The psilocybin mushroom story is only gaining momentum. This comes as a result of evidence that the drug can improve obsessive-compulsive disorder, PTSD, opioid addiction, alcoholism, eating disorders, depression, anxiety, and even smoking. Cities throughout the U.S. have now legalized its use, including Denver, Oakland, and Santa Cruz. Washington, D.C. and Oregon residents will vote on a similar measure in November 2020 elections.
Canada just granted permission to four end-of-life patients to use psilocybin to help ease anxiety and depression in a landmark decision. “In April, four Canadians suffering from terminal illness asked the government’s Health Ministry for a legal exemption for them to obtain and use “magic mushrooms,” which studies have shown help alleviate anxiety and depression,” as noted in Rolling Stone.
“The approvals mark the first publicly-known individuals to receive a legal exemption from the Canadian Drugs and Substances Act to access psychedelic therapy,” says Marijuana Moment.
In addition, with the support of the U.S. Food and Drug Administration (FDA), major institutions such as Johns Hopkins are even studying its use for the treatment of depression, addiction, and psychological disorders. For example, in 2018, the US FDA gave “breakthrough therapy” status to psilocybin treatments being developed by Compass Pathways Ltd. for clinical depression. That’s creating opportunity for companies such as The Yield Growth Corp. (CSE:BOSS) (OTC:BOSQF), Mind Medicine Inc. (OTC:MMEDF), Revive Therapeutics Ltd. (CSE:RVV)(OTC:RVVTF), Johnson & Johnson (NYSE:JNJ), and Mota Ventures Corp. (CSE:MOTA)(OTC:PEMTF).
The Yield Growth Corp. (CSE:BOSS)(OTCQB:BOSQF) BREAKING NEWS: The Yield Growth Corp. majority owned subsidiary NeonMind Biosciences Inc. announces submission of an application to Health Canada for an exemption to use a controlled substance for scientific purposes, pursuant to Section 56(1) of the Controlled Drugs and Substances Act, S.C. 1996, c. 19 (a “Section 56 Exemption”) for NeonMind’s planned preclinical trial using psilocybin.
In May 2020, NeonMind completed the design of its preclinical study focused on using psilocybin as a treatment for weight loss and food cravings. NeonMind has identified a laboratory at a Canadian university in which to conduct the Study and the Section 56 Exemption application was submitted on July 27, 2020 by the person at the Lab who is expected to be the lead investigator in the Study.
Obesity has been formally recognized by the World Health Organization (WHO) as a global epidemic, with at least 2.8 million people dying each year as a result of being overweight or obese. The WHO reported that in 2016, more than 1.9 billion adults, 18 years and older, were overweight.
“We expect to receive the exemption within several months. Researchers at the Lab have previously successfully obtained Section 56 Exemptions for research involving controlled substances,” said Penny White, CEO of NeonMind. “Obesity is an enormous problem in modern society, increasing incidence of disease and putting a significant strain on our healthcare systems. The treatment of obesity is shifting focus towards root causes of the problem. We are looking at the problem from a more holistic standpoint, and believe that psychedelics may have great potential to make a positive impact in this area.”
The Lab must first obtain a Section 56 Exemption before it can use psilocybin, a controlled substance, in the Study.
“I believe that we are reaching a tipping point when it comes to awareness about what psychedelics can offer. Therapsil has just announced that four terminal cancer patients have been approved by Health Canada to use psilocybin therapy in the treatment of their end-of-life distress,” added White. “These are the first known patients to be able to legally use psilocybin since the compound became illegal in Canada in 1974.”
Theraspil is a non-profit coalition that advocates for legal, compassionate access to psilocybin therapy for palliative Canadians. The Minister of Health, Patty Hajdu, granted the approval for 4 patients to use psilocybin therapy, marking the first publicly-known individuals to receive a legal exemption from the Canadian Drugs and Substances Act.
The goal of NeonMind’s Study is to use preclinical models to generate data to demonstrate that psilocybin can be used as an effective treatment for weight loss. NeonMind plans to use data from the Study to inform dosing strategies in a Phase 2 human clinical trial to demonstrate potential efficacy of psilocybin as a weight loss treatment.
The global projected market for weight loss and weight management according to marketsandmarkets is estimated at US$245 billion.
Section 56 grants the Minister of Health the discretionary power to provide an individual with an exemption to possess a specified quantity of the controlled substance and to administer the controlled substance to human subjects or animals for the purpose of research. Section 56 states:
“The Minister may, on any terms and conditions that the Minister considers necessary, exempt from the application of all or any of the provisions of this Act or the regulations any person or class of persons or any controlled substance or precursor or any class of either of them if, in the opinion of the Minister, the exemption is necessary for a medical or scientific purpose or is otherwise in the public interest.”
The details of the Section 56 Exemption process are as follows:
An application form for a Section 56 Exemption to use a controlled substance for scientific purposes must be completed, which includes a declaration signed and dated by the person who will be the principal investigator, and sent to the Office of Controlled Substances. According to Health Canada guidelines, exemptions are protocol, principal investigator, site and substance specific. Sufficient information must be supplied to Health Canada to support the use of a controlled substance in the project or protocol and to provide confirmation that the controlled substance will be stored in a secure manner. According to the Government of Canada website, the average processing time for a Section 56 Exemption (once all information required is provided) is 42 working days. An applicant may be contacted for clarification of information submitted or if the application is incomplete. Exemptions are valid for one year from the issuance date, and applications for extensions may be made if required.
Other related developments from around the markets include:
Mind Medicine Inc. (OTC:MMEDF), the leading psychedelic pharmaceutical company, has concluded dosing in a Phase 1 Single Ascending Dose (SAD) study of 18-MC. The dosing of 18-MC was well tolerated in humans and will help advance planning for a Phase 2a clinical trial in opioid addiction. Further, the study has not incurred any delays due to the COVID-19 pandemic and the Multiple Ascending Dose (MAD) study is on track according to the original development timeline. 18-MC is a non-hallucinogenic molecule based on the psychedelic substance ibogaine. The study tested doses ranging from 4mg to 16mg twice a day and all participants were evaluated for pharmacokinetics and safety. MindMed’s addiction treatment unit is currently focused on developing novel medicines inspired by psychedelics for addiction to address the growing opioid crisis in both Canada and the United States. The US opioid crisis is estimated to cost the US economy over $500 billion annually.
Revive Therapeutics Ltd. (CSE:RVV)(OTC:RVVTF), a specialty life sciences company focused on the research and development of therapeutics for medical needs and rare disorders, is pleased to announce that following the U.S. Food & Drug Administration (“U.S. FDA”) approval to proceed with the Company’s Phase 3 clinical trial to evaluate the safety and efficacy of Bucillamine in patients with mild-moderate COVID-19, the Company is finalizing agreements and aligning resources to initiate the Phase 3 clinical trial in September. “With the FDA approval of the Phase 3 clinical study to evaluate Bucillamine in the treatment of patients with mild-moderate COVID-19, our team and partners are working diligently to align our resources and expertise that will fast-track the Phase 3 study,” said Michael Frank, Revive’s Chief Executive Officer. Revive expects to engage up to 10 clinical trial sites in the U.S. and open the Phase 3 clinical trial for patient screening in Q3-2020. The Company is finalizing vendor agreements in the project management, medical monitoring, data management and clinical packaging for the trials. In addition, Revive and its clinical trial partners will be evaluating potential U.S. clinical sites and clinical investigators in major COVID-19 affected U.S. states, such as Florida, California, Arizona and Texas.
Johnson & Johnson (NYSE:JNJ) announced its Janssen Pharmaceutical Companies have entered into an agreement with the U.S. government for the large scale domestic manufacturing and delivery in the U.S. of 100 million doses of Janssen’s SARS-CoV-2 investigational vaccine, Ad26.COV2.S, for use in the United States following approval or Emergency Use Authorization by the U.S. Food and Drug Administration (FDA). The Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response, in collaboration with the U.S. Department of Defense, is committing over $1 billion for this agreement. The vaccine will be provided at a global not-for-profit basis for emergency pandemic use. The U.S. government may also purchase an additional 200 million doses of Ad26.COV2.S under a subsequent agreement.
Mota Ventures Corp. (CSE:MOTA)(OTC:PEMTF) announced that its US based Nature’s Exclusive brand acquired 102,844 new customers during the six month period ending June 30, 2020. Total new customers acquired during the reported period represents an all-time high for new customers within any given six-month period for the brand. This record number of customers acquired can be attributed to the Company’s increased marketing efforts of its Nature’s Exclusive brand, as well as a successful scaling of the Company’s supply chain, and its ability to respond to market demand in the midst of a global pandemic through the introduction of new and relevant products.
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