Vancouver, British Columbia, November 1, 2021 – Global Wellness Strategies Inc. (CSE:GWS) (Frankfurt:O3X4) (OTCQB: PNNRF) (“Global” or the “Company”) updates on study progress, clinical trials and appoints world class Key Opinion Leader (KOL) AssociateProfessor Michael Keane to the team.
Shanti Therapeutics is a first-in-class biotech utilizing the neuromodulation properties of MDMA Gamma, , Buck, A., Berthold, T. et al. 3,4-Methylenedioxymethamphetamine (MDMA) Modulates Cortical and Limbic Brain Activity as Measured by [H215O]-PET in Healthy Humans. Neuropsychopharmacol 23, … Continue reading (aka Ecstasy) to pre- emptively treat preoperative pain. It has been well researched that the psychosocial component of preoperative and surgical pain is significant and can be influenced by the choice of adjunct therapy including anxiolytics. Recently, it has been postulated that pre-emptively psychedeliccompounds may modulate the brain pathways such that the perception of pain is alteredRamaekers, , Hutten, N. et al. A low dose of lysergic acid diethylamide decreases pain … Continue reading which could permanently reduce an individual’s perioperative pain sensation and even postoperative analgesic requirements.
Appointment of our Key Opinion Leader (KOL): Dr. Michael Keane (MBBS FANZCA)
The company has appointed Dr. Keane as our Key Opinion Leader (KOL) to guide our study methodology and choice of efficacy endpoints for the Shanti trials. Associate Professor Michael Keane is a specialist anesthesiologist with academic appointments at Swinburne University and Monash University in Australia. Professor Keane brings two decades of research experience across a widevariety of clinical and scientific disciplines. Additionally, he is the author of multiple MDMA articles, published in peer-reviewedscientific journals.
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 undergoing finalization currently, with HREC (Human Research Ethics Committee) (aka Institutional Review Board) submission tabledfor late November with a view to commence in-human trials in Q1 2022. Both are standard research reviews on proposals involving human participants to ensure that they are ethically acceptable and that approved steps are taken to protect the rights and welfare ofhumans participating as subjects in the trials.
“Opioid-based treatments have been the cornerstone of perioperative pain management for decades and have been associated with side effects such as nausea, constipation and potential opiate addiction. The management of a patient’s post-surgical pain can be oneof the biggest challenges faced by OR physicians. Shanti Therapeutics believes that MDMA could be a first-in-class treatment where it isused to neuromodulate the perioperative pain response.
The Company is extremely pleased with the quick progress of the Shanti team and welcomes Professor Keane to the squad. GlobalWellness is aware that the psychedelic biopharma sector is now becoming a crowded sector, but with the caliber of the Shanti team, which includes acclaimed physician researcher Dr. Sud Agarwal, Shanti is well differentiated.” stated Meris Kott, CEO Global WellnessStrategies.
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:
Or Contact Meris Kott CEO 604.484.0355 or email to firstname.lastname@example.org
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 notplace undue reliance on forward-looking information. The foregoing statements expressly qualify any forward-looking information contained herein.
|↑1||Gamma, , Buck, A., Berthold, T. et al. 3,4-Methylenedioxymethamphetamine (MDMA) Modulates Cortical and Limbic Brain Activity as Measured by [H215O]-PET in Healthy Humans. Neuropsychopharmacol 23, 388–395 |
|↑2||Ramaekers, , Hutten, N. et al. A low dose of lysergic acid diethylamide decreases pain perception in healthy volunteers. Journal of Psychopharmacology 2021, Vol. 35(4) 398–405|