Cannabis industry advocates hail rescheduling as a significantly positive first step in the national effort to end prohibition and call on Congress to enact broader reforms

WASHINGTON, D.C. – Today, the Associated Press reported that the U.S. Drug Enforcement Administration (DEA) is planning to move cannabis from Schedule I status to Schedule III in the federal Controlled Substances Act. This historic move that acknowledges the medical benefits of cannabis products still needs to be reviewed by the White House Office of Management and Budget before the DEA initiates a public comment period.

Marijuana and its most well known psychoactive compound, THC, have been listed as Schedule I substances in the federal Controlled Substances Act since 1970, a designation reserved for drugs with high potential for abuse and no medical value. A move to Schedule III acknowledges the medicinal value of cannabis that has been known to the medical community and millions of patients using it under the care of their physicians for decades.

Rescheduling would not resolve the conflict that exists between federal law and the laws on the books in 38 states which have regulated the legal production and sale of cannabis for medical or adult use but a move to Schedule III would provide federal tax parity to state-legal cannabis businesses by allowing them to take deductions for ordinary expenses currently prohibited under a little-known provision of the federal tax code.

The cannabis industry widely agrees that rescheduling as a significant positive step but that broader federal reforms are needed to resolve the myriad issues plaguing the industry resulting from federal prohibition.

“Moving marijuana out of its absurd classification as a Schedule I drug is long overdue and we applaud the administration for finally acknowledging the therapeutic value that has been widely accepted by the medical community and millions of medical cannabis patients for decades,” said National Cannabis Industry Association CEO, Aaron Smith. “While this is undoubtedly a very positive first step, rescheduling will not end federal marijuana prohibition and doesn’t harmonize federal law with the laws allowing some form of legal cannabis in the vast majority of the states. In order for this move to be meaningful on the ground, we need clear enforcement guidelines issued to the DEA and FDA that would ensure the tens of thousands of state-licensed businesses responsibly serving cannabis to adults are not subject to sanctions or criminal prosecution under federal laws.”

“Further, it’s imperative that Congress build upon this development by passing comprehensive legislation to remove cannabis from the Controlled Substances Act and forge a new regulatory framework for whole plant cannabis products.” added Smith.

Just over half of Americans live in a state that has made cannabis legal for adults over 21 and three out of four Americans live in a state that has legalized cannabis for medical use. A November 2023 Gallup survey found that 70% of Americans support making cannabis legal for adults and a recent Pew Research Center poll found that less than 10% of Americans still support marijuana prohibition.

# # #

The National Cannabis Industry Association (NCIA) is the largest cannabis trade association in the U.S. and the only national organization representing small and independent cannabis-related businesses. NCIA promotes the growth of a responsible, sustainable, and inclusive cannabis industry and works for a favorable social, economic, and regulatory environment for that industry throughout the United States.

Proposed Menthol Ban Could Leave 22nd Century’s VLN^® Menthol King as the Only Menthol Cigarette in the $26 Billion U.S. Menthol Market

FDA to Advance Reduced Nicotine Content Standards for All Combustible Cigarettes in Q4 2023

Paradigm Shift in Tobacco Health Policy and Regulation Expected to Generate Major Gains for Public Health

Buffalo, New York–(Newsfile Corp. – January 17, 2023) – 22nd Century Group, Inc. (NASDAQ: XXII), a leading biotechnology company dedicated to improving health with reduced nicotine tobacco, hemp/cannabis and hops advanced plant technologies, today announced that the Company is poised to greatly benefit from the recent advancement of the U.S. Food and Drug Administration’s (FDA) proposed ban on menthol as a flavoring agent in combustible cigarettes to final rule status, with expectations of a final decision in August 2023.

“The most recent updates to the Biden administration’s Unified Agenda on Regulatory and Deregulatory Actions (Unified Agenda) include major advancements in the FDA’s proposed tobacco harm reduction policies in 2023,” stated John Miller, president of tobacco products for 22nd Century Group. “Advancement of FDA’s proposed menthol ban could position VLN^® Menthol King as the only combustible menthol tobacco cigarette on the market, providing a critical off-ramp to the estimated more than 15 million menthol smokers in the U.S.“

Menthol cigarettes account for an estimated $26 billion in retail sales. Menthol is also known to enhance nicotine’s addictive effects, making it more difficult to quit, and a disproportionate amount of menthol smokers are members of minority groups, particularly African American.

“FDA’s proposed menthol policy specifically contemplates exempting certain products from the ban, such as our MRTP authorized VLN^® cigarettes, providing a critical off-ramp opportunity for adult menthol smokers,” stated John Pritchard, vice president of regulatory science for 22nd Century Group. “Without an off-ramp product, both research and real-world experience show the vast majority of menthol smokers would simply transition to traditional combusted cigarettes. 22nd Century’s MRTP authorization documents how VLN^® products can help people to smoke less, leading to a true reduction in smoking in line with FDA’s important public health goals.”

The Unified Agenda also indicates that the FDA intends to advance its transformative reduced nicotine content standards later in 2023, which seeks to limit the nicotine levels in all cigarettes to a level considered “minimally or non-addictive.” Both of these standards are considered game changers for public health and could be extremely favorable for 22nd Century Group due to VLN^®‘s 95% reduced nicotine content.

The 22nd Century VLN^® expansion is going well, with VLN^®‘s availability already expanding across five states with anchor partners including Circle K and Smoker Friendly. Following the Company’s stated growth strategy to expand to 12-15 states during 2023, 22nd Century is actively engaged with multiple industry leading distribution partners and retail store chains wanting to introduce the Company’s transformative VLN^® products to adult smokers in both existing and new markets.

Mr. Miller concluded, “The proactive and forward-thinking policies of the FDA have the power to reduce the harms of smoking and save millions of lives. 22nd Century Group continues to fully support these policies, and VLN^® reduced nicotine content products demonstrate that these programs are 100% achievable.”

22nd Century Group’s VLN^® brand cigarettes are the only combustible cigarettes that the FDA has authorized as Modified Risk Tobacco Products (MRTP). The Company’s VLN^® King and VLN^® Menthol King contain 95% less nicotine than traditional addictive cigarettes, a level considered to be minimally or non-addictive. Reduced nicotine content cigarettes, such as VLN^®, have been studied extensively by federal health agencies, documenting their ability to help smokers smoke less. To inform adult smokers of the product’s distinctive purpose, the FDA requires 22nd Century to include the statement “Helps You Smoke Less” on every package of VLN^® sold.

As demonstrated by leading independent scientists, reducing the nicotine level in cigarettes has the potential to substantially reduce the enormous burden of smoking-related death and disease. It is estimated that a nicotine product standard to a level that is 95% less than the level of nicotine contained in U.S. conventional cigarettes could save millions of lives and tens of millions of life-years over the next several decades.

About 22nd Century Group, Inc.
22nd Century Group, Inc. (NASDAQ: XXII) is a leading agricultural biotechnology company focused on tobacco harm reduction, reduced nicotine tobacco and improving health and wellness through plant science. With dozens of patents allowing it to control nicotine biosynthesis in the tobacco plant, the Company has developed proprietary reduced nicotine content (RNC) tobacco plants and cigarettes, which have become the cornerstone of the FDA’s Comprehensive Plan to address the widespread death and disease caused by smoking. The Company received the first and only FDA Modified Risk Tobacco Product (MRTP) authorization of a combustible cigarette in December 2021. In tobacco, hemp/cannabis and hop plants, 22nd Century uses modern plant breeding technologies, including genetic engineering, gene-editing, and molecular breeding to deliver solutions for the life science and consumer products industries by creating new, proprietary plants with optimized alkaloid and flavonoid profiles as well as improved yields and valuable agronomic traits.

Learn more at xxiicentury.com, on Twitter, on LinkedIn, and on YouTube.

Learn more about VLN^® at tryvln.com.

###

Cautionary Note Regarding Forward-Looking Statements
Except for historical information, all of the statements, expectations, and assumptions contained in this press release are forward-looking statements. Forward-looking statements typically contain terms such as “anticipate,” “believe,” “consider,” “continue,” “could,” “estimate,” “expect,” “explore,” “foresee,” “goal,” “guidance,” “intend,” “likely,” “may,” “plan,” “potential,” “predict,” “preliminary,” “probable,” “project,” “promising,” “seek,” “should,” “will,” “would,” and similar expressions. Actual results might differ materially from those explicit or implicit in forward-looking statements. Important factors that could cause actual results to differ materially are set forth in “Risk Factors” in the Company’s Annual Report on Form 10-K filed on March 1, 2022, and in the Company’s Quarterly Report filed on November 8, 2022. All information provided in this release is as of the date hereof, and the Company assumes no obligation to and does not intend to update these forward-looking statements, except as required by law.

Investor Relations & Media Contact
Darrow Associates Investor Relations
Matt Kreps
[email protected]
214-597-8200

To view the source version of this press release, please visit https://www.newsfilecorp.com/release/151471

SOURCE 22nd Century Group

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.

• Committed to Supporting New Zealand’s Reduced Nicotine Law with Its Tobacco Biotechnology
• New Law Represents Significant Opportunity to Improve National Health through Well Designed Public Policy Framework
• Believes New Zealand Law Provides a Template for Similar Action in Other Countries, Including the United States

Buffalo, New York–(Newsfile Corp. – December 13, 2022) –  22nd Century Group, Inc. (NASDAQ: XXII), a leading agricultural biotechnology company dedicated to improving health with reduced nicotine tobacco, hemp/cannabis, and hops advanced plant technologies, today commented on the advancement of a proposed New Zealand law designed to reduce the harms of smoking.

A key provision of the newly passed Smokefree Environments and Regulated Products (Smoked Tobacco) Amendment Bill requires all combustible tobacco cigarettes sold in New Zealand to contain no more than 0.8 mg of nicotine per gram of tobacco, inclusive of testing variance, a level considered to be non-addictive.

By including testing variance in the maximum permitted nicotine content of smoked tobacco products, New Zealand is compelling cigarette makers to target an average value of approximately 0.5 mg of nicotine per gram of tobacco content, the level achieved by 22nd Century Group’s VLN^® products, the only tobacco cigarette that meets the New Zealand standard today.

“We applaud New Zealand for leading the world with a groundbreaking new policy approach to improve public health by eliminating highly addictive nicotine cigarettes, the leading cause of preventable disease and death in the country and around the world,” said John D. Pritchard, vice president of regulatory science at 22nd Century. “This policy is exactly what we were hoping for and more, particularly considering the inclusion of testing variance in evaluating nicotine content. This innovative approach forces manufacturers to cut the nicotine content in cigarettes to a level even below the new threshold. Our VLN^® products are designed specifically for this type of policy, with years of research, documentation, and industry expertise to support our unique capabilities. In crafting the new law, New Zealand has been particularly focused on improving the health as well as financial well-being of Māori and Pasifika peoples where smoking rates are disproportionately higher than the national average.”

Despite 20-years of declining smoking rates, New Zealand smokers still consume approximately 2 billion highly addictive tobacco cigarettes each year. Reducing the nicotine content of smoked tobacco is expected to help New Zealand achieve its goal to reduce the smoking rate to less than 5% of its population. The reduced nicotine requirement will become law following Royal Assent, the final procedural step for a bill to become law in New Zealand, with the requirement taking effect within 27 months.

At 0.5 mg/g of nicotine, VLN^® from 22nd Century is the only cigarette in the world purposefully designed to “Help You Smoke Less” and able to meet the New Zealand standard today. 22nd Century Group’s proprietary VLN^® cigarettes smoke, smell, and taste like a cigarette but contain approximately 95% less nicotine than conventional cigarettes, a level designed to reduce nicotine dependence.

“22nd Century Group is 100% committed to enabling a reduced nicotine future for New Zealand through our plant biotechnology and VLN^® reduced nicotine content cigarettes, the world’s first and only combustible cigarettes to receive Modified Risk Tobacco Product authorization from the U.S. Food and Drug Administration,” said James A. Mish, chief executive officer of 22nd Century Group. “New Zealand’s trailblazing policy approach provides a template for other countries around the world to secure the tremendous public health and economic benefits of reduced smoking rates, through the reduction of nicotine.”

More information about the Smokefree Environments and Regulated Products (Smoked Tobacco) Amendment Bill and New Zealand’s legislative process can be found on New Zealand’s parliamentary website.

Similar to New Zealand, the U.S. FDA is presently advancing two game changing policy proposals to reduce the harms of smoking. 22nd Century supports the FDA’s proposed menthol cigarette ban, which could leave VLN^® Menthol King as the only combustible menthol cigarette on the market, providing a critical off-ramp to help current menthol smokers to smoke less. Additionally, the FDA’s Comprehensive Plan for tobacco and nicotine regulation proposes to require that all cigarettes be made “minimally or non-addictive.” 22nd Century has the only FDA-authorized combustible cigarette able to meet the stringent reduced nicotine content product standard proposed under the FDA’s plan.

About 22nd Century Group, Inc.

22nd Century Group, Inc. (NASDAQ: XXII) is a leading agricultural biotechnology company focused on tobacco harm reduction, reduced nicotine tobacco and improving health and wellness through plant science. With dozens of patents allowing it to control nicotine biosynthesis in the tobacco plant, the Company has developed proprietary reduced nicotine content (RNC) tobacco plants and cigarettes, which have become the cornerstone of the FDA’s Comprehensive Plan to address the widespread death and disease caused by smoking. The Company received the first and only FDA MRTP authorization of a combustible cigarette in December 2021. In tobacco, hemp/cannabis, and hop plants, 22nd Century uses modern plant breeding technologies, including genetic engineering, gene-editing, and molecular breeding to deliver solutions for the life science and consumer products industries by creating new, proprietary plants with optimized alkaloid and flavonoid profiles as well as improved yields and valuable agronomic traits.

Learn more at xxiicentury.com, on Twitter, on LinkedIn, and on YouTube.

Learn more about VLN^® at tryvln.com.

###

Cautionary Note Regarding Forward-Looking Statements
Except for historical information, all of the statements, expectations, and assumptions contained in this press release are forward-looking statements. Forward-looking statements typically contain terms such as “anticipate,” “believe,” “consider,” “continue,” “could,” “estimate,” “expect,” “explore,” “foresee,” “goal,” “guidance,” “intend,” “likely,” “may,” “plan,” “potential,” “predict,” “preliminary,” “probable,” “project,” “promising,” “seek,” “should,” “will,” “would,” and similar expressions. Actual results might differ materially from those explicit or implicit in forward-looking statements. Important factors that could cause actual results to differ materially are set forth in “Risk Factors” in the Company’s Annual Report on Form 10-K filed on March 1, 2022, and in the Company’s Quarterly Report filed on November 8, 2022. All information provided in this release is as of the date hereof, and the Company assumes no obligation to and does not intend to update these forward-looking statements, except as required by law.

Investor Relations & Media Contact
Darrow Associates Investor Relations
Matt Kreps
T: 214-597-8200
[email protected]

To view the source version of this press release, please visit https://www.newsfilecorp.com/release/147834

SOURCE 22nd Century Group

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.

• Reduced nicotine cigarettes increase cessation, decrease consumption, decrease dependence, and reduce toxicants
• Study dispels common misconception that reduced nicotine cigarettes worsen general health and mental health problems

BUFFALO, N.Y., Nov. 07, 2022 (GLOBE NEWSWIRE) — 22nd Century Group, Inc. (Nasdaq: XXII), a leading agricultural biotechnology company dedicated to improving health with reduced nicotine tobacco, hemp/cannabis, and hops advanced plant technologies, highlighted a recent study that found switching to 22nd Century’s reduced nicotine content (RNC) cigarettes “reduces toxicant exposure and increases smoking cessation without worsening mental health among smokers with mood or anxiety disorders.”

The study conclusively dispelled a common misconception that RNC’s may exacerbate general health and mental health problems. The study also concluded that a national nicotine reduction policy for cigarettes will likely result in reduced nicotine absorption and likely result in greater smoking cessation from smokers with mood and anxiety disorders.

The study examined adult smokers with a current or lifetime anxiety or unipolar mood disorder. The participants were randomly assigned to smoke conventional cigarettes or 22nd Century’s RNC research cigarettes. Adult smokers who were assigned to smoke 22nd Century’s RNC cigarettes had significantly lower cigarette consumption, lower cigarette dependence, lower plasma cotinine (metabolite of nicotine), and lower exhaled carbon-monoxide than smokers assigned to the conventional group.

At the end of the study, despite having selected only participants not intending to stop smoking, those randomized to the group using 22nd Century’s RNC cigarettes were more likely to have quit smoking.

“Study after study, reduced nicotine cigarettes are shown to be beneficial to adult smokers. The combination of reduced nicotine cigarettes and a proposed nicotine standard have the potential to forever change the trajectory of public health by helping adult smokers smoke less,” said James A. Mish, chief executive officer of 22nd Century Group. “Based on last week’s comments from FDA’s Center for Tobacco Products Director, Dr. Brian King, we are confident the FDA will use its existing authority to advance both a reduced nicotine policy and a menthol ban. These policies and 22nd Century’s reduced nicotine cigarettes are expected to save millions of lives and increase the chances that current smokers quit. Our VLN^® reduced nicotine content cigarettes are backed by clear science and evidence which support FDA’s proposed product standards and are the only FDA-authorized combustible product able to meet the stringent reduced nicotine levels determined by the FDA to be ‘minimally or non-addictive’.”

In related news, a webinar hosted by Mitchell Hamline School of Law’s Public Health Law Center on November 3, 2022, featured FDA’s Center for Tobacco Product (CTP) Director Dr. Brian King publicly stating that the proposed menthol standard remains a key priority for him, the FDA, and CTP. The FDA is currently in the process of reviewing the comments they received as they move forward with the proposed rule. Dr. King also noted that the FDA remains committed to using its regulatory authority to protect public health and intends to finalize a nicotine standard for the maximum level of nicotine allowed in combusted tobacco products. The reduced nicotine rule is of high priority for the FDA as it has profound health benefits in terms of preventing initiation of smoking and promoting cessation for current smokers and a huge potential to have a positive impact on public health.

22nd Century believes that the menthol cigarette ban could leave VLN^® Menthol King as the only combustible menthol cigarette on the market, providing a critical off-ramp to help current menthol smokers to smoke less. The Company expects VLN^® Menthol King reduced nicotine cigarettes to be exempted from FDA’s menthol ban under procedures detailed in FDA’s proposed rule announced April 28, 2022. 22nd Century’s VLN^® cigarette products are the only FDA-authorized combustible cigarette able to meet the stringent reduced nicotine content product standard under the FDA’s Comprehensive Plan requiring that all cigarettes be made “minimally or non-addictive.”

About 22nd Century Group, Inc.
22nd Century Group, Inc. (Nasdaq: XXII) is a leading agricultural biotechnology company focused on tobacco harm reduction, reduced nicotine tobacco and improving health and wellness through plant science. With dozens of patents allowing it to control nicotine biosynthesis in the tobacco plant, the Company has developed proprietary reduced nicotine content (RNC) tobacco plants and cigarettes, which have become the cornerstone of the FDA’s Comprehensive Plan to address the widespread death and disease caused by smoking. The Company received the first and only FDA MRTP authorization of a combustible cigarette in December 2021. In tobacco, hemp/cannabis, and hop plants, 22nd Century uses modern plant breeding technologies, including genetic engineering, gene-editing, and molecular breeding to deliver solutions for the life science and consumer products industries by creating new, proprietary plants with optimized alkaloid and flavonoid profiles as well as improved yields and valuable agronomic traits.

Learn more at xxiicentury.com, on Twitter, on LinkedIn, and on YouTube.

Learn more about VLN^® at tryvln.com.

Cautionary Note Regarding Forward-Looking Statements
Except for historical information, all of the statements, expectations, and assumptions contained in this press release are forward-looking statements. Forward-looking statements typically contain terms such as “anticipate,” “believe,” “consider,” “continue,” “could,” “estimate,” “expect,” “explore,” “foresee,” “goal,” “guidance,” “intend,” “likely,” “may,” “plan,” “potential,” “predict,” “preliminary,” “probable,” “project,” “promising,” “seek,” “should,” “will,” “would,” and similar expressions. Actual results might differ materially from those explicit or implicit in forward-looking statements. Important factors that could cause actual results to differ materially are set forth in “Risk Factors” in the Company’s Annual Report on Form 10-K filed on March 1, 2022, and in the Company’s Quarterly Report filed on August 9, 2022. All information provided in this release is as of the date hereof, and the Company assumes no obligation to and does not intend to update these forward-looking statements, except as required by law.

Investor Relations & Media Contact
Mei Kuo
22nd Century Group, Inc.
Director, Communications & Investor Relations
[email protected]

Darrow Associates Investor Relations
Matt Kreps
T: 214-597-8200
[email protected]

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.

Shipment of GMP DMT, In Vitro HERG and Genotox Assays Completed, and In Vivo Toxicity Assays Underway

Vancouver, British Columbia–(November 24, 2021) – Entheon Biomedical Corp. (CSE: ENBI) (OTCQB: ENTBF) (FSE: 1XU1) (“Entheon” or the “Company”), a biotechnology company focused on developing psychedelic medicines to treat addiction, is pleased to provide an update on its upcoming human trial, EBRX-101 and on nonclinical DMT initiatives.

Clinical Trial Update

The Company announces today that GMP DMT drug product has shipped from Ofichem Laboratorium to CHDR’s partner pharmacy. Formulation and stability testing of the DMT drug product by CHDR’s partner pharmacy has commenced in accordance with the projected start date of EBRX-101, a study that will evaluate the pharmacodynamics, pharmacokinetics and safety of a target controlled intravenous infusion of N, N-dimethyltryptamine (“DMT”) in a population of healthy smokers.

Pre-Clinical Update

With the understanding that DMT possesses a favourable safety and toxicology profile based on historical preclinical and clinical research, Entheon has embarked on several pre-clinical studies to further characterize the drug in support of Entheon’s specific clinical pathway and to satisfy anticipated requirements for a future meeting with the FDA. In connection with its nonclinical program, Entheon is pleased to announce that in vitro HERG and genotox assays have been completed, and in vivo toxicity assays have commenced with final reports for both studies expected in the fourth quarter of 2021.

“Entheon’s science team is pleased to report that formulation and testing of the DMT drug product is currently underway in preparation for our upcoming human trial. In parallel, we are making great progress with our preclinical toxicology program, which is expected to bolster the abundant safety data available in the published DMT literature,” said Andrew Hegle, PhD, Chief Science Officer of Entheon.

About Entheon Biomedical Corp.

Entheon is a biotechnology research and development company committed to developing and commercializing a portfolio of safe and effective N,N-dimethyltryptamine based psychedelic therapeutic products (“DMT Products“) for the purposes of treating addiction and substance use disorders. Subject to obtaining all requisite regulatory approvals and permits, Entheon intends to generate revenue through the sale of its DMT Products to physicians, clinics and licensed psychiatrists in the United States, certain countries in the European Union and throughout Canada.

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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The study is expected to be the world’s first Phase 2a clinical trial evaluating the efficacy of psilocybin and psychotherapy to treat fibromyalgia

San Diego, California–(Newsfile Corp. – July 21, 2021) – Tryp Therapeutics (CSE: TRYP) (OTCQB: TRYPF) (“Tryp”), a pharmaceutical company focused on developing psilocybin-based compounds for diseases with unmet medical needs through accelerated regulatory pathways, announced today its plans to conduct a Phase 2a clinical trial with the Chronic Pain & Fatigue Research Center in the Department of Anesthesiology at the University of Michigan Medical School.

The open-label Phase 2a clinical trial will evaluate the efficacy of TRYP-8802, an oral formulation of synthetic psilocybin, in tandem with psychotherapy for treating fibromyalgia. The treatment is designed to target nociplastic pain originating in the central nervous system through the neuroplasticity benefits of psilocybin. The Principal Investigator for the trial will be Kevin Boehnke, Ph.D., Research Investigator, University of Michigan Department of Anesthesiology. Tryp will seek to identify a response in patients to the treatment to inform the design of a Phase 2b clinical trial for fibromyalgia that will use the company’s proprietary, psilocybin-based drug product, TRP-8803, that includes a novel formulation and unique method of delivery.

“Existing treatment options for fibromyalgia are often ineffective and show significant side effects,” said Daniel Clauw, M.D., Director of the Chronic Pain & Fatigue Research Center. “Kevin Boehnke and I are excited to be working with the team at Tryp Therapeutics, who have shown exceptional scientific rigor in their approach to evaluate a new treatment paradigm for the millions of patients suffering from fibromyalgia and other pain-related indications.”

Fibromyalgia is a disease of the central nervous system that is estimated to affect as much as 2% to 8% of the population. The disease is characterized by widespread pain commonly accompanied by fatigue, memory problems, and sleep disturbances. With available treatment options often proving ineffective, nearly 30% of fibromyalgia patients alarmingly resort to opioid-based medications in an attempt to address symptoms of pain stemming from the disease. Tryp expects to submit the Investigational New Drug (IND) application to the FDA for the Phase 2a clinical trial in 3Q 2021.

“We are thrilled to collaborate with such forward-looking clinicians and scientists to develop additional treatment options for fibromyalgia,” commented Jim Gilligan, Ph.D., President and Chief Science Officer at Tryp Therapeutics. “The Chronic Pain & Fatigue Research Center at the University of Michigan brings incomparable experience with evaluating treatments for fibromyalgia and other chronic pain indications, and there is nothing more important to our collective team than creating therapies that will address the daily distress of these patients.”

About Tryp Therapeutics:

Tryp Therapeutics is a pharmaceutical company focused on developing psilocybin-based compounds for the treatment of diseases with unmet medical needs through accelerated regulatory pathways. Tryp’s Psilocybin-For-Neuropsychiatric Disorders (PFN) program is focused on the development of synthetic psilocybin as a new class of drug for the treatment of chronic pain and eating disorder indications. The company has announced upcoming Phase 2a clinical trials with the University of Michigan and the University of Florida to evaluate its drug products for fibromyalgia and eating disorders, respectively. Tryp is also developing a proprietary psilocybin-based product, TRP-8803, that uses a novel formulation and method of delivery to improve the patient experience.

For more information, please contact us:

1-833-811-TRYP (8797)

[email protected]

www.tryptherapeutics.com

Forward-Looking Information

Certain information in this news release 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.

To view the source version of this press release, please visit https://www.newsfilecorp.com/release/90865

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.

VANCOUVER, British Columbia, April 08, 2021 (GLOBE NEWSWIRE) — Algernon Pharmaceuticals Inc. (CSE: AGN) (FRANKFURT: AGW) (OTCQB: AGNPF) (the “Company” or “Algernon”) a clinical stage pharmaceutical development company, is pleased to announce that it plans to formalize discussions with the U.S. Food and Drug Administration (“FDA”) by filing an End-of-Phase 2 meeting request (EOP2) based on the completion of the Phase 2b part of its Phase 2b/3 COVID-19 trial (the “Study”) of NP-120 (Ifenprodil).

Algernon has now completed its initial review of the full data set from the Study and will be seeking guidance from the FDA on moving forward with a potential Phase 3 study.

The purpose of an EOP2 meeting is to facilitate interaction between the FDA and sponsors who seek guidance related to clinical trial design, to determine the safety of proceeding to Phase 3, to evaluate the Phase 3 plan, including protocols and endpoints for adequacy, and to identify information necessary to support a marketing application.

As part of the EOP2 meeting request, the Company is preparing a briefing package that includes a summary of Study data and a protocol synopsis for a potential Phase 3 trial. The EOP2 meeting is an essential part of the process to help guide the Company and determine the next steps forward.

The EOP2 meeting will focus on the data from three key endpoints from the Study including all-cause mortality, oxygenation (SpO2) and time in ICU, from the 20mg Ifenprodil treatment arm.

The Company has been reviewing the data from the 40mg Ifenprodil treatment arm of the Study. While the full data set review confirmed no significant changes were observed compared to the untreated arm of the Study, the data showed a negative dose effect trend with some clinical outcomes.

As a complex receptor, NMDA’s relationship with drugs that stimulate or inhibit it is not completely understood. In some cases of being inhibited or antagonized, the receptor, instead of shutting down, appears to protest over-inhibition, possibly leading to adverse responses in patients. This has been identified in studies of Memantine and Ketamine, also NMDA receptor antagonists.

This may represent a class effect observed at doses higher than those at which a more customary dose-response relationship is shown, and as such, may inform observations on the 40mg dose data. There was very little historical data to guide dosing for this Study of Ifenprodil in COVID-19 patients, and the Company chose to include a high dose 40mg treatment arm in the Study, in view of Ifenprodil’s considerable safety record.

“When we consider the totality of the Study’s data set, we are very confident that the next appropriate step is a formal EOP2 meeting with the FDA in order to discuss the results and explore the potential of a Phase 3 trial,” said Christopher J. Moreau, CEO of Algernon Pharmaceuticals. “We look forward to feedback from the FDA so that we can determine our next steps.”

The Company advises that it is not making any express or implied claims that Ifenprodil has the ability to eliminate, cure or contain COVID-19 (or the SARS-2 Coronavirus) at this time.

About Algernon Pharmaceuticals Inc.

Algernon is a drug re-purposing company that investigates well-tolerated, already approved drugs, including naturally occurring compounds for new disease applications, moving them efficiently and safely into new human trials, developing new formulations and seeking new regulatory approvals in global markets. Algernon specifically investigates compounds that have never been approved in the U.S. or Europe to avoid off label prescription writing.

CONTACT INFORMATION

Christopher J. Moreau
CEO
Algernon Pharmaceuticals Inc.
604.398.4175 ext 701
[email protected]
[email protected]
www.algernonpharmaceuticals.com

Neither the Canadian Securities Exchange nor its Market Regulator (as that term is defined in the policies of the Canadian Securities Exchange) accepts responsibility for the adequacy or accuracy of this release.

CAUTIONARY DISCLAIMER STATEMENT: No Securities Exchange has reviewed nor accepts responsibility for the adequacy or accuracy of the content of this news release. This news release contains forward-looking statements relating to product development, licensing, commercialization and regulatory compliance issues and other statements that are not historical facts. Forward-looking statements are often identified by terms such as “will”, “may”, “should”, “anticipate”, “expects” and similar expressions. All statements other than statements of historical fact, included in this release are forward-looking statements that involve risks and uncertainties. There can be no assurance that such statements will prove to be accurate and actual results and future events could differ materially from those anticipated in such statements. Important factors that could cause actual results to differ materially from the Company’s expectations include the failure to satisfy the conditions of the relevant securities exchange(s) and other risks detailed from time to time in the filings made by the Company with securities regulations. The reader is cautioned that assumptions used in the preparation of any forward-looking information may prove to be incorrect. Events or circumstances may cause actual results to differ materially from those predicted, as a result of numerous known and unknown risks, uncertainties, and other factors, many of which are beyond the control of the Company. The reader is cautioned not to place undue reliance on any forward-looking information. Such information, although considered reasonable by management at the time of preparation, may prove to be incorrect and actual results may differ materially from those anticipated. Forward-looking statements contained in this news release are expressly qualified by this cautionary statement. The forward-looking statements contained in this news release are made as of the date of this news release and the Company will update or revise publicly any of the included forward-looking statements as expressly required by applicable law.

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.

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 69^th 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.

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.