BALTIMORE, July 05, 2023 (GLOBE NEWSWIRE) — Greater Cannabis Company, Inc. (“GCANRx” or the “Company”) (OTC: GCAN) a publicly traded biopharmaceutical company pioneering development of next generation therapeutics is pleased to announce that it has been granted final approval for its double blind, placebo controlled Phase II Clinical Trial for the treatment of Autism Spectrum Disorder (ASD) from the Israel Ministry of Health.

The Company previously announced that it is planning to conduct a Phase II clinical trial spearheaded by principal investigator, Dr. Adi Aran, M.D., to study the safety and efficacy of its neuroprotective cannabinoid therapeutic to treat autism related spectrum disorders (ASD) and other neuropsychiatric disorders such as Parkinson’s Disease, Alzheimer’s Disease, schizophrenia, and epilepsy.

The primary objective of the clinical trial is to evaluate the efficacy, safety and tolerability of GCANRx’s proprietary therapeutic in pediatric patients (between 4 and 13 years of age) using a daily oral treatment. The patients will be randomized in a 1:1 ratio to receive either GCANRx’s therapeutic or a matched placebo. The primary efficacy objective of the study will be to assess the effect of the neuroprotective therapeutic compared to placebo on behavioral problems, using the Aberrant Behavior Checklist-Irritability Subscale (ABC-I) score – change from baseline to week 12. The primary safety objective of the study will be to assess absolute and relative frequencies of serious adverse events for therapeutic and placebo groups. The main secondary objective is to assess the effect of the neuroprotective therapeutic compared to placebo on the core ASD symptoms using the Vineland TM Adaptive Behavior Scales (3rd edition, VABS3)- 2-Domain Composite Score, and Social Responsiveness Scale 2nd edition (SRS-II) total score – change from baseline to week 12. The study, which will be conducted in Israel, is expected to begin enrolling patients in the coming weeks.

ASD is a life long condition with no cure that affects 7 million people in the US (about 5.4 million adults), and over 75 million people globally. Current pharmaceutical therapies are only minimally effective and have significant side effect profiles including obesity and altered hormone production. The cost of caring for autistic Americans reached $268 billion in 2015 and could increase to $461 billion by 2025, with the total cost of medication to treat estimated to be $37 billion. Today there are 1.5 million people already using CBD to treat ASD in the US. A recent survey found that 22.6% of parents are using CBD for their ASD child, with annual spending on CBD to treat ASD symptoms exceeding $1.85 billion.

“We are excited to announce that GCANRx has received a final official approval to embark on its Phase II Clinical Trial for our therapeutic aimed at treating ASD and other neuropsychiatric disorders. This significant milestone marks another pivotal moment in our path to develop innovative therapeutic solutions for patients suffering from complex neurological disorders”, said Aitan Zacharin, Chief Executive Officer of GCANRx. “Positive results in this study carry promise for a novel treatment for ASD as well as for other neuropsychiatric disorders such as schizophrenia, Alzheimer’s disease, and Parkinson’s disease, which share similar pathophysiological processes, and can have an enormous impact on the lives of countless families as well as on public health,” added Zacharin. “GCANRx’s therapeutic represents a promising candidate in our pipeline, leveraging cutting-edge research and scientific advancements. This Phase II Clinical Trial will enable us to rigorously evaluate the safety and efficacy of our therapeutic, and we believe will further solidify its potential as a game-changing treatment.”

ENDS

For GCANRx Investor Relations inquiries visit www.gcanrx.com, or contact info@gcanrx.com. To receive the latest information about GCANRx sign up to the investor email at https://bit.ly/2ZNlBoj or follow @GCANRX on Twitter.

About Greater Cannabis Company: The Greater Cannabis Company (OTC: GCAN), (“GCANRx” or the “Company”) is a publicly traded clinical stage biopharmaceutical company focused on the development of new and effective cannabinoid therapeutics. The Company conducts medical research, and is pursuing clinical trials, to develop innovative cannabis-based treatments for various medical conditions and their symptoms with an initial focus on neuropsychiatric disorders. GCANRx’s mission is to bring its products to the global market for the benefit of patients seeking better solutions for their unmet medical needs.

Disclaimer: Safe Harbor Statement under the Private Securities Litigation Reform Act of 1995. Statements in this press release that are not strictly historical are “forward-looking” statements within the meaning of Section 27A of the Securities Act of 1933, as amended and Section 21E of the Securities Exchange Act of 1934, as amended. These statements involve a high degree of risk and uncertainty, are predictions only and actual events or results may differ materially from those projected in such forward-looking statements. Factors that could cause or contribute to differences include the uncertainty regarding viability and market acceptance of the Company’s products and services, the ability to complete development plans in a timely manner, changes in relationships with third parties, product mix sold by the Company and other factors described in the Company’s most recent periodic filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K and quarterly reports on Form 10-Q.

Forward-Looking Statements: This press release contains certain 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 and Private Securities Litigation Reform Act, as amended, including those relating to the Company’s product development, clinical and regulatory timelines, market opportunity, competitive position, possible or assumed future results of operations, business strategies, potential growth opportunities and other statement that are predictive in nature. These forward-looking statements are based on current expectations, estimates, forecasts and projections about the industry and markets in which we operate and management’s current beliefs and assumptions.

These statements may be identified by the use of forward-looking expressions, including, but not limited to, “expect,” “anticipate,” “intend,” “plan,” “believe,” “estimate,” “potential, “predict,” “project,” “should,” “would” and similar expressions and the negatives of those terms. These statements relate to future events or our financial performance and involve known and unknown risks, uncertainties, and other factors which may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Such factors include those set forth in the Company’s filings with the Securities and Exchange Commission. Prospective investors are cautioned not to place undue reliance on such forward-looking statements, which speak only as of the date of this press release. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.

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.

• ARDS-003 is a novel therapeutic for acute systemic inflammation and prevention of acute respiratory distress syndrome (ARDS).
• ARDS-003 may offer steroid-sparing opportunities.
• ARDS-003 has demonstrated antiviral properties.
• ARDS-003 developed as an oral formulation for an immediate release administration.

OTTAWA, ON, Aug. 10, 2022 /PRNewswire/ – Tetra Bio-Pharma Inc. (“Tetra” or the “Company”) (TSX: TBP) (OTCQB: TBPMF) (FRA: JAM1), a leader in cannabinoid-derived drug discovery and development announced today new positive preclinical results from live SARS-CoV-2 virus infection studies as well as a septic lung model, carried out by independent researchers.

These studies explored the potential of ARDS-003 to increase survival metrics following SARS-CoV-2 infection in the humanized ACE2 mouse model. Secondary outcomes evaluated ARDS-003 against an antiviral drug, a clinical standard of care therapeutic used for patients with COVID, in SARS-CoV-2 infected animals. Results indicate that compared to placebo, ARDS-003 dose dependently reduced signs of morbidity and mortality, including respiratory distress. ARDS-003 also outperformed the antiviral drug in reducing multiple proinflammatory mediators (i.e., cytokines) involved in hyperinflammation and immune system dysfunction following viral infection.

Using a recent septic lung model, the administration of ARDS-003 produced a significant reduction of systemic cytokine/chemokine release.  In addition, lung histology was improved, peripheral immune hyper activation was reduced, and there was an improvement in capillary perfusion in lung tissue compared to controls.  An additional study evaluated in vitro viral infectivity and demonstrated dose dependent inhibition of viral replication.

Guy Chamberland, CEO and CRO at Tetra commented “ARDS-003 is a clinical stage asset that has a huge potential as it is focused on developing novel treatments for unmet medical needs, such as lung inflammation, viral encephalitis, and brain inflammation conditions.”

ARDS-003 Oral Formulation

Further to the ARDS-003 injection formulation, Tetra’s research team has developed an oral formulation using its proprietary technology for an immediate release administration that can be administered for longer term care in an outpatient setting. ARDS-003 has the potential to reduce the cytokine storm associated with CAR T immunotherapy complications and has been shown to have synergistic antiviral effects in several viral in vivo infection models.

Dr. Chamberland further commented “ARDS-003, for example, could be used as an adjunct to Paxlovid or other antivirals to help reduce the morbidities associated with prolonged infection by SARS-CoV-2 and other viruses.  In the case of COVID, the treatment period with ARDS-003 could be extended to continue to improve clinical outcome and prevent the rebound effect observed in immunocompromised patients receiving existing antivirals.”

About ARDS-003

ARDS-003 is a novel First in Human (FIH) drug product containing the active pharmaceutical agent, Onternabez, a potent and selective full agonist of the type 2 cannabinoid receptor (CB2R), an important immunomodulatory target. ARDS-003 is positioned to modulate acute systemic inflammation and prevent Sepsis, ARDS, and organ damage – ARDS represents the severe end of lung dysfunction resulting from systemic inflammation secondary to infectious or non-infectious clinical insult (McIntosh, 2020).  While the clinical profile of ARDS arising from viral (COVID) or bacterial Sepsis can vary, hyperinflammation involving a dysfunctional immune response is a common mediator of lung damage. Tetra’s preclinical studies have demonstrated that ARDS-003 decreases this hyperinflammatory response and slows disease progression.

About Tetra Bio-Pharma

Tetra Bio-Pharma (TSX: TBP) (OTCQB: TBPMF) (FRA: JAM1) is a leader in cannabinoid-derived drug discovery and development with a FDA and a Health Canada cleared clinical program aimed at bringing novel prescription drugs and treatments to patients and their healthcare providers. Their evidence-based scientific approach has enabled them to develop a pipeline of cannabinoid-based drug products for a range of medical conditions, including pain, inflammation, and oncology. With patients at the core of what they do, Tetra Bio-Pharma is focused on providing rigorous scientific validation and safety data required for inclusion into the existing biopharma industry by regulators, physicians and insurance companies.

For more information visit: www.tetrabiopharma.com

Neither the TSX Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Exchange) accepts responsibility for the adequacy or accuracy of this release.

Forward-looking statements
Some statements in this release may contain forward-looking information. All statements, other than of historical fact, that address activities, events or developments that the Company believes, expects or anticipates will or may occur in the future (including, without limitation, statements regarding potential acquisitions and financings) are forward-looking statements. Forward-looking statements are generally identifiable by use of the words “may”, “will”, “should”, “continue”, “expect”, “anticipate”, “estimate”, “believe”, “intend”, “plan” or “project” or the negative of these words or other variations on these words or comparable terminology. Forward-looking statements are subject to a number of risks and uncertainties, many of which are beyond the Company’s ability to control or predict, that may cause the actual results of the Company to differ materially from those discussed in the forward-looking statements. Factors that could cause actual results or events to differ materially from current expectations include, among other things, without limitation, the inability of the Company to obtain sufficient financing to execute the Company’s business plan; competition; regulation and anticipated and unanticipated costs and delays, the success of the Company’s research and development strategies, including the success of this product  or any other product, the applicability of the discoveries made therein, the successful and timely completion and uncertainties related to the regulatory process, the timing of clinical trials, the timing and outcomes of regulatory or intellectual property decisions and other risks disclosed in the Company’s public disclosure record on file with the relevant securities regulatory authorities. Although the Company has attempted to identify important factors that could cause actual results or events to differ materially from those described in forward-looking statements, there may be other factors that cause results or events not to be as anticipated, estimated or intended. Readers should not place undue reliance on forward-looking statements. The forward-looking statements included in this news release are made as of the date of this news release and the Company does not undertake an obligation to publicly update such forward-looking statements to reflect new information, subsequent events or otherwise unless required by applicable securities legislation.

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.