GCANRx Announces Submission of Phase 2 Clinical Trial Application to Treat Autism Related Spectrum Disorders

Rhea-AI Summary

Greater Cannabis Company (GCAN) has submitted a clinical trial application to the Israel Ministry of Health for a Phase 2 trial of its cannabinoid therapy targeting autism spectrum disorders (ASD) and other neuropsychiatric illnesses. The double-blind trial will involve 100 patients aged 4-17, aiming to assess safety and efficacy. Expected to enroll participants in the first half of 2023, this study may lead to a treatment option for ASD and similar disorders, addressing a significant unmet medical need.

Positive

• Submitted clinical trial application for a Phase 2 trial on cannabinoid therapy.
• Targets significant unmet medical needs in autism spectrum disorders and neuropsychiatric illnesses.
• Leading a double-blind trial with 100 participants, indicating substantial research commitment.

Negative

• None.

BALTIMORE, Oct. 07, 2022 (GLOBE NEWSWIRE) -- Greater Cannabis Company, Inc. (“GCANRx” or the “Company”) (OTC: GCAN) a biopharmaceutical company pioneering development of next generation cannabinoid therapeutics today announced that it has submitted a clinical trial application to the Israel Ministry of Health for approval of a Phase 2 clinical trial for its novel neuropsychiatric cannabinoid therapy.

The Company intends to conduct a Phase 2 clinical trial spearheaded by principal investigator, Dr. Adi Aran, to study the safety and efficacy of its neuroprotective cannabinoid therapeutic to treat autism related spectrum disorders (ASD) and other neuropsychiatric illnesses. The study will be conducted as a double-blind, placebo controlled trial with 100 patients ranging in age from 4-17 years old. The study is expected to begin enrolling patients in the first half of 2023, pending approval of the Health Ministry, and to run for 12 to 18 months, including a possible open-label phase.

“We are excited to take this next step in the advancement of our novel therapeutic to clinical trials,” said Aitan Zacharin, Chief Executive Officer of GCANRx. “ASDs are common and lifelong neurodevelopmental disabilities with a substantial emotional and economic impact on the individual, family, and society. Despite worldwide efforts, currently, there is no established pharmacological treatment for the core symptoms of ASD leaving patients and families with an unmet need. 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.”

The Company looks forward to updating shareholders on the approval of the Phase 2 study as it progresses through the review process.

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 fully reporting publicly traded 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.

Contact: The Greater Cannabis Company, Inc.
443-738-4051
info@gcanrx.com
www.gcanrx.com

FAQ

What is the purpose of GCAN's Phase 2 clinical trial?

The trial aims to assess the safety and efficacy of a neuroprotective cannabinoid therapy for treating autism spectrum disorders and other neuropsychiatric conditions.

When is the GCAN clinical trial expected to begin?

Enrollment for the clinical trial is expected to start in the first half of 2023, pending approval from the Israel Ministry of Health.

How long will the GCAN clinical trial last?

The trial is anticipated to run for 12 to 18 months, which may include a possible open-label phase.

How many participants will be involved in the GCAN clinical trial?

The Phase 2 clinical trial will involve 100 patients aged 4-17.

What are the implications of the trial results for GCAN investors?

Positive results could pave the way for a novel treatment approach for significant neuropsychiatric conditions, potentially impacting market opportunity and company growth.