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With US FDA Support and Breakthroughs, Psilocybin a Step Closer to Legalization

With support from the US FDA and several clinical studies, psilocybin is emerging as a way to help treat mental illness – great news for companies such as Pure Extracts Technologies Corp. (CSE:PULL)(OTC:PRXTF)(XFRA:A2QJAJ), Psyence Group Inc. (CSE:PSYG), Compass Pathways Inc. (NASDAQ:CMPS), Cybin Inc. (NEO:CYBN)(OTC:CLXPF), and MindMed (NEO:MMED) (OTC:MMEDF). For example, a study from JAMA Psychiatry just found that psilocybin “worked better than the usual antidepressant medications,” as noted by NPR, for example. New York Univ. found “Psilocybin produced immediate, substantial, and sustained improvements in anxiety and depression and led to decreased cancer-related demoralization and hopelessness, and improved spiritual well-being.”

The Beckley Foundation said, “Psilocybin was well-tolerated and induced rapid and lasting reduction in the severity of depressive symptoms.” Helping, the US FDA says psilocybin is a “breakthrough therapy” for clinical depression.

In addition, pharmaceutical companies could begin to enter the psychedelic space, according to Wired. “As patients’ prescriptions on many conventional antidepressants begin to expire – and public and regulatory opinion regarding psychedelics is changing – 2021 will be the time that psychedelic therapy casts a spotlight on the limitations of current mental-health care treatments, and highlights a bold alternative.”

Pure Extracts Technologies and Psyence Sign JV Letter of Intent

Pure Extracts Technologies Corp. (CSE: PULL)(OTC: PRXTF)(XFRA: A2QJAJ) and Psyence Group Inc. (CSE: PSYG) just announced the signing of a Letter of Intent to form a Joint Venture to develop superior techniques for the extraction of psilocybin from psychedelic mushrooms, as well as the development of advanced formulations containing psilocybin for the long-term treatment of psychological trauma and its mental health consequences.

Psyence is one of the world’s first psychedelic mushroom companies operating a federally legal commercial cultivation and extraction facility in Southern Africa and possessing an experienced global team of doctors and scientists striving for breakthroughs in palliative care, neurology, neuroscience and drug development.

Pure Extracts is a plant-based extraction company focused on cannabis, hemp, functional mushrooms and the rapidly emerging psychedelic sector with a state-of-the-art processing facility and has submitted an application to Health Canada for a Dealer’s Licence under the Controlled Drugs and Substances Act (CDSA).

The companies plan to maximize the use of their combined infrastructure and networks in order to attain near-term milestones. Pure Extracts has a strong Canadian network of psychedelic mushroom experts, from cultivation to research & development, including Dr. Alexander MacGregor and his team at the Toronto Institute of Pharmaceutical Technology, while Psyence’s network in South Africa, Lesotho and Jamaica has the expertise for the JV to rapidly develop natural psychedelics and novel drug delivery systems for patients throughout the world. Additionally, the Psyence team is experienced in structuring and running clinical trials and a near term goal will be to participate in a Canadian based, human clinical trial.

Pure Extracts CEO, Ben Nikolaevsky, remarked, “We are excited about working with the deeply qualified science team at Psyence, one of only a handful of companies in the world operating a vertically integrated, federally licensed, psychedelic mushroom facility.” Dr. Justin Grant, Chief Scientific Officer of Psyence, commented, “This partnership with Pure Extracts will facilitate the importation of our standardized psychedelic mushrooms into Canada, giving us the opportunity to further optimize extraction methods and produce advanced products needed for safe clinical research. Our companies share the vision of providing the highest quality and most innovative psilocybin products for Canada, as evidenced by our facilities being constructed to GMP standards, and our commitment to rigorous scientific and clinical research for the development of transformational treatments for mental health disorders, with a particular focus on oncology palliative care.”

Other related developments from around the markets include:

Compass Pathways Inc., a mental health care company dedicated to accelerating patient access to evidence-based innovation in mental health, announced that it has been granted two new patents by the US Patent and Trademark Office (USPTO). These patents cover oral formulations of COMPASS’s synthetic psilocybin in the treatment of major depressive disorder (MDD), which includes treatment-resistant depression (TRD). US Patent No 10,954,259 was granted on 23 March 2021, with claims to COMPASS’s high-purity crystalline psilocybin (including the form used in its synthetic formulation, COMP360), pharmaceutical formulations containing crystalline psilocybin and methods of treating MDD with the crystalline psilocybin. US Patent No 10,947,257 was granted on 16 March 2021, with claims to oral dosage forms of crystalline psilocybin and methods of treating MDD with the oral dosage forms.

Cybin Inc., a biotechnology company focused on progressing psychedelic therapeutics, announced key senior management changes to lead the buildout of its development and clinical operations in the United States and Europe. Effective immediately, Alexander Belser, PhD, will serve as Chief Clinical Officer, and Aaron Bartlone will serve as Chief Operating Officer of Cybin US Holdings Inc. The Company also announced that co-founder and former Chief Operating Officer, Paul Glavine will assume the role of Chief Growth Officer of Cybin Inc., and co-founder and former SVP, Business Development, John Kanakis will assume the role of Chief Business Officer.

MindMed, a leading psychedelic medicine biotech company, has announced the addition of Dr. Robert C. Malenka, an accomplished neuroscientist and psychiatry professor from Stanford University, to Chair the Company’s Scientific Advisory Board. Dr. Malenka is an elected member of the National Academy of Sciences and the National Academy of Medicine as well as an elected fellow of the American Academy of Arts and Sciences, the American Association for the Advancement of Science, and the American College of Neuropsychopharmacology. He has served on the National Advisory Council on Drug Abuse and as a Counselor for the Society for Neuroscience and the American College of Neuropsychopharmacology. He is well known for his landmark contributions to understanding of brain plasticity mechanisms, and has extensive experience as an advisor to various pharmaceutical and biotechnology companies.

Legal Disclaimer / Except for the historical information presented herein, matters discussed in this article contains forward-looking statements that are subject to certain risks and uncertainties that could cause actual results to differ materially from any future results, performance or achievements expressed or implied by such statements. Winning Media is not registered with any financial or securities regulatory authority and does not provide nor claims to provide investment advice or recommendations to readers of this release. For making specific investment decisions, readers should seek their own advice. Winning Media is only compensated for its services in the form of cash-based compensation. Pursuant to an agreement Winning Media has been paid three thousand five hundred dollars for advertising and marketing services for Pure Extracts Technologies Corp. by Pure Extracts Technologies Corp. We own ZERO shares of Pure Extracts Technologies Corp. Please click here for full disclaimer.

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