Numinus Announces Phase 1 Clinical Trial of Natural Psilocybin Mushroom Extraction Prepared at Company Lab
Ryan Allway
April 26th, 2021
Psychedelics
Clinical trial will evaluate safety and psychoactive properties of natural Psilocybin product
extracted and formulated at 7,000-square-foot laboratory in British Columbia, Canada
VANCOUVER, BC, April 26, 2021 /CNW/ – Numinus Wellness Inc. (“Numinus” or the “Company”) (TSXV: NUMI), a mental health care company advancing innovative treatments and safe, evidence-based psychedelic-assisted therapies, announced today that it has formed a partnership with KGK Science, a leading contract research organization with expertise in natural products, to undertake a new Psilocybin extraction clinical trial.
The Phase 1 trial will enroll 14 human volunteers and assess the safety and psychoactive properties of a Psilocybe mushroom product extracted and formulated at the Numinus Bioscience lab in British Columbia, Canada. Successful completion of the landmark trial would result in safety and efficacy data for a natural Psilocybin product which could subsequently be used for further research and government-approved special access or compassionate access programs.
In addition, the trial would support Canada’s leadership in the safe production of a key psychedelic that has shown promise in treating mental health conditions including depression, end of life anxiety and substance use disorders, when used in conjunction with a standardized psychotherapy program under clinical supervision.
“This Phase 1 trial supports our mandate to improve access to safe, evidence-based psychedelic-assisted therapies in Canada and around the world,” said Payton Nyquvest, CEO, Numinus. “Through this trial, we expect to demonstrate that Numinus is well ahead in the development of natural Psilocybin therapeutics that are safe for humans and can be used to support our sector’s growth through sales to other research organizations, the creation of new intellectual property, and the ability to conduct our own Phase 2 and Phase 3 clinical trials, if we choose to do so.”
“We’re thrilled to help lead ground-breaking clinical work using Psilocybin,” said Najla Guthrie, President & CEO, KGK Science. “Our team’s expertise in the area of natural health products makes us uniquely positioned to contribute to the burgeoning psychedelics industry.”
Numinus is less than three years old, but already has a history of innovation in psychedelics. Numinus completed the first legal extraction of Psilocybe mushrooms in Canada by a public company for research and development purposes, and completed the cultivation and harvest of the first legal flush of Psilocybe mushrooms.
“We believe there are several likely advantages to naturally occurring Psilocybin therapeutics that will make them attractive for researchers and consumers alike,” said Sharan Sidhu, Science Officer and General Manager at Numinus Bioscience. “We are confident that this trial will document that natural Psilocybin extractions meet health regulator requirements for safety, efficacy and quality, and ultimately enable the establishment of better access to this medicine.”
“We are excited to see Health Canada grant legal exemptions for certain patients to use Psilocybin alongside psychotherapy in situations when other treatments have failed, and to consider revisions to its Special Access Programme that could allow Canadian patients access to psychedelic medications when other drugs have been unsuccessful,” added Dr. Evan Wood, Chief Medical Officer, Numinus. “As research interest and the potential for increased compassionate access to Psilocybin grows, it is imperative that patients have access to safe, pharmaceutical-grade supply that offers consistent psychoactive properties at scale. With this trial, we are taking the first steps towards that goal.”
Currently, Numinus is also partnering with Syreon Corporation, a global contract research organization, to undertake a single-arm, open-label compassionate access trial that will assess the efficacy and safety of Psilocybin-assisted motivational enhancement therapy using a synthetic Psilocybin product. The study will contribute to a growing body of research to inform larger randomized controlled trials for these indications. The study will take place in Vancouver and will enroll 30 individuals with opioid, stimulant and/or alcohol use disorders.
About Numinus
Numinus Wellness (TSX-V; NUMI) empowers people to heal and be well through the development and delivery of innovative mental health care and access to safe, evidence-based psychedelic-assisted therapies. The Numinus Wellness model – including psychedelic production, research and clinic care – is at the forefront of a transformation aimed at healing rather than managing symptoms for depression, anxiety, trauma, pain and substance abuse. At Numinus, we are leading the integration of psychedelic-assisted therapies into mainstream clinical practice, and building the foundation for a healthier society.
Learn more at numinus.ca, and follow us on Facebook, Twitter, and Instagram.
About KGK
As a global Contract Research Organization (CRO), KGK Science performs a productive and pioneering role in the realm of scientific study. For over two decades, it has offered well-designed, customized solutions to each of its clients, consolidating its scientific, clinical, commercial, and regulatory abilities into one full-service package. Equipped with state-of-the-art technologies, novel research techniques, and a seasoned team of thought leaders, KGK remains at the forefront of its industry. And, by seamlessly matching its experience with its drive for innovation, this CRO is able to respond effectively to expanding trade and consumer demands.
Forward Looking Statements
This news release contains forward-looking statements within the meaning of applicable securities laws. All statements that are not historical facts, including without limitation, statements regarding future estimates, plans, programs, forecasts, projections, objectives, assumptions, expectations or beliefs of future performance, are “forward-looking statements.” Forward-looking statements can be identified by the use of words such as “plans”, “expects” or “does not expect”, “is expected”, “estimates”, “intends”, “anticipates” or “does not anticipate”, or “believes”, or variations of such words and phrases or statements that certain actions, events or results “may”, “could”, “would”, “might” or “will” be taken, occur or be achieved. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results, events or developments to be materially different from any future results, events or developments expressed or implied by such forward looking statements. Such risks and uncertainties include, among others, dependence on obtaining and maintaining regulatory approvals, including acquiring and renewing federal, provincial, municipal, local or other licences and any inability to obtain all necessary governmental approvals licences and permits to operate and expand the Company’s facilities; regulatory or political change such as changes in applicable laws and regulations, including federal and provincial legalization, due to inconsistent public opinion, perception of the medical-use of psychedelics, bureaucratic delays or inefficiencies or any other reasons; any other factors or developments which may hinder market growth; the Company’s limited operating history and lack of historical profits; reliance on management; the Company’s requirements for additional financing, and the effect of capital market conditions and other factors on capital availability; competition, including from more established or better financed competitors; and the need to secure and maintain corporate alliances and partnerships, including with research and development institutions, customers and suppliers; the development and implementation of medical protocols and treatment standard operating procedures for the use of psychedelic therapies; the Company’s goals to develop and implement partnerships with research organizations and other key players in the integrative mental health industry; the Company’s ability to successfully withstand the economic impact of COVID-19; the medical benefits, safety, efficacy, dosing and social acceptance of psychedelics; the approval and/or success of compassionate access clinical trials; the cultivation and harvest of Psilocybe mushrooms; and the availability of trained personnel and medical professionals. These factors should be considered carefully, and readers are cautioned not to place undue reliance on such forward-looking statements. Although the Company has attempted to identify important risk factors that could cause actual actions, events or results to differ materially from those described in forward-looking statements, there may be other risk factors that cause actions, events or results to differ from those anticipated, estimated or intended. There can be no assurance that forward-looking statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in forward-looking statements. The Company has no obligation to update any forward-looking statement, even if new information becomes available as a result of future events, new information or for any other reason except as required by law.
Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
SOURCE Numinus Wellness Inc.
For further information: May Lee, Communications Manager, Numinus, may@numinus.ca; For media inquiries: Catherine Snider, Kaiser & Partners, catherine.snider@kaiserpartners.com
Related Links
This article was published by CFN Enterprises Inc. (OTCQB: CNFN), owner and operator of CFN Media, the industry’s leading agency and digital financial media network dedicated to the burgeoning CBD and legal cannabis industries. Call +1 (833) 420-CNFN for more information.
About Ryan Allway
Mr. Allway has over a decade of experience in the financial markets as both a private investor and financial journalist. He has been actively involved in the cannabis industry since its inception, covering public and private companies.
Search CannabisFN
Press Coverage
Psychedelics Index
Top Videos
In addition to his role as Founder and CEO at MAZAKALI, Sumit is a consultant to The Arcview Group and the Managing Partner of Emerald Ventures. A frequent speaker at investment seminars, Sumit acts as a mentor to Arcview and Canopy companies and serves on the Canopy Investment committee as well as the NCIA Finance […]
Alan Brochstein’s 420 Investor is the go-to community for investors to learn, explore, and profit from the marijuana companies. The main goal of 420 Investor is to provide real-time, objective information about the top marijuana companies in the market in order to help investors capitalize on cannabis.
The Supreme Cannabis Company is a Canadian publicly traded company committed to providing premium brands and products that proudly reflect its consumers, people and uniquely innovative culture.
Aleafia, a vertically integrated, national cannabis company, operates major medical clinic, cannabis cultivation and R&D facilities.
Network Partners
About CFN Media Group
CFN Enterprises Inc. (OTCQB: CNFN) owns and operates CFN Media Group, the premier agency and financial media network reaching executives, entrepreneurs and consumers worldwide. Through its proprietary content creation, video library, and distribution via www.CannabisFN.com, CFN has built an extensive database of cannabis interest, assisting many of the world’s largest cannabis firms and CBD brands to build awareness and thrive. For more information, please visit www.cfnenterprisesinc.com.
Disclaimer: Matters discussed on this website contain 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. CFN Media Group, which owns CannabisFN, 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. CFN Media Group, which owns CannabisFN, may from time-to-time have a position in the securities mentioned herein and will increase or decrease such positions without notice. The Information contains forward-looking statements, i.e. statements or discussions that constitute predictions, expectations, beliefs, plans, estimates, or projections as indicated by such words as "expects", "will", "anticipates", and "estimates"; therefore, you should proceed with extreme caution in relying upon such statements and conduct a full investigation of the Information and the Profiled Issuer as well as any such forward-looking statements. Any forward looking statements we make in the Information are limited to the time period in which they are made, and we do not undertake to update forward looking statements that may change at any time; The Information is presented only as a brief "snapshot" of the Profiled Issuer and should only be used, at most, and if at all, as a starting point for you to conduct a thorough investigation of the Profiled Issuer and its securities and to consult your financial, legal or other adviser(s) and avail yourself of the filings and information that may be accessed at www.sec.gov, www.pinksheets.com, www.otcmarkets.com or other electronic sources, including: (a) reviewing SEC periodic reports (Forms 10-Q and 10-K), reports of material events (Form 8-K), insider reports (Forms 3, 4, 5 and Schedule 13D); (b) reviewing Information and Disclosure Statements and unaudited financial reports filed with the Pink Sheets or www.otcmarkets.com; (c) obtaining and reviewing publicly available information contained in commonlyknown search engines such as Google; and (d) consulting investment guides at www.sec.gov and www.finra.com. You should always be cognizant that the Profiled Issuers may not be current in their reporting obligations with the SEC and OTCMarkets and/or have negative signs at www.otcmarkets.com (See section below titled "Risks Related to the Profiled Issuers, which provides additional information pertaining thereto). For making specific investment decisions, readers should seek their own advice and that of their own professional advisers. CFN Media Group, which owns CannabisFN, may be compensated for its Services in the form of cash-based and/or equity-based compensation in the companies it writes about, or a combination of the two. For full disclosure, please visit: https://www.cannabisfn.com/legal-disclaimer/. A short time after we acquire the securities of the foregoing company, we may publish the (favorable) information about the issuer referenced above advising others, including you, to purchase; and while doing so, we may sell the securities we acquired. In addition, a third-party shareholder compensating us may sell his or her shares of the issuer while we are publishing favorable information about the issuer. Except for the historical information presented herein, matters discussed in this article contain 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. CFN Media Group, which owns CannabisFN, 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. CFN Media Group, which owns CannabisFN, may from time to time have a position in the securities mentioned herein and will increase or decrease such positions without notice. For making specific investment decisions, readers should seek their own advice and that of their own professional advisers. CFN Media Group, which owns CannabisFN, may be compensated for its Services in the form of cash-based and/or equity- based compensation in the companies it writes about, or a combination of the two. For full disclosure please visit: https://www.cannabisfn.com/legal-disclaimer/.
Copyright © Accelerize Inc. · All Rights Reserved · Privacy Policy · Legal Disclaimer
