Cannabis
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–(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.
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 anti-inflammatory therapies for the treatment of cardiovascular disease (“CVD”). The Company’s lead product, CardiolRx™, is an oral cannabidiol formulation pharmaceutically manufactured under cGMP 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 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™ for the treatment of inflammation in the heart that is associated with the development and progression of heart failure.
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 innovative anti-inflammatory therapies for the treatment of CVD, plans to expand the clinical trial infrastructure to include up to an additional 20 clinical research centers, the expectation the LANCER trial will achieve over 50% patient recruitment by the end of the first half of 2022 and complete full patient enrollment during the second half of 2022, the expectation the updates will remove key barriers to participation in LANCER as well as expand the eligible patient pool, the expectation Brazil will be a key contributor to patient enrollment and the belief CardiolRx™ has the potential to reduce a number of cardiopulmonary complications associated with COVID-19 infection. 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 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
[email protected]
To view the source version of this press release, please visit https://www.newsfilecorp.com/release/115202
TORONTO and GLIL YAM, Israel, Sept. 11, 2024 /PRNewswire/ — IM Cannabis Corp. (“IMC” or the “Company“) (NASDAQ: IMCC) (CSE: IMCC), a leading medical cannabis company with operations in Israel and Germany, is pleased to announce that Mr. Shmulik Arbel has been appointed to the Company’s board of directors (the “Board“) effective September 9, 2024. Mr. Arbel brings a wealth of experience in strategic plans that drive profitability, as well as, finance and corporate governance, further strengthening the company’s commitment to driving growth while focusing on sustainable profitability.
“We are thrilled to welcome Shmulik to our Board of Directors,” said Oren Shuster, Chief Executive Officer of IM Cannabis. “Shmulik’s extensive international experience at Leumi, coupled with his proven track record in banking and finance will be invaluable as we continue to deliver on our strategic initiatives.”
Mr. Arbel retired as Deputy CEO from Leumi, Israel’s largest banking group, in April 2023, where he was instrumental in business growth and leading the service revolution. With over 25 years of experience at Leumi, Arbel has held senior roles throughout the organization, such as head of retail banking, head of the corporate division, and as chairman of Leumi UK. With key roles in Israel, New York and London, Mr. Arbel has a wide view on international business.
“I am honored to join the Board of Directors at IMCC,” said Mr. Arbel. “I look forward to leveraging my experience in banking and finance, providing guidance as IMCC continues to establish itself as the go-to brand in the cannabis world. I look forward to contributing to the company’s growth.”
Arbel holds a BA and MBA from Tel Aviv University.
About IM Cannabis Corp.
IMC (Nasdaq: IMCC) (CSE: IMCC) is an international cannabis company that provides premium cannabis products to medical patients in Israel and Germany, two of the largest medical cannabis markets. The Company has focused its resources to achieve sustainable and profitable growth in its highest value markets, Israel and Germany. The Company leverages a transnational ecosystem powered by a unique data-driven approach and a globally sourced product supply chain. With an unwavering commitment to responsible growth and compliance with the strictest regulatory environments, the Company strives to amplify its commercial and brand power to become a global high-quality cannabis player.
The IMC ecosystem operates in Israel through its commercial relationship with Focus Medical Herbs Ltd., which imports and distributes cannabis to medical patients, leveraging years of proprietary data and patient insights. The Company also operates medical cannabis retail pharmacies, online platforms, distribution centers, and logistical hubs in Israel that enable the safe delivery and quality control of IMC products throughout the entire value chain. In Germany, the IMC ecosystem operates through Adjupharm GmbH, where it distributes cannabis to pharmacies for medical cannabis patients.
Disclaimer for Forward-Looking Statements
This press release contains forward-looking information or forward-looking statements under applicable Canadian and United States securities laws (collectively, “forward-looking statements“). All information that addresses activities or developments that we expect to occur in the future are forward-looking statements. Forward-looking statements are often, but not always, identified by the use of words such as “seek”, “anticipate”, “believe”, “plan”, “estimate”, “expect”, “likely” and “intend” and statements that an event or result “may”, “will”, “should”, “could” or “might” occur or be achieved and other similar expressions. Forward-looking statements are based on the estimates and opinions of management on the date the statements are made. In the press release, such forward-looking statements include, but are not limited to, statements relating to: the stated benefits Mr. Arbel’s appointment, including the further strengthening the Company’s commitment to driving growth in the German market while focusing on sustainable profitability; and Mr. Arbel’s international experience and track record in banking and finance will be invaluable to the Company.
Forward-looking statements are based on assumptions that may prove to be incorrect, including but not limited to: the Company’s ability to realize upon the stated benefits Mr. Arbel’s appointment; and Mr. Arbel’s international experience and track record in banking and finance becoming invaluable to the Company.
The above lists of forward-looking statements and assumptions are not exhaustive. Since forward-looking statements address future events and conditions, by their very nature they involve inherent risks and uncertainties. Actual results may differ materially from those currently anticipated or implied by such forward-looking statements due to a number of factors and risks. These include: the failure of the Company to comply with applicable regulatory requirements in a highly regulated industry; unexpected changes in governmental policies and regulations in the jurisdictions in which the Company operates; the Company’s ability to continue to meet the listing requirements of the Canadian Securities Exchange and the NASDAQ Capital Market; any unexpected failure to maintain in good standing or renew its licenses; the ability of the Company and its subsidiaries (collectively, the “Group“) to deliver on their sales commitments or growth objectives; the reliance of the Group on third-party supply agreements to provide sufficient quantities of medical cannabis to fulfil the Group’s obligations; the Group’s possible exposure to liability, the perceived level of risk related thereto, and the anticipated results of any litigation or other similar disputes or legal proceedings involving the Group; the impact of increasing competition; any lack of merger and acquisition opportunities; adverse market conditions; the inherent uncertainty of production quantities, qualities and cost estimates and the potential for unexpected costs and expenses; risks of product liability and other safety-related liability from the usage of the Group’s cannabis products; supply chain constraints; reliance on key personnel; the risk of defaulting on existing debt; risks surrounding war, conflict and civil unrest in Eastern Europe and the Middle East, including the impact of the Israel-Hamas war on the Company, its operations and the medical cannabis industry in Israel; risks associated with the Company focusing on the Israel and Germany markets; the inability of the Company to achieve sustainable profitability and/or increase shareholder value; the inability of the Company to actively manage costs and/or improve margins; the inability of the company to grow and/or maintain sales; the inability of the Company to meet its goals and/or strategic plans; the inability of the Company to reduce costs and/or maintain revenues; the Company’s inability to take advantage of the legalization of medicinal cannabis in Germany; and the Company’s inability to realize upon the stated benefits Mr. Arbel’s appointment; and Mr. Arbel’s international experience and track record in banking and finance not becoming valuable to the Company.
Please see the other risks, uncertainties and factors set out under the heading “Risk Factors” in the Company’s annual report dated March 28, 2024, which is available on the Company’s issuer profile on SEDAR+ at www.sedarplus.ca and Edgar at www.sec.gov/edgar. Any forward-looking statement included in this press release is made as of the date of this press release and is based on the beliefs, estimates, expectations and opinions of management on the date such forward looking information is made. The Company does not undertake any obligation to update forward-looking statements except as required by applicable securities laws. Investors should not place undue reliance on forward-looking statements. Forward-looking statements contained in this press release are expressly qualified by this cautionary statement.
Company Contact:
Anna Taranko, Director Investor & Public Relations
IM Cannabis Corp.
+49 157 80554338
[email protected]
Oren Shuster, CEO
IM Cannabis Corp.
[email protected]
Logo: https://mma.prnewswire.com/media/1742228/IM_Cannabis_Logo.jpg
View original content:https://www.prnewswire.co.uk/news-releases/im-cannabis-announces-appointment-of-shmulik-arbel-to-board-of-directors-302244961.html
Cannabis
Europe Medical Cannabis Market Forecast 2024-2032: Tilray, Aurora Cannabis, and GW Pharmaceuticals Dominate the Market Landscape
Dublin, Aug. 29, 2024 (GLOBE NEWSWIRE) — The “Europe Medical Cannabis Oil Market Size, Industry Dynamics, Opportunity Analysis and Forecast 2024-2032.” report has been added to ResearchAndMarkets.com’s offering.
The Europe Medical Cannabis Oil market is poised for significant growth, projected to escalate from US$ 0.91 billion in 2023 to US$ 2.40 billion by 2032, advancing at a CAGR of 12.08%. In this comprehensive research report, the market is analyzed by:
- Derivatives;
- Source;
- Application;
- Route of Administration;
- End-user;
- Distribution Channel; and
- Country.
Market Highlights Identified in the Report
- Progressive legalization across Europe is creating a favorable regulatory environment, enhancing market expansion for medical cannabis oil products.
- Germany leads the market with a robust infrastructure and supportive regulations, while other countries like the UK, Italy, and Spain show significant growth potential based on evolving regulatory landscapes and market dynamics.
- Key players such as Tilray, Aurora Cannabis Inc., and GW Pharmaceuticals dominate the market, emphasizing research, strategic partnerships, and innovation to maintain competitive edge amidst evolving industry dynamics.
The medical cannabis oil market has experienced substantial growth as legalization and acceptance of cannabis-based treatments expand globally. Cannabis oil, derived from the cannabis plant through extraction methods, contains cannabinoids such as THC and CBD, known for their therapeutic properties. Increasing recognition of cannabis oil’s potential in alleviating symptoms of various medical conditions, including chronic pain, epilepsy, and anxiety disorders, has driven its adoption in medical settings.
Governments in several countries are progressively legalizing medical cannabis, creating a conducive regulatory environment for market expansion. Additionally, growing consumer awareness about alternative and natural therapies has fueled the demand for cannabis oil products. The market is characterized by diverse product offerings, including full-spectrum and CBD-isolate oils, catering to different therapeutic needs and preferences.
Despite regulatory challenges and stigma associated with cannabis, the medical cannabis oil market continues to evolve, driven by ongoing research, favorable legislative changes, and shifting attitudes toward cannabis-based therapies in healthcare.
Regional Insights
Germany is likely to maintain its leadership position in the European medical cannabis oil market due to its established infrastructure, supportive regulations, and strong healthcare system. Germany legalized medical cannabis in 2017, giving the market a head start compared to many other European countries. This established infrastructure and experience position Germany as a leader in the field. As awareness and acceptance of medical cannabis increase, the number of patients seeking treatment in Germany is steadily rising. This fuels market growth and incentivizes further investment in research and development.
Germany’s regulatory framework for medical cannabis is considered relatively patient-friendly compared to some other European countries. This facilitates access for patients with qualifying conditions. The UK legalized medical cannabis in 2018 and is experiencing an increase in patient access programs. This, coupled with ongoing research, could lead to significant market growth. Italy legalized medical cannabis in 2006 but has faced challenges with availability. As regulations become more streamlined and patient access expands, the Italian market holds significant growth potential. Spain has a well-established medical cannabis industry with a focus on domestic production. As regulations evolve and export opportunities increase, the Spanish market could see a boost.
Competitive Landscape
The Medical Cannabis Oil market is characterized by a vigorous competitive landscape, with prominent entities like Tilray, Aurora Cannabis Inc., GW Pharmaceuticals, Almiral, Bedrocan, and others at the forefront, collectively accounting for approximately 41 % of the overall market share. This competitive milieu is fueled by their intensive efforts in research and development as well as strategic partnerships and collaborations, underscoring their commitment to solidifying market presence and diversifying their offerings.
The primary competitive factors include pricing, product caliber, and technological innovation. As the Medical Cannabis Oil industry continues to expand, the competitive fervor among these key players is anticipated to intensify. The impetus for ongoing innovation and alignment with evolving customer preferences and stringent regulations is high. The industry’s fluidity anticipates an uptick in novel innovations and strategic growth tactics from these leading corporations, which in turn propels the sector’s comprehensive growth and transformation.
Key Topics Covered
Chapter 1. Research Framework
Chapter 2. Research Methodology
Chapter 3. Executive Summary: Europe Medical Cannabis Oil Market
Chapter 4. Europe Medical Cannabis Oil Market Overview
Chapter 5. Europe Medical Cannabis Oil Market Analysis, by Derivatives
Chapter 6. Europe Medical Cannabis Oil Market Analysis, by Source
Chapter 7. Europe Medical Cannabis Oil Market Analysis, by Application
Chapter 8. Europe Medical Cannabis Oil Market Analysis, by Route of Administration
Chapter 9. Europe Medical Cannabis Oil Market Analysis, by End-user
Chapter 10. Europe Medical Cannabis Oil Market Analysis, by Distribution Channel
Chapter 11. Europe Medical Cannabis Oil Market Analysis, by Country
Chapter 12. The UK Medical Cannabis Oil Market Analysis
Chapter 13. Germany Medical Cannabis Oil Market Analysis
Chapter 14. The Netherlands Medical Cannabis Oil Market Analysis
Chapter 15. Italy Medical Cannabis Oil Market Analysis
Chapter 16. Spain Medical Cannabis Oil Market Analysis
Chapter 17. Poland Medical Cannabis Oil Market Analysis
Chapter 18. Rest of Europe Medical Cannabis Oil Market Analysis
Chapter 19. Company Profiles (Company Overview, Financial Matrix, Key Product Landscape, Key Personnel, Key Competitors, Contact Address, and Business Strategy Outlook)
A selection of companies mentioned in this report includes, but is not limited to:
- Aurora Cannabis Inc.
- Bedrocan
- Biocann
- BIOTA Biosciences LLC
- Cannamedical
- Mary Jane CBD
- Sanity Group GmbH
- Tilray
- Valcon Medical
For more information about this report visit https://www.researchandmarkets.com/r/dh7q46
About ResearchAndMarkets.com
ResearchAndMarkets.com is the world’s leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.
