The medical world has only just begun to tap into the potential of cannabinoid-based medicines, including cannabidiol (CBD).

CBD is widely being used for mild pain relief and as a general wellness product, but the potential medical utility could go much deeper. At least one CBD product has already been approved by the US Food and Drug Administration (FDA) to treat certain forms of epilepsy in children, and pre-clinical studies of CBD have shown a positive impact in reducing inflammation. Inflammation in the form of redness or swelling of tissue is the body’s natural reaction to injury or infection and can typically be easily treated. However, serious complications can occur when uncontrolled inflammation disrupts vital organ function. Researchers and drug developers are now looking at CBD as a possible answer to a serious and potentially life-threatening form of inflammation, acute myocarditis. A clinical trial is being planned that could result in CBD gaining orphan drug status for the treatment of this condition.

Acute myocarditis: A potential use case for CBD

Acute myocarditis is a disease that results in inflammation of the heart muscle. Inflamed hearts can become weakened and enlarged, creating scar tissue that disrupts heart function and forces the heart to work harder to pump blood and oxygen throughout the body, which in turn can cause further inflammation. Acute myocarditis is one of the leading causes of heart failure in young people from puberty through their early 30s, and it is the leading cause of sudden death in children and young adults. Symptoms may include heart palpitations, chest pain, shortness of breath and swelling in the lower extremities. Serious complications include heart failure and even sudden cardiac death. Myocarditis is usually caused by viral infections but can also be caused by a number of bacterial agents or certain drugs, especially drugs used in the treatment of cancer.

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This INNspired Article is brought to you by:

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.Send me an Investor Kit

Once acute myocarditis is diagnosed, there are few treatment options available. In mild cases, the inflammation may subside spontaneously over a few days and may even go undiagnosed. In cases where there is evidence of cardiac dysfunction, it is common to prescribe medications normally used to treat heart failure. In severe cases, there is often a need for intravenous medications, implantable devices to support cardiac function or even heart transplantation. Corticosteroids have been used but there has been no uniformly accepted evidence of benefit, and long term use can produce serious side effects. This lack of satisfactory treatment options has fueled interest and research into alternative means for treating acute myocarditis.

CBD and cannabis-based treatments for myocarditis

Cannabis legalization has allowed researchers to finally take a serious look at the medical applications of cannabinoids like CBD. There’s a long way to go to bridge the knowledge gap caused by prohibition, but the anti-inflammatory properties of CBD are becoming well-recognized. One study in the European Journal of Pain showed in an animal model that CBD could reduce inflammation caused by arthritis. Other studies have helped to demonstrate the mechanism through which CBD inhibits inflammatory pain.

A growing body of pre-clinical research suggests that there are anti-inflammatory and cardioprotective properties of cannabidiol in models of cardiovascular disease. One 2016 study published in the medical journal Molecular Medicine used an animal model to test the effects of CBD on T cell-mediated inflammation, cardiomyocyte cell death, fibrosis and myocardial dysfunction. The study demonstrated that CBD inhibited T cell-mediated myocardial inflammation and improved myocardial dysfunction.

“Collectively, our study demonstrates that CBD treatment markedly attenuates autoimmune myocarditis and improves myocardial dysfunction and heart failure primarily by its anti-inflammatory and anti-fibrotic effects,” the study concludes. “These results, coupled with the proven safety of CBD in human clinical trials and its current orphan drug approval by the FDA for different neurological seizure disorders, suggest that it has tremendous therapeutic potential in the therapy of acute myocarditis with different etiologies and various autoimmune disorders.”

Based on the evidence presented by studies like these, pharmaceutical CBD company Cardiol Therapeutics (TSX:CRDL,OTCQX:CRTPF) believes that there is an opportunity to develop a potential breakthrough CBD-based therapy for acute myocarditis. The company hopes that such a therapy will be eligible for designation as an orphan drug in the US and European Union. In November 2019, Cardiol formed a clinical steering committee made up of key opinion leaders in acute myocarditis from North America and Europe to guide a Phase 2 international trial in acute myocarditis using Cardiol’s pharmaceutically produced high-concentration cannabidiol formulation. The trial is being planned at world-renowned medical research institutes, including Cleveland Clinic, the Mayo Clinic, the Houston Methodist DeBakey Heart and Vascular Center, the University of Ottawa Heart Institute and Charité University Medicine Berlin.

If Cardiol is successful in obtaining orphan drug designation, their pharmaceutically produced high concentration cannabidiol formulation would receive benefits in the US and Europe, including accelerated marketing approvals and an increased period during which Cardiol would have exclusive rights to market the drug for myocarditis treatment. Orphan drug designation is typically granted to incentivize the development of drugs for serious conditions that affect fewer than 200,000 people in the US or fewer than 5 in 10,000 people across the European Union.

“The US orphan drug program was successfully utilized to accelerate the first FDA approval of CBD for the treatment of rare forms of pediatric epilepsy,” stated David Elsley, president and CEO of Cardiol Therapeutics. “Given the mortality and the significant morbidity risk associated with acute myocarditis, we believe there is a similar opportunity in pursuing an expedited development program of our pharmaceutical CBD formulation for this serious orphan disease, which has no accepted standard of care.”

Takeaway

As CBD’s anti-inflammatory properties become better understood and documented, researchers could unlock its potential as a life-saving medicine. Exploration of this cannabinoid’s cardioprotective possibilities could offer a safe and effective approach to treating people afflicted with acute myocarditis.


This INNSpired article is sponsored by Cardiol Therapeutics (TSX:CRDL,OTCQX:CRTPF). This INNSpired article provides information which was sourced by the Investing News Network (INN) and approved by Cardiol Therapeutics in order to help investors learn more about the company. Cardiol Therapeutics is a client of INN. The company’s campaign fees pay for INN to create and update this INNSpired article.

This INNSpired article was written according to INN editorial standards to educate investors.

INN does not provide investment advice and the information in this article should not be considered a recommendation to buy or sell any security. INN does not endorse or recommend the business, products, services or securities of any company profiled.

The information contained here is for information purposes only and is not to be construed as an offer or solicitation for the sale or purchase of securities. Readers should conduct their own research for all information publicly available concerning the company. Prior to making any investment decision, it is recommended that readers consult directly with Cardiol Therapeutics and seek advice from a qualified investment advisor.

Cannabis Market Update: Q3 2020 in Review

Click here to read the previous cannabis update.

During the first few months of investment time in 2021, cannabis faced some volatility alongside optimism about federal changes in the most important market for the drug.

The cannabis business found its stride during Q1 thanks to policy change signals and consolidation.

To find out more, the Investing News Network (INN) asked experts about progress in the market during the first major period of the new year, and which developments investors should watch out for.

 

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Cannabis market update: New York and US potential boost operations

New York state’s legalization of recreational cannabis was a huge Q1 announcement that added pressure to the federal government when it comes to cannabis policy, said George Mancheril, co-founder and CEO of Bespoke Financial, a debt financing business with a particular focus on servicing cannabis businesses.

“It’s going to add to the chorus of voices in the federal scene to basically move sooner rather than later,” he explained to INN.

Following the US election in 2020, the momentum for cannabis businesses went on the upswing, as did company valuations, with the idea of expansion at the heart of it all, according to Mancheril.

Before starting Bespoke Financial, Mancheril learned from traditional investment banks, where he worked on lending, fixed income and debt markets with Goldman Sachs (NYSE:GS) and Guggenheim Partners.

Nawan Butt, portfolio manager with Purpose Investments, agrees with Mancheril. The financial expert told INN the ongoing legalization process seen in the US market is leading to expansion.

“It’s becoming more of a national move, then small pockets of proliferation. That’s very exciting about cannabis right now,” said Butt, who co-manages the Purpose Marijuana Opportunities Fund (NEO:MJJ).

This proliferation effect is causing a change in valuations and enthusiasm for US-based operations. Mancheril told INN that by the end of Q1, multi-state operators (MSOs) had raised approximately US$3.3 billion.

The cannabis lender said he sees the industry as having grown from the woes of 2019; it is now seeing a return to form by way of the excitement for an ongoing opening process in the US.

The expert explained that there is likely to be a windfall of capital in the wake of major federal changes for cannabis policy, although the timeline for these changes is becoming increasingly hard to predict.

Leading up to that capital influx, Mancheril said he wants to see operators really drill down on the value of desired assets and whether they make sense.

 

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“What I’d hope is that we continue to see bullish sentiment, but with some measure of responsibility, and let’s not just get over ahead of ourselves,” Mancheril told INN. “The idea is let’s minimize the volatility and continue growing responsibly.”

As far as struggles go, Butt explained that the cannabis industry has cemented itself as a growth-type sector, and as such there are macro environment pressures affecting the way these assets operate.

“We’ve seen this preference for cash flows at growth in the current or in the near future, rather than in the far future, and that’s what we’re seeing as far as valuations go in the broad market,” Butt said.

Cannabis market update: Volatility continues to rule as industry foundations build

Despite the industry’s current potential and the growing pains it has gone through as a whole in both the US and Canada, volatility remains a key factor in the cannabis investment scene.

Butt explained that the current shareholder base, which is dominated by hedge funds and retail investors, still lacks enough institutional support to avoid the day-to-day volatility cannabis has come to be known for.

These two investor groups, Butt said, can be easily spooked and excited by the news of the day when it comes to their investments.

“A lot of these institutions’ strategies are not about short-term profits, but they’re about long-term sustainability of the businesses themselves,” Butt said.

“That’s why you see a lot of volatility in the space, and that’s essentially what we’ve seen over the past, I’d say, three to two months as well,” he added.

That means investors shouldn’t expect an end to volatility anytime soon.

“It’s not about whether we continue to expect volatility, because we do,” Butt said. “We really think that the volatility will be taken out when the shareholder base becomes more institutional, but it’s really about understanding why there is volatility in the first place.”

Cannabis market update: Canadians talk up US business potential, but questions remain

A surge of mergers and acquisitions has taken over the Canadian cannabis sector recently as more producers see potential in America.

One of the biggest announcements in this regard came when Organigram Holdings (NASDAQ:OGI,TSX:OGI) secured a C$221 million investment deal from British American Tobacco (NYSE:BTI,LSE:BATS).

Using the funds, the two will work in tandem to develop new branded products designed to work on the international stage, including in the US. Organigram CEO Greg Engel previously told INN that the US represents a critical opportunity for Canadian companies, but the entry point isn’t as clean as it could be at the moment.

 

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While the long-term potential may be exciting for investors, Butt told INN he’s still unsure how the approach will work for Canadian companies.

The Purpose Investments expert said there will be plenty of space for the biggest Canadian names to pursue US market entries, beyond the initial hemp-derived CBD moves some operators have mde, since the US represents the biggest market in the world.

“But there’s just way too many unknowns right now to say exactly what that participation is going to look like, or when that participation will happen,” he said.

“What we do know is that currently the US MSOs are in a wonderful sort of position to expand on their market leadership that they have. And it will be tough for Canadians to come in and compete with them,” Butt said.

Canadian players still retain the upper hand at times in terms of valuation, which is confusing for both Butt and Dan Ahrens, chief operating officer and portfolio manager at AdvisorShares.

“The performance in quarterly earnings of US companies has been rather spectacular. They’ve knocked it out of the park in most instances,” Ahrens told INN.

Butt praised the recent performance reports from MSOs across the board, pointing to year-over-year growth lines and projections for continued positive performance.

In his view, share prices still don’t reflect company value. “Those are really being discounted at this point,” Butt told INN.

“We’ve seen the Canadian licensed producers be really hot stock performance-wise, outpacing the US (MSOs), and I’ll say it’s rather nonsensical to me,” said Ahrens, who oversees the AdvisorShares Pure Cannabis ETF (ARCA:YOLO) and the recently launched AdvisorShares Pure US Cannabis ETF (ARCA:MSOS).

Cannabis market update: Investor takeaway

The cannabis investment proposition finds itself at an interesting moment in time, as the entire sector eagerly awaits confirmation in the US at the federal level.

While for the Canadians waiting on the sidelines, this development may feel like a major necessity to address current financial struggles, for US-based operators, the heat around the corner could represent an increase to their already thriving operations.

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 Trulieve Cannabis Corp. (“Trulieve” or the “Company”) (CSE: TRUL) (OTC: TCNNF), a leading and top-performing cannabis company in the United States will release its first quarter 2021 financial results on Thursday, May 13, 2021 before markets open. Following the earnings release, management will host a conference call at 8:30 AM Eastern Time to review the financial results.

All interested parties can join the conference call by dialing 1-888-231-8191 or 1-647-427-7450, conference ID: 4880609. Please dial in 15 minutes prior to the call to secure a line. The conference call will be archived for replay until May 20, 2021 . To access the archived conference call, please dial 1-855-859-2056 and enter the encore code 4880609.

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Appointment of Dr. Kelmendi, Assistant Professor of Psychiatry at Yale University and co-founder of the Yale Psychedelic Science Group, brings another experienced medical professional to Lobe’s advisory team.

 Lobe Sciences Ltd. (CSE: LOBE) (OTC Pink: GTSIF) (“Lobe” or the “Company”) is pleased to announce the appointment of Benjamin Kelmendi, MD, Assistant Professor of Psychiatry at Yale University School of Medicine, to its Scientific Advisory Board.

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Ayurcann Holdings Corp. ( CSE: AYUR ) (the “ Company ” or ” Ayurcann “), a Canadian extraction company specializing in the processing of cannabis and hemp for the production of oils and various derivative products, is pleased to unveil further details of its Phase 2 expansion plans.

Ayurcann has commenced trading on the Canadian Securities Exchange (” CSE “) on April 8, 2021 and subsequently announced a private placement of up to $500,000 (” Financing “), as per the Company’s press release dated April 12, 2021. The proceeds of the Financing are intended to be used to further pursue Phase 2 of the expansion of the production capacity of the Company’s Pickering facility.

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