Biotech

SECFilings.com, a leading financial news and information portal offering free real time public company filing alerts, announces the publication of an article covering a potentially major development in the quest to improve outcomes for COVID-19 patients. The US Food and Drug Administration (FDA) recently approved an Investigational New Drug application by Cardiol Therapeutics Inc. (TSX: CRDL) (OTCQX: CRTPF) that opens the door for Cardiol to conduct its Phase IIIII trial. The trial, designed by leading experts on inflammatory heart disease, will test the cardioprotective properties of cannabidiol (CBD) for COVID-19 patients with a prior history of, or risk factors for, cardiovascular disease (CVD).

Heart Issues and COVID

The US Centers for Disease Control (CDC) lists pre-existing serious heart conditions as a major risk factor for COVID-19 patients. The CDC provided data for cases in the US through May, and found that 45% of hospitalized patients had underlying conditions, with CVD the most common of these at 32%. The European Society of Cardiology notes that the body's inflammatory response to the COVID-19 viral infection can stress the cardiovascular system and warns that, "Individuals with heart conditions, such as heart failure, dilated cardiomyopathy, advanced forms of arrhythmogenic right ventricular cardiomyopathy and patients with congenital cyanotic heart disease are at highest risk."

To be clear, CVD does not increase the chances of being infected, but rather increases the chances of severe complications should one become infected. COVID was originally thought to be primarily a respiratory disease, but the link to heart conditions has the scientific community scrambling to precisely identify the nature of that link and to come up with treatments that can improve outcomes for these patients.

Cardiol's Potential Therapy

Cardiol Therapeutics is a Canadian company started and run by a team of cardiovascular disease experts. The CEO, David Elsley, founded Vasogen, Inc. back in 1990 to develop therapies for heart failure and other inflammatory conditions. CMO Dr. Eldon R. Smith was the Editor-in-Chief of the Canadian Journal of Cardiology following a long stint at the University of Calgary as Head of Cardiology and Dean of Medicine.

The company took note of a wealth of clinical evidence suggesting that CBD demonstrates anti-inflammatory properties that could prove effective in treating inflammation-related heart conditions such as acute myocarditis and heart failure. Following its own pre-clinical studies, Cardiol is even more convinced of the potential value of CBD. The company is developing a patented subcutaneous formulation to improve the bioavailability of CBD.

Cardiol formed a clinical trial pipeline to investigate CBD as a treatment for acute myocarditis (Phase 1 launched in August 2020) and heart failure. Along the way, the company noticed the connection between CVD and severe COVID-19 outcomes, filing a patent in early May 2020 to cover "the administration of CBD to reduce the severity of disease in COVID-19 patients with pre-existing cardiovascular conditions, and to prevent the progression of such conditions."

Cardiol's Phase II/III trial will be conducted at major centers in the United States, where the prevalence of COVID-19 remains high and will be overseen by an independent steering committee, consisting of an impressive collection of inflammatory heart disease experts: Dr. Dennis McNamara (Chair), Professor of Medicine and Director of the Heart Failure/Transplantation Program, 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; Dr. Matthias Friedrich, Professor of Medicine and Chief, Cardiovascular Imaging, McGill University Health Centre.

Where It's Headed

The hope is to prove efficacy "in preventing cardiovascular and pulmonary 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 successful IND application provides Cardiol an expedited regulatory approval process that should not only shorten the duration of the clinical program from start to finish but also reduce costs from a standard clinical program.

Cardiol expects to initiate the trial in Q4 with results expected in H2 2021. Along with the company's Phase I trial in Canada, expected to wrap up by the end of 2020 and intended to support a Phase II international trial for the efficacy of CBD as a treatment for acute myocarditis, this trial represents a major potential catalyst for the company's stock in the coming months. Simultaneously, Cardiol anticipates the imminent launch of its pharmaceutical CBD product into the Canadian market in collaboration with Shoppers Drug Mart, representing a major commercial revenue opportunity for the company. Investors might want to keep an eye on Cardiol Therapeutics for more developments as the company tends to its several oars in the water.

Please follow the link to read the full article: http://www.secfilings.com/news/fda-approves-landmark-covidheartcbd-clinical-trial-174/

About SECFilings.com

Founded in 2004, SECFilings.com provides free real time filing alerts to over 600,000 registered members.

Disclaimer

SECFilings.com is not an independent financial investment advisor or broker-dealer. You should always consult with your own independent legal, tax, and/or investment professionals before making any investment decisions. The information provided on http://www.secfilings.com (the 'Site') is either original financial news or paid advertisements drafted by our in-house team or provided by an affiliate. SECFilings.com, a financial news media and marketing firm enters into media buys or service agreements with the companies that are the subject of the articles posted on the Site or other editorials for advertising such companies. We are not an independent news media provider. We make no warranty or representation about the information including its completeness, accuracy, truthfulness or reliability and we disclaim, expressly and implicitly, all warranties of any kind, including whether the Information is complete, accurate, truthful, or reliable. As such, your use of the information is at your own risk. Nor do we undertake any obligation to update the items posted. SECFilings.com received compensation for producing and presenting high quality and sophisticated content on SECFilings.com along with financial and corporate news.

The above article is sponsored content. Emerging Growth LLC, which owns SECFilings.com, has been hired to create awareness. Please follow the link below to view our full disclosure outlining our compensation: http://www.secfilings.com/legal/disclaimer.

Paul Archie
406.862.2242
parchie@tdmfinancial.com

To view the source version of this press release, please visit https://www.newsfilecorp.com/release/64934

News Provided by Newsfile via QuoteMedia

TSX:CRDL

Cardiol Therapeutics


Keep reading...Show less
The Gummy Project Announces Launch of New Investor Relations Website

The Gummy Project Announces Launch of New Investor Relations Website

The Gummy Project (CSE: GUMY) (FSE: 0OS) (OTCQB: GUMYF) ("GUMY" or the "Company")  is pleased to announce the launch of its new investor relations website at https:shopgummies.compagesinvestors.

The investor relations website features excellent functionality and streamlined access to essential investor information, including recent company press releases, sector information and more.

News Provided by Newsfile via QuoteMedia

Keep reading...Show less
bowl with healthy food on it alongside an avocado and cutlery

Hungry for Change: Investing in the Plant-Based Food Industry

Animal agriculture is one of the top five sources of greenhouse gas emissions, much of which is directly attributable to livestock. It's been estimated by the United Nations, for instance, that the livestock sector represents approximately 14.5 percent of all global greenhouse gas emissions. Given the current international push for sustainability, this is a problem — and people are demanding a solution.

Driven by concerns about health, climate change and animal welfare, consumers are demandingethical and sustainable alternatives to meat, dairy, fish, and poultry. Nearly two-thirds (63 percent) of respondents to a survey on flexitarian diets would swap to plant-based alternatives because they're more ethical.

Unsurprisingly, this demand represents a considerable opportunity for anyone interested in sustainable investing. According to Bloomberg Intelligence, the global plant-based food market is expected to reach a total value of US$162 billion by 2030. A survey from the Food Institute shows that 79 percent of Americans from Generation Z choose meatless options at least once or twice a week.

Keep reading...Show less

BELLUS Health Reports Second Quarter 2022 Financial Results and Business Highlights

- Completed positive End-of-Phase 2 meeting with the Food and Drug Administration ("FDA") and received scientific advice from the European Medicines Agency ("EMA") to support design of its CALM Phase 3 program, which is expected to initiate in Q4 2022 -

- Ended second quarter 2022 with approximately US$384.6 million in pro-forma cash, cash equivalents and short-term investments, including net proceeds from the July 2022 financing; Cash runway extended to 2H 2025 and through the topline results of both CALM-1 and CALM-2 trials -

News Provided by Business Wire via QuoteMedia

Keep reading...Show less

Bristol Myers Squibb and 2seventy bio Announce Topline Results from KarMMa-3 Trial Showing Abecma Significantly Improves Progression-Free Survival Versus Standard Regimens in Relapsed and Refractory Multiple Myeloma

Abecma is the first BCMA-directed CAR T cell therapy to demonstrate superiority versus standard regimens in relapsed and refractory multiple myeloma

Bristol Myers Squibb (NYSE: BMY) and 2seventy bio, Inc. (Nasdaq: TSVT) today announced positive topline results from KarMMa-3, a Phase 3, global, randomized, multicenter, open-label study evaluating Abecma (idecabtagene vicleucel) compared to standard combination regimens in adults with multiple myeloma that is relapsed and refractory after two to four prior lines of therapy and refractory to the last regimen. KarMMa-3 is the first randomized clinical trial to evaluate a CAR T cell therapy in multiple myeloma. Results of a pre-specified interim analysis conducted through an independent review committee showed that KarMMa-3 met its primary endpoint of demonstrating a statistically significant improvement in progression-free survival. Treatment with Abecma also showed an improvement in the key secondary endpoint of overall response rate compared to standard regimens. Follow-up for overall survival, a key secondary endpoint, remains ongoing.

News Provided by Business Wire via QuoteMedia

Keep reading...Show less

Gilead Sciences and a Coalition of LGBTQ+ and Human Rights-Focused Organizations Mobilize to Address Monkeypox Public Health Emergency

Gilead Will Provide up to $5 Million in Global Grant Funding to Immediately Support Public Education and Vaccine Hesitancy Communications, a Public Policy Response and a Global Outbreak Emergency Fund for Community Organizations in Regions with Active Monkeypox Outbreaks –

Gilead Sciences, Inc. (Nasdaq: GILD), GLAAD, the Human Rights Campaign (HRC), the National Black Justice Coalition (NBJC), the National Center for Lesbian Rights (NCLR) and NMAC today announced immediate action in response to the emerging monkeypox virus (MPV) outbreak, which is disproportionately impacting the LGBTQ+ community, particularly men who have sex with men (MSM), as well as those who are living with HIV. Gilead will provide up to $5 million in global grant funding to help support three areas of focus: a public education and vaccine hesitancy communications campaign, a public policy response and a global outbreak emergency fund.

News Provided by Business Wire via QuoteMedia

Keep reading...Show less
The Gummy Project Announces That Its Gummies Land on North America's Largest Passenger Ferry Line

The Gummy Project Announces That Its Gummies Land on North America's Largest Passenger Ferry Line

  • The Ferry line is one of the largest ferry operators in the world carrying millions of passengers and vehicles each year.
  • The Ferry line to provide high traffic opportunities on board to grow brand awareness while forming strong consumer connections.

 The Gummy Project (CSE: GUMY) (FSE: 0OS) (OTCQB: GUMYF) ("GUMY" or the "Company") is excited to announce that its Peachy Bees and Watermelon Sharks will be rolling out on North America's largest passenger ferry line later this summer.

"Our multi-channel sales strategy is designed to build significant brand awareness and connection with our purpose-driven mandate through highly strategic partnerships, such as this one, our Flair Airlines partnership along with Bard on the Beach - all supported by a growing retail presence and online ecommerce availability," said Mr. Charlie Lamb, CEO of The Gummy Project. "Having our product available on this ferry line puts our gummies and purpose-driven mandate in front of millions of people each year allowing us to engage consumers and drive revenue growth while aligning the brand and our great tasting gummies with people in the community."

News Provided by Newsfile via QuoteMedia

Keep reading...Show less

Latest Press Releases

Related News

×