clinical trials – MJ Shareholders https://mjshareholders.com The Ultimate Marijuana Business Directory Thu, 31 Aug 2023 19:43:59 +0000 en-US hourly 1 https://wordpress.org/?v=6.5.5 Number of Clinical Trials Using Cannabis-Based Medicines to Treat Symptoms From Conditions Like Cancer Increases by 650% Since 2010, Report Finds https://mjshareholders.com/number-of-clinical-trials-using-cannabis-based-medicines-to-treat-symptoms-from-conditions-like-cancer-increases-by-650-since-2010-report-finds/ Thu, 31 Aug 2023 19:43:59 +0000 https://cannabisfn.com/?p=2974026

Ryan Allway

August 31st, 2023

News, Top News


Key Findings:

  • Pain, from various conditions, is by far the most prevalent symptom treated in clinical trials involving cannabinoids – with pain being the target condition in 46% of trials since 2010.
  • The most commonly featured conditions in the patent landscape include epilepsy, cancer and associated conditions, seizures, and autism spectrum disorder.
  • Clinical trials featuring patented compounds (Sativex and Epidiolex) dominate completed phase 3 trials
  • It is estimated that global sales within the pharmaceutical cannabis industry will amount to approximately US$1.11 billion in 2023, with projections indicating a growth to US$1.37 billion by 2027.

The number of clinical trials using cannabis-based medicines to treat patients with symptoms from a variety of conditions – including cancer, epilepsy and autism spectrum disorder – has exploded since 2010, a new report has found.

In 2010, only eight clinical trials globally used cannabis-based medicines as a treatment for conditions such as Diabetes and Anxiety. In 2022 alone, 60 clinical trials began – a 650% increase in comparison to 2010.

So far this year, 49 clinical trials involving cannabis-based medicines have already started, with more due to kick-off before the end of the year.

Almost every year since 2015, the number of clinical trials has increased year-on-year.

Almost half of all clinical trials globally involving pharmaceutical cannabis medicines since 2010 have targeted ‘pain’ from various conditions.

Of the 440 clinical trials analysed, in 46% – or 202 trials in total – ‘pain’ was found to be the target condition for treatment. Chronic or neuropathic pain, in particular, has been the target symptom in the majority of trials, encompassing conditions such as fibromyalgia/myofascial pain, cancer-related pain and pain associated with neurodegenerative diseases such as MS and Parkinson’s.

In recent years, there has, instead, been a notable increase in clinical trials examining the potential benefits of cannabis and cannabinoids for various mental-related disorders, such as anxiety and depression.

The types of medicines being used in these clinical trials consist of a variety of different cannabinoids. Of all trials analysed, 34.5% used a combination of the two most commonly-known cannabinoids – THC and CBD.

Lawrence Purkiss, senior analyst at Prohibition Partners and co-author of the report, said: “Looking at the development of clinical trials in cannabis over the last decade gives great insight into the potential breakthroughs in the space in the coming years. From analysing the patent landscape in conjunction with the clinical trials record, it’s clear that the possibilities for further cannabinoid-based treatments are incredibly broad, with significant interest already in specific areas.”

Analysis and findings have been published this week by Prohibition Partners in The Pharmaceutical Cannabis Report: 3rd Edition, in collaboration with Cannabiscientia, just hours before the US Department of Health and Human Services (HHS) sent a recommendation to the Drug Enforcement Administration (DEA), stating that cannabis should be reclassified from Schedule I to Schedule III – potentially paving the way for many more patients to benefit from cannabis-based medicines.

On the HHS’s recommendation, Stephen Murphy, CEO of Prohibition Partners, said: “The HHS recommendation further splits the path of cannabis between adult-use and medical purposes. This helps advance access, but also opens the door for the existing healthcare and pharmaceutical industry to embrace patient demand.”

“The just-published The Pharmaceutical Cannabis Report: 3rd Edition highlights the path forward for cannabis and the explosion of clinical research and development that will be further enhanced once this recommendation comes to fruition.”

ABOUT PROHIBITION PARTNERS

Prohibition Partners is a data, media and tech company operating in the fast-growing legal cannabis industry. We provide the industry with specialist information, data analytics and digital commerce solutions.

Michael Hoban

Head of Marketing & Comms

31 New Inn Yard, London, EC2A 3EY

+44 (0)7841 697433

This article was published by CFN Enterprises Inc. (OTCQB: CNFN), owner and operator of CFN Media, the industry’s leading agency and digital financial media network dedicated to the burgeoning CBD and legal cannabis industries. Call +1 (833) 420-CNFN for more information.

About Ryan Allway

Mr. Allway has over a decade of experience in the financial markets as both a private investor and financial journalist. He has been actively involved in the cannabis industry since its inception, covering public and private companies.


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Optimi Health Announces Closing Of Strategic Non-Brokered Private Placement https://mjshareholders.com/optimi-health-announces-closing-of-strategic-non-brokered-private-placement/ Tue, 11 Oct 2022 22:20:33 +0000 https://www.cannabisfn.com/?p=2965296 Highlights:

• $1.85 million in proceeds received through a strategic offering of units at $0.325 per unit with each unit comprised of one common share and one-half of one (1/2) Common Share purchase warrant exercisable at $0.50, for total potential proceeds of $3.27 million.

• Financing will fuel Optimi’s ongoing commercialization efforts, support new product development and provide necessary working capital to be strategic in the marketplace, with opportunities being explored in Oregon and Alberta.

• Chip Wilson, founder of lululemon athletica inc., is an advisor to the Company and health and wellness advocate.

• The Private Placement increases Chip’s ownership to 9.5% on a fully diluted basis.

VANCOUVER, BC — October 11, 2022 — Optimi Health Corp. (CSE: OPTI) (OTCQX: OPTHF) (FRA: 8BN) (“Optimi” or the “Company”), a leading GMP producer and safe supply advocate licensed by Health Canada to produce and distribute natural, EU-GMP grade psilocybin and other psychedelic substances, most notably MDMA, is pleased to announce it has closed a non-brokered private placement of 5,692,308 units of the Company (each a “Unit”) at a price of $0.325 per Unit (the “Private Placement”) for gross proceeds of $1,850,000 with Wilson Capital, the Private Equity Division Chip Wilson’s (“Chip”) family office. The Company intends to use the proceeds from the issuance of the Units to support its psychedelic product commercialization efforts, ongoing psilocybin and MDMA research and clinical trial initiatives, in-house drug development, and for general working capital.

Each Unit consists of one (1) common share of the Company (a “Common Share”) and one-half of one (1/2) Common Share purchase warrant (each whole warrant, a “Warrant”). Each Warrant is exercisable at $0.50 for a period of two (2) years from the date of issuance. The Common Shares and Warrants comprising the Units and any Common Shares issued upon exercise of the Warrants are subject to a statutory hold period of four months plus a day from the date of issuance in accordance with applicable securities laws.

Optimi welcomes this strategic investment led by the family office of Chip Wilson, founder of lululemon athletica inc., who also serves on the Advisory Board of Optimi. Mr. Wilson, stated, “Our participation in the placement speaks to our belief that the Company can achieve its plan to be a world leader in psychedelic product development and global distribution.”

Optimi CEO, Bill Ciprick, commented, “It is important to demonstrate both to our existing shareholders and the market at large that Optimi’s leadership is taking an active role in raising smart capital. When looking at a variety of potential funding options to lead this round of financing, apart from ensuring the terms of the financing were highly competitive, expanding its relationship with Chip through this investment was the preferred scenario given Chip’s familiarity with the operational business, his ongoing support to Optimi in an advisory capacity, and understanding of management and the Board’s track record and commitment to achieving its near and long-term corporate milestones.”

The private placement increases the amount of the Company’s Common Shares owned by Founders, members of the Advisory Board, Directors, and Officers.

Optimi co-founder, director and CFO, Jacob Safarik, says, “This pivotal financing puts the Company in the enviable position of being backed by one of the most trusted family offices in Canada. In a time of market instability, Optimi has maintained the necessary flexibility to execute on its path to profitability while strengthening its working capital position to continue pursuing important product development and research initiatives that support Optimi’s position as a leading safe supply advocate,” said Safarik. “It is crucial to our continued success that Optimi be ready for opportunities including the implementation of legal psychedelic therapy in new markets taking shape, such as Oregon and Alberta, and that we have a variety of safe, lab tested, EU-GMP psilocybin and MDMA products available to patients around the world as the global regulatory markets continue to evolve.”

The strategic offering sets the foundation for the Company’s upcoming expansion milestones, including Phase I and II psilocybin and MDMA clinical trials with ATMA Journey Centers, the rollout and expansion of Optimi’s functional mushroom and psychedelic product catalogues, and establishing an operational footprint in Oregon’s regulated psilocybin market.

Optimi co-founder, director and CMO, Dane Stevens, stated, “This sends the right message at the right time to investors paying close attention to the psychedelics market. When an investor like Chip Wilson offers to increase his position and back the future of Optimi, you find a way to get a deal done. Optimi would not exist without the vision and commitment of JJ and Chip Wilson, the Safarik family, and the shared belief that the work we are doing today will improve the health of so many in need for many years to come. With this strategic raise, we are building trust with shareholders and operations team alike, and demonstrating that the Company’s Founders and leadership team are committed to the long-term success and growth of Optimi.”

The Wilson family recently made news for their $100,000,000 donation, the largest in history, to the B.C. Parks Foundation — as well as the establishment of Solve FSHD (a foundation to research into a cure for facioscapulohumeral muscular dystrophy) with an additional $100 million, in September and March of 2022, respectively. These were facilitated by the Wilson 5 Foundation, the family’s private foundation.

FOR INTERVIEW REQUESTS OR FURTHER INFORMATION PLEASE CONTACT:

Michael Kydd
Investor Relations
Email: [email protected]

NOT FOR DISTRIBUTION TO U.S. NEWSWIRE SERVICES OR FOR DISSEMINATION IN THE UNITED STATES. ANY FAILURE TO COMPLY WITH THIS RESTRICTION MAY CONSTITUTE A VIOLATION OF U.S. SECURITIES LAWS.

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Big Data and AI Can Guide Cannabis Medicine https://mjshareholders.com/big-data-and-ai-can-guide-cannabis-medicine/ Mon, 30 Aug 2021 11:45:43 +0000 https://www.cannabisfn.com/?p=2932074

Robin Lefferts

August 30th, 2021

App, Exclusive, News, Top Story


In order for cannabis medicine to make the big leap to mainstream acceptance, a few things likely have to take place. Doctors, not just cannabis providers, need to become more comfortable discussing and prescribing the plant. Regulations need to become more homogenous and universal, like the pharmaceutical industry. Pharma companies need to advance more cannabis-derived medicines for approval.

In order for those things to happen, robust data around the efficacy of cannabis treatments needs to be gathered and widely understood. In the meantime, cannabis patients and providers are often stuck with a personal trial-and-error approach to finding the right treatment for their own needs. RYAH Group Inc. (CSE: RYAH) is one company that is pushing forward in all of these areas. The company’s smart delivery devices, database with over 200,000 users, and artificial intelligence-powered data engine combine to form a powerful Internet of Things solution with the potential to more fully legitimize cannabis medicine while making it more effective for current patients.

Moving the Industry Forward

Regulators like the United States Food and Drug Administration (FDA) need data to make informed decisions. Big pharma companies need data to even undertake research programs aimed at developing new potential drugs. Doctors need data to feel comfortable giving prescriptions or recommendations for treatment.

Since the cannabis industry is so young, was prohibited for so long, and still faces a myriad of patchwork and inconsistent regulations, cannabis medicine is severely lacking the large datasets that are crucial for the industry’s development. In this regard, RYAH is well-positioned to provide all interested parties with the information necessary for growth and advancement.

RYAH’s Data Sharing Benefits

The company’s smart devices and data solutions are gaining traction with cannabis researchers across the globe. The controlled dosing, easily recorded personal feedback from patients, wealth of data stored in RYAH’s Cloud database, and AI-powered data interpretation and organization give researchers tools that make their studies more effective and efficient. RYAH is involved in trials and studies in Britain, Italy, Italy again, and the Channel Islands. The company also has deals in France and New Zealand for distribution and potential inclusion in clinical trials and major studies.

RYAH’s goal is to provide regulators, researchers, and drug companies all the data they need to mainstream plant-based medicine, and it looks like the company is on its way.

Click here to receive an investor presentation and corporate updates

Improving the Patient Experience

RYAH’s smart devices, connected apps, and AI data interpreter can help patients and doctors effectively hone a treatment regimen according to the patient’s own feedback combined with that of the other users in the system. Without the insights from a large patient pool and the ability to easily record, track, and interpret personal experiences and preferences, many cannabis patients can get a little lost. Which strain? What is the proper dose? Has this particular type of treatment worked for other people?

Watch how Ryah technology Benefits to Patients and Doctors

RYAH’s system offers control and assurance, not only to researchers and patients involved in clinical trial programs but also to normal, everyday medical cannabis users in search of a little guidance. To many, using cannabis presents a great unknown fraught with risks. RYAH helps to alleviate those concerns and bring the cannabis patient experience more in line with that of conventional patients.

The Takeaway

This type of system is right in line with the larger trend toward tele-health and the use of machine learning and artificial intelligence to improve patient outcomes. Overall, the market for remote treatment is growing at a 26.5% CAGR, expected to reach $475 billion in the next five years. It’s a huge trend in healthcare, and RYAH is at the forefront of the movement in the cannabis industry.

The two aspects of RYAH’s business go hand in hand, improving treatments for cannabis patients while providing data and a platform that enables research and regulation that will further legitimize the industry as a whole. Keep an eye out for continued developments in the RYAH story.

Click here to receive an investor presentation and corporate updates

Disclaimer

The above article is sponsored content. CannabisFN.com and CFN Media, have been hired to create awareness. Please follow the link below to view our full disclosure outlining our compensation: http://www.cannabisfn.com/legal-disclaimer/

This article was published by CFN Enterprises Inc. (OTCQB: CNFN), owner and operator of CFN Media, the industry’s leading agency and digital financial media network dedicated to the burgeoning CBD and legal cannabis industries. Call +1 (833) 420-CNFN for more information.

About Robin Lefferts

Robin Lefferts has been involved in the legal cannabis industry since 2012, sometimes as an active participant and always as an interested observer.


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New CBD Trials Point the Way for Enveric, MagicMed https://mjshareholders.com/new-cbd-trials-point-the-way-for-enveric-magicmed/ Fri, 30 Jul 2021 12:40:00 +0000 https://www.cannabisfn.com/?p=2927827

Ryan Allway

July 30th, 2021

Psychedelics, Top Story


As the cannabis industry strives to gain widespread acceptance in the mainstream, scientific studies into the potential benefits of the plant and its active ingredients play a key role in reaching that goal. There are currently very few approved pharmaceutical drug applications for cannabinoids, but that could change. After decades of effective prohibition there is a growing body of research surrounding cannabinoids, and more drug approvals are likely to follow.

All of the above applies equally to the promising area of psychedelic research, though the psychedelic industry is at an even earlier stage than the cannabis industry. Studies point to potential benefits for patients suffering from conditions such as PTSD, anxiety, addiction, and depression to name a few. More research is needed and getting psychedelics into clinical trials is really the next step.

Two companies on the verge of a merger are looking to push clinical research forward in both areas. Enveric Biosciences (NASDAQ: ENVB) is a pioneer in cannabinoid research that recently announced a Phase 1/2 trial focused on CBD as a complementary treatment for recurrent cases of the devastating brain cancer glioblastoma (GBM). Enveric also recently announced a definitive agreement to acquire and combine with MagicMed Industries, a leader in the research and development of novel derivative psychedelic molecules designed for clinical use. The combination of the two companies has the potential to greatly advance pharmaceutical development in both sectors.

Clinical Trial

Enveric’s clinical trial has been approved by the Israeli Ministry of Health and will be conducted at the Davidoff Institute of Oncology, Rabin Medical Center, in Israel under Principal Investigator Dr. Tali Siegal. Israel has long been a global leader in cannabis research with the backing of the federal government, and the country continues to push the boundaries of our knowledge of the plant and its benefits.

GBM is the most common and lethal form of cancer affecting the central nervous system. Five year survival rates for patients with the disease are very poor, with about 5% surviving through that time and the average length of survival less than two years. Despite much research over the last few decades, these rates remain largely unchanged.

Enveric is studying the combination of its lead synthetic CBD candidate, EV101, with two currently accepted forms of treatment for GBM. Preclinical data supports the idea of the combined treatments, which suggest that CBD may improve the efficacy of chemo- or immuno-therapies while potentially allowing for lower doses of chemotherapeutic agents.

Glioblastoma tumors express CB2 receptors, which are the channels through which CBD and other cannabinoids are thought to exert their anti-cancer effects. Research indicates CBD may induce apoptosis, or cell death, in cancer cells. The results of Enveric’s Phase 1/2 trial could greatly further the understanding of these mechanisms and ideally improve outcomes for GBM patients.

The Combined Company

MagicMed has established a growing library, called the Psybrary™, of novel compounds based on or derived from psychedelic molecules such as psilocybin and DMT. The company’s approach is to create patentable drug candidates that enhance the therapeutic effects of the naturally occurring molecules. MagicMed’s expertise lies in research and development, and its business model is to sell or license these drug candidates to pharmaceutical companies, like Enveric, with the capabilities to conduct clinical trials.

With the pending acquisition, the combined companies would be able to keep the whole process, from drug discovery and molecule development through clinical trials and drug approval, under one roof. The hope is to advance psychedelic therapies and research into the mainstream and, of course, gain approvals for drug treatments of major indications like anxiety, PTSD, and depression. The fact that Enveric is listed on the NASDAQ and has clinical trial experience should only work to the benefit of achieving those goals, both in terms of access to capital for development and more generally the acceptance of psychedelic research in the investment community.

Once the deal is finalized, some members of the MagicMed executive team will assume their existing roles in the new version of Enveric Biosciences. CEO Dr. Joseph Tucker will become CEO of Enveric, with current Enveric CEO David Johnson becoming the Executive Chairman. Meanwhile, MagicMed CSO Dr. Peter Facchini and CTO Dr. Jillian Hagel will be named to the same positions in the new company.

The Takeaway

Investors interested in early mover companies in emerging health care sectors may want to track Enveric Biosciences’ development. Upcoming inflection points include the GBM trial, the finalization of the merger between MagicMed and Enveric, and the further development of potential psychedelic therapies. The combined capabilities of the two companies could serve to greatly enhance our understanding of both cannabis and psychedelic science after decades of neglect. Stay tuned.

Disclaimer

The above article is sponsored content. CannabisFN.com and CFN Media, have been hired to create awareness. Please follow the link below to view our full disclosure outlining our compensation: http://www.cannabisfn.com/legal-disclaimer/

This article was published by CFN Enterprises Inc. (OTCQB: CNFN), owner and operator of CFN Media, the industry’s leading agency and digital financial media network dedicated to the burgeoning CBD and legal cannabis industries. Call +1 (833) 420-CNFN for more information.

About Ryan Allway

Mr. Allway has over a decade of experience in the financial markets as both a private investor and financial journalist. He has been actively involved in the cannabis industry since its inception, covering public and private companies.


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Regulatory Approvals Place Filament Health at the Forefront of Natural Psychedelic Research and Manufacturing https://mjshareholders.com/regulatory-approvals-place-filament-health-at-the-forefront-of-natural-psychedelic-research-and-manufacturing/ Thu, 29 Jul 2021 20:24:00 +0000 https://www.cannabisfn.com/?p=2927758

Ryan Allway

July 29th, 2021

Psychedelics


Health Canada Dealer’s License to allow the possession, production, and delivery of all controlled natural psychedelic substances

VANCOUVER, BC July 29, 2021 /CNW/ – Filament Health Corp. (NEO: FH) (“Filament” or the “Company”), a global leader in natural psychedelic drug development, has been granted an amendment to its existing Health Canada Dealer’s License, amplifying the Company’s position at the forefront of natural psychedelic research and manufacturing.

Filament operates a state-of-the-art GMP facility currently manufacturing drug candidates naturally extracted from psychoactive mushrooms. The amendment to Filament’s Health Canada Dealer’s License allows the possession, production, research supply, export, import, and delivery for all remaining controlled natural psychedelic substances, including N,N-dimethyltryptamine, mescaline, and others. Filament will seek to create the first-ever natural pharmaceutical grade extracts of these substances and enter them into clinical trials to demonstrate their safety and efficacy.

“This license amendment significantly increases the scope of our work with natural psychedelics,” said Filament’s Director of Research, Ryan Moss . “By studying untapped psychedelics in a scientific setting, we believe we can unlock and standardize their healing power. This is a promising step forward in our mission to get safe, natural psychedelics into the hands of everyone who needs them, as soon as possible.”

The compounds covered by Filament’s license amendment have a long history of use in traditional medicine and recreational settings. The company plans to develop naturally derived, standardized preparations, and study their applications for therapeutic use to treat a range of health conditions.

“We are encouraged by this development, which we believe strengthens Filament’s position and opens up new revenue sources for us,” said Filament Chief Executive Officer Benjamin Lightburn . “The benefits of these valuable plants are well-documented; we will be among the first to purposefully explore their pharmaceutical applications.”

Filament will produce the psychedelic extracts in-house at its GMP-certified facility in Metro Vancouver, where it has also developed compounds which will be studied in the first ever FDA-approved natural-psilocybin clinical trials, beginning in Q3 2021.

ABOUT FILAMENT HEALTH
Filament is an exclusively-natural psychedelic drug discovery and extraction technology company. Its mission is to see safe, approved, natural psychedelics in the hands of everyone who needs them as soon as possible. Filament believes measurable and efficacious medicines will be a catalyst to addressing many of the world’s mental health problems and that natural psychedelics provide an optimal option for widespread adoption of these substances. Filament engages in natural extraction technology commercialization, utilizing its intellectual property portfolio, in-house GMP facility, and Health Canada Dealer’s License for all natural psychedelics. Filament is headquartered in Vancouver, British Columbia and trades on Canada’s NEO Exchange (NEO:FH).

FORWARD LOOKING INFORMATION
Certain statements and information contained herein may constitute “forward-looking statements” and “forward-looking information,” respectively, under Canadian securities legislation. Generally, forward-looking information can be identified by the use of forward-looking terminology such as, “expect”, “anticipate”, “continue”, “estimate”, “may”, “will”, “should”, “believe”, “intends”, “forecast”, “plans”, “guidance” and similar expressions are intended to identify forward-looking statements or information. The forward-looking statements are not historical facts, but reflect the current expectations of management of Filament regarding future results or events and are based on information currently available to them. Certain material factors and assumptions were applied in providing these forward-looking statements. The forward-looking statements discussed in this press release may include, but are not limited to, information concerning compliance with extensive government regulation; general business, economic, competitive, political and social uncertainties; Filament’s expectations concerning its ability conduct clinical trials; the timing and results of such clinical trials; the nature, timing, and possible success of Filament’s Health Canada Dealer’s License amendment on Filament’s business and controlled natural psychedelic substances; and the impact and accessibility of psychedelic treatments. Forward-looking statements regarding the Company are based on the Company’s estimates and are subject to known and unknown risks, uncertainties and other factors that may cause the actual results, levels of activity, performance or achievements of Filament to be materially different from those expressed or implied by such forward-looking statements or forward-looking information, including capital expenditures and other costs. There can be no assurance that such statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, readers should not place undue reliance on forward-looking statements and forward-looking information. Filament will not update any forward-looking statements or forward-looking information that are incorporated by reference herein, except as required by applicable securities laws.

SOURCE Filament Health Corp.

This article was published by CFN Enterprises Inc. (OTCQB: CNFN), owner and operator of CFN Media, the industry’s leading agency and digital financial media network dedicated to the burgeoning CBD and legal cannabis industries. Call +1 (833) 420-CNFN for more information.

About Ryan Allway

Mr. Allway has over a decade of experience in the financial markets as both a private investor and financial journalist. He has been actively involved in the cannabis industry since its inception, covering public and private companies.


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Wake Network Retains CRO Santé Cannabis to Conduct Clinical Trials in Psilocybin Therapies https://mjshareholders.com/wake-network-retains-cro-sante-cannabis-to-conduct-clinical-trials-in-psilocybin-therapies/ Wed, 16 Jun 2021 14:57:57 +0000 https://www.cannabisfn.com/?p=2922108

Ryan Allway

June 16th, 2021

Psychedelics


TORONTOJune 16, 2021 /CNW/ – Wake Network Inc. (“Wake” or the Company“), a global leader in psilocybin and medicinal mushroom production and developer of genomics-based integration therapies, is pleased to announce that it has entered into an agreement with Santé Cannabis (“Sante”) for consultation and clinical research services to support Wake clinical trials in Canada. Both parties to this new relationship are committed to excellence in clinical research and patient access to psychedelic medicine with a focus on naturally derived psilocybin.

This agreement, under which Wake and Santé will collaborate on clinical research initiatives in Canada, is the first of its kind, bringing together an innovative leader in the psychedelic medicine space with a pioneer of medical cannabis research and clinical practice to bring trailblazing discoveries of new and more effective treatment options for patients. As two emergent complementary medicines, many parallels exist between the medical cannabis industry and the currently developing psychedelic medicine industry. This engagement will build on the strong foundation on Santé, having treated more than 10,000 patients since 2014 under a real-world data protocol. With this engagement, Wake finds significant value by capitalizing on Santé’s experience navigating complex regulatory changes and leveraging years of expertise with naturally derived controlled substances.

“Santé is a key partner to for Wake as they are a leading contract research organization (CRO) in Canada with expertise in advancing plant-based pharmaceutical products through various phases of clinical trial development. This relationship enables us to initiate our clinical research program and marks an important step for Wake in Canada. Working with such an experienced partner in the field of complementary medicines, we can offer a unique opportunity for physicians to learn about our clinical research program and to broaden their knowledge base on all aspects relating to the benefits of psychedelics,” stated Nick Murray, Chief Executive Officer of Wake.

Under this engagement, in addition to the clinical trials, Santé will also engage with physicians, therapists, and research investigators as partners in psychedelic medicine and research development.

“The opportunity to work with Wake Network, a company committed to the scientific advancement of psychedelic medicines, is one that our team values greatly. Our clinical research and professional training experience has shown us the positive impact of bringing a new clinical tool to physicians. We are excited to explore the potential of emergent psychedelic therapies. Patients deserve more options, and to be assured of the safety and efficacy of their treatments; similarly, physicians deserve answers and are a critical partner in the development of this new therapeutic class,” says Erin Prosk, President of Santé.

Training will be provided within the research program for licensed practitioners to assess the safety of psychedelic medicines and to classify and report positive and adverse events. Wake and Santé will create a portfolio of resources for all licensed practitioners that will include the pillars of safe and effective use including informed consent, harm reduction, patient monitoring and ongoing support.

ABOUT WAKE NETWORK, INC.

Wake Network Inc. is a fungi bioscience company focused on advancing, through research, the field of psychedelic and fungi-based therapeutics. To address the growing need for psychedelic-assisted mental health support in medicine and society at large, Wake has partnered with academics, governments and best-in-class mycologists around the world. Wake is currently developing fungus-derived psilocybin and medicinal mushroom products and is making advancements in the engineering of novel psychedelic biologics, while working on proving out their safety through proprietary genetics-based integration therapies.

ABOUT SANTÉ CANNABIS

Santé Cannabis is a leading medical clinic and research centre dedicated to medical cannabis treatments and complementary medicines. With four clinics in Quebec, Canada, and a network of over 4,000 referring doctors, the multidisciplinary team of physicians and nurses of Santé Cannabis have collected data from, and delivered education to, over 10,000 patients since 2014, through their peer-reviewed world-leading model of care.

Established as Canada’s first independently accredited cannabis Contract Research Organization (CRO) with experience developing and executing cannabis clinical trials, Santé Cannabis is an experienced clinical trial site. They have completed successful healthcare professional training programs in more than five unique countries and are recognized as a university teaching site. Santé Cannabis is at the forefront of safe and supported patient access to complementary medicines.

Caution Regarding Forward-Looking Information

This news release contains forward-looking statements within the meaning of applicable securities laws. All statements that are not historical facts, including without limitation, statements regarding future estimates, plans, programs, forecasts, projections, objectives, assumptions, expectations, or beliefs of future performance, are “forward-looking statements.” Forward-looking statements can be identified by the use of words such as “plans”, “expects” or “does not expect”, “is expected”, “estimates”, “intends”, “anticipates” or “does not anticipate”, or “believes”, or variations of such words and phrases or statements that certain actions, events or results “may”, “could”, “would”, “might” or “will” be taken, occur or be achieved. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results, events or developments to be materially different from any future results, events or developments expressed or implied by such forward looking statements. 

Forward looking statements are based on certain assumptions regarding the Company, including but not limited to expected growth, results of operations, performance, industry trends and growth opportunities. While the Company considers these assumptions to be reasonable based on currently available information, they may prove to be incorrect. By their nature, forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including but not limited to: dependence on obtaining and maintaining regulatory approvals, including federal, provincial, municipal, local or other licences, to operate and expand the Company’s facilities;  the Company’s limited operating history and lack of historical profits; reliance on management; the Company’s requirements for additional financing and the effect of capital market conditions and other factors on the availability of capital; competition, including from more established or better financed competitors; the need to secure and maintain corporate alliances and partnerships, including with research and development institutions, customers and suppliers; the Company’s ability to conduct the clinical trials that it intends to;  the ability of the Company to discover new and/or more effective options for patients to treat their conditions; the development and implementation of medical protocols and treatment standard operating procedures for the use of psychedelic therapies; the Company’s ability to successfully withstand the economic impact of COVID-19; the medical benefits, safety, efficacy, dosing and social acceptance of psychedelics; and the cultivation and harvest of psilocybe mushrooms; and any other factors or developments that may hinder the market or the Company’s growth. 

These factors should be considered carefully, and readers are cautioned not to place undue reliance on such forward-looking statements. Although the Company has attempted to identify important risk factors that could cause actual actions, events, or results to differ materially from those described in forward-looking statements, there may be other risk factors that cause actions, events or results to differ from those anticipated, estimated or intended. There can be no assurance that forward-looking statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in forward-looking statements. The Company has no obligation to update any forward-looking statement, even if new information becomes available as a result of future events, new information or for any other reason except as required by law.

SOURCE Wake Network, Inc.

This article was published by CFN Enterprises Inc. (OTCQB: CNFN), owner and operator of CFN Media, the industry’s leading agency and digital financial media network dedicated to the burgeoning CBD and legal cannabis industries. Call +1 (833) 420-CNFN for more information.

About Ryan Allway

Mr. Allway has over a decade of experience in the financial markets as both a private investor and financial journalist. He has been actively involved in the cannabis industry since its inception, covering public and private companies.


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RYAH Medtech Expanding Internationally with Flurry of Deals https://mjshareholders.com/ryah-medtech-expanding-internationally-with-flurry-of-deals/ Thu, 03 Jun 2021 12:00:08 +0000 https://www.cannabisfn.com/?p=2920681

Robin Lefferts

June 3rd, 2021

App, Exclusive, Top Story


A sometimes overlooked aspect of the cannabis industry is the global potential for North American companies. To be sure, the United States and Canada represent the largest and most mature legal cannabis markets, and many companies are rightfully focused on them exclusively. But some companies are set up to not only capitalize on these domestic markets but to pioneer emerging industries in the European Union and elsewhere. It’s not easy for North American companies to do business across the pond from a regulatory perspective, but companies that manage to pull it off might be worth considering due to the greatly increased addressable market.

One company that is aggressively expanding internationally is RYAH Group, Inc. (CSE: RYAH) and its wholly-owned subsidiary RYAH Medtech Inc. The company has developed a suite of smart cannabis and plant-based medicine devices designed to help everyone involved, from patients to doctors to researchers to growers, make more informed decisions based on accumulated data and analysis. Over the last few weeks, and on the heels of the company going public, RYAH has announced a few international deals that provide a look at the global potential for the business model.

Here is an overview of the company’s product offerings, data-centric model, and AI-fueled approach to deciphering that data. Short version: RYAH has developed smart inhalers, patches, and pens that allow patients to precisely control their dosing while recording their experiences by using the proprietary software that RYAH built. Prescribing doctors have access to this information, allowing them to perfect the treatment regimen in concert with the patient. RYAH assembles this data into a mass of information managed and analyzed by the RYAH Cloud data engine. The parsed data is then made available to interested parties from all angles of the medical cannabis world, helping them make better decisions based on a broad data set.

International Expansion

Since commencing trading on the Canadian Securities Exchange on May 10, 2021, RYAH has announced three deals in international markets. Most recently, the company shipped its proprietary Smart Dose-Measuring Inhalers to Italy where they will be used in a pioneering study of medical cannabis use there. The client is CLINN medical center in Milan, the first and only cannabis-specialized clinic in Italy. CLINN was recently named the Best Medicinal Cannabis Clinic in Europe by Canex.

CLINN is utilizing the inhalers to study medical cannabis use, utilizing the precise dosing and patient feedback functions to gain greater insight into how patients use cannabis and their experiences resulting from that use. Though CLINN is Italy’s only cannabis-specific clinic, the country represents Europe’s second largest medical cannabis market. Sales in Italy increased 30% in 2020 over the previous year in spite of the pandemic, in the seventh year of legal medical cannabis there.

In France, RYAH announced an exclusive distribution and development agreement for its inhalers with DelleD SAS. France’s government is conducting a two-year national experiment to gather data about the effectiveness and safety of medical cannabis in anticipation of eventual legalization. Here, RYAH is laying the groundwork in a potentially lucrative market while possibly participating in the government study. The company’s inhalers provide just the sort of data required for such a study, but at this point it is not certain they will be used there.

In New Zealand, RYAH has an exclusive supply and distribution agreement with Medical Kiwi Ltd., a multi-faceted and market leading medical cannabis company involved in cultivation, distribution, and device manufacturing. The deal will enable RYAH’s suite of connected IoT devices and cloud-based data analytics to be connected with Medical Kiwi’s cultivated medical cannabis formulations and patient network for pre-clinical and clinical trial settings as well as medical patient care in New Zealand. The companies are also looking at registering RYAH’s inhaler as a medical device in the country, which would be the first of its kind there.

In addition to that, RYAH has also very recently completed a shipment for a previously announced UK-based clinical trial. This 5-year study is expected to cover tens of thousands of patients suffering from chronic pain, which makes it one of the largest and most ambitious research projects to be conducted in the plant-based treatment arena.

Put It All Together

You can see RYAH’s approach to the international cannabis industry taking shape here. By partnering with prominent companies in both established and potential markets, RYAH is able to establish a presence in the early stages of development. The company is already active in Australia and is surely pursuing deals in other countries as well.

Another aspect of these deals is the addition of valuable data to RYAH’s growing database of medical cannabis information. The database already contains information from over 300,000 medical cannabis users, perhaps the largest repository of its kind in the world. Regardless of the country of origin, more data means better information for all of the users in the RYAH ecosystem. Keep an eye on the company as it continues its quest to bring order and insights from its big, smart data to the sometimes chaotic world of the emerging cannabis industry.

Disclaimer

The above article is sponsored content. CannabisFN.com and CFN Media, have been hired to create awareness. Please follow the link below to view our full disclosure outlining our compensation: http://www.cannabisfn.com/legal-disclaimer/

This article was published by CFN Enterprises Inc. (OTCQB: CNFN), owner and operator of CFN Media, the industry’s leading agency and digital financial media network dedicated to the burgeoning CBD and legal cannabis industries. Call +1 (833) 420-CNFN for more information.

About Robin Lefferts

Robin Lefferts has been involved in the legal cannabis industry since 2012, sometimes as an active participant and always as an interested observer.


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Tryp Therapeutics Partners with Clinlogix for Clinical Trial Support https://mjshareholders.com/tryp-therapeutics-partners-with-clinlogix-for-clinical-trial-support/ Mon, 10 May 2021 14:39:56 +0000 https://www.cannabisfn.com/?p=2920288

Ryan Allway

May 10th, 2021

Psychedelics, Uncategorized


San Diego, California–(Newsfile Corp. – May 10, 2021) – Tryp Therapeutics (CSE: TRYP) (OTCQB: TRYPF) (FSE: 8FW) (“Tryp”), a pharmaceutical company focused on developing clinical-stage compounds for diseases with unmet medical needs, announced today a master service agreement with Clinlogix, a Contract Research Organization (CRO), to support Tryp’s clinical development of its Psilocybin-for-Neuropsychiatric Disorders (PFNTM) program.

Clinlogix has global experience with providing CRO services for the development of novel pharmaceutical products. The company will collaborate with Tryp and its clinical partners in a number of areas including medical writing, biostatistical analysis, data management, and trial monitoring.

“Clinlogix is pleased to partner with Tryp Therapeutics in support of their next stage in clinical development. We look forward to leveraging our core expertise in clinical research to advance this novel technology,” said JeanMarie Markham, Founder & CEO of Clinlogix. “Sharing a common goal to deliver innovative solutions for unmet medical needs, Clinlogix is proud to support Tryp in advancing their novel treatments through the clinical trial process. We look forward to a collaborative and successful partnership!”

Tryp’s collaboration with Clinlogix will initially focus on supporting Tryp’s upcoming Phase 2a clinical trials for eating disorders and fibromyalgia. These studies are being conducted at leading academic centers, including the University of Florida, with deep expertise in their respective disease areas. Eating disorders such as binge eating and hypothalamic obesity that Tryp is targeting in its Phase 2a clinical study are often poorly addressed by currently available therapies. And Tryp’s upcoming Phase 2a clinical trial for fibromyalgia is aimed at providing an additional treatment option for the nearly one-third of patients suffering from the condition that rely on opioids to address their symptoms.

“The proper execution of a clinical study is of paramount importance in order to achieve clinical success; working with the team from Clinlogix provides Tryp with key elements needed for the conduct of a successful clinical study,” commented Jim Gilligan, Ph.D., President and Chief Science Officer of Tryp.

About Tryp Therapeutics

Tryp Therapeutics is a pharmaceutical company focused on developing clinical-stage compounds for the treatment diseases with unmet medical needs through accelerated regulatory pathways. Tryp’s Psilocybin-For-Neuropsychiatric Disorders, or PFN™, program is focused on the development of synthetic psilocybin as a new class of drug for the treatment of certain neuropsychiatric-based disorders. Tryp’s lead PFN™ drug candidate is TRP-8802 for the treatment of fibromyalgia, a chronic pain syndrome estimated to affect more than 5 million people in the United States. The Company is also preparing to initiate a Phase 2a clinical study for eating disorders in partnership with Dr. Jennifer Miller at the University of Florida.

In addition to its PFN™ Program, Tryp is developing TRP-1001, an oral formulation of razoxane for the treatment of soft tissue sarcomas. Soft tissue sarcomas are a rare and diverse group of tumors that account for about 1% of all cancers in adults and 7% in children. Based on the prevalence of soft tissue sarcomas in the United States, Tryp believes that TRP-1001 should qualify for orphan status with the FDA.

For inquiries, please contact us at:
T: 1-833-811-TRYP (8797)
E: [email protected]
W: www.tryptherapeutics.com

About Clinlogix

Founded in 1999, Clinlogix has helped companies conduct complex, next-generation research and find success in new frontiers of health and medicine. By pairing world-class scientific and regulatory leadership with a robust project management approach, the company ensures proper strategic guidance and execution through the entire program. From concept to commercialization, we leverage the expertise of a thoroughly vetted global network of scientific advisors and thought leaders to ensure excellence in every project. Clinlogix is headquartered in Lower Gwynedd, Pennsylvania, and has offices in Japan, Germany, and Colombia to support global product development programs.

www.clinlogix.com

Forward-Looking Information

Certain information in this news release, including statements relating to the anticipated closing date of the Placement, constitutes forward-looking information. In some cases, but not necessarily in all cases, forward-looking information can be identified by the use of forward-looking terminology such as “plans”, “targets”, “expects” or “does not expect”, “is expected”, “an opportunity exists”, “is positioned”, “estimates”, “intends”, “assumes”, “anticipates” or “does not anticipate” or “believes”, or variations of such words and phrases or state that certain actions, events or results “may”, “could”, “would”, “might”, “will” or “will be taken”, “occur” or “be achieved”. In addition, any statements that refer to expectations, projections or other characterizations of future events or circumstances contain forward-looking information. Statements containing forward-looking information are not historical facts but instead represent management’s expectations, estimates and projections regarding future events.

Forward-looking information is necessarily based on a number of opinions, assumptions and estimates that, while considered reasonable by Tryp as of the date of this news release, are subject to known and unknown risks, uncertainties, assumptions and other factors that may cause the actual results, level of activity, performance or achievements to be materially different from those expressed or implied by such forward-looking information, including but not limited to the factors described in greater detail in the “Risk Factors” section of Tryp’s final prospectus available at www.sedar.com. These factors are not intended to represent a complete list of the factors that could affect Tryp; however, these factors should be considered carefully. There can be no assurance that such estimates and assumptions will prove to be correct. The forward-looking statements contained in this news release are made as of the date of this news release, and Tryp expressly disclaims any obligation to update or alter statements containing any forward-looking information, or the factors or assumptions underlying them, whether as a result of new information, future events or otherwise, except as required by law.

NEITHER THE CANADIAN SECURITIES EXCHANGE NOR ITS REGULATION SERVICES PROVIDER HAS REVIEWED OR ACCEPTED RESPONSIBILITY FOR THE ADEQUACY OR ACCURACY OF THIS RELEASE.

This article was published by CFN Enterprises Inc. (OTCQB: CNFN), owner and operator of CFN Media, the industry’s leading agency and digital financial media network dedicated to the burgeoning CBD and legal cannabis industries. Call +1 (833) 420-CNFN for more information.

Ryan Allway

About Ryan Allway

Mr. Allway has over a decade of experience in the financial markets as both a private investor and financial journalist. He has been actively involved in the cannabis industry since its inception, covering public and private companies.


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Cybin Raises C$45 Million: The Largest Go Public Capital Raise in the Canadian Psychedelic Sector https://mjshareholders.com/cybin-raises-c45-million-the-largest-go-public-capital-raise-in-the-canadian-psychedelic-sector/ Thu, 22 Oct 2020 14:03:02 +0000 https://www.cannabisfn.com/?p=2859689

Ryan Allway

October 22nd, 2020

Psychedelics, Top Story


The COMPASS Pathways Inc. (NASDAQ: CMPS) initial public offering on the NASDAQ has reinvigorated the psychedelics industry over the past couple of weeks. While COMPASS Pathways Inc. is certainly one of the largest companies in the space, there are a handful of other companies, with experienced management teams, that have raised a significant amount of capital.

Let’s take a look at Cybin’s successful capital raises thus far and why investors may want to take a closer look as it gears up to go public in the near-term.

Successful Capital Raises

Cybin raised a total of C$10.3 million through a C$3.5 million seed round and a C$6.8 million Series A round that closed in April. In June, the company entered into an amalgamation agreement with Clarmin Explorations Inc. (TSX-V: CX) to conduct a reverse takeover, set to raise C$14 million to C$21 million and ultimately list on a Canadian stock exchange.

On October 19, Cybin announced that its initial raise of between C$14 million and C$21 million was oversubscribed to C$45 million, making it the largest capital raise in the psychedelic industry in Canada to date. The private placement consisted of 60 million subscription receipts at C$0.75 a piece and was led by Stifel GMP and Eight Capital.

Click here to receive an investor presentation and receive corporate updates

“The strong interest we received from distinguished healthcare investors enabled us to exceed our original capital-raising goals,” said CEO Doug Drysdale. “The potential for psychedelic therapies to treat mental illness and addiction disorders has never been more significant. With this investment, we will continue to advance our robust pipeline of psychedelic-based products through clinical development.”

The success in raising capital comes from both a strong management team and a unique business model that’s focused on both near and long-term potential. CEO Doug Drysdale brings decades of company-building experience in the pharmaceutical space where he raised $4 billion in private and public capital and completed 15 acquisitions across three continents.

Learn more about Cybin CEO Doug Drysdale here: 

https://www.cannabisfn.com/cybin-corp-a-psychedelics-pioneer-led-by-a-biotech-veteran/

Near & Long-term Potential

Cybin seeks to be one of the first companies to bring to market a psilocybin product targeting Major Depressive Disorder (MDD); Phase 2A and Phase 2B clinical trials scheduled to begin in early 2021. To that end, the company has entered into an agreement with IntelGenx Corp. (TSX-V: IGX), licensing its sublingual film technology to deliver enhanced bioavailability of the active drug(s) in development.

A  life sciences company, Cybin is advancing both psychedelic pharmaceutical therapies as well as non-psychedelic nutraceutical products for a number of psychiatric and neurological conditions. The company is committed to leading with innovation;  developing technologies and delivery systems to achieve the desired effects of psychedelics at low dosage levels. Cybin will be conducting clinical trials to assess the safety and efficacy of all these technologies.

Click here to receive an investor presentation and receive corporate updates

Looking Ahead

Cybin raised a total of approximately C$55M million in private funding and plans to go public through a reverse merger on a Canadian stock exchange. The company is one of the best-funded companies in the psychedelic industry with both near and long-term revenue opportunities, making it a compelling addition to investor portfolios.

To learn more, visit the company’s website or download their investor presentation.

Disclaimer

The above article is sponsored content. CannabisFN.com and CFN Media, have been hired to create awareness. Please follow the link below to view our full disclosure outlining our compensation: http://www.cannabisfn.com/legal-disclaimer/

This article was published by CFN Enterprises Inc. (OTCQB: CNFN), owner and operator of CFN Media, the industry’s leading agency and digital financial media network dedicated to the burgeoning CBD and legal cannabis industries. Call +1 (833) 420-CNFN for more information.

Ryan Allway

About Ryan Allway

Mr. Allway has over a decade of experience in the financial markets as both a private investor and financial journalist. He has been actively involved in the cannabis industry since its inception, covering public and private companies.


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Cardiol Therarpeutics Receives FDA Approval For Investigational New Drug (IND) Application For Phase II/III COVID-19 Trial https://mjshareholders.com/cardiol-therarpeutics-receives-fda-approval-for-investigational-new-drug-ind-application-for-phase-ii-iii-covid-19-trial/ Fri, 25 Sep 2020 13:03:44 +0000 https://www.cannabisfn.com/?p=2818943

Ryan Allway

September 25th, 2020

News, Top News


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
[email protected]

Trevor Burns, Investor Relations +1-289-910-0855
[email protected]

Cautionary statement regarding forward-looking information:

This news release contains “forward-looking information” within the meaning of applicable Canadian securities laws. All statements, other than statements of historical fact, that address activities, events, or developments that Cardiol Therapeutics Inc. (“Cardiol” or the “Company”) 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 with respect to that, subject to study outcomes, our Phase II/III study may be used as a registration study in support of a New Drug Application, the opportunity to significantly accelerate the commercial development of CardiolRx, the Company’s plans for a Phase II international trial of CardiolRx™ in acute myocarditis, its development of a proprietary cannabidiol formulation for the treatment of chronic heart failure, the potential for this study to contribute valuable new information about the role of anti-inflammatory agents in the management of COVID-19, and the likely improvement of outcomes from COVID-19 resulting from a strategy to prevent or limit the number or severity of cardiovascular complications. Forward-looking information contained herein reflects the current expectations or beliefs of Cardiol based on information currently available to it and is 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. These risks and uncertainties and other factors include the risks and uncertainties referred to in the Company’s Annual Information Form dated March 30, 2020, including the risks and uncertainties associated with product commercialization and clinical studies, and uncertainties in predicting treatment outcomes. These 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. Although Cardiol believes that the expectations reflected in the forward-looking information are reasonable, they do involve certain assumptions, risks, and uncertainties and are not (and should not be considered to be) guarantees of future performance. It is important that each person reviewing this news release understands the significant risks attendant to the operations of Cardiol.

To view the source version of this press release, please visit https://www.newsfilecorp.com/release/64626

This article was published by CFN Enterprises Inc. (OTCQB: CNFN), owner and operator of CFN Media, the industry’s leading agency and digital financial media network dedicated to the burgeoning CBD and legal cannabis industries. Call +1 (833) 420-CNFN for more information.

Ryan Allway

About Ryan Allway

Mr. Allway has over a decade of experience in the financial markets as both a private investor and financial journalist. He has been actively involved in the cannabis industry since its inception, covering public and private companies.


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