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."
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.
Or Contact Meris Kott CEO 604.484.0355 or email to email@example.com
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. Our team of dedicated professionals includes regulatory experts, scientists, and biomanufacturing professionals. 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. PharmAla’s research and development unit has also begun preclinical research into two patented Novel Chemical Entities (NCEs) based on MDXX class molecules, with proof-of-concept research currently ongoing at the University of Arkansas Medical School.
Nicholas Kadysh, CEO