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Psychedelic Stock News: Global Wellness (CSE: GWS) Readies for First Clinical Trial

Shanti's Focus on Chronic Pain Market with Psychedelics

 

Vancouver, Canada, and Rehovot, Israel - May 12, 2022 (Newsfile Corp.) (Investorideas.com Newswire) Global Wellness Strategies Inc. (CSE: GWS) (OTCQB: GWSFF) (FSE: O3X) ("Global" or the "Company") announces Shanti Therapeutics MDMA Clinical Trial Update.

Shanti's product suite of MDMA could be the global market winner finding a solution to the chronic puzzle of pain.

iNGENü, a subsidiary of Australian leader Cannvalate, is engaged as the CRO (clinical research organization) by the Company to conduct clinical trials for Shanti Therapeutics. The protocol is a single center, randomized crossover study to investigate the efficacy of MDMA vs placebo in a model of experimental pain in healthy adults. Shanti has a targeted research pathway to clinical success, with strong proprietary protection under its already submitted patent providing a method for the treatment or prevention of pain.

  • The Shanti Key Opinion Leader (KOL) Dr. Michael Keane, who is a specialist anesthesiologist announced in November 2021, has already assembled the Shanti team with a wealth of data to support the potential development of a new generation of drugs to help patients suffering from chronic pain. He is the author of multiple MDMA articles, published in peer-reviewed scientific journals.
  • As previously announced in November 2021, Shanti submitted an application to Swinburne University (Melbourne, Australia) to the University Institutional Review Board (IRB) or HREC committee. The purpose of the HREC (Human Research Ethics Committee) review is to ensure that all clinical trials are conducted in accordance with Good Clinical Practice (GCP) and pose minimal safety concerns for the trial participants.
  • iNGENü, on behalf of Shanti as the sponsor of the trials, will begin the selection of the 22 healthy volunteers shortly in Australia for the trial; comparing the pain tolerance threshold in patients who have had exposure to a proprietary dose and formulation of MDMA.
  • iNGENü signed a supply agreement in February 2022 with Canada-based PharmAla Biotech to supply MDMA for the Shanti Therapeutics upcoming clinical trial and will disclose receipt of MDMA when appropriate.

The Company is excited to be working with iNGENü and Shanti on the development of a novel drug to be used in the treatment of perioperative pain. Psychosocial elements can exacerbate the perception of pain but similarly, pain can often have significant psychological sequelae and lead to prolonged mental health issues. Depression, anxiety and other mental health issues often coexist with pain syndromes by the time they present to the treating physician.

"Developing a novel pharmaceutical compound for the treatment of perioperative pain is an exciting journey. We are thrilled at the progress of our subsidiary to date and look forward to the commencement of the initial dosing in this first-in-man trial," stated, Meris Kott, CEO, Global Wellness Strategies Inc.

About Global Wellness Strategies
Global Wellness Strategies is a prospect generator that provides high growth companies with financial, operational, and management assistance in the fast-growing market for wellness consumer products. The focus of the Company is on global wellness, psychedelics, mycology, hemp and CBD, healthcare-related target companies.

For further information visit websites:
www.globalwellnessstrategies.com and www.shantitherapeutics.com

Or Contact Meris Kott CEO 604.484.0355 or email to info@globalwellnessstrategies.com

Further information about the Company is available on www.SEDAR.com under the Company's profile.

Neither the Canadian Securities Exchange nor its Regulation Services Provider (as that term is defined in the policies of the Canadian Securities Exchange) accepts responsibility for the adequacy or accuracy of this release. Certain statements contained in this release may constitute "forward-looking statements" or "forward-looking information" (collectively "forward-looking information") as those terms are used in the Private Securities Litigation Reform Act of 1995 and similar Canadian laws. These statements relate to future events or future performance. The use of any of the words "could", "intend", "expect", "believe", "will", "projected", "estimated", "anticipates" and similar expressions and statements relating to matters that are not historical facts are intended to identify forward-looking information and are based on the Company's current belief or assumptions as to the outcome and timing of such future events. Actual future results may differ materially. In particular, this release contains forward-looking information relating to the business of the Company, its financing and certain corporate changes. The forward-looking information contained in this release is made as of the date hereof and the Company is not obligated to update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as required by applicable securities laws. Because of the risks, uncertainties and assumptions contained herein, investors should not place undue reliance on forward-looking information. The foregoing statements expressly qualify any forward-looking information contained herein.


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