Global Wellness Strategies Signs MDMA Supply Agreement with PharmAla Biotech

The Shanti Therapeutics Focus on Chronic Pain Market with Psychedelics

February 10, 2022 9:36 AM EST | Source: XTACY Therapeutics

Vancouver, British Columbia--(Newsfile Corp. - February 10, 2022) - Global Wellness Strategies Inc. (CSE: GWS) (FSE: O3X4) (OTCQB: GWSFF) ("Global" or the "Company") and their Contract Research Organization ("CRO") iNGENü (a fully owned subsidiary of Cannvalate Pty Ltd) sign supply agreement with Canada-based PharmAla Biotech (CSE: MDMA) to supply GMP MDMA for the Shanti Therapeutics upcoming clinical trial.

Global Wellness' Shanti Therapeutics is a first-in-class biotech utilizing the neuromodulation properties of MDMA (aka Ecstasy) to pre-emptively treat preoperative pain. Shanti has commenced a path to their clinical trial in 22 healthy volunteers comparing the pain tolerance threshold in patients who have had exposure to a proprietary dose and formulation of MDMA. This proof-of-concept clinical study is to gauge the effect size of an increase in the pain threshold in subjects who have been pre-emptively treated with MDMA. iNGENü was chosen as the Contract Research Organization (CRO), as they are a niche CRO specialized in novel psychedelic clinical trials.

"Biotechs face many roadblocks as a drug development journey begins. Choosing the right CRO can make or break a molecule's future and a bad selection can derail the most aggressive clinical trial. Developing an integrated, big-picture roadmap for a molecule and company can only work with a formidable CRO, as even a lucrative discovery is a challenging and expensive endeavor. Not only do we have both a strong CRO to guide the research and trials plus the recently formed alliance with PharmAla, but also another Canadian partner Pharmascience Inc. completes their MDMA orders, which is Canada's second largest manufacturer of generic and branded drugs and a tremendous milestone check mark for Shanti! These strategic partnerships are pivotal to the success of Shanti as the sponsor of the project and the discovery of a new molecule to solve the puzzle of chronic pain," said Meris Kott, CEO, Global Wellness Strategies Inc.

"I'm thrilled that, as the first company to develop a full GMP MDMA value chain in North America, we can now help enable other companies such as Global Wellness Strategies," said Nick Kadysh, founding CEO, PharmAla Biotech. "Alleviating the backlog of clinical-grade MDMA for research will accelerate the entire Psychedelics category, and help bring MDMA in the mainstream. Over the coming months we will be working diligently to fulfill Global Wellness Strategies' needs, and support them as they move their research forward."

PharmAla Biotech Holdings Inc. (CSE: MDMA) is a biotechnology company focused on the research, development, and manufacturing of MDXX class molecules, including MDMA. PharmAla was founded with a dual focus: alleviating the global backlog of generic, clinical-grade MDMA to enable clinical trials, and to develop novel drugs in the same class. PharmAla is a "regulatory first" organization, formed under the principle that true success in the psychedelics industry will only be achieved through excellent relationships with regulators. PharmAla has built what it believes to be North America's first cGMP MDMA value chain, encompassing GMP manufacturing of Active Pharmaceutical Ingredient (API), and drug product formulation.

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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