Significant progress made as Numinus-sponsored PRIME study on psilocybin-assisted psychotherapy for opioid, stimulant and/or alcohol use disorders enters pre-implementation stage
Numinus Wellness Inc. (“Numinus” or the “Company”) (TSXV: NUMI), a company creating an ecosystem of health solutions centered around developing and supporting the safe, evidence-based, accessible use of psychedelic-assisted psychotherapies (PAP), and Syreon Corporation (Syreon), a global contract research organization with expertise in conducting clinical trials across a broad range of diseases, are pleased to share that significant progress has been made in the single-arm, open-label compassionate access 1 trial of Psilocybin-Research Intervention with Motivational Enhancement (PRIME) for substance use disorders. Currently in the development stage, the PRIME study will assess the efficacy and safety of psilocybin-assisted motivational enhancement therapy.
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. Syreon is leading the trial as Clinical Research Organization (CRO) with Numinus as the trial sponsor.
Numinus is pleased to share that several key milestones have been met since the trial was announced in November . The protocol is now finalized, having gone through two rounds of external expert peer review by a leading psychedelic research foundation. The overall structure selected for this protocol is consistent with current best practices developed internationally for psilocybin-assisted treatment. The psilocybin administration will occur in the context of a behavioural intervention consisting of motivational enhancement therapy, which is a structured counseling approach based on principles of motivational psychology and is designed to produce rapid, internally motivated change.
“Syreon is pleased to partner with Numinus to conduct this ground-breaking study in substance use disorders,” says Paul Keown , founder and CEO of Syreon. “These are among the most complex and challenging areas of modern healthcare, with enormous clinical and societal consequences. Psilocybin is a promising new therapy for personalized care in this field, and Numinus and Syreon combine the deep medical knowledge and broad trial expertise required for expert research in this expanding area of natural bioactive therapeutics.”
Numinus is also proud to announce the appointment of several key members to the study, including Dr. Lindsay Mackay , MD, CCFP, a clinician-scientist and addictions specialist who has been selected as Principal Investigator. Dr. Mackay is a graduate of the British Columbia Centre on Substance Use, NIDA-funded International Collaborative Addictions Medicine Research Fellowship, and has extensive experience in the exploration of psychedelics and novel therapies as treatments for mental health and addictions. Elena Argento , PhD, MPH, has been appointed Co-Principal Investigator. Argento works collaboratively with the BC Centre on Substance Use to conduct and lead innovative research and interventions in response to the overdose crisis and is a Postdoctoral Researcher at the University of British Columbia .
While psilocybin remains a restricted substance in Canada , the evolving regulatory landscape has shown the potential to enable greater accessibility to psilocybin-assisted psychotherapy, particularly in light of Health Canada’s recent announcement of its intention to revise the Special Access Programme (SAP). The PRIME trial is expected to contribute to the growing interest in expanding access to psilocybin-assisted treatments.
“We have made important progress to develop the framework and a team of experts to conduct this compassionate access trial that will contribute meaningful insights to treatment methods for individuals with opioid, stimulant and/or alcohol use disorders,” said Dr. Evan Wood , Chief Medical Officer, Numinus.
Several new objectives are underway in preparation for the implementation phase, with Syreon, as CRO, initiating study materials. Numinus will continue the ongoing establishment of physical, technical, and human resource infrastructure to support the Compassionate Access trial, with the aim of enabling wider delivery through the SAP, if approved.
1 Health Canada recommends compassionate access open-label clinical trials when drug manufacturers anticipate exceptional demand for a drug, “to meet the needs of patients not eligible for enrollment in other pivotal trials” ( Special Access Program for Drugs: Guidance document for industry and practitioners, Published 2020-10-14 ). This program is not related to the U.S. FDA Expanded Access program, sometimes referred to as “compassionate use” or the Breakthrough Therapy designation .
Numinus Health delivers treatments through clinics and virtual services, with clinics in Vancouver and Montreal .
Numinus R&D develops clinical and therapeutic protocols to use in treatments, in collaboration with research partners and regulators.
Numinus Bioscience develops formulations and methods for a safe supply, using Health Canada licences, scientific expertise and cutting-edge technology.
About Syreon Corporation
Syreon provides a full suite of adaptive clinical trials, health economics and outcomes research ensuring safe, effective and value-driven clinical use of innovative therapies in more than 40 countries.
Syreon partners with an elite portfolio of global pharmaceutical corporations and early-stage biotech companies to speed the evaluation of new therapies and improve health outcomes. Its expert research services identify precise therapeutic needs, rapidly evaluate new health interventions, monitor clinical use and define optimal economic value in today’s competitive health environment.
Syreon scientists have contributed to many groundbreaking innovations, from the first blockbuster signal inhibitors, chimeric and humanized monoclonals, recombinant human proteins and companion diagnostics to the developing fields of immuno-oncology, stem cell therapeutics and other recent initiatives in precision medicine.
Syreon’s head offices in North America and Europe coordinate an international network of regional offices and expert research teams providing personal support and professional coordination to clients, investigators, providers, purchasers and payers. Our services through all phases of study planning, operation, analysis and reporting ensure safe, effective and value-driven clinical use.
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 and adult-use marijuana industry, 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. 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.
SOURCE Numinus Wellness Inc.
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Ayurcann Holdings Corp. (CSE: AYUR) (the “Company” or “Ayurcann”) an integrated Canadian extraction company specializing in the processing of cannabis and hemp for the production of oils and various derivative products, announces the granting of stock options and restricted share units.
The Company has announced that it has granted incentive stock options to directors, officers, employees and consultants of the Company to purchase an aggregate of 1,000,100 common shares under the Company’s Stock Option Plan. Each option is exercisable at a price of $0.16 per common share, expires three years from the date of grant and vest six months from the date of the grant.
The Company has also granted restricted share unit grants, pursuant to the Company’s Restricted Share Unit plan, dated April 1, 2021, totaling 1,548,875 to certain eligible participants.
For further information, please contact:
Igal Sudman, Chairman, Chief Executive Officer and Corporate Secretary
Ayurcann Holdings Corp.
About Ayurcann Holdings Corp.:
Ayurcann is a leading post-harvest solution provider with a focus on providing and creating custom processes and pharma grade products for the adult use and medical cannabis industry in Canada. Ayurcann is focused on becoming the partner of choice for leading Canadian cannabis brands by providing best-in-class, proprietary services including ethanol extraction, formulation, product development and custom manufacturing.
Neither the Canadian Securities Exchange nor its Regulation Services Provider have reviewed or accept responsibility for the adequacy or accuracy of this release.
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A planned business merger between two leading cannabis producers hit a small delay this week as a critical vote got moved.
Keep reading to find out more cannabis highlights from the past five days.
Tilray delays critical shareholder meeting
On Thursday (April 15), Tilray (NASDAQ:TLRY) announced it will be postponing its shareholder vote on the fate of its merger with Aphria (NASDAQ:APHA,TSX:APHA). It will take place on April 30 instead of April 16.
Neither cannabis company offered an explanation for the change. Tilray has asked shareholders to participate in this vote regardless of how many shares they may hold. “Tilray stockholders who have not already voted, or wish to change their vote, are strongly encouraged to do so,” the company said.
This news came days after Aphria shareholders overwhelmingly voted in favor of the business transaction, with a total of 99.38 percent of shareholders voting for the deal to continue. Confirmation from Aphria Chairman and CEO Irwin Simon indicated the partnership was en route to being complete.
This past week Aphria also released financial results for the third quarter of its 2021 fiscal year, in which the firm highlights the overall direction of the company with the Tilray deal.
“We expect to have a tremendous runway for long-term sustainable growth as we build upon our existing foundation in Canada and internationally by increasing the scale of our global operations,” Simon said in a statement.
Cannabis retailer celebrates digital trend
Bidding for the piece, named “Non-Fungible Toke“ started at a price of C$4.20. The retailer plans to donate the proceeds to two charities, Second Harvest and Less.
The latter is designed to counter the carbon footprint of blockchain technology, a common criticism drawn against the rise of NFTs and other novel technologies.
As of 11:00 a.m. EST on Friday (April 16), the NFT bid was up to C$169.11.
Cannabis company news
- The Valens Company (TSX:VLNS,OTCQX:VLNCF) issued its financial report for the first quarter of its 2021 fiscal year. In its results, the company highlights a net revenue uptick of 24.7 percent from the previous quarter, resulting in C$20 million for the period.
- Trulieve Cannabis (CSE:TRUL,OTCQX:TCNNF) closed a public offering of 5 million subordinate voting shares at a price of C$50 each for total gross proceeds of C$287.5 million. The company celebrated its financial position after an offering in January, which will lead to the pursuit of merger and acquisition targets.
- Australis Capital (CSE:AUSA,OTCQB:AUSAF) appointed Jason Dyck as its new chief science officer and chairman of the firm’s scientific advisory board. Dyck previously served as an executive at Aurora Cannabis (NASDAQ:ACB,TSX:ACB), leading the scientific efforts for the cannabis producer. “I look forward to providing AUSA with advice and direction in its scientific efforts towards bringing innovations to market with immediate and significant commercial appeal,” Dyck said.
- Truss Beverage, a cannabis drinks venture co-owned by Molson Coors Beverage Company (NYSE:TAP,TSX:TPX) and HEXO (NYSE:HEXO,TSX:HEXO), released the details of its new lineup of infused beverages. Six new drinks will become available around the summer and are intended to pair with the season.
Don’t forget to follow us @INN_Cannabis for real-time updates!
Securities Disclosure: I, Bryan Mc Govern, hold no direct investment interest in any company mentioned in this article.
Partnerships with Minardi Law , Minorities for Medical Marijuana, CultivatED, and the Georgia Justice Project will include clinics and virtual events across Florida , Georgia , and Massachusetts
Trulieve Cannabis Corp. (CSE: TRUL) (OTCQX: TCNNF) (“Trulieve” or “the Company”), a leading and top-performing cannabis company based in the United States announced today a series of expungment clinics located throughout south and central Florida as well as virtual events in Georgia and Massachusetts . The clinics are part of the Company’s celebration of the 50 th anniversary of 420.
During the month of April, Minardi Law has hosted expungment clinics and will be hosting two more as follows:
- Releaf Patient Appreciation Day, April 17 th ( Valrico )
- First Annual 4/20 Event ( St. Petersburg Beach )
At these clinics, an attorney will be present to review records and see if someone is eligible for a sealing or expungment of their records. As part of the events, Trulieve will be helping cover the costs for finger prints, legal fees, and court costs.
Trulieve is working with Minorities for Medical Marijuana (“M4MM”) to host a 4/20 Expungement Clinic, part of M4MM’s Project Clean Slate. This event will take place on Saturday, April 24, 2021 , from 9:30am – 4:30pm at Riviera Beach City Hall. Anyone seeking to take place in this event is required to register in advance at http://trulieve.cc/expungementpreregistration .
In addition, Trulieve is sponsoring the First Friday Series , a weekly virtual event from the Georgia Justice Project to help Georgia citizens with record restrictions, and is also sponsoring the Fellowship Presentation and Expungement Clinic being offered through CultivateEd and GBLS on Friday, April 23 from 3:00pm – 4:00pm . You can register for the Massachusetts expungement clinic in advance here: HTTPS://BIT.LY/2Q655KK
“Our mission as a company has always been to improve people’s lives,” said Trulieve CEO Kim Rivers . “We’ve always been dedicated to improving the communities we call home. Partnering with Minardi Law , Minorities for Medical Marijuana, Georgia Justice Project and CultivatED on these clinics was a simple decision for us; we encourage anyone seeking help with the expungement process to attend one of these clinics in your own state to start the process.”
For more information about Trulieve and the April expungment clinics, please visit www.Trulieve.com .
Trulieve is primarily a vertically integrated “seed-to-sale” company in the U.S. and is the first and largest fully licensed medical cannabis company in the State of Florida . Trulieve cultivates and produces all of its products in-house and distributes those products to Trulieve-branded stores (dispensaries) throughout the State of Florida , as well as directly to patients via home delivery. Trulieve also has operations in California , Massachusetts , Connecticut and Pennsylvania. Trulieve is listed on the Canadian Securities Exchange under the symbol TRUL and trades on the OTCQX market under the symbol TCNNF.
To learn more about Trulieve, visit www.Trulieve.com .
SOURCE Trulieve Cannabis Corp.
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Seth Rogen’s New Cannabis Brand are Now Available at Apothecarium Dispensaries in San Francisco , Berkeley and Capitola
The Apothecarium is offering cannabis from Houseplant, the cannabis lifestyle brand founded by Seth Rogen and Evan Goldberg at its five California dispensaries. The Apothecarium has three San Francisco locations (Castro, SOMA and Marina ) and one each in Berkeley and Capitola (outside of Santa Cruz ).
“With the vast number of dispensaries in California , we put a lot of effort into identifying the right ones that align with Houseplant’s values,” said Seth Rogen , Co-Founder of Houseplant. “The Apothecarium shares the same commitment to creating a strong consumer experience that we pride ourselves on and we are thrilled to bring our three initial strains to their stores in the Bay Area.”
Houseplant is launching with three flower strains, all of which will be available at The Apothecarium, including: Diablo Wind (sativa), Pancake Ice (sativa) and Pink Moon (indica). Like their founder’s groundbreaking film “Pineapple Express”, Houseplant strains are named after weather phenomena. Each strain will be sold in a custom tin.
“We are so proud to be one of the very first dispensaries in California to offer Houseplant to our customers,” said Ryan Hudson , CEO and co-founder of The Apothecarium. “Seth, Evan and everyone at Houseplant love and respect cannabis as much as we do. We simply cannot wait to share their beautiful and delicious flowers with our guests.”
“We’ve been working with the Houseplant team for more than a year and are grateful to have a partner that shares so many of our values, including an emphasis on cannabis education, quality, reform of cannabis laws and beautifully designed, recyclable packaging.”
“Seth has been hands-on during the process, spending time with our store managers to make sure they know the products and how much care has gone into vetting and selecting the best strains. We think our guests are going to love Houseplant.”
About The Apothecarium
The Apothecarium is recognized as one of the nation’s premier cannabis dispensaries, with an emphasis on education via in-depth one-on-one consultations from highly trained cannabis consultants. The company was founded by three first cousins and two family friends in 2011. Our dispensaries are known for providing educational events that are open to the public at no cost — and for welcoming seniors, first-time dispensary visitors, and people with serious medical conditions. The Apothecarium’s flagship San Francisco dispensary was named the best-designed dispensary in the country by Architectural Digest . Patients and customers may order at our dispensaries or online for pickup or delivery at apothecarium.com [apothecarium.com] .
The Apothecarium is committed to giving back to the communities we serve. We have donated more than $400,000 in cash to community groups and nonprofits — plus more than $300,000 worth of in-kind donations.
All Apothecarium dispensaries continue to implement safety measures to protect guests and team members. Protocols include strict social distancing inside and outside the dispensaries, a mask requirement for everyone inside the dispensaries, no contact check-in procedures and ongoing sanitizing throughout the day.
CA Licenses: C10-0000523-LIC; C10-0000522-LIC; C10-0000515-LIC, C10-0000738-LIC, C10-0000706-LIC
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MISSISSAUGA, Ontario TheNewswire – April 16, 2021 Sire Bioscience Inc. (CSE:SIRE) (OTC:BLLXF) (FSE:BR1B) (CNSX:SIRE.CN) (“SIRE” or the “Company”) announces that Brian Nugent has resigned as a member of the Company’s board of directors (the “ Board ”). It has been a pleasure and a blessing to have worked with Brian Nugent over the past few years, his business acumen and tremendous experience will certainly be missed, SIRE wishes him nothing but the best in all his future endeavors.
About Sire Bioscience
SIRE is headquartered in Mississauga, Ontario with its wholly owned subsidiary PLANTFUEL® based in Denver, Colorado. SIRE is managed by a group of successful entrepreneurs who have extensive experience in the areas of consumer-packaged goods, manufacturing, logistics, and distribution. SIRE is a CPG life science company focused on the plant-based foods and supplements industry.
For additional information contact:
Sire Bioscience Inc.
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