Vancouver, British Columbia, May 12, 2022 – Global Wellness Strategies Inc. (CSE:GWS) (OTCQB:GWSFF) (Frankfurt:O3X4) (“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) 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 oftenhave significant psychological sequelae and lead to prolonged mental health issues. Depression, anxiety and other mentalhealth 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.
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Or Contact Meris Kott CEO 604.484.0355 or email to [email protected]
Further information about the Company is available on www.SEDAR.com under the Company’s profile.
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