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
Trevor Burns, Investor Relations +1-289-910-0855
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
Greene Concepts Fortifies Financial Positioning Through Major Debt Reduction Combined with Share Buyback in Alignment with the Company’s Growth Strategy
Marion, North Carolina–(Newsfile Corp. – October 28, 2020) – Greene Concepts Inc. (OTC Pink: INKW) is excited to report the company has completed a debt forgiveness agreement in the amount of $340,898 previously owed to one of our largest note holders. This reduces our notes payable by 56%. The debt holder, Greene Concepts’ management and accountants have agreed to write-off and eliminate $340,898 of the third-party convertible notes from the company’s finances as debts that are no longer due.
Additionally, the Company is in the process of finalizing a substantial share buyback of its common stock. This common stock buyback will reduce the common share count by over 280 million shares. The company has taken powerful actions financially in a short time span by increasing its Assets, Cash, Inventory, and Sales.
|Greene Concepts 3rd and 4th Quarter Finance Comparisons|
|3rd Quarter Report (Period Ending 4/30/2020)||4th Quarter Annual Report (Period Ending 7/31/2020)|
Lenny Greene, CEO of Greene Concepts notes, “Today’s announcement marks an important step forward in significantly strengthening Greene Concepts in terms of debt reduction which wipes out 56% of our debt (over $340,000 worth of payable debt) off our books. We would like to give a profound thanks to this Debt holder for their strong work and altruism in this action. This bold and forward-looking gesture better positions us for increased revenue generation, faster inventory turnaround times, increased gross and profit margins, a rise in working capital, employee additions and positive cash flows. It also allows us to increase our assets, our cash reserves, and our total sales. We will continue to focus on the things we can control with aggressive cost management and working capital reductions. This focus will allow us to reduce debt, achieve positive liquidity and balance sheet improvement.”
Mr. Greene continues, “We are pleased to continue making strides in our ongoing efforts to strengthen our business, increase our flexibility and improve returns on capital. It is our intention to do whatever we can to continually reduce our debt and monitor our Key Performance Indicators for our financial condition to include our cash, accounts receivable and accounts payable. While we amplify our sales and reduce our debt, we also maintain an inventory of $51,425 of cases of our bottled ‘Be Water’ Brand ready to ship to Amazon and throughout the country. Our new ‘Be Water’ Label production run begins next week.”
BeWater New Label
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“Finally, we are in the process of finalizing a share buyback of our stock. This common share buyback will reduce our common share count by over 280 million shares. We are confident that each of these financial actions offer improved security during these uncertain times and better positions us to pull the trigger on future partnership or acquisition opportunities while preparing us for unprecedented growth.”
Greene Concepts Creek Running Water
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About Greene Concepts, Inc., Mammoth Ventures, Inc. and Water Club, Inc.
Greene Concepts, Inc. (http://www.greeneconcepts.com) is a publicly traded company. Through its recently acquired wholly owned subsidiary, Mammoth Ventures Inc., the Company has entered the specialty beverage and bottling business and is an emerging leader in the global scientifically formulated beverage industry. Through its subsidiary Water Club, Inc. we intend to pursue subscription-based delivery of water and scientifically formulated beverages directly to the consumers home and market the convenience of this service thru social media affiliate marketing partners.
Safe Harbor: This Press Release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. These forward-looking statements are based on the current plans and expectations of management and are subject to a number of uncertainties and risks that could significantly affect the company’s current plans and expectations, as well as future results of operations and financial condition. A more extensive listing of risks and factors that may affect the company’s business prospects and cause actual results to differ materially from those described in the forward-looking statements can be found in the reports and other documents filed by the company with the Securities and Exchange Commission and OTC Markets, Inc. OTC Disclosure and News Service. The company undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
Greene Concepts, Inc.
To view the source version of this press release, please visit https://www.newsfilecorp.com/release/67028
TransGlobal Assets Inc. (TMSH) Expands in Pittsburgh Area with Property Acquisition
Company seeks a foothold on manufacturing of Monster Elixir branded CBD products and beverages
Pittsburgh, Pennsylvania–(Newsfile Corp. – October 28, 2020) – TransGlobal Assets, Inc. (OTC Pink: TMSH) is proud to announce the purchase of a 3,500 square foot building in Pittsburgh that will serve as the headquarters of Monster Elixir Inc., a wholly-owned subsidiary. It will house manufacturing for Monster Elixir’s line of CBD beverages and topical healing products.
To view an enhanced version of this graphic, please visit:
The purchase expands on the company’s growth plan, which currently features a 2,400 square foot rental space in the city that will be a storage unit for production. The plan also entails the purchase of the first of many additional store front retail spaces in the Pittsburgh area.
The company is securing space for its line of heavily demanded drinks called Green Essence Beverages. The CBD-infused drinks will be sold in the following flavors:
Pineapple Agave (Dark)
Strawberry Pineapple Lemonade
Monster Elixir will also launch a line of CBD wellness products that include, but are not limited to, the following:
Joint & Muscle Cream
Joint & Muscle Balm
In addition, the company is also launching a line of hemp-infused hair care products that will include shampoos & conditioners, healthy hair butters & tinctures, as well as beard care products. These fine CBD products will be sold at local dispensaries and other retail outlets.
For further inquiries please contact:
Curtis Philpot CEO
TransGlobal Assets Inc.
Office: (833) 217-8764
To view the source version of this press release, please visit https://www.newsfilecorp.com/release/67026
Hemp, Inc. Set to Distribute Full King of Hemp® Product Line Across Country
Las Vegas, NV, Oct. 28, 2020 (GLOBE NEWSWIRE) — via NewMediaWire — Hemp, Inc. (OTC PINK: HEMP), a global leader in the industrial hemp industry with bi-coastal processing centers, announced today it will be aggressively shipping its King of Hemp® product line to stores across the country over the next 30-60 days. To date, the King of Hemp® product line consists of Bubba Kush hemp; Pre-rolls, Fortified Pre-rolls, Caviar/Moon Rocks; and Diamonds.
According to Bruce Perlowin, CEO of Hemp, Inc., the Company is revving up to launch one of its most aggressive marketing campaigns to date. “Our number one goal has been to produce top-of-the-line CBD and CBG smokable products and CBD consumption options that fit consumer lifestyles and deliver unparalleled results. We’ve done just that with the King of Hemp® line.”
Hemp, Inc.’s Diamonds and Crumbles (smaller Diamond pieces) are dabbable CBD products, derived from a golden-hued high CBD, THC-free distillate taken directly from the hemp plant that includes blends of valuable terpenes. Diamonds and Crumbles promise to deliver the strongest, most potent effects of any other product from the line containing between 92% and 98.7% pure CBD.
Consumption methods include, but are not limited to, utilizing a dab rig or a wax vaporizer for the fastest, strongest results. (While Hemp, Inc. does not cultivate, manufacture or produce any type of THC product, consumers of the Company’s CBD product Diamonds report that mixing Diamonds with a THC concentrate helps to mellow THC’s effects).
“Diamonds or Crumbles are the perfect way for our customers to get a pure, clean CBD dabbing experience with instant results that last,” said Perlowin.
Hemp, Inc.’s Caviar, similar to Moon Rocks, is a highly potent and rich tasting smokable product with less than 0.3% THC. It is made from Hemp, Inc.’s high-quality Southern Oregon-grown Bubba Kush hemp flower, which is covered with a THC-Free distillate (with and without added terpenes), and then rolled in CBG-rich kief. The product contains over 45% CBD and over 10% CBG.
Many people prefer to smoke their hemp products due to the speed and effectiveness of the delivery system. By entering the body through the respiratory system, there is a dramatic increase in bioavailability as compared to oral consumption. It is the fastest way to receive CBD and CBG’s potential calming and pain-relieving benefits.
Consumption methods include but are not limited to vaporizing Caviar in an all-ceramic or stainless steel vaporizer to capture the full terpene profile and cannabinoid effects; or using a glass water pipe. While Caviar is not a cannabis product, smoking it the way hash is smoked is recommended to achieve the best results.
“Caviar exemplifies the variety of ways consumers can enjoy CBD and CBG and reflects our brand vision of providing a superior, royal experience,” said Perlowin.
The King of Hemp® pre-roll line offers high-end products that are an effective and flavorful, smokable alternative to cigarettes and other hemp consumption methods. The King of Hemp® pre-rolls can be purchased individually or in packs of 6. Each pre-roll is 1 gram and does not exceed 0.3% THC.
King of Hemp® pre-rolls use A and B hemp colas which are derived from Pre-98 OG Bubba Kush hemp, one of the top selling cultivars on the market. The strain, rich soil and climate lend themselves to these colas being among the highest quality buds, positioning them to be some of the best tasting for consumption.
The Company’s website for its King of Hemp® line (www.kingofhempusa.com) also has CBD oil tinctures available for purchase. The tinctures are available in two flavors, Natural and Peppermint, and contain full-spectrum hemp oil extracted from the flowers and leaves of hemp plants sustainably sourced from Colorado. They are also compliant with the regulations created by the Colorado Department of Agriculture in regards to industrial hemp. The tinctures contain 0.3% or less THC and are compliant with the 2018 Farm Bill.
To learn more, go to the King of Hemp® website, here.
According to Nielsen, market researchers project 2020 sales in the current smokable-hemp market to reach $70 million to $80 million. This category includes loose CBD flower, hemp-CBD pre-rolls, cigars and other inhalables.
To see one-minute videos of Hemp, Inc.’s current activities, visit Bruce Perlowin’s personal Facebook fan page, where he shares posts of Hemp, Inc.’s activities around the country. Additionally, follow Hemp, Inc. on Instagram here and on Twitter here.
To view the webinar featuring Hemp, Inc.’s CEO, Bruce Perlowin, click here.
WHAT IS HEMP, INC.?
What is Hemp, Inc.? With a deep-rooted social and environmental mission at its core, Hemp, Inc. seeks to build a business constituency for the American small hemp farmer, the American veteran, and other groups experiencing the ever-increasing disparity between tapering income and soaring expenses. The Company is on a mission to be a powerful engine for social change and economic revival, worldwide, by providing hemp products that are eco-friendly, sustainable and healthy. Hemp, Inc. executives believe there can be tangible benefits reaped from adhering to a corporate social responsibility plan.
FORWARD-LOOKING DISCLAIMER AND DISCLOSURES
This press release may contain certain forward-looking statements and information, as defined within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, and is subject to the Safe Harbor created by those sections. The Securities and Exchange Commission (SEC) requires issuers to provide “adequate current information” and Hemp, Inc. does… using the SEC’s Alternative Reporting Standard to publicly report its quarterly and yearly financials. All current information can be found on www.hempinc.com/hemp-financial-disclosures/. This material contains statements about expected future events and/or financial results that are forward-looking in nature and subject to risks and uncertainties. Such forward-looking statements by definition involve risks, uncertainties.
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