Investor Ideas #Potcasts 511, #Cannabis News and #Stocks on the Move; #Psychedelic Spotlight (OTCQB: $ALID) (CSE: $PULL.C) (CSE: $NOVA.C)
Delta, Kelowna, BC, December 30, 2020 (Investorideas.com Newswire) www.Investorideas.com, a global news source covering leading sectors including marijuana and hemp stocks and its potcast site, www.potcasts.ca release today’s podcast edition of cannabis news and stocks to watch plus insight from thought leaders and experts.
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Today’s podcast overview/transcript:
Good afternoon and welcome to another episode of Investorideas.com "Potcast" featuring cannabis news, stocks to watch as well as insights from thought leaders and experts.
In today’s podcast we will be looking at a few private and public company announcements, specifically focussing on the psychedelic sector.
SYNTAC Institute, an Alberta-based non-profit organization dedicated to bringing legal psychedelic-assisted therapy to Canadians, recently confirmed that it has facilitated the first announced approval from Health Canada for an Alberta-based patient facing a terminal illness diagnosis.
The legal exemption from the Canadian Drugs and Substances Act, granted by the Office of Controlled Substances at Health Canada, paves the way for Calgary resident Anthony White to immediately undergo psilocybin-assisted treatment to deal with the severe mental health challenges that come with a terminal medical diagnosis. White's situation has been even more difficult to contend with as he is in his forties and has a young daughter.
Under the Section 56 Exemption approved by Health Canada, White will now be eligible to participate in a therapy process overseen by a medical team that includes the use of psilocybin, an active hallucinogenic substance found in "magic mushrooms".
"Facing this devastating prognosis has been incredibly difficult, but I am grateful I can soon gain some comfort and relief through this promising therapy. I appreciate the help from the folks at SYNTAC to bring this to reality, and to Health Canada for putting the patient first in this important decision."
Encouraging research continues to emerge that suggests psychedelic-assisted therapeutic approaches to mental and emotional health conditions demonstrate remarkable efficacy and outcomes for a variety of conditions including end-of-life distress, Post Traumatic Stress Disorder (PTSD), depression and anxiety.
"We are extremely grateful to Health Canada and the Hon. Minister Hajdu and her team for delivering this exemption so that Mr. White can immediately access this innovative therapy," stated David Harder, Executive Director of SYNTAC Institute in Calgary.
"We are also deeply appreciative of the tireless efforts of Dr. Bruce Tobin and his team at Therapsil in Victoria B.C. for putting in so much of the groundwork required for this kind of announcement to be possible."
With the traditional approach to mental health and wellness in Canada already struggling, COVID-19 is creating a tsunami of mental and emotional health challenges that threaten to overwhelm the Canadian healthcare system. "We believe psychedelic medicines will be a huge part of the solution that Canadians need and deserve", added Harder.
"We are not only incredibly thrilled for Mr. White gaining immediate access to this powerful therapeutic tool, but also for every Canadian who is suffering with mental and emotional health challenges. This is another step forward in the battle against our country's mental health crisis."
Allied Corp (OTCQB: ALID) – an international medical cannabis company focused on creating and providing health solutions to address today’s medical mental health issues, recently announced the signing of a letter of intent to acquire the psilocybin company Pacific Sun Fungi. This further expands upon Allied’s press release of October 20, 2020 communicating the submission of the provisional patent for Allied’s functional mushroom formulation targeting major depression and anxiety.
Pacific Sun is a British Columbia corporation that has been working on Research and Development activities in the psilocybin space for the past 10 years. Pacific Sun holds several formulations that have been tested under physician supervision. Pacific Sun also has proprietary extraction technology, proprietary formulations for several specific disease targets and physician-led therapy protocols that have proven to be effective for several specific disease targets.
Over the past two years, in parallel with psilocybin moving into the pharmaceutical research realm, Allied has continued to develop its pharmaceutical research infrastructure. This represents the evolution of Allied beyond specific cannabis-based therapies to more pharma-based health targets.
Allied was born out of the need to support veterans and first responders suffering from PTSD with targeted cannabinoid solutions. This acquisition has advanced Allied into the broader mental health market encompassing both pharmaceutical and natural health products. Building upon our experience with PTSD, we are expanding our research and treatment options to encompass depression, anxiety and general mental health. This puts Allied in the unique position to provide a full-scope, closed-loop therapy protocol. Typical psilocybin therapies support the patient for an episodic micro-dosing treatment regime which follows a specific dosing and wash out cycle. Unfortunately, this leaves the patient with a treatment gap between dosing periods. This can now be bridged with Allied’s existing cannabinoid treatment solutions. A “full scope treatment” option.
The proprietary “Allied full scope treatment” offers the patient continual therapy with treatment options both before and after the psilocybin treatment period. This is accomplished by offering Allied’s cannabinoid and natural health products combined with the psilocybin products and protocols. This will all be accomplished under legal license and physician supervision.
A timeline leading towards Allied as being positioned as a leader in this space:
● In 2018, the FDA recognized psilocybin therapies as a “breakthrough” therapy for PTSD and Major Depressive Disorder. (Food and Drug Administration, 2018).
● In 2019, Imperial College of London and John Hopkins open the first psychedelic research centers. MAPS clinics across the nation conduct research on psilocybin therapy. (Forbes.com, 2019).
● In 2020, Health Canada approves psilocybin for select patient with terminal illness. 2020 Oregon State decriminalizes psilocybin. On November 30, 2020 Oregon state issues call for participants in State Guidance Committee. Allied executive applies to be a member of this committee. (Health Canada, 2020 and Oregon State Health, 2020).
● On October 20, 2020, Allied submits provisional patent on drug formulation containing psilocybin and a combination of additional functional mushrooms for the disease targets of PTSD, depression and general anxiety. (Allied Corp press release of Oct 20, 2020).
● On December 20th, 2020, Allied moves to acquire Pacific Sun Fungi by signing Letter of Intent to acquire.
Allied’s initial focus will be on pharmaceutical R&D while also entering the Oregon State market with additional markets to follow as legislation allows. As well, Allied is in the process of applying for a Section 56 exemption in Canada for Allied’s Physician group to be able to prescribe Allied’s formulation to veterans and first responders. With this infrastructure in place, Allied will be able to be one of the first companies to come to market in the psilocybin space with both psilocybin products augmented by Allied’s current natural health and cannabis-derived pharma products.
Pure Extracts Technologies Corp. (CSE: PULL) announced that it is commencing a study on the formulation and manufacturing of psilocybin based active treatments for oral tablets, capsules and a nasal gel that will be used as an investigational product. The study with be conducted at the Toronto Institute of Pharmaceutical Technology (“TIPT”) by Dr. Alexander MacGregor, a key scientific advisor to the Company.
The study will focus on formulating, manufacturing and clinical bioavailability testing of rapid onset psilocybin dosage forms that could be used in future efficacy clinical trials by both Pure Extracts and its pharmaceutical customers. Clinical batch manufacturing, packaging and labelling are all included in the study as is conformity testing and stability testing (including both long-term and accelerated). The study will conform to both Canadian Good Manufacturing Practice (“GMP”) and Good Clinical Practice (“GCP”) standards.
Dr. MacGregor is a pharmaceutical science inventor, an expert in pharmaceutical technology and novel drug delivery systems. He is a recipient of several global patents in the field of medical treatments and pharmaceutical drug delivery technologies most notably from Canada, US, Australia, Europe, Latin America, China, India and Japan. Dr. MacGregor’s inventions have led to groundbreaking therapeutic drugs for the treatment of cancer, management of diabetes, systemic infections and post-operative pain. His company has a Health Canada Drug Establishment License, a Cannabis Drug License and a Dealer’s License issued under the Controlled Drugs and Substances Act (CDSA) and is thus licensed to possess psychedelic drug compounds.
Pure Extracts CEO, Ben Nikolaevsky, remarked, “Having the support of TIPT, one of Canada’s premiere pharmaceutical R&D companies, while waiting to receive our Dealer’s License from Health Canada is invaluable. We are very excited to be laying the groundwork for our move into the controlled substances world of psychedelics and to be furthering our knowledge-base in psilocybin and associated novel delivery mechanisms.”
Nova Mentis Life Science Corp. (CSE: NOVA) (OTC: LIBFF)
announced that it has added two additional psychedelic compounds to its drug portfolio. NOVA has contracted with its U.S. partner to begin manufacturing the active pharmaceutical ingredients (API), baeocystin and aeruginascin. NOVA is currently developing C-GMP API psilocybin at its U.S. partner's facility which has highly trained quality control staff on site and certifies all release testing prior to human studies. Per contractual agreements, NOVA has ownership of the API Drug Master Files ("DMF's"), which will be used for regulatory submission prior to commencing human clinical trials.
"The availability of greater than 95 per cent pure synthetic psilocybin, baeocystin and aeruginascin will allow the creation of unique combinatory formulations with potential therapeutic applications to various subsets of ASD," stated Marvin S. Hausman MD, Chairman of NOVA's Scientific Advisory Board. "Furthermore, the availability of these compounds will allow our collaborative scientific chemists to develop technology to deliver our proprietary formulations to organ systems outside of the brain. Are there tryptamine related therapeutic receptors in the small intestine, colon and liver that need to be discovered?"
Baeocystin is an analog of psilocybin and is found in most psilocybin mushrooms along with other minor tryptamine derivatives. Aeruginascin is also a tryptamine derivative and an analog of psilocybin, but it occurs naturally within a different mushroom, Inocybe aeruginascens. The pharmacological effects of both of these compounds are not well understood and anecdotal usage reports reveal different euphoric experiences.
It is theorized that psilocybin and mushroom tryptamine derivatives, such as baeocystin and aeruginascin, when utilized in concert, may produce what is referred to as an "entourage effect". This theory was proposed for cannabis compounds but essentially is applicable to other compounds within natural foods that work together to create unique effects and benefits.
Pending final production of the additional API compounds, NOVA plans to test their efficacy and potential "entourage effect" related therapeutic benefits in the autism spectrum disorder (ASD) preclinical rat model that was designed by Dr. Viviana Trezza at Roma Tre University, Rome, Italy.
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