Therapsil Applies Cannabis Legalization Strategy to Psilocybin Efforts
B.C. non-profit organization Therapsil spent months drafting a 165-page proposal advocating for the therapeutic use of psilocybin as the legal and political battle continues in Canada.
- The proposal calls for regulations based on the same ones the federal government created 20 years ago for medicinal cannabis.
- The document outlines every aspect of licensing for growers and sellers, quality control, location, security, and packaging.
- Proposals also include details for patient registrations to grow their own, including how much an individual can grow.
TheraPsil CEO Spencer Hawkswell said they’re “taking all of the bureaucratic processes, all of the hard work that people put into cannabis, such as how to apply for a license if you want to grow it… and just making it the exact same for psilocybin.”
Change is going to come
- MAPS and the Canadian Psychedelic Association are also drafting their own regulatory blueprints for Health Canada to consider.
- Health Canada’s official stance is to endorse clinical trials as a means to further study psilocybin’s potential benefits and risks.
- So far, 64 patients and therapists have received legal exemptions from Health Canada; however more than 150 applications have gone unanswered.
‘Decriminalize Nature’ Movement Growing Nationwide
There’s a growing movement seeking to dispel confusion and fears about decriminalizing psychedelics.
With Decriminalize Nature’s dedication to community education, the gears are in motion in several more cities: Easthampton, Massachusetts; Grand Rapids, Michigan; and Arcata, California.
The organization’s proposals are aimed at the de-prioritization by law enforcement with regards to the possession and cultivation of substances in several states.
- The Law Enforcement Action Partnership and advocates from the Bay Staters for Natural Medicine are spearheading the effort.
- Easthampton City Council is exploring a resolution to decriminalize a wide range of entheogenic substances. The resolution seeks to make enforcement of laws against certain psychedelics among the city’s lowest priorities.
Easthampton would be the 4th city in MA to enact the reform. Other Massachusetts cities that have enacted the policy change are: Northampton, Somerville and Cambridge.
- In Grand Rapids, City Commissioner Kurt Reppart said the measures being taken could go to a vote by the end of the year, although no official actions are currently scheduled.
- City attorneys are reviewing the proposed language before being submitted to the commission’s Legislative Committee.
- In Arcata, the City Council’s Public Safety Committee has advanced a psychedelic reform resolution led by ‘Decriminalize Nature Humboldt.’
- The panel revised the resolution to further restrict policies on de-prioritizing enforcement to use and possession in private spaces.
- They also urged the inclusion of an educational campaign on the issue.
Psychedelic Medicine Expert Joins Clearmind
Following his departure from MAPS Canada, industry expert Mark Haden has now joined Clearmind Medicine’s ‘Scientific Advisory Board.’
A laundry list of qualifications
Haden has spent his career advancing the use of psychedelics in medicine.
- 25 years working with patients through the ‘Vancouver Coastal Health Addiction Services’ at the ‘Pacific Spirit Community Health Centre.’
- 10 years as Founder, Chairman and Executive Director of MAPS Canada.
- Haden held a leadership role in the ‘Psilocybin Research Investigating Medical Efficacy’ study.
- Currently serves as director of clinical research at Psygen Industries, and as adjunct professor at the University of British Columbia School of Population and Public Health.
Patents in progress
Clearmind’s (CSE: CMND) IP portfolio consists of two patent streams:
- Patent for “Binge Behavior Regulators” has been granted in the US, EU, China and India; with pending divisional applications in Europe and the U.S.
- Patent for an “Alcohol Beverage Substitute” has been approved for an EU patent, with pending applications in the US, China and India.
Global Consortium of Scientists to Collaborate on Medicine Development
A body of researchers from all around the globe will soon be calling Melbourne, Australia ‘home’ for some of the most innovative developments in psychedelic medicine.
- The new ‘Psychae Institute’ will focus on developing novel pharmaceutical-grade psychedelic medicines and psycho-therapeutic treatment models for mental health disorders, and other conditions.
- The Australian team will oversee clinical studies with partners at remote sites in Brazil, Canada, Europe, and the UK.
- They will also investigate advanced technologies for the purpose of enhancing therapeutic effects.
The organization anticipates to begin clinical studies as soon as next year. In the meantime, they will develop relationships with local pharmaceutical manufacturers.
Come together, right now
- Australian collaborators of the institute will include Swinburne University and the University of Melbourne, Florey Institute of Neuroscience & Mental Health, NICM Health Research Institute, and Agriculture Victoria Research.
- Hailing from around the globe, scientists from the University of Toronto, King’s College London, University of Zurich, and Federal University of Rio Grande (Brazil) will also contribute to the institute’s research efforts.
Phase 2 Ketamine Clinical Study is a Go for PharmaTher
PharmaTher Holdings (OTC: PHRRF) is advancing to a Phase-2 ketamine clinical study for neurological disorders, in the US.
- The FDA has granted ‘Orphan Drug Designation’ for ketamine in the treatment of Amyotrophic Lateral Sclerosis, also known as Lou Gehrig’s disease.
- Ketamine has the potential to increase the life expectancy and quality of life of those at any stage of ALS.
- It can slow the progressive loss of muscle associated with the disease.
- Mechanisms of ketamine contribute in part to the drug’s neuro-protective effects, which may extend to the motor neurons targeted in ALS.
What’s this about orphans?
- The ‘Orphan Drug Act’ grants special status to a drug, or biological product, to treat a rare disease or condition, upon request by a sponsor.
- The FDA defines rare diseases as those currently affecting fewer than 200K people in the US.
- This designation may qualify a drug for benefits and incentives: 7 years of marketing exclusivity, tax credits for clinical drug testing costs, eligibility for grants, and waiver of the FDA’s ‘New Drug Application’ filing fee of approximately $2.4 million.
The lowdown on ALS
- It’s a progressive neuromuscular disease with no known cure and a life expectancy of only 2-6 years after diagnosis.
- Approximately 50K people in the US and EU are affected by this condition, with >5K new cases annually.
- As the condition advances, upper and lower motor neurons die. This causes the brain to lose all ability to control muscle movement.
PsyBio Therapeutics (OTC: PSYBF) filed a new provisional patent and is initiating pre-clinical studies aimed at treating neurological and psychological conditions.
After months of pre-clinical trials, Psyched Wellness (CSE: PSYC) is getting closer to market after commencing stability tests on ‘AME-1’ formulation.
Mydecine (OTC: MYCOF) expands its portfolio of novel molecules with new patent filing for MDMA-like compounds.
Small Pharma Inc (OTC: DMTTF) reports “strong progress” in Phase I/IIa clinical trial. Phase IIb trial anticipated to begin next year.