Vancouver, British Columbia, November 29, 2021 – Global Wellness Strategies Inc. (CSE:GWS) (OTCQB: GWSFF) (Frankfurt:O3X4) ( (“Global” or the “Company”) and Shanti Therapeutics has submitted their Human Research Ethics Committee (HREC) Application for their first-in-man trials using MDMA for its anti-nociceptive effects. The Company updates on study progress, clinical trials and submission of clinical trial paperwork for the HREC committee.
Shanti therapeutics has submitted an application to Swinburne University (Melbourne, Australia) to the University Institutional Review Board (IRB) or HREC committee. The purpose of the HREC 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.
Shanti Therapeutics will be performing one of the first studies globally for the assessment of the effects of MDMA in the treatment of acute pain. It is proposed that MDMA has powerful anti-nociceptive properties that can modulate perioperative pain and could eventually form part of a balanced multimodal analgesia strategy
Path to Clinical Trials Update:
Shanti Therapeutics is commencing 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 is proof-of-concept, clinical study to gauge the effect size of increase in pain threshold in subjects who have been pre-emptively treated with MDMA. The study protocol is has been finalized, the investigational medical product has been sourced, HREC (Human Research Ethics Committee)submission completed with a view to commence in-human trials in late Q1 2022.
“A key milestone of HREC submission by Shanti has been completed on time. The ability of the scientific team to meet the deadline needed for this last ethics committee of the year involved multiple team members working around the clock. I am deeply grateful to our neuroscientist, medical writers, KOLs and clinical experts in being able to coordinate together with a short turnaround time. The Company 2022 outlook for our shareholders looks extremely positive.” stated Meris Kott, CEO Global Wellness Strategies.
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]
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