Could your next surgery involve MDMA?
Shanti Therapeutics of Global Wellness Strategies (GWS) is preparing for a study to see if MDMA has an impact on pain tolerance in healthy volunteers.
The goal is to treat and prevent perioperative pain, or pain associated with surgery.
Managing pain immediately after surgery can help prevent chronic pain and the mental health issues that often follow.
Vancouver, British Columbia, April 12, 2022 – Global Wellness Strategies Inc. (CSE: GWS) (Frankfurt:O3X4) (OTCQB: GWSFF) (“Global” or the “Company”) today announces their brand KaleidoMyco will be launching their proprietary fizz tablets this month to the American marketplace. KaleidoMyco is focused on working with doctors and integrative medical practitioners in a collaborative effort in the discovery of products combining mycology formulas with hemp extract derived cannabinoids focused on health and wellness.
“In the competitive global space of plant based medicines being the first mover has plenty of advantages. The strong team of mycologists and scientists took near a year to perfect the fizz tablets launching. We congratulate them on all their efforts and look forward to sharing their successes together and helping them create worldwide sales distribution networks.“ said Meris Kott, CEO Global Wellness Strategies.
Hemp infused medicinal mushroom products aka functional mushrooms are increasingly relevant, because of their ancient healing powers on an array of modern-day ailments. Taking these two powerful plant medicines together enables one to experience enhanced effects. The synergistic combination of both a hemp-derived blend plus medicinal mushrooms is amazing. An immunity boost, increased cognitive focus, de-stress affect and balanced energy are all benefits of functional mushrooms; while hemp benefits can also include decreased anxiety, reduced pain and improved sleep. KaleidoMyco has developed the first-ever dissolvable hemp infused myco tablets to enter the effervescent category. The tablets dissolve quickly in a glass of water or any beverage hot or cold, adding effervescence and flavor, and are an excellent way to supplement a healthy diet with an array of complementary and synergistic ingredients. The first 3 SKUs are a combo 1+1 of 25mg cannabinoids plus 25mg of functional mushrooms flavored by natural citrus, berry and grape. “According to the report published by Allied Market Research, the global functional mushroom market generated $7.98 billion in 2020, and is estimated to reach $19.33 billion by 2030, witnessing a CAGR of 9.3% from 2021 to 2030.” [1]
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
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.
References
| ↑1 | https://www.alliedmarketresearch.com |
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Vancouver, British Columbia, February 18, 2022 – Global Wellness Strategies Inc. (CSE: GWS) (Frankfurt:O3X4) (OTCQB: GWSFF) (“Global” or the “Company”) today announced the addition of two International Pedigreed Senior Advisors to its team and the appointment of Meris Kott to the board of Shanti Therapeutics. Shanti Therapeutics is focused on finding a solution to chronic pain with Psychedelics using MDMA.
“As we engage in our largest capital raise to date, our bolstered team of advisers is pivotal to our success. They put us in a stronger position as we continue to disrupt the status quo of the psychedelic sector with our focus on finding a solution to the unmet needs of the chronic pain epidemic. We are eager to introduce Shanti to the biotech investment community globally to join our current shareholders as investors. I am delighted to join the Shanti team and to help change the puzzle of pain landscape together with them.” said Meris Kott, CEO, Global Wellness Strategies Inc.
Global Wellness Strategies’ advisory hires across pharma, product and business development, investment banking and sales are in place to support Shanti Therapeutics as 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.
Advisory Team Strengthened with Diverse International Experience
Darryl Davies (B.Sc.) is a global leader and a founder of Shanti Therapeutics and has over 15 years experience in healthcare and in the medicinal cannabis industry with a strong background in psychology, harm minimization and medicinal cannabis regulatory. He has facilitated and executed meaningful relationships with public and private global cannabis licensed producers, biotech, and research institutions. He coordinated the execution of Australia’s first leadership program for the cannabis industry in partnership with Deakin University and the University of Western Sydney. He is the co-founder of private Australian award-winning cannabis company, Cannvalate, specializing in the late part of the cannabis value chain; appointed Australia’s only Director for Canadian manufacturing powerhouse, The Valens Company (TSX: VLNS); Director of New Zealand’s Greenfern Industries Ltd (NZE: GFI); and Australia’s InhaleRx Ltd. (ASX:IRX) .
Shiry Eden (MBA) is CEO and Founder at NISHOT, a strategy and analysis firm focusing on the global cannabis and psychedelic industries. In 2022 she founded the Israeli cannabis and psychedelic magazine “Cannabis Capital”. Since 2018, Shiry is a partner in an Israeli-global oriented mutual fund “SELA CANNABIS”. She has over 20 years of experience as an economist and strategic advisor for medium to large-scale corporates in Israel, with expertise in the capital market. Prior to the establishment of Nishot, she founded and managed Eden Communications and LivingGift, served as a corporate communications manager in the second largest investment house in Israel, media advisor for the Minister of Defense, and an economist in the Budget Department of the Ministry of Defense. Shiry holds a BA in Economics and Communications from the Hebrew University and an MBA from Tel Aviv University.
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.
Vancouver, British Columbia, February 10, 2022 – Global Wellness Strategies Inc. (CSE:GWS) (Frankfurt: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.
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.
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
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.
Vancouver, British Columbia, January 20, 2022 – Global Wellness Strategies Inc. (CSE:GWS) (OTCQB: GWSFF) (Frankfurt:O3X4) (“Global” or the “Company”) announces that it has signed an agreement with Next Frontier Pharmaceuticals, Inc.’s subsidiary Benuvia Manufacturing, Inc.; a merger partner of Jupiter Wellness (NASDAQ: JUPW) to work with Shanti Therapeutics as the manager of their novel psychedelic development program using MDMA.
Benuvia, based in Round Rock, Texas, is a leading drug developer and provider of cannabinoid and psychedelic APIs. Benuvia has a growing portfolio of drug products and intellectual property, and an 83,000 square foot synthetic compound manufacturing facility that is permitted by the U.S. DEA for Schedule I to III controlled substances, and is FDA registered. Benuvia also has a platform of drug master files and drug development libraries, manufacturing process technologies, and intellectual property, including patents, for the development and manufacture of organic and synthetic cannabinoids, and has a pending application for quota with the U.S. DEA to manufacture psychedelic APIs. Benuvia has begun focusing on three primary psychedelic ingredients: Psilocybin, N,N-Dimethyl-5-Methoxy-Tryptamine, or DMT, and 3,4-Methylenedioxymethamphetamine, or MDMA.
“Shanti chose Benuvia as its development partner due to its proven track record and best in class status as a developer and manufacturer of synthetic APIs. We are creating a pipeline of novel agonists as a new class of therapeutics designed to treat the root causes of mental illness disorders and chronic pain.” said Meris Kott, CEO, Global Wellness Strategies Inc. “By partnering with Benuvia, Shanti will continue with its strategy of collaborating with the emerging leaders in the field to realize our mission to provide innovative new medicines to patients.”
“We are excited to announce our entry into the global psychedelic market and our partnership program with emerging providers of psychedelic-based drugs focused on mental illness and chronic pain indications,” said Shannon Soqui, Executive Chairman of Next Frontier Pharmaceuticals. “As pharmaceutical companies become more aware of the positive effects of cannabinoids and psychedelic compounds for therapeutic use, the demand for APIs is expected to grow. Our diversified portfolio of APIs and entry into the development of novel psychedelic compounds aims to increase Next Frontier Pharmaceuticals’ and Benuvia’s position as a leading drug developer and provider of APIs focused on cannabinoids and psychedelics.”
As part of its launch into the market, Benuvia has signed an agreement to provide life cycle management services to Shanti Therapeutics for their psychedelic development program which uses MDMA. Benuvia will develop and file intellectual property on formulations of MDMA, and will provide full toxicology, and chemistry, manufacturing and controls, or CMC, and full data analysis. In addition, Benuvia, through its partners, will manage all research and development, manufacturing, analytical methods, intellectual property capture, placebo manufacture, randomization, and assistance with clinical trials. This will enable Benuvia to create custom technologies that allow rapid and cost-effective scale up of commercial operations for production in anticipation of research success.
“We are excited to partner with Shanti Therapeutics as we have a shared vision to develop and commercialize innovative medicines that provide an alternative treatment option for health care providers and their patients,” said Brandon Kidd, Chief Business Development Officer of Next Frontier Pharmaceuticals. “As pharmaceutical companies look to optimize the life cycle management of their cannabinoid and psychedelic drug products, Benuvia is an ideal partner to facilitate all facets of the process from drug development and formulation to manufacturing.”
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.
About Shanti Therapeutics Pty Ltd
Shanti Therapeutics Pty Ltd, is a subsidiary of Global Wellness Strategies Inc. and is a clinical stage drug development company focused on identifying novel uses for MDMA in the treatment of acute and chronic pain management. Its core strategy involves identifying innovative uses for entheogen drugs and pushing them into in-human clinical trials. Its lead asset is scheduled to commence Phase 2 clinical trials in late 2022.
About Next Frontier Pharmaceuticals, Inc.
Next Frontier Pharmaceuticals, Inc., through its wholly owned subsidiary, Benuvia Manufacturing, Inc., is a leading drug developer and provider of cannabinoid and psychedelic APIs. Benuvia owns the FDA approved cannabinoid drug SYNDROS® (dronabinol oral solution CII), and the largest captive synthetic cannabinoid manufacturing facility in the U.S. SYNDROS® is FDA approved as a prescription drug for the treatment of chemotherapy-induced nausea and vomiting in cancer patients and loss of appetite in AIDS patients who have lost weight. Next Frontier Pharmaceuticals is also pursuing a 505(b)(2) approval pathway with the FDA for six Investigational New Drugs (INDs). The Company’s 83,000 square foot manufacturing facility in Texas is permitted by the U.S. DEA to manufacture and export Schedule I to III controlled substances and is FDA registered. The facility has received millions in manufacturing infrastructure investments and currently operates for Benuvia’s internal capacity needs and as a contract manufacturer of APIs. Next Frontier Pharmaceuticals also has a robust portfolio of patents and patents pending on organic and synthetic cannabinoids and provides life cycle management services for drug development companies focused on cannabinoids and psychedelics.
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
Shanti Therapeutics, a subsidiary of Global Wellness (GWS), is awaiting ethics committee approval to conduct one of the first studies on MDMA for pain management.
