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.
Listen to the podcast:
https://www.investorideas.com/Audio/Podcasts/2020/123020-StocksToWatch.mp3
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at https://www.investorideas.com/news/2020/cannabis-potcasts/12301ALID-PULL-NOVA.asp
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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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