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Revive Therapeutics Enters into Research Collaboration Agreement with PharmaTher for Development of Psilocybin Microneedle Patch

Revive Therapeutics Enters into Research Collaboration Agreement with PharmaTher for Development of Psilocybin Microneedle Patch

Building specialty psilocybin-based product pipeline

Evaluating potential for neuropsychiatric indications for clinical studies in 2022

TORONTO, Nov. 03, 2021 – Revive Therapeutics Ltd. (“Revive” or the “Company”) (OTCQB: RVVTF) (CSE: RVV) (FRANKFURT: 31R), a specialty life sciences company focused on the research and development of therapeutics for medical needs and rare disorders, is pleased to announce it has entered into a research collaboration agreement with PharmaTher Holdings Ltd. (“PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a clinical-stage psychedelics biotech company, to evaluate the delivery of psilocybin with PharmaTher’s proprietary microneedle (“MN”) patch technology for neuropsychiatric disorders.

PharmaTher is currently conducting IND-enabling research studies with MicroDose-MN™, a patent-pending biocompatible and biodegradable gelatin methacryloyl microneedle patch, to deliver psilocybin to support an IND application with the FDA for clinicals studies in 2022. Research results with MicroDose-MN™ for psilocybin will be made available in November 2021 by PharmaTher.

Revive is building a specialty psilocybin-based product pipeline with the aim to treat mental illness, substance abuse and neurological disorders. In addition to the proposed psilocybin MicroDose-MN™ patch, the Company has the following development and commercial programs:

  • Feasibility agreement with LTS Lohmann Therapie-Systeme AG, a leader in pharmaceutical oral thin films, to develop and manufacture a proprietary psilocybin oral thin film strip;
  • Evaluating psilocybin as a potential treatment for methamphetamine use disorder, traumatic brain injury and stroke in a research collaboration with the University of Wisconsin-Madison;
  • Developing a novel biosynthetic version of psilocybin based on a natural biosynthesis enzymatic platform under its research collaboration with North Carolina State University; and
  • Research and commercialization agreement with the University of Health Sciences Antigua to utilize Revive’s novel psychedelic-assisted therapies including its tannin-chitosan delivery system and to pioneer the clinical research and development of psychedelics in Antigua and Barbuda and commercial partnerships with specialty pharmaceutical companies in the Caribbean and Latin America.

The collaboration agreement will give Revive the ability to evaluate the MicroDose-MN™ for psilocybin program to support upcoming clinical and commercial developments globally.

Michael Frank, CEO of the Company commented, “We are maintaining our focus in building a unique psilocybin-based product portfolio through research collaborations, licensing and commercialization agreements with academic research institutions and specialty pharmaceutical companies. The collaboration with PharmaTher complements our psilocybin product offerings as potential treatments for mental illness, substance abuse and neurological disorders. We believe there is no one fits all product profile solution with psilocybin and that for psilocybin to be a next generation therapeutic, it will require different use and delivery forms to achieve the intended target indications. As such, we aim to become a leader in psilocybin-based solutions for unmet medical needs by collaborating with companies that have intellectual property and experience in their delivery technologies.”

“Revive is a valued partner of PharmaTher and we are pleased to collaborate with them to achieve their objective in building a specialty psilocybin-based product pipeline that encompasses various delivery methods including our proprietary microneedle patch, which can deliver various psychedelics via the skin, enable flexible drug load capacity and combinations, and control-release delivery; overcome the potential drawbacks of oral administration, subcutaneous injections, topical and nasal delivery systems; maintain constant plasma levels for more than 24 hours; and aim to empower patients to dose their medication remotely, safely and conveniently rather than under supervision by a healthcare provider at a certified medical office,” said Fabio Chianelli, CEO of PharmaTher.

About PharmaTher Holdings Ltd.

​PharmaTher Holdings Ltd. (OTCQB: PHRRF) (CSE: PHRM) is a clinical-stage psychedelics biotech company focused on the research, development and commercialization of novel uses, formulations and delivery methods of psychedelics, such as ketamine, to treat mental health, neurological and pain disorders. PharmaTher is currently advancing an FDA approved phase 2 clinical study with ketamine to treat Parkinson’s disease and is developing a novel microneedle patch for the intradermal delivery of psychedelics and infectious disease treatments.
​
Learn more at: PharmaTher.com and on Twitter and LinkedIn.

About Revive Therapeutics Ltd.

Revive is a life sciences company focused on the research and development of therapeutics for infectious diseases and rare disorders, and it is prioritizing drug development efforts to take advantage of several regulatory incentives awarded by the FDA such as Orphan Drug, Fast Track, Breakthrough Therapy and Rare Pediatric Disease designations. Currently, the Company is exploring the use of Bucillamine for the potential treatment of infectious diseases, with an initial focus on severe influenza and COVID-19. With its acquisition of Psilocin Pharma Corp., Revive is advancing the development of Psilocybin-based therapeutics in various diseases and disorders. Revive’s cannabinoid pharmaceutical portfolio focuses on rare inflammatory diseases and the company was granted FDA orphan drug status designation for the use of Cannabidiol (CBD) to treat autoimmune hepatitis (liver disease) and to treat ischemia and reperfusion injury from organ transplantation. For more information, visit www.ReviveThera.com.

For more information, please contact:

Michael Frank
Chief Executive Officer
Revive Therapeutics Ltd.
Tel: 1 888 901 0036
Email: mfrank@revivethera.com
Website: www.revivethera.com

Neither the Canadian Securities Exchange nor its Regulation Services Provider has reviewed or accepts responsibility for the adequacy or accuracy of this release.

Cautionary Statement

This press release contains ‘forward-looking information’ within the meaning of applicable Canadian securities legislation. These statements relate to future events or future performance. The use of any of the words “could”, “intend”, “expect”, “believe”, “will”, “projected”, “estimated” and similar expressions and statements relating to matters that are not historical facts are intended to identify forward-looking information and are based on Revive’s current belief or assumptions as to the outcome and timing of such future events. Forward looking information in this press release includes information with respect to the Company’s cannabinoids, psychedelics and infectious diseases programs. Forward-looking information is based on reasonable assumptions that have been made by Revive at the date of the information and is subject to known and unknown risks, uncertainties, and other factors that may cause actual results or events to differ materially from those anticipated in the forward-looking information. Given these risks, uncertainties and assumptions, you should not unduly rely on these forward-looking statements. The forward-looking information contained in this press release is made as of the date hereof, and Revive is not obligated to update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as required by applicable securities laws. The foregoing statements expressly qualify any forward-looking information contained herein. Reference is made to the risk factors disclosed under the heading “Risk Factors” in the Company’s annual MD&A for the fiscal year ended June 30, 2021, which has been filed on SEDAR and is available under the Company’s profile at www.sedar.com.

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PharmaTher Enters into Research Collaboration Agreement with Revive Therapeutics for Development of Psilocybin Microneedle Patch

PharmaTher Enters into Research Collaboration Agreement with Revive Therapeutics for Development of Psilocybin Microneedle Patch

  • Focusing on partnership model for MicroDose-MN™ and MacroDose-MN™ patches to deliver psychedelics.
  • Creating value and intellectual property protection for psychedelic programs.
  • Providing pathways for partners to enter FDA Phase 1 and 2 clinical studies in 2022 with psychedelics.
TORONTO, November 3, 2021 — PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a clinical-stage psychedelics biotech company, is pleased to announce it has entered into a research collaboration agreement with Revive Therapeutics Ltd. (“Revive”) (OTCQB: RVVTF) (CSE: RVV) (FRANKFURT:31R), a specialty life sciences company focused on the research and development of therapeutics for medical needs and rare disorders, to evaluate the delivery of psilocybin with PharmaTher’s proprietary microneedle (“MN”) patch technology for neuropsychiatric disorders.

PharmaTher is currently conducting IND-enabling research studies with MicoDose-MN™, a patent-pending biocompatible and biodegradable gelatin methacryloyl microneedle patch, to deliver psilocybin to support an IND application with the FDA for clinical studies in 2022.  Research results with MicroDose-MN™ for psilocybin will be made available in November 2021.

The Company is also conducting research studies with its MicoDose-MN™ and MacroDose-MN™ patch as a next generation delivery system for psychedelics with ketamine, 3,4-methylenedioxy-methamphetamine (“MDMA”), lysergic acid diethylamide (“LSD”), and N, N-dimethyltryptamine (“DMT”).  Also, the Company has decided to expand research to include ibogaine and mescaline.

Partnership opportunities currently exist with MDMA, LSD, DMT, ibogaine and mescaline for specialty pharmaceutical companies seeking a differentiated and validated delivery system for psychedelics, desired pharmacokinetic profiles, intellectual property protection, cGMP microneedle patches for IND-enabling and clinical studies, and a clear clinical pathway towards FDA Phase 1 and 2 clinical studies in 2022.

The Company’s MicroDose-MN™ and MacroDose-MN™ patches have the potential to efficiently penetrate the stratum corneum layer (outer layer of the skin), enable flexible drug load capacity and combinations, and control-release delivery, which may overcome the potential drawbacks of oral administration, subcutaneous injections, topical and nasal delivery systems.  In addition to the potential of maintaining constant plasma levels for more than 24 hours, the MN patches aim to empower patients to dose their medication remotely, safely and conveniently rather than under supervision by a healthcare provider at a certified medical office. To achieve this, the Company will incorporate anti-tampering and anti-abuse features that would parallel the approach used for the tamper-resistant transdermal fentanyl patch.

“We are pleased to collaborate with Revive in achieving their product portfolio objectives with psilocybin.  Our microneedle patch technologies aim to become a next generation delivery system for psychedelics for various indications and healthcare environments.  Although our focus remains on building our ketamine-based product pipeline, we will continue to partner with specialty pharmaceutical companies seeking a delivery solution for psychedelics and proprietary drugs to unlock significant value and return on investment for PharmaTher,” said Fabio Chianelli, CEO of PharmaTher.

Michael Frank, CEO of the Company, commented, “Our focus is developing and commercializing a specialty psilocybin-based product portfolio, and the research collaboration with PharmaTher complements our psilocybin product offerings as potential treatments for mental illness, substance abuse and neurological disorders.  We believe there is no one-fits-all product profile solution with psilocybin. For psilocybin to be a next-generation therapeutic, different use and delivery forms will be required to achieve the intended target indications.  As such, we aim to become a leader in psilocybin-based solutions for unmet medical needs by collaborating with companies that have intellectual property and experience in their delivery technologies, such as PharamTher.”

About Revive Therapeutics Ltd.
Revive is a life sciences company focused on the research and development of therapeutics for infectious diseases and rare disorders, and it is prioritizing drug development efforts to take advantage of several regulatory incentives awarded by the FDA such as Orphan Drug, Fast Track, Breakthrough Therapy and Rare Pediatric Disease designations. Currently, the Company is exploring the use of Bucillamine for the potential treatment of infectious diseases, with an initial focus on severe influenza and COVID-19. With its acquisition of Psilocin Pharma Corp., Revive is advancing the development of Psilocybin-based therapeutics in various diseases and disorders. Revive’s cannabinoid pharmaceutical portfolio focuses on rare inflammatory diseases and the company was granted FDA orphan drug status designation for the use of Cannabidiol (CBD) to treat autoimmune hepatitis (liver disease) and to treat ischemia and reperfusion injury from organ transplantation. For more information, visit www.ReviveThera.com.
About PharmaTher Holdings Ltd.

​PharmaTher Holdings Ltd. (OTCQB: PHRRF) (CSE: PHRM) is a clinical-stage psychedelics biotech company focused on the research, development and commercialization of novel uses, formulations and delivery methods of psychedelics, such as ketamine, to treat mental health, neurological and pain disorders.  PharmaTher is currently advancing an FDA approved phase 2 clinical study with ketamine to treat Parkinson’s disease and is developing a novel microneedle patch for the intradermal delivery of psychedelics and infectious disease treatments.
​
Learn more at:  PharmaTher.com and follow us on Twitter and LinkedIn.

For more information about PharmaTher, please contact:

Fabio Chianelli
Chief Executive Officer
PharmaTher Holdings Ltd.
Tel: 1-888-846-3171
Email: info@pharmather.com
Website: www.pharmather.com

Neither the Canadian Securities Exchange nor its Regulation Services Provider have reviewed or accept responsibility for the adequacy or accuracy of this release.

Cautionary Statement

This press release contains ‘forward-looking information’ within the meaning of applicable Canadian securities legislation. These statements relate to future events or future performance. The use of any of the words “could”, “intend”, “expect”, “believe”, “will”, “projected”, “estimated”, “potential”, “aim” and similar expressions and statements relating to matters that are not historical facts are intended to identify forward-looking information and are based on PharmaTher Holdings Ltd. (the “Company”) current belief or assumptions as to the outcome and timing of such future events. Forward-looking information is based on reasonable assumptions that have been made by the Company at the date of the information and is subject to known and unknown risks, uncertainties, and other factors that may cause actual results or events to differ materially from those anticipated in the forward-looking information. Given these risks, uncertainties and assumptions, you should not unduly rely on these forward-looking statements. The forward-looking information contained in this press release is made as of the date hereof, and Company is not obligated to update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as required by applicable securities laws. The foregoing statements expressly qualify any forward-looking information contained herein. Factors that could cause actual results to differ materially from those anticipated in these forward-looking statements are described under the caption “Risk Factors” in Company’s management’s discussion and analysis for the period of August 31, 2021 (“MD&A”), dated October 27, 2021, which is available on the Company’s profile at www.sedar.com.

This news release does not constitute an offer to sell or the solicitation of an offer to buy, and shall not constitute an offer, solicitation or sale in any state, province, territory or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state, province, territory or jurisdiction.

 

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PharmaTher Provides Research Update on Microneedle Patch Delivery Technologies for Psychedelics

PharmaTher Provides Research Update on Microneedle Patch Delivery Technologies for Psychedelics

  • Completing IND-enabling studies with novel microneedle patch for ketamine, psilocybin, MDMA, LSD, and DMT.
  • Expanding research in evaluating ibogaine and mescaline.
  • Aiming for FDA Phase 1 and 2 clinical studies in Q2-2022.
  • Discussing partnership opportunities for delivering psychedelics with MicroDose-MN™ and MacroDose-MN™ patches.
TORONTO, November 1, 2021 — PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a clinical-stage psychedelics biotech company, today provides an update on the ongoing research studies with its novel microneedle (“MN”) patch as a next generation delivery technology for psychedelics, including ketamine, psilocybin, 3,4-methylenedioxy-methamphetamine (“MDMA”), lysergic acid diethylamide (“LSD”), and N, N-dimethyltryptamine (“DMT”).

The Company has research collaborations with the Terasaki Institute to evaluate MicoDose-MN™; a patent-pending biocompatible and biodegradable gelatin methacryloyl microneedle patch, to deliver psilocybin, MDMA, LSD and DMT, and with The Queen’s University of Belfast (“QUB”) to evaluate MacroDose-MN™; a patented hydrogel-forming microneedle patch, to deliver ketamine and PharmaTher’s proprietary ketamine combination formulation, ketamine and betaine (“KETABET™”) for mental health, neurological and pain disorders.

Research results with MicroDose-MN™ for psilocybin and LSD will be made available in November 2021, followed by results with MDMA and DMT in December 2021.  Research results with MacroDose-MN™ for ketamine and KETABET™ will be made available in December 2021.  Current research results are very encouraging; therefore, the Company has decided to expand research to include ibogaine and mescaline, prepare IND applications with the FDA for Phase 1 and 2 clinical studies in Q2-2022, and discuss partnership opportunities with specialty pharmaceutical companies seeking a novel and validated delivery system for psychedelics targeting specific indications and desired pharmacokinetic profiles.

PharmaTher is proceeding with its IND-enabling studies and manufacturing scale-up for cGMP microneedle patches for its expected clinical studies in 2022.  The MicroDose-MN™ and MacroDose-MN™ patches can efficiently penetrate the stratum corneum layer (outer layer of the skin), enable flexible drug load capacity and combinations, and control-release delivery, which may overcome the potential drawbacks of oral administration, subcutaneous injections, topical and nasal delivery systems.  In addition to the potential of maintaining constant plasma levels for more than 24 hours, the MN patches aim to empower patients to dose their medication remotely, safely and conveniently rather than under supervision by a healthcare provider at a certified medical office. To achieve this, the Company will incorporate anti-tampering and anti-abuse features that would parallel the approach used for the tamper-resistant transdermal fentanyl patch.

“We are nearing completion of our research programs in validating the utility of our microneedle patch delivery technologies for psychedelics, derisking our plans in advancing the completion of our IND-enabling studies to support future clinical studies and partnering opportunities,” said Fabio Chianelli, CEO of PharmaTher.  “As we look forward to announcing our research results, our focus continues to expand our ketamine-based product pipeline and advance our microneedle patch programs to unlock significant value and return on investment for long-term revenue potential through our products and our future partners.”

About PharmaTher Holdings Ltd.

​PharmaTher Holdings Ltd. (OTCQB: PHRRF) (CSE: PHRM) is a clinical-stage psychedelics biotech company focused on the research, development and commercialization of novel uses, formulations and delivery methods of psychedelics, such as ketamine, to treat mental health, neurological and pain disorders.  PharmaTher is currently advancing an FDA approved phase 2 clinical study with ketamine to treat Parkinson’s disease and is developing a novel microneedle patch for the intradermal delivery of psychedelics and infectious disease treatments.
​
Learn more at:  PharmaTher.com and follow us on Twitter and LinkedIn.

For more information about PharmaTher, please contact:

Fabio Chianelli
Chief Executive Officer
PharmaTher Holdings Ltd.
Tel: 1-888-846-3171
Email: info@pharmather.com
Website: www.pharmather.com

Neither the Canadian Securities Exchange nor its Regulation Services Provider have reviewed or accept responsibility for the adequacy or accuracy of this release.

Cautionary Statement

This press release contains ‘forward-looking information’ within the meaning of applicable Canadian securities legislation. These statements relate to future events or future performance. The use of any of the words “could”, “intend”, “expect”, “believe”, “will”, “projected”, “estimated”, “potential”, “aim” and similar expressions and statements relating to matters that are not historical facts are intended to identify forward-looking information and are based on PharmaTher Holdings Ltd. (the “Company”) current belief or assumptions as to the outcome and timing of such future events. Forward-looking information is based on reasonable assumptions that have been made by the Company at the date of the information and is subject to known and unknown risks, uncertainties, and other factors that may cause actual results or events to differ materially from those anticipated in the forward-looking information. Given these risks, uncertainties and assumptions, you should not unduly rely on these forward-looking statements. The forward-looking information contained in this press release is made as of the date hereof, and Company is not obligated to update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as required by applicable securities laws. The foregoing statements expressly qualify any forward-looking information contained herein. Factors that could cause actual results to differ materially from those anticipated in these forward-looking statements are described under the caption “Risk Factors” in Company’s management’s discussion and analysis for the period of August 31, 2021 (“MD&A”), dated October 27, 2021, which is available on the Company’s profile at www.sedar.com.

This news release does not constitute an offer to sell or the solicitation of an offer to buy, and shall not constitute an offer, solicitation or sale in any state, province, territory or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state, province, territory or jurisdiction.

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A better way to get drunk: issue 21

Here’s what’s in store for you in today’s issue:

🍄 The future of psychedelics, according to an expert

🍄 A better way to get drunk

🍄 A first-of-its-kind severe anxiety study

🍄 The race for a dementia treatment

🍄 And more.

Be sure to check out this week’s Daily Mushroom podcast:

The DMT Cure to Chronic Pain and PTSD

Kieran, a retired black ops vet who magically cured his neck pain with a wild DMT trip. Kieran talks about being in a constant stress state while serving and how psychedelics help him cope with ongoing PTSD.

Therapeutic banner

A better way to get drunk

This psychedelic makes you feel drunk. Could it be used to treat alcoholism?

5-Methoxy-2-aminoindane (MEAI) is a synthetic molecule that simulates the euphoric feeling of alcohol while reducing the desire to drink.

Pre-clinical studies conducted by Clearmind Medicine Inc. (CMND) show promising evidence that MEAI could treat alcohol use disorder (AUD) and binge drinking. Clinical trials are expected to begin in the second half of 2022. 

The company just signed a development and supply agreement with Aragen Life Sciences to manufacture the molecule.

First-of-its-kind study on severe anxiety

Monash University just got the go-ahead to conduct a first-of-its-kind study!

Yesterday, the Australian university received ethics approval for a triple-blinded, active-placebo-controlled study that will investigate psilocybin-assisted psychotherapy as a treatment for severe Generalized Anxiety Disorder (GAD).

Researchers are looking to recruit 72 patients for the study, which will be conducted in partnership with Incannex Healthcare Ltd (IHL).

The therapists facilitating the study will have the option to undergo their own psilocybin session to better understand what the patients will experience.

Does neuroplasticity benefit healthy people too?

Psychedelics clearly have a huge impact on people with mental health issues, but how do they impact people who are already mentally healthy? A new research project at University College London will give us more insights!

After two years of planning, the university is launching the “Understanding Neuroplasticity Induced by Tryptamines” or UNITy Project.

UNITy Project will use fMRI scans, eye-tracking, and experience sampling to understand how the naturally functioning brain responds to various tryptamines (psychedelics that bind to serotonin receptors, such as psilocybin).

The first study will evaluate how DMT affects language processing, sensory processing, and memory in both healthy participants and heavy drinkers, and if neuroplasticity drives the results.

inspirational banner

The future of psychedelics, according to this pioneering researcher

Rick Doblin, a pioneering psychedelic researcher and activist, made some interesting predictions about the future of psychedelics in the US:

  • MDMA will be FDA-approved by the end of 2023, with psilocybin following a year or two after.
  • By 2023 or 2024, there will be 6000+ psychedelic therapy clinics (there are currently about 1000). Every town with a hospice center will have enough demand for a psychedelic clinic.
  • By 2030, one million MDMA therapy sessions will have been administered by 25,000 trained therapists.
  • A licensed legalization model could be implemented around 2035 in which patients can earn a license to use psychedelics outside the clinic once undergoing a supervised session.

Doblin is hopeful that the tremendous impacts on mental health will result in a spiritualized society that “has finally come to the point of embracing global thinking, global humanity, and dealt with economic inequity.”

Donation heals traumatized children

“We’re all traumatized children running around in adult bodies, and (psychedelic) medicines can help us all,” according to venture capitalist Sanjay Singhal.

That’s why his charity donated $5 million to launch The Nikean Psychedelic Psychotherapy Research Centre at Toronto’s University Health Network (UHN).

The centre will study psilocybin therapy as a treatment for terminally-ill patients, patients with body dysmorphia, families who have lost a child, and grieving caregivers. It will also study 5-MeO-DMT as a PTSD treatment and will train therapists to administer psychedelic therapy.

Singhal, who was diagnosed with bipolar disorder in his 30s, was inspired to fund psychedelic research after a psilocybin trip helped him break down his emotional walls and fix his relationships.

Can shrooms make you a better leader?

Magic mushrooms may have been the key to this NHL legend’s success.

Mark Messier, the only NHL player to lead two different teams to Stanley Cup championships, said that a magic mushroom trip at age 19 sparked his interest in spirituality and the power of the mind.

“I had no idea the mind was that powerful. Obviously it turned out to be an amazing experience, but more important was the question afterwards: wow, how can I use my mind to empower myself to be a better player, to be a better person, to have more energy, to create a better aura?”

The trip inspired Messier to learn about Eastern philosophies, Buddhism, Indigenous spirituality, and meditation, which had a major influence on him both as a player and a leader.

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Tripping on an island to help frontline workers

Cybin (CYBN) is sending therapists on a psychedelic retreat so they can learn how to provide support to frontline healthcare workers.

Clinical trial facilitators will head to a small island in Washington to be trained on Cybin’s new EMBARK therapy model and gain experiential knowledge of psychedelics. The EMBARK model combines aspects of several psychotherapy models and incorporates patients’ spiritual experiences, bodily experiences, and relationships into the healing process.

The retreat will prepare the facilitators for an upcoming clinical trial at the University of Washington that aims to treat healthcare workers suffering from COVID-related distress, depression, anxiety, and PTSD.

Optimizing the DNA of plant medicines 

Delic Labs of Delic Corp (DELC) is partnering with GT Research Inc. to help mushroom and cannabis producers optimize their products. 

Through the deal, Delic Labs will use DNA analysis to evaluate the commercial value of different cannabis and psychedelic mushroom strains based on certain gene traits. The services will help Canadian producers optimize their compounds through genetic engineering to produce more effective plant medicines.

Which company will develop a dementia treatment first?

If treatments don’t improve, the number of Americans battling Alzheimer’s is expected to nearly triple by 2050 — reaching $1.1 trillion in care costs.

Fortunately, two more companies joined the race to develop a new treatment using psychedelics!

On Tuesday, MYND Life Sciences (MYND) acquired IP rights from Cava Healthcare Inc. for dementia treatments using psilocybin and other psychedelics. It received the assets in exchange for 450,000 shares at $0.85 each, plus $120,000 and an annual royalty fee.

Silo Pharma Inc. (SILO) also joined the race this week through a sponsored research agreement. The company will work with Columbia University to develop a psychedelic treatment that could halt or reverse Alzheimer’s.

Researching ADHD treatments in Korea

These companies are joining forces to develop unique treatments for a range of debilitating conditions.

Agtech Global International Inc. (AGGL) and  KRTL Biotech Inc. are partnering to develop CBD and psilocybin-based medicines to treat conditions like ADHD, pain from cancer, autism, PTSD, depression, and addiction.

The agreement will leverage KRTL’s team of researchers in the US and Korea, where they have already received the Korean equivalent of FDA approval to study the compounds.

Several other companies are supporting the research project including Here To Serve Holding Corp. (HTSC) and Pervasip Corp. (PVSP).

legal banner

Here’s what you missed:

  • Next Tuesday, Detroit will vote on a bill to decriminalize possession and therapeutic use of entheogens including psilocybin mushrooms, ayahuasca, and peyote. Read more…
  • A DC non-profit called The Plant Medicine Coalition issued $50K in grants to community organizations that promote psychedelic education and reform thanks to donations from Dr. Bronner’s soap company. Read more…
  • Dr. Bronner’s is also funding a lobbyist group that’s working to legalize psilocybin for therapeutic uses in Connecticut. Read more…

Industry Quick Hits

Oct 25 – HAVN Life (HAVN) Announces Departure Of Rick Brar As Director Read more…

Oct 26 – Nova Mentis (NOVA) Earns Psilocybin Orphan Drug Designation in Europe for Fragile X Syndrome Read more…

Oct 27 – Mindset Pharma (MSET) Reports Fiscal Year 2021 Financial Results and Provides Corporate Update Read more…

Oct 27 – PharmaTher (PHRM) Provides Business Update and Releases Financial Results for the First Quarter of Fiscal 2022 Read more…

Oct 28 – Blackhawk Growth’s (BLR) Subsidiary MindBio Therapeutics Appoints Patrick Moher as Advisor Read more…

Oct 28 – Greenbrook TMS (GTMS) Announces Dates For Its Third Quarter 2021 Financial Results Read more… 

Oct 28 – MYND Life Sciences (MYND) Announces Appointment of New Director Read more…

Oct 29 – Blackhawk Growth (BLR) Files Fiscal Year Ended June 30, 2021 Financial Reports Read more…

Video of the Week

Trip with your breath: Intro to holotropic breathwork

Playlist of the Week

Lo-Fi | psychedleia
jack O' lantern mushroom
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World Leading Drug Delivery Researcher Professor Ryan Donnelly Joins PharmaTher as Scientific and Technical Advisor

World Leading Drug Delivery Researcher Professor Ryan Donnelly Joins PharmaTher as Scientific and Technical Advisor

  • Focus on expanding the delivery of controlled-substances in a microneedle patch.
  • Evaluating potential uses of a microneedle patch for infectious diseases.
  • Strengthening capabilities in the manufacturing of microneedle patches for FDA clinical studies and commercialization.

TORONTO, October 27, 2021 — PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a clinical-stage psychedelics biotech company, is pleased to announce the appointment of Professor Ryan Donnelly, a world leader in the research and development of microneedle delivery technologies, as scientific and technical advisor for PharmaTher’s microneedle patch delivery programs involving controlled-substances such as ketamine and compounds treating infectious diseases.

Professor Donnelly currently leads the Company’s research program to develop a patented hydrogel-forming microneedle patch to deliver ketamine and KETABET™, a patented ketamine formulation, which represents a potential next-generation treatment for neuropsychiatric, neurodegenerative and pain disorders.  Professor Donnelly’s lab successfully completed research and published a paper titled “Hydrogel-forming microneedle arrays as a therapeutic option for transdermal esketamine delivery.” His research validates the delivery of esketamine, the S(+) enantiomer of ketamine, in a novel microneedle patch which may overcome the drawbacks associated with ketamine administration in an intravenous or nasal spray format.1  In addition, Professor Donnelly has successfully published research in the delivery of drugs to treat certain infectious diseases via a microneedle patch.

Professor Ryan Donnelly is the Chair of Pharmaceutical Technology at QUB. He is a leading expert and researcher in the field of transdermal delivery with a primary focus on microneedle drug delivery and its applications on improving therapeutic outcomes for patients. He has authored over 600 peer-reviewed publications, including several granted patents, 5 textbooks and approximately 250 full papers. His work has attracted numerous awards, including the Academy of Pharmaceutical Sciences Innovative Science Award in 2020, the Controlled Release Society Young Investigator Award in 2016, BBSRC Innovator of the Year in 2013, the GSK Emerging Scientist Award in 2012 and the Royal Pharmaceutical Society Science Award in 2011. He graduated with a B.Sc. degree in pharmacy (1999) and a Ph.D. in pharmaceutics (2003) from QUB.

Professor Ryan Donnelly commented, “I am delighted to expand my role with PharmaTher in the research, development and manufacturing of a next generation microneedle patch for the intradermal delivery of controlled-substances and compounds to treat infectious diseases.  I have been involved in the research of microneedle drug delivery technologies for over 10 years and the potential for delivering controlled-substances, such as ketamine, via a microneedle patch offers a superior alternative delivery method that can overcome the limitations of delivery options faced with controlled-substances without comprising the safety and compliance of patients.”

“We have been working with Ryan closely this year to advance the development of our patented microneedle patch to deliver ketamine and KETABET™ as a potential treatment for mental health, neurological and pain disorders.  He brings extensive experience in microneedle patch development and he will be essential in guiding us into our next stage of clinical and commercial development of our microneedle patch for our product pipeline and future pharmaceutical partners,” said Fabio Chianelli, CEO of PharmaTher.

PharmaTher continues to focus on developing and manufacturing a microneedle patch for FDA approval to deliver better controlled-substances for mental health, neurological and pain disorders, and compounds that treat infectious diseases that may overcome the potential drawbacks of oral administration, subcutaneous injections, topical and nasal delivery systems.

About PharmaTher Holdings Ltd.

​PharmaTher Holdings Ltd. (OTCQB: PHRRF) (CSE: PHRM) is a clinical-stage psychedelics biotech company focused on the research, development and commercialization of novel uses, formulations and delivery methods of psychedelics, such as ketamine, to treat mental health, neurological and pain disorders.  PharmaTher is currently advancing an FDA approved phase 2 clinical study with ketamine to treat Parkinson’s disease and is developing a novel microneedle patch for the intradermal delivery of psychedelics and infectious disease treatments.
​
Learn more at:  PharmaTher.com and follow us on Twitter and LinkedIn.

For more information about PharmaTher, please contact:

Fabio Chianelli
Chief Executive Officer
PharmaTher Holdings Ltd.
Tel: 1-888-846-3171
Email: info@pharmather.com
Website: www.pharmather.com

Neither the Canadian Securities Exchange nor its Regulation Services Provider have reviewed or accept responsibility for the adequacy or accuracy of this release.

Cautionary Statement

This press release contains ‘forward-looking information’ within the meaning of applicable Canadian securities legislation. These statements relate to future events or future performance. The use of any of the words “could”, “intend”, “expect”, “believe”, “will”, “projected”, “estimated”, “potential”, “aim” and similar expressions and statements relating to matters that are not historical facts are intended to identify forward-looking information and are based on PharmaTher Holdings Ltd. (the “Company”) current belief or assumptions as to the outcome and timing of such future events. Forward-looking information is based on reasonable assumptions that have been made by the Company at the date of the information and is subject to known and unknown risks, uncertainties, and other factors that may cause actual results or events to differ materially from those anticipated in the forward-looking information. Given these risks, uncertainties and assumptions, you should not unduly rely on these forward-looking statements. The forward-looking information contained in this press release is made as of the date hereof, and Company is not obligated to update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as required by applicable securities laws. The foregoing statements expressly qualify any forward-looking information contained herein. Factors that could cause actual results to differ materially from those anticipated in these forward-looking statements are described under the caption “Risk Factors” in Company’s management’s discussion and analysis for the period of May 31, 2021 (“MD&A”), dated September 7, 2021, which is available on the Company’s profile at www.sedar.com.

This news release does not constitute an offer to sell or the solicitation of an offer to buy, and shall not constitute an offer, solicitation or sale in any state, province, territory or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state, province, territory or jurisdiction.

References:

1. Courtenay, et al. Hydrogel-forming microneedle arrays as a therapeutic option for transdermal esketamine delivery, Journal of Controlled Release, Volume 322, 2020, Pages 177-186.

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PharmaTher Provides Busines Update and Releases Financial Results for the First Quarter of Fiscal 2022

PharmaTher Provides Busines Update and Releases Financial Results for the First Quarter of Fiscal 2022

​TORONTO, October 27, 2021 — PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a clinical-stage psychedelics biotech company, today released its business update and financial results for the three months ended August 31, 2021.  All amounts are stated in Canadian dollars unless otherwise indicated.  

“To date, we have made tremendous progress across all drug programs including the initiation of our FDA Phase 2 clinical study with ketamine to treat Parkinson’s disease, the advancement of KETABET™ to treat depression, the FDA grant of two orphan drug designations for ketamine in the treatment of Amyotrophic Lateral Sclerosis and Complex Regional Pain Syndrome, the expansion of our microneedle patch to deliver psychedelics, and our commitment to develop a proprietary ketamine product for FDA approval in 2022,” said Fabio Chianelli, CEO of PharmaTher.  “As for our financial situation we are funded to meet our product portfolio milestones and subsequent to our recent financing we are not considering a reverse stock split to the Company’s common shares.”

Q1 Fiscal 2022 Business Highlights

  • Granted FDA orphan drug designation for ketamine to treat amyotrophic lateral sclerosis;
  • Entered into a co-development agreement for microneedle patch delivery technology for psychedelics and antivirals;
  • Filed Pre-IND meeting request and briefing package for KETABET™ to treat depression; and
  • Expanded patent portfolio with filing of U.S. patent applications for novel ketamine formulation.

Subsequent to Quarter End Business Highlights

  • Added to the North American Psychedelics Index and First Psychedelic Exchange Traded Fund;
  • Retained former FDA psychiatry division director Dr. Thomas Laughren as regulatory affairs advisor and drug delivery researcher Professor Ryan Donnelly as scientific and technical advisor;
  • Initiated Phase 2 clinical trial of ketamine in the treatment of Parkinson’s disease;
  • Engaged Alcami for clinical and commercial manufacturing of novel ketamine products; and
  • Granted FDA orphan drug designation for ketamine to treat Complex Regional Pain Syndrome.

Q1 Fiscal 2022 Financial Highlights

  • Cash and cash equivalents ($2,432,788) and Investment ($2,700,000) for a total of $5,132,788 as at August 31, 2021;
  • Net loss was for the three months ended August 31, 2021 was $914,474; and
  • Subsequent to quarter end, announced closing of CAD$10 million private placement with institutional investors.

A copy of the Company’s financial statements for the three months ended August 31, 2021, and the related management’s discussion and analysis are available under the Company’s profile on SEDAR at www.sedar.com.

About PharmaTher Holdings Ltd.

​PharmaTher Holdings Ltd. (OTCQB: PHRRF) (CSE: PHRM) is a clinical-stage psychedelics biotech company focused on the research, development and commercialization of novel uses, formulations and delivery methods of psychedelics, such as ketamine, to treat mental health, neurological and pain disorders.  PharmaTher is currently advancing an FDA approved phase 2 clinical study with ketamine to treat Parkinson’s disease and is developing a novel microneedle patch for the intradermal delivery of psychedelics and infectious disease treatments.
​
Learn more at:  PharmaTher.com and follow us on Twitter and LinkedIn.

For more information about PharmaTher, please contact:

Fabio Chianelli
Chief Executive Officer
PharmaTher Holdings Ltd.
Tel: 1-888-846-3171
Email: info@pharmather.com
Website: www.pharmather.com

Neither the Canadian Securities Exchange nor its Regulation Services Provider have reviewed or accept responsibility for the adequacy or accuracy of this release.

Cautionary Statement

This press release contains ‘forward-looking information’ within the meaning of applicable Canadian securities legislation. These statements relate to future events or future performance. The use of any of the words “could”, “intend”, “expect”, “believe”, “will”, “projected”, “estimated”, “potential”, “aim” and similar expressions and statements relating to matters that are not historical facts are intended to identify forward-looking information and are based on PharmaTher Holdings Ltd. (the “Company”) current belief or assumptions as to the outcome and timing of such future events. Forward-looking information is based on reasonable assumptions that have been made by the Company at the date of the information and is subject to known and unknown risks, uncertainties, and other factors that may cause actual results or events to differ materially from those anticipated in the forward-looking information. Given these risks, uncertainties and assumptions, you should not unduly rely on these forward-looking statements. The forward-looking information contained in this press release is made as of the date hereof, and Company is not obligated to update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as required by applicable securities laws. The foregoing statements expressly qualify any forward-looking information contained herein. Factors that could cause actual results to differ materially from those anticipated in these forward-looking statements are described under the caption “Risk Factors” in Company’s management’s discussion and analysis for the period of August 31, 2021 (“MD&A”), dated October 27, 2021, which is available on the Company’s profile at www.sedar.com.

This news release does not constitute an offer to sell or the solicitation of an offer to buy, and shall not constitute an offer, solicitation or sale in any state, province, territory or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state, province, territory or jurisdiction.

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PharmaTher Engages Alcami for Clinical and Commercial Manufacturing of Novel Ketamine Products

PharmaTher Engages Alcami for Clinical and Commercial Manufacturing of Novel Ketamine Products

  • Leading U.S.-based CDMO to manufacture PharmaTher’s proprietary ketamine products for FDA Phase 3 clinical studies and global commercialization.
  • Expected FDA clinical and commercial supply in H2-2022.
  • Unlocking potential partnership opportunities with research labs, clinics and pharmaceutical companies globally.​

TORONTO, October 19, 2021 — PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a clinical-stage psychedelics biotech company, announces it has entered into an agreement with Alcami Corporation (“Alcami”), a global pharmaceutical contract development and manufacturing organization (CDMO) with extensive experience in cGMP sterile fill-finish products and handling of controlled substances, for the clinical and commercial manufacturing of the Company’s proprietary ketamine products.  

PharmaTher is focused on building a specialty ketamine-based product pipeline to support its internal product pipeline, including rare and near-rare neurological disorders such as Parkinson’s disease and ALS (Lou Gehrig’s disease).  The ability to manufacture and supply ketamine products in different dosage forms enables PharmaTher to not only guarantee delivery on its product pipeline but creates opportunity to partner in other value creation opportunities.  The Company expects to form partnerships with research labs, ketamine clinics and pharmaceutical companies that are: seeking a secure supply of cGMP ketamine and ketamine products for current portfolios; exploring alternative dose forms for multiple existing indications; and requiring support to develop and eventually commercialize specific ketamine products for new indications.  It is expected that PharmaTher’s proprietary ketamine drug product(s) will be available for FDA Phase 3 clinical studies and commercial use in H2-2022.

On September 29, 2021, Alcami announced an additional $31 million investment to expand its sterile development and manufacturing operation in Charleston, SC, that will substantially increase its fill-finish and lyophilization capacity.  This expansion will also be able to support PharmaTher’s ketamine product development and commercialization plans globally.

“We are thrilled to work with PharmaTher and offer our expertise in GMP sterile fill-finish manufacturing and controlled-substances to support PharmaTher’s ketamine product programs,” commented Patrick Walsh, Chairman & Chief Executive Officer of Alcami. “The support we have been engaged to provide is a testament to our broad capabilities, technical expertise, and ability to collaborate with customers to consistently deliver high quality results,” added Mr. Walsh.

“PharmaTher is evolving to become a leader in ketamine-based solutions for mental health, neurological and pain disorders, and partnering with Alcami as our exclusive manufacturer for the clinical and commercial supply of ketamine allows us to fulfill our objectives in serving these large markets and future partnering opportunities globally,” said Fabio Chianelli, CEO of PharmaTher.

About Alcami Corporation

Alcami is a contract development and manufacturing organization headquartered in North Carolina with over 40 years of experience advancing products through every stage of the development lifecycle. Leveraging four US-based scientific campuses, Alcami serves biologics and pharmaceutical companies of all sizes providing customizable and innovative solutions for development, clinical to commercial sterile and oral solid manufacturing, packaging, microbiology, and analytical services. Alcami’s private equity owners include Madison Dearborn Partners and Ampersand Capital Partners. For more information, please visit alcaminow.com, mdcp.com, or ampersandcapital.com. 

About PharmaTher Holdings Ltd.

​PharmaTher Holdings Ltd. (OTCQB: PHRRF) (CSE: PHRM) is a clinical-stage psychedelics biotech company focused on the research, development and commercialization of novel uses, formulations and delivery methods of psychedelics, such as ketamine, to treat mental health, neurological and pain disorders.  PharmaTher is currently initiating an FDA approved phase 2 clinical study with ketamine to treat Parkinson’s disease and is developing a novel microneedle patch for the intradermal delivery of psychedelics.
​
Learn more at:  PharmaTher.com and follow us on Twitter and LinkedIn.

For more information about PharmaTher, please contact:

Fabio Chianelli
Chief Executive Officer
PharmaTher Holdings Ltd.
Tel: 1-888-846-3171
Email: info@pharmather.com
Website: www.pharmather.com

Neither the Canadian Securities Exchange nor its Regulation Services Provider have reviewed or accept responsibility for the adequacy or accuracy of this release.

Cautionary Statement

This press release contains ‘forward-looking information’ within the meaning of applicable Canadian securities legislation. These statements relate to future events or future performance. The use of any of the words “could”, “intend”, “expect”, “believe”, “will”, “projected”, “estimated”, “potential”, “aim” and similar expressions and statements relating to matters that are not historical facts are intended to identify forward-looking information and are based on PharmaTher Holdings Ltd. (the “Company”) current belief or assumptions as to the outcome and timing of such future events. Forward-looking information is based on reasonable assumptions that have been made by the Company at the date of the information and is subject to known and unknown risks, uncertainties, and other factors that may cause actual results or events to differ materially from those anticipated in the forward-looking information. Given these risks, uncertainties and assumptions, you should not unduly rely on these forward-looking statements. The forward-looking information contained in this press release is made as of the date hereof, and Company is not obligated to update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as required by applicable securities laws. The foregoing statements expressly qualify any forward-looking information contained herein. Factors that could cause actual results to differ materially from those anticipated in these forward-looking statements are described under the caption “Risk Factors” in Company’s management’s discussion and analysis for the period of May 31, 2021 (“MD&A”), dated September 7, 2021, which is available on the Company’s profile at www.sedar.com.

This news release does not constitute an offer to sell or the solicitation of an offer to buy, and shall not constitute an offer, solicitation or sale in any state, province, territory or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state, province, territory or jurisdiction.

Posted on

PharmaTher Granted FDA Orphan Drug Designation For Ketamine To Treat Complex Regional Pain Syndrome

PharmaTher Granted FDA Orphan Drug Designation For Ketamine To Treat Complex Regional Pain Syndrome

  • Achieving its second FDA orphan drug designation with ketamine.
  • Building a proprietary ketamine-based product pipeline for rare and near-rare disorders in pain and inflammation.
  • Seeking to enter Phase 2 clinical trial in 2022.

TORONTO, October 13, 2021 — PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a clinical-stage psychedelics biotech company, is pleased to announce that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation (ODD) for ketamine in the treatment of complex regional pain syndrome (CRPS), a rare chronic pain and inflammatory condition following an injury to a limb (arm, leg, hand or foot).  This follows the FDA ODD grant of ketamine for the treatment of Amyotrophic Lateral Sclerosis (ALS), also known as Lou Gehrig’s disease, announced by the Company on August 4, 2021.

Fabio Chianelli, Chief Executive Officer of PharmaTher, said, “Receiving our second FDA orphan drug designation with ketamine for CRPS continues our momentum in building a specialty ketamine-based product pipeline for not only mental health disorders, but also for rare and near-rare conditions present in neurological (Parkinson’s disease, ALS), pain and inflammatory disorders.  We expect to pursue a Phase 2 clinical study using our proprietary cGMP ketamine product in 2022 for CRPS.”

CRPS is a debilitating condition characterized by severe, continuous, burning or throbbing pain in a limb.  CRPS is known as one of the most painful disorders and the risk of suicide is significantly higher in patients with CRPS with one study demonstrating that 75% of patients had a high risk for suicide (Lee et al., Psychiatry Investig 2014;11(1):32-8).  CRPS has acute (recent, short-term) and chronic (lasting greater than six months) forms of excessive pain accompanied by changes in skin color, temperature and/or swelling, which results in loss of physical function and can lead to significant and sometimes permanent disability.  CRPS can occur after surgery or trauma, including brain or spinal cord injury.  There is currently no medication approved for the treatment of CRPS.

Ketamine acts as a noncompetitive, NMDA channel blocker that can prevent the induction of synaptic potentiation.  NMDA receptors play a central role in the processes of induction and maintenance of pain sensitization, accounting for the analgesic efficacy of ketamine.  Although ketamine has actions at other relevant sites, including nicotinic and opioid receptors, as well as, via monoamine reuptake transporters, it is likely that both the anesthetic and the analgesic actions of ketamine are largely mediated by NMDA receptor antagonism.  Likewise, the psychotropic and sympatho-excitatory side effects of ketamine are also predominantly mediated through NMDA receptor blockade.

The Orphan Drug Act grants special status to a drug or biological product to treat a rare disease or condition upon request of a sponsor. This status is referred to as orphan designation (or sometimes “orphan status”). The FDA grants orphan status to products that treat rare diseases, providing incentives to sponsors developing drugs or biologics. The FDA defines rare diseases as those affecting fewer than 200,000 people in the United States at any given time. Orphan drug designation would qualify a drug for certain benefits and incentives, including seven years of marketing exclusivity if regulatory approval is ultimately received for the designated indication, potential tax credits for certain clinical drug testing costs, activities, eligibility for orphan drug grants, and the waiver of the FDA New Drug Application filing fee of approximately $2.4 million.

About PharmaTher Holdings Ltd.

​PharmaTher Holdings Ltd. (OTCQB: PHRRF) (CSE: PHRM) is a clinical-stage psychedelics biotech company focused on the research, development and commercialization of novel uses, formulations and delivery methods of psychedelics, such as ketamine, to treat mental health, neurological and pain disorders.  PharmaTher is currently initiating an FDA approved phase 2 clinical study with ketamine to treat Parkinson’s disease and is developing a novel microneedle patch for the intradermal delivery of psychedelics.
​
Learn more at:  PharmaTher.com and follow us on Twitter and LinkedIn.

For more information about PharmaTher, please contact:

Fabio Chianelli
Chief Executive Officer
PharmaTher Holdings Ltd.
Tel: 1-888-846-3171
Email: info@pharmather.com
Website: www.pharmather.com

Neither the Canadian Securities Exchange nor its Regulation Services Provider have reviewed or accept responsibility for the adequacy or accuracy of this release.

Cautionary Statement

This press release contains ‘forward-looking information’ within the meaning of applicable Canadian securities legislation. These statements relate to future events or future performance. The use of any of the words “could”, “intend”, “expect”, “believe”, “will”, “projected”, “estimated”, “potential”, “aim” and similar expressions and statements relating to matters that are not historical facts are intended to identify forward-looking information and are based on PharmaTher Holdings Ltd. (the “Company”) current belief or assumptions as to the outcome and timing of such future events. Forward-looking information is based on reasonable assumptions that have been made by the Company at the date of the information and is subject to known and unknown risks, uncertainties, and other factors that may cause actual results or events to differ materially from those anticipated in the forward-looking information. Given these risks, uncertainties and assumptions, you should not unduly rely on these forward-looking statements. The forward-looking information contained in this press release is made as of the date hereof, and Company is not obligated to update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as required by applicable securities laws. The foregoing statements expressly qualify any forward-looking information contained herein. Factors that could cause actual results to differ materially from those anticipated in these forward-looking statements are described under the caption “Risk Factors” in Company’s management’s discussion and analysis for the period of May 31, 2021 (“MD&A”), dated September 7, 2021, which is available on the Company’s profile at www.sedar.com.

This news release does not constitute an offer to sell or the solicitation of an offer to buy, and shall not constitute an offer, solicitation or sale in any state, province, territory or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state, province, territory or jurisdiction.

Posted on

PharmaTher Initiates Phase 2 Clinical Trial of Ketamine for the Treatment of Parkinson’s Disease

PharmaTher Initiates Phase 2 Clinical Trial of Ketamine for the Treatment of Parkinson’s Disease

“KET-LID” trial to evaluate ketamine’s safety and efficacy in the treatment of levodopa-induced dyskinesia in patients with Parkinson’s disease

TORONTO, October 6, 2021 — PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a clinical-stage psychedelics biotech company, announced today that it has initiated its Phase 2 KET-LID clinical trial of Ketamine for the treatment of Levodopa-Induced Dyskinesia in Subjects with Parkinson’s Disease. Patient screening and enrollment is expected to begin in October 2021 with data anticipated in late-Q4 2021.The Phase 2 KET-LID clinical trial is a randomized, double-blind, active placebo-controlled study evaluating the safety, efficacy and pharmacokinetics of ketamine in the treatment of levodopa-induced dyskinesia in patients with Parkinson’s disease.  The primary and secondary endpoints are the changes in the following: i) total score of the Unified Dyskinesia Rating Scale (UDysRS), ii) total objective score (III, IV) of the UDysRS, iii) total daily OFF times as assessed by subject- completed 24-hour diaries, and iv) Unified Parkinson’s Disease Rating Scale (UPDRS) total score of part III (motor) and sum score of Questions 4.1 and 4.2 (dyskinesia) in part IV.

As previously announced, an IND for the trial has been approved by the FDA.  The Company has completed its clinical trial start-up activities and selection of essential vendors including  project management, central laboratory, clinical supply kits and logistics, data management and biostatistics, and clinical site management and monitoring.  Clinical trial drug product (ketamine) and active placebo (midazolam) have also been obtained.  

For further detail about the KET-LID trial (ClinicalTrials.gov Identifier: NCT04912115), titled “A Multi-Center, Phase II, Randomized, Double-Blind, Prospective, Active Placebo-Controlled Trial of Sub-Anesthetic Intravenous Infusion of Ketamine to Treat Levodopa-Induced Dyskinesia in Subjects with Parkinson’s Disease,” please visit https://clinicaltrials.gov/ct2/show/NCT04912115?term=PharmaTher&draw=2&rank=1.

If the Phase 2 clinical study is positive, the Company will request a meeting with the FDA to discuss its plan and obtain an agreement to move to a Phase 3 clinical study under the 505(b)2 regulatory pathway in the first half of 2022.  

“Initiation of the Phase 2 clinical trial of ketamine to treat Parkinson’s disease, or the KET-LID trial, is a significant milestone for PharmaTher and we are excited about the opportunity to advance a potential new therapeutic solution for Parkinson’s disease patients,” said Fabio Chianelli, CEO of PharmaTher.  
There can be no assurance that the FDA will support any potential request for an expedited path to approval or further development for ketamine in the treatment of Parkinson’s disease.

Ketamine’s Potential In Parkinson’s Disease       

Ketamine is an FDA-approved N-methyl-D-aspartate (NMDA) receptor-modulating drug that is widely used as an anesthetic agent either alone or in combination with other anesthetic agents [Smith et al, 1987; Pacheco et al, 2014]. The possible therapeutic effect of low-dose ketamine on levodopa-induced dyskinesia (LID) was noted in a retrospective analysis of Parkinson’s disease patients who received ketamine for pain relief. During this analysis, it was observed that the patients experienced an improvement in LID lasting several weeks beyond treatment [Sherman et al, 2016]. These results were corroborated in a test of low-dose ketamine in a rodent LID model, and this possible effect has also been examined in a controlled study [Bartlett et al, 2016]. Ketamine may also have additional benefits in the treatment of pain [Niesters et al, 2014] and depression [Diamond et al, 2014; Murrough et al, 2013], which are frequent comorbidities of Parkinson’s disease.

Parkinson’s disease is a debilitating disorder that affects over 1 million people in the U.S. and more than 7 million people worldwide. There is currently no cure for Parkinson’s disease, although some drug combinations are used to treat the disease symptoms. The global Parkinson’s disease market is expected to grow from USD $5 billion in 2019 to USD $7.5 billion by the end of 2025 [360iResearch 2020] and it is estimated that the potential market opportunity for LID Parkinson’s disease to be over USD $3 billion in the U.S. alone.

About Parkinson’s Disease

There is currently no cure for Parkinson’s disease. Although the etiology of Parkinson’s disease is not fully understood, it is thought to result from loss of pigmented dopaminergic neurons in the Substantia nigra and their striatal projections, leading to dopamine deficiency in the striatum [Schapira and Jenner, 2011]. This ultimately affects the cortico-striatal system that controls movement. As a progressive neurogenerative disorder of the central nervous system that primarily affects the motor nerve system, symptoms of Parkinson’s disease may emerge slowly and include tremors, rigidity, bradykinesia, and postural instability [Paulson and Stern, 2004]. Also, patients may experience non-motor symptoms such as autonomic dysfunction (orthostatic hypotension, constipation, bladder dysfunction), psychiatric (depression), cognitive and sensory symptoms (pain) [Olanow, et al, 2009]. These non-motor symptoms become more common as the disease progresses. Treatments, including levodopa and dopamine agonists, which restore the dopamine deficits in the brain, have been employed for almost 50 years. However, with continued treatment using levodopa, dose-limiting motor side-effects often emerge. This includes the emergence of abnormal involuntary movements termed Levodopa Induced Dyskinesias, which can be identified in about 50% of patients within five years after initiation of levodopa treatment and in almost all patients within ten years post-treatment initiation. These side effects often limit further dose increases in dopaminergic therapy.

About PharmaTher Holdings Ltd.

​PharmaTher Holdings Ltd. (OTCQB: PHRRF) (CSE: PHRM) is a clinical-stage psychedelics biotech company focused on the research, development and commercialization of novel uses, formulations and delivery methods of psychedelics, such as ketamine, to treat mental health, neurological and pain disorders.  PharmaTher is currently initiating an FDA approved phase 2 clinical study with ketamine to treat Parkinson’s disease and is developing a novel microneedle patch for the intradermal delivery of psychedelics.
​
Learn more at:  PharmaTher.com and follow us on Twitter and LinkedIn.

For more information about PharmaTher, please contact:

Fabio Chianelli
Chief Executive Officer
PharmaTher Holdings Ltd.
Tel: 1-888-846-3171
Email: info@pharmather.com
Website: www.pharmather.com

Neither the Canadian Securities Exchange nor its Regulation Services Provider have reviewed or accept responsibility for the adequacy or accuracy of this release.

Cautionary Statement

This press release contains ‘forward-looking information’ within the meaning of applicable Canadian securities legislation. These statements relate to future events or future performance. The use of any of the words “could”, “intend”, “expect”, “believe”, “will”, “projected”, “estimated”, “potential”, “aim” and similar expressions and statements relating to matters that are not historical facts are intended to identify forward-looking information and are based on PharmaTher Holdings Ltd. (the “Company”) current belief or assumptions as to the outcome and timing of such future events. Forward-looking information is based on reasonable assumptions that have been made by the Company at the date of the information and is subject to known and unknown risks, uncertainties, and other factors that may cause actual results or events to differ materially from those anticipated in the forward-looking information. Given these risks, uncertainties and assumptions, you should not unduly rely on these forward-looking statements. The forward-looking information contained in this press release is made as of the date hereof, and Company is not obligated to update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as required by applicable securities laws. The foregoing statements expressly qualify any forward-looking information contained herein. Factors that could cause actual results to differ materially from those anticipated in these forward-looking statements are described under the caption “Risk Factors” in Company’s management’s discussion and analysis for the period of May 31, 2021 (“MD&A”), dated September 7, 2021, which is available on the Company’s profile at www.sedar.com.

This news release does not constitute an offer to sell or the solicitation of an offer to buy, and shall not constitute an offer, solicitation or sale in any state, province, territory or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state, province, territory or jurisdiction.

Posted on

Elon takes shrooms to the moon!: issue 17

Here’s what’s in store for you in today’s issue:

🍄 Struggling with negative self image

🍄 Pneumonia drug + shrooms repair the brain?

🍄 Build your brain without getting high

🍄 Is Elon going to take shrooms to the moon?

🍄 And more.

You’ll want to stay till the end to learn how someone became a cartoon on magic truffles!

(Did a good friend forward this to you? If so be sure to subscribe here)

Be sure to check out last week’s Daily Mushroom podcast!
Psilocybin, is it the next cannabis wave?

In this episode we have Lenny Kerman, a strategic financial consultant who works with various psilocybin and cannabis companies. He talks about how he’s invested in the space and has some valuable information for those looking to invest as well.

Therapeutic banner

Struggling with a negative self image?

A recent study suggests that repeated psychedelic drug use may be effective in reducing PTSD symptoms and internalized shame in people who endured maltreatment during childhood.

The researchers surveyed adults with severe physical, emotional, or sexual trauma and found that those who took psychedelics for therapeutic purposes (in non-clinical settings) were less likely to have a negative self-concept or disturbances in relationships.

Participants who used psychedelics with therapeutic intent 5 times showed the lowest levels of internalized shame and complex trauma.

Enhancing psilocybin…with a pneumonia drug?

A drug that loosens mucus in the lungs could also help treat concussions!?

Lobe Sciences (LOBE) discovered that psilocybin might work better when paired with N-Acetylcysteine (NAC), a drug used to treat Tylenol overdose and respiratory conditions like pneumonia, bronchitis, and asthma.

In rodent models of mild traumatic brain injury (TBI) and PTSD, the combination of psilocybin and NAC performed significantly better than psilocybin, NAC, or a placebo alone.

The company is working on finding a supplier of high purity cGMP psilocybin to continue research and expand on these findings.

Reducing fish seizures

This Vancouver company is making advancements across its drug pipeline.

Dravet Syndrome, a disorder that causes epilepsy from a young age, is the target of a new study by Bright Minds (DRUG). In preclinical studies on zebrafish, DRUG was effective in reducing seizure duration and frequency and is now on track to be tested in human trials early next year.

In rat models, DRUG showed efficacy in treating opioid use disorder and binge eating disorder with rats demonstrating a 50% reduction in binge eating episodes.

The company also has a mixed compound that is in preclinical development for cluster headaches, chemotherapy-induced peripheral neuropathy, and other pain disorders.

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Tripping in Times Square

This week, the first-ever psychedelic billboard campaign debuted in Times Square to spark a conversation about the healing power of plant medicines and disrupt profit-driven ads.

The #CelebratePlantMedicine campaign encourages viewers to share their personal experiences with plant medicines to destigmatize the use of psychedelics. It also aims to amplify the importance of set and setting, integration, and respecting Indigenous wisdom.

The campaign is run by DoubleBling Magazine, Musings Magazine, Rainbo Mushrooms, and Honeysuckle Magazine, which ran Time Square’s first cannabis billboard.

Go share your story with the hashtag to join the movement!

3 women + microdosing = )

Chelsea says that microdosing allows her to “stay fully present” and is the only tool that helps her focus her busy mind, but the biggest shift was in her anxiety. “For over fifteen years, I had severe anxiety, but through microdosing, I could sit with and deliberate my fears. I now rarely suffer with it, and if I do, it’s fleeting,” she shares.

One woman, Amber, was so depressed that everything felt dull and uninteresting, until she started microdosing. “When I microdosed for the first time I found myself noticing the beauty of the things around me again,” she says. She explains that microdosing is “akin to a child-like wonder” and makes her feel “more positive, open-minded and creative but still completely functional and sober”.

Bea finds that microdosing three times per week acts as a natural mood booster and study aid, brings her mental clarity, and helps her organize her life. She says she’s now able to be her true, stable self and is no longer the “people-pleasing, anxious version” of herself.

Is Elon going to take shrooms to the moon? 

Elon Musk has been known to have a major influence on the stock market, with his Tweets causing Bitcoin and Dogecoin to skyrocket almost instantaneously. His latest interview could take shroom stocks to the moon 😉

In an interview with Ronan Levy, co-founder of Field Trip Health (FTRP), Musk was asked what role he thinks psychedelics have in “addressing some of the more destructive tendencies of humanity.”

Elon replied, “I think, generally, people should be open to psychedelics. A lot of people making laws are kind of from a different era, so I think, as the new generation gets into political power, I think we will see greater receptivity to the benefits of psychedelics.”

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Build a better brain without getting high

“We are not a one- or two-asset company. We’ve got a large pipeline coming out,” warns David E. Olson, founder of Delix Therapeutics.

The Boston-based startup just raised $70 million in series A financing to develop psychedelic-inspired compounds that are safe enough to take at home.

The company has already synthesized about 1,000 compounds across 8+ classes of psychedelics, with the goal of creating compounds that form synapses between brain cells without inducing hallucinations.

The researchers have found a couple of promising contenders, which are on track to be studied in Phase 1 clinical trials by the end of this year.

Are stoners getting bored with cannabis?

These two companies are joining forces to become a leader in commercialized psilocybin extracts.

Pure Extracts (PULL), a cannabis, hemp, and mushroom extraction company, signed a Joint Venture agreement with Psyence Group (PSYG) to form “Pure Psyence”.

The agreement leverages Psyence Group’s licensed cultivation facility and standardized psilocybin mushroom supply to create high-purity, naturally-derived mushroom extracts. Yesterday, Psyence Group completed its first official validated harvest, bringing it one step closer to receiving a British Standards Institute (BSI) certification.

The combined expertise will make standardized psilocybin more accessible to Canadian research institutions and will allow Pure Psyence to conduct human clinical trials using the extracts.

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Healing the Armed Forces

The US government is funding psychedelic research to get military members the relief they deserve!

A new measure, filed by Rep. Dan Crenshaw of Texas, would allow the Secretary of Defense to award research grants to study psychedelic therapy as a PTSD treatment for active military members.

The measure would allow any State or Federal agency, academic institution, or nonprofit to study the therapeutic effects of psilocybin, ibogaine, MDMA, or 5-MeO-DMT. If passed, funds could be used for Phase 2 clinical studies involving members of the Armed Forces or to train practitioners to offer the treatment.

Another city decriminalizes psychedelics

Well, kind of…

In a 5-2 vote, Grand Rapids, Michigan approved a psychedelics decriminalization resolution, yet activists feel the measure falls short.

The resolution calls for law enforcement deprioritization for use and possession of psilocybin, peyote, ayahuasca, and ibogaine, but it doesn’t address the cultivation, purchase, transportation or distribution of the entheogens, unlike the measure passed in Ann Arbor.

On the bright side, the measure notes that the Mayor and City Commission will support efforts to decriminalize the entheogenic plants and fungi on a local, state, and federal level.

Psychedelic research coming to Florida

“The science regarding psilocybin is real, cannot be ignored, and soon will be a universally-accepted form of treatment in the U.S.,” said Rep. Michael Grieco (D) of Florida.

That’s why he and Senate Minority Leader Lauren Book (D) filed bills that would require the state to study the medical potential of psilocybin and MDMA.

The bills were modeled on the measure enacted in Texas earlier this year to study psychedelic therapy for veterans with PTSD, but with an even broader scope. If enacted, the Department of Health would be directed to research other conditions like depression, anxiety, bipolar disorder, chronic pain and migraines.

Industry Quick Hits

Sept 27 – Clearmind Medicine (CMND) To Fund Second R&D Partnership With Hebrew University’s Technology Transfer Company Read more…

Sept 27 – Nikean Foundation announces $5 million gift to create a Psychedelic Psychotherapy Research Centre at Toronto’s University Health Network (UHN) Read more…

Sept 27 – Delic (DELC) Closes C$7.0 Million Private Placement With U.S. Institutional Investor to Fuel Growth of Largest National Presence Read more…

Sept 28 – NeonMind (NEON) Advances Strategy For Specialty Clinic Launch Read more…

Sept 28 – PharmaTher (PHRM) Announces Closing of CAD$10 Million Private Placement with Institutional Investors Read more…

Sept 29 – MYND Life Sciences Inc. (MYND) Announces RSU Grant Read more…

Sept 29 – Blackhawk Growth’s (BLR) Mindbio Therapeutics Signs Collaboration Agreement With Digital Mind Technology Technology Read more… 

Sept 30 – MINDCURE Announces Commencement of Trading on the OTCQX Best Market Under Symbol ‘MCURF’ Read more…

Sept 30 – Novamind (NM) Opens 6th Integrative Psychiatry Clinic, Adds 3rd Clinical Research Site Read more… 

Video of the Week

LIFE BEYOND: Chapter 1

Becoming an extremely pleasing ball of flesh

This Reddit user had a memorable first trip on magic truffles.

“We cycled to an extremely secluded hill with trees covering it from all sides and where no one ever goes. It’s our secret chill spot mostly used for smoking weed. We sat down in pure awe of the spot and nature. Generating sentences and word combinations was EXTREMELY HARD, because every time we wanted to get a thought out, when we started explaining it, our brains had already moved on to the next thought. It was a rapid fire of thoughts and ideas and we laid down looking at the sky and the trees in silence just thinking about the universe and different topics.

Everything had patterns and colors were extremely bright and vibrant. Everything was breathing and flowing and when I looked at my phone, I couldn’t decipher words as all the letters on my keyboard and screen kept moving and switching places. I didn’t see words, but rather letter combinations. Looking at the camera, my face was constantly moving, shrinking and getting bigger. My eyes looked big and cartoony. It looked like I was living in a cartoon as everything looked like a drawing and too symmetrical to be real. At one point I pressed my head against my knee and felt like my body was merging into a ball of flesh, but it felt extremely pleasing. Everything was positive, loving and peaceful. I was at peace with myself and the universe. Orange juice tasted amazing. Me and my friend didn’t have much interaction as we were both fully engulfed in the trip. He told me afterwards that he had many similar effects to me.

At the end of the peak, I noticed my friend shedding tears and put my hand on his shoulder and asked him if everything was ok. He said he wasn’t sad, but they were rather tears of joy and acceptance. Seems like he was having an even more intense experience than me, but he said his trip was extremely good just like mine and no signs of a bad trip or negative thoughts.”

Playlist of the Week

Psychedlic and Chill
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