaceutical-quality, data-supported CBD products in Canada would represent material upside for CRDL. This said, CRDL’s concurrent development of a pharmaceutical treatment for heart disease — through Health Canada and the U.S. FDA — we see as the real prize here.
“CRDL, leveraging its biopharmaceutical heritage and pedigree, is taking advantage of an opportunity that, as far as we understand, is unique to this moment in time in Canada. Because of the Cannabis Act, for the first time in history a pharmaceutically-manufactured drug, CardiolRx (chemically-synthesized cGMP-quality CBD) can be sold to medical cannabis patients while, concurrently, being developed as a pharmaceutical drug in gold-standard clinical trials with Health Canada and the U.S. FDA. We believe CRDL’s veteran management team—with its deep pharmaceutical roots, many hailing from Vasogen (VSGN)—has the discipline and experience to pull off this tandem commercial/clinical enterprise.”
He set a target price of $5 per share, which falls $4 short of the consensus.
12yearplan
4 years ago
Cardiol Therapeutics' Exclusive Manufacturing Partner Receives Three-Year Renewal and Amendment of its Cannabis Act License from Health Canada
Oakville, Ontario--(Newsfile Corp. - January 15, 2020) - Cardiol Therapeutics Inc. (TSX: CRDL) (OTCQX: CRTPF) ("Cardiol" or the "Company"), a leader in the production of pharmaceutical cannabidiol (CBD) and the development of innovative cannabidiol medicines for heart disease, is pleased to announce that its exclusive manufacturing partner, Dalton Pharma Services ("Dalton"), has received a three-year renewal and license amendment of its Cannabis Act Processing License from Health Canada. This renewal and amendment will permit scaled commercial production of Cardiol's high concentration pharmaceutical cannabidiol formulations and their sale to other license holders.
"Today's announcement is one of Cardiol's most important milestones to date, as it enables the commercial introduction of the first pharmaceutically produced cannabidiol for patients who should not be exposed to THC," stated David Elsley, President and CEO of Cardiol Therapeutics. "This accomplishment is the culmination of a significant collaborative effort between the Cardiol and Dalton teams and will facilitate the commercialization of what we believe to be the purest form of cannabidiol in the world."
Established in 1986 and located in Toronto, Dalton is a leading international cGMP manufacturer for the pharmaceutical and biotechnology industries and the only Health Canada approved and FDA registered and inspected company in Canada licensed to produce pharmaceutical cannabidiol. They manufacture over 200 active pharmaceutical ingredients, including pharmaceutical cannabinoids, with manufacturing capability scalable to support all levels of commercialization.
"The Dalton team is committed to utilizing our decade of cannabinoid formulation experience and state-of-the-art cGMP manufacturing facility to support Cardiol's commercial launch in Canada and plans for international expansion," said Peter Pekos, President and CEO of Dalton Pharma Services. "The ever-increasing understanding of the therapeutic benefits of cannabidiol complements Cardiol's dedication to developing the purest and most consistent formulation of this medicine."
Cardiol's ultra-pure cannabidiol formulation is pharmaceutically produced specifically for medical purposes. It is free from the psychotropic effects of THC and is produced using controlled processes in a cGMP, Health Canada approved, FDA registered and inspected pharmaceutical facility. This allows for consistent quality and purity from batch to batch, resulting in a THC free (<10 ppm) cannabidiol oil - ideal for patients who should not be exposed to THC.
About Cardiol Therapeutics
Cardiol Therapeutics Inc. (TSX: CRDL) (OTCQX: CRTPF) is focused on producing pharmaceutical cannabidiol (CBD) products and developing innovative therapies for heart disease, including acute myocarditis and other causes of heart failure. The Company's lead product, CardiolRx™, is designed to be one of the safest and most consistent cannabidiol formulations on the market. CardiolRx is pharmaceutically produced, manufactured under cGMP, and is THC free (<10 ppm). The Company plans to commercialize CardiolRx in the billion-dollar market for medicinal cannabinoids in Canada and is also pursuing distribution opportunities in Europe and Latin America.
In heart failure, Cardiol is planning an international clinical study of CardiolRx in acute myocarditis, a condition caused by inflammation in heart tissue, which remains the most common cause of sudden cardiac death in people less than 35 years of age. The Company is also developing proprietary nanotechnology to uniquely deliver pharmaceutical cannabidiol and other anti-inflammatory drugs directly to sites of inflammation in the heart that are associated with heart failure. Heart failure is the leading cause of death and hospitalization in North America with associated healthcare costs in the U.S. alone exceeding $30 billion. For further information about Cardiol Therapeutics, please visit www.cardiolrx.com.
For further information, please contact:
David Elsley, President & CEO +1-289-910-0850
david.elsley@cardiolrx.com
Trevor Burns, Investor Relations +1-289-910-0855
trevor.burns@cardiolrx.com
12yearplan
4 years ago
Press Release – Oakville, Ontario, December 18, 2019
Cardiol Therapeutics Inc. (TSX: CRDL; OTCQX: CRTPF) (“Cardiol” or the “Company”), a leader in the production of pharmaceutical cannabidiol (CBD) and the development of innovative cannabidiol medicines for heart disease, is pleased to announce that it has appointed Michael J. Willner, Esq. as Business Advisor to the Company.
Mr. Willner has been an active investor for over forty years and is the founder of Willner Capital, Inc., an investment company specializing in both public and private equities. Over the past several years, Willner Capital has made significant investments in both the biotechnology and medicinal cannabinoid industries, focusing primarily on clinical-stage companies that seek to address significant unmet medical needs. Mr. Willner has served on numerous panels and advisory boards and as a judge in the medicinal cannabinoid industry start-up competitions and conferences. He has been quoted in the New York Times regarding his investments and is considered an expert in the medicinal/pharmaceutical cannabinoids industry.
Mr. Willner currently serves on the advisory boards of CannaVC, a cannabis-focused venture capital fund for the Israeli market, managed by the Everest Group, which plans to invest in companies that have developed an innovative solution/service/product for the cannabinoid sector, and CURE Pharmaceutical® (OTCQB: CURR), a vertically integrated drug delivery and development company that partners with biotech and pharmaceutical companies worldwide.
“I am pleased to welcome Michael Willner as Business Advisor to our Company,” said David Elsley, President and CEO of Cardiol Therapeutics. “This coming year will be transformative for Cardiol as we prepare to commercialize the world’s first pharmaceutically produced cannabidiol, formulated for patients who should not be exposed to THC, and advance the development of novel cannabidiol medicines for the treatment of heart failure. Michael’s expertise in both the biotechnology and medical cannabinoid industries, paired with his wealth of investment knowledge in clinical-stage companies and other high-growth organizations, will be invaluable as we enter the next phase of corporate development.”
“I am very pleased to serve as Business Advisor to Cardiol,” stated Mr. Willner. “Cardiol has developed a differentiated business model that combines a new therapeutic approach to the treatment of heart failure and the commercialization of a unique medicinal cannabidiol formulation. This creates an exceptional opportunity for the Company to potentially generate significant revenue while offering new hope to patients with heart failure.”
Michael J. Willner is both an Attorney and a Certified Public Accountant. He graduated from Emory University Law School as a member of the Emory Law Review. Subsequently, he practiced real estate law with New York City-based Milbank, Tweed, Hadley & McCloy, one of the most prominent international law firms in the U.S. Mr. Willner is also the founder of Willner Properties Commercial Services, Inc., which develops and invests in office, retail, industrial, and residential properties.
About Cardiol Therapeutics
Cardiol Therapeutics Inc. (TSX: CRDL; OTCQX: CRTPF) is focused on producing pharmaceutical cannabidiol (CBD) products and developing innovative therapies for heart disease, including acute myocarditis and other causes of heart failure. The Company’s lead product, CardiolRx™, is designed to be one of the safest and most consistent cannabidiol formulations on the market. CardiolRx is pharmaceutically produced, manufactured under cGMP, and is THC free (<10 ppm). The Company plans to commercialize CardiolRx in the billion-dollar market for medicinal cannabinoids in Canada and is also pursuing distribution opportunities in Europe and Latin America.
In heart failure, Cardiol is planning an international clinical study of CardiolRx in acute myocarditis, a condition caused by inflammation in heart tissue, which remains the most common cause of sudden cardiac death in people less than 35 years of age. The Company is also developing proprietary nanotechnology to uniquely deliver pharmaceutical cannabidiol and other anti-inflammatory drugs directly to sites of inflammation in the heart that are associated with heart failure. Heart failure is the leading cause of death and hospitalization in North America with associated healthcare costs in the U.S. alone exceeding $30 billion. For further information about Cardiol Therapeutics, please visit cardiolrx.com.
12yearplan
4 years ago
2019-12-03 09:13 ET - News Release
Oakville, Ontario--(Newsfile Corp. - December 3, 2019) - Cardiol Therapeutics Inc. (TSX: CRDL) (OTCQX: CRTPF) ("Cardiol" or the "Company"), a leader in the production of pharmaceutical cannabidiol (CBD) and the development of innovative cannabidiol medicines for heart disease, is pleased to announce the appointment of Mr. Colin Stott to its Board of Directors, effective immediately. Mr. Stott is the former Scientific Affairs Director, International and R&D Operations Director for GW Pharmaceuticals plc ("GW Pharma"), a world leader in the development of cannabinoid therapeutics and the company which created Epidiolex®, the first FDA-approved cannabidiol therapy for use as an orphan drug in rare forms of pediatric epilepsy.
Currently Chief Operating Officer of Alinova Biosciences Ltd, Mr. Stott is a veteran of the pharmaceutical and biotech industries, having almost 30 years' experience in pre-clinical and clinical development, with specific expertise in the development of cannabinoid-based medicines, and 19 years' experience in the field. As R&D Operations Director at GW Pharma for over 16 years, Colin was a key player in the development of their discovery and development pipeline, and was closely involved in the Marketing Authorization Application submission and approval of Sativex® and the New Drug Application submission of Epidiolex®, which was approved by the U.S. Food and Drug Administration in June 2018. More recently, as Scientific Affairs Director, International, he was part of the Medical Affairs team responsible for the preparation of the international launch of Epidiolex®.
"I am pleased to welcome Colin Stott to our Board of Directors," stated David Elsley, President and CEO of Cardiol Therapeutics. "Mr. Stott brings unparalleled experience in the biopharmaceutical industry, particularly with cannabinoid medicines, regulatory approvals, and product launches. Colin's involvement in the successful approval of Epidiolex® in the U.S. as an orphan drug will also prove invaluable to Cardiol as we advance our plans to develop CardiolRx™100 pharmaceutical cannabidiol as a potential orphan drug for the treatment of acute myocarditis."
CardiolRx™100, a 100mg/mL pharmaceutical cannabidiol formulation (the same concentration as Epidiolex®) is manufactured under cGMP, is THC free (<10 ppm), and is designed to be the safest and most consistent high concentration cannabidiol formulation available. Cardiol plans to commercialize CardiolRx™100 in the $1.2 billion-dollar market for medicinal cannabinoids in Canada and believes there is a significant opportunity to develop its pharmaceutical cannabidiol formulation as an orphan drug for the treatment of acute myocarditis, a serious inflammatory condition of the heart that is a major cause of sudden death in children and young adults.
An independent Clinical Steering Committee comprising eight highly distinguished thought leaders in cardiology from the Cleveland Clinic, the Mayo Clinic, the Houston Methodist DeBakey Heart and Vascular Center, the University of Ottawa Heart Institute, McGill University Health Centre, the University of Pittsburgh Medical Center, and Charit University Medicine Berlin, has been established to design, oversee, and guide Cardiol's Phase 2 international trial in acute myocarditis.
Mr. Terry Lynch has stepped down from the Board of Directors to accommodate Mr. Stott's appointment. Cardiol would like to take this opportunity to thank Mr. Lynch for his contributions to the Company both as a founding shareholder and director. Mr. Lynch has been instrumental in the success and progress of Cardiol since its inception, and he will continue to work closely with the Company in a strategic advisory role focused on corporate development.
About Cardiol Therapeutics
Cardiol Therapeutics Inc. (TSX: CRDL) (OTCQX: CRTPF) is focused on producing pharmaceutical cannabidiol (CBD) products and developing innovative therapies for heart disease, including acute myocarditis and other causes of heart failure. The Company's lead product, CardiolRx™, is designed to be one of the safest and most consistent cannabidiol formulations on the market. CardiolRx is pharmaceutically produced, manufactured under cGMP, and is THC free (<10 ppm). The Company plans to commercialize CardiolRx in the billion-dollar market for medicinal cannabinoids in Canada and is also pursuing distribution opportunities in Europe and Latin America.
In heart failure, Cardiol is planning an international clinical study of CardiolRx in acute myocarditis, a condition caused by inflammation in heart tissue, which remains the most common cause of sudden cardiac death in people less than 35 years of age. The Company is also developing proprietary nanotechnology to uniquely deliver pharmaceutical cannabidiol and other anti-inflammatory drugs directly to sites of inflammation in the heart that are associated with heart failure. Heart failure is the leading cause of death and hospitalization in North America with associated healthcare costs in the U.S. alone exceeding $30 billion. For further information about Cardiol Therapeutics, please visit cardiolrx.com.
12yearplan
4 years ago
Oakville, Ontario--(Newsfile Corp. - November 25, 2019) - Cardiol Therapeutics Inc. (TSX: CRDL) (OTCQX: CRTPF)("Cardiol" or the "Company"), a leader in the production of pharmaceutical cannabidiol ("CBD") products and in the development of innovative cannabidiol medicines for heart disease, commented on Purisys, LLC's news release issued on November 21st which states that the U.S. Drug Enforcement Agency ("DEA") has removed their cannabinoid ingredients from Schedule I of the Controlled Substances Act ("CSA"). Purisys, LLC ("Purisys") is Cardiol's exclusive supplier of ultra-high purity cannabidiol for the Company's CardiolRx™ formulation. Pharmaceutically produced and cGMP certified, CardiolRx is designed to be the safest and most consistent cannabidiol formulation on the market.
Headquartered in Athens, Georgia, Purisys is a recent spinoff of Cardiol's cannabidiol supply partner, Noramco, Inc., and was formed to provide pharmaceutical companies with the highest quality active pharmaceutical ingredients (APIs) to support commercialization of cannabinoid formulations around the world. Purisys has been manufacturing ultra-high purity cannabidiol (<0.001% THC) via a patented process since 2016. The cannabinoids produced by Purisys are distinguished by their ultra-low THC concentration, purity, world-scale capacity, exacting quality control, ease of formulation compared to hemp-derived isolates, and strong regulatory support.
"The DEA's descheduling of Purisys' pharmaceutical cannabidiol clearly establishes their acknowledgement of the consistent purity and quality of Purisys' product," said David Elsley, President and CEO of Cardiol Therapeutics. "This landmark decision underscores Cardiol's rationale for selecting Purisys to supply the API for our CardiolRx formulation and supports our unwavering commitment to produce the safest and most consistent cannabidiol formulations for patients who should not be exposed to THC.
"At Purisys, we stand ready to back Cardiol Therapeutics' imminent commercialization of the world's first pharmaceutical cannabidiol formulation (CardiolRx) with our applications support, cGMP manufacturing, world-scale supply capability for commercial production, and analytical reference standards," said Jim Mish, CEO of Purisys. "Now that our ultra-pure pharmaceutical cannabidiol is no longer subject to DEA Schedule I status, Cardiol will also be able to accelerate its ground-breaking research programs aimed at developing important cannabidiol medicines for life-threatening heart disease."
Cardiol recently announced the completion of manufacturing scale up of its high-concentration pharmaceutical cannabidiol formulation for commercialization in the $1.2 billion-dollar market for medicinal cannabinoids in Canada. The removal of Purisys' pharmaceutical cannabidiol from the DEA's Controlled Substance Act now opens up prospects for new commercial opportunities for CardiolRx around the world.
About Cardiol Therapeutics
Cardiol Therapeutics Inc. (TSX: CRDL) (OTCQX: CRTPF) is focused on producing pharmaceutical cannabidiol (CBD) products and developing innovative therapies for heart disease, including acute myocarditis and other causes of heart failure. The Company's lead product, CardiolRx™, is designed to be one of the safest and most consistent CBD formulations on the market. CardiolRx is pharmaceutically produced, cGMP certified, and is THC free. The Company plans to commercialize CardiolRx in the billion-dollar market for medicinal cannabinoids in Canada and is also pursuing distribution opportunities in Europe and Latin America.
In heart failure, Cardiol is planning an international clinical study of CardiolRx in acute myocarditis, a condition caused by inflammation in heart tissue, which remains the most common cause of sudden cardiac death in people less than 35 years of age. The Company is also developing proprietary nanotechnology to uniquely deliver pharmaceutical CBD and other anti-inflammatory drugs directly to sites of inflammation in the heart that are associated with heart failure. Heart failure is the leading cause of death and hospitalization in North America with associated healthcare costs in the U.S. alone exceeding $30 billion. For further information about Cardiol Therapeutics, please visit cardiolrx.com.
For further information, please contact:
David Elsley, President & CEO +1-289-910-0850
david.elsley@cardiolrx.com
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