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Revive Therapeutics Provides Update on Oral Thin Film Product with Psilocybin

TORONTO, Nov. 11, 2020 – Revive Therapeutics Ltd. (“Revive” or the “Company”) (CSE: RVV, USA: RVVTF), a specialty life sciences company focused on the research and development of therapeutics for medical needs and rare disorders, is pleased to provide an update on its oral thin-film delivery system with psilocybin being developed under a research partnership agreement with Reed Research Group out of the University of Wisconsin-Madison.

Following several months of prototyping on a wide range of dosage forms, the Company has completed an oral thin-film strip product with psilocybin with dosage forms ranging between 1 mg and 20 mg and demonstrating its versatility through physio-chemical characterization (e.g. tensile strength of films) of bio comparable tannin-chitosan composite materials, dissolution and disintegration testing, and rate of psilocybin release from composites.   Currently technical and scientific data is being processed and finalized.

“We are very pleased to have achieved this development milestone of our orally dissolvable thin film strip for psilocybin, which can be used in FDA human clinical studies and as a unique product for medical use in states where psilocybin therapy use is permitted, such as Oregon following the passage of Measure 109,” said  Michael Frank, CEO of Revive.  “There is a significant market opportunity for our unique oral thin film strip technology for not only delivering psilocybin but also delivering numerous psychedelic-based medicines to treat various diseases and disorders that would benefit from such a delivery method. Also, we are in a position to begin partnering with life sciences companies seeking to add unique offerings in their psychedelic-based product pipeline and with companies operating in the U.S. where psilocybin therapy use is legal.”

Psilocybin Oral Thin-film Product

Under its sponsored research partnership with the Reed Research Group out of the University of Wisconsin-Madison, the Company is developing its tannin-chitosan composite of orally dissolvable thin films which offers a unique delivery platform for therapeutic doses (1-20mg) of psilocybin into the oral cavity. The Company has finalized the prototypes and is preparing to scale for manufacturing for future clinical studies involving psilocybin and other psychedelic-derived medicines.

There are a number of advantages and benefits of an orally dissolvable psilocybin thin film such as the rapid dissolving and onset of action to the bloodstream, the ease and convenience for patients to administer without the need of water, chewing or swallowing, the potential of improved therapeutic outcomes and efficacy for underserved diseases and disorders including the flexibility to create accurate dosing and tasteful options.

Revive’s Drug Delivery Technology

The drug delivery technology aims to deliver both synthetic and natural extract of psilocybin in a potential number of ways such as orally dissolvable thin films, topical gels, creams or ointments, oral or transdermal patches, oral dosages and foams.

The delivery technology is a natural, non-toxic, biodegradable and biocompatible composite that combines a tannin material, which is derived from a plant group having antibacterial, antifungal, antioxidant and wound healing properties, and a chitosan material, which is derived from the crustacean group having blood-clotting and antimicrobial properties. The delivery technology has a rapid onset of action and controlled or sustained release potential capabilities and may allow combining multiple extracts from mushrooms in one formulation.

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 recent 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 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” 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 Offering, including the intended use of proceeds. 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, 2020, which has been filed on SEDAR and is available under the Company’s profile at www.sedar.com.

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Prolific Parkinson’s Researcher Dr. Alberto J. Espay Joins Pharmather as Scientific Advisor

TORONTO, Nov. 11, 2020 (GLOBE NEWSWIRE) — Pharmather Inc., a wholly-owned subsidiary of Newscope Capital Corporation (“Pharmather” or the “Company”) (CSE: PHRM) and a specialty life sciences company focused on the research and development of psychedelic pharmaceuticals, is pleased to announce the appointment of Dr. Alberto J. Espay, MD, MSc, FAAN, as a scientific and clinical advisor to the Company. Dr. Espay currently serves as Professor and Endowed Chair of the University of Cincinnati James J. and Joan A. Gardner Family Center for Parkinson’s Disease and Movement Disorders.

“We would like to welcome Dr. Espay as a scientific and clinical advisor to our team and we look forward to his contributions in our clinical development of ketamine in the treatment of levodopa-induced dyskinesia associated with Parkinson’s Disease,” said Fabio Chianelli, CEO of Pharmather. “Dr. Espay brings invaluable knowledge and experience in the clinical paradigm in Parkinson’s Disease and he will be instrumental in our regulatory and clinical plans to advance our ketamine program for Parkinson’s Disease and movement disorders.”

Dr. Espay stated: “There is a significant need for new therapies in the treatment of Parkinson’s Disease and movement disorders. The established research with ketamine as a potential treatment for levodopa-induced dyskinesia associated with Parkinson’s Disease is very promising and I am pleased to serve as advisor to Pharmather at this stage of their clinical development.”

Dr. Alberto Espay, MD, is professor and endowed chair of the University of Cincinnati James J. and Joan A. Gardner Family Center for Parkinson’s Disease and Movement Disorders. He trained in neurology at Indiana University as well as in clinical and electrophysiology of movement disorders at the University of Toronto, where he obtained a master’s degree in clinical epidemiology and healthcare research. A prolific researcher and author, Dr. Espay has published more than 250 peer-reviewed research articles, 25 book chapters and seven books. His most recent is the first targeting the general public, Brain Fables.

Dr. Espay has served as chair of the Movement Disorders Section of the American Academy of Neurology; associate editor of Movement Disorders, the official journal of the International Parkinson and Movement Disorder Society (MDS); and in the executive committee of the Parkinson Study Group. He currently serves as chair of MDS Technology Task Force and as secretary of the Pan-American Section of the MDS. Dr. Espay is also an honorary member of the Mexican Academy of Neurology.

His research efforts focus on the measurement of motor and behavioural phenomena in – and clinical trials for – Parkinson’s Disease as well as in the understanding and management of functional movement disorders. With colleagues at the University of Cincinnati and several international collaborators, he recently launched the first biomarker study of aging at the University of Cincinnati (CCBPstudy.com), designed to match people with neurodegenerative disorders to available disease-modifying therapies from which they are most biologically suitable to benefit.

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 20251 and it is estimated that the potential market opportunity for LID-PD to be over USD $3 billion in the U.S. alone.

Promising Results with Ketamine in Parkinson’s Disease
Ketamine is an FDA-approved drug with a known safety profile. Prior clinical reports suggest that low-dose ketamine infusions are well tolerated and can improve pain and depression, both often comorbidities in Parkinson’s Disease patients.

Inventors Dr. Scott Sherman and Dr. Torsten Falk, both associate professors at the University of Arizona College of Medicine – Tucson, are working with Tech Launch Arizona to patent the results from preclinical data and five case studies in Parkinson’s disease patients showing that low-dose sub-anesthetic ketamine infusion indicates tolerability, safety and the potential of long-term therapeutic benefit to reduce Levodopa-induced dyskinesia, improve on time, and reduce depression.2-6

About 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.

Levodopa is the gold standard for Parkinson’s Disease treatment but features significant drawbacks related to its pharmacokinetic profile, including the development of dyskinesia. Approximately 50% of patients with Parkinson’s disease will develop dyskinesia about 4-5 years after the initiation of levodopa, and this number rises to 80% after 10-12 years of levodopa treatment. LID may interfere with motor function, cause or aggravate pain and is known to worsen the quality of life.

Individuals with Parkinson’s Disease may experience a host of non-motor symptoms such as autonomic dysfunction, psychiatric (depression), cognitive and sensory symptoms (pain). Therefore, the urgent need for alternative treatments has been identified by the regulatory authorities, patient advocacy groups such as Michael J. Fox Foundation, and key opinion leaders as a substantial unmet medical need.

About Pharmather Inc.
Pharmather Inc., a wholly-owned subsidiary of Newscope Capital Corporation (CSE: PHRM), is a specialty life sciences company focused on the research and development of psychedelic pharmaceuticals. Pharmather repurposes psychedelic pharmaceuticals, such as ketamine and psilocybin, for FDA approval to treat disorders of the brain and nervous system. Our team includes world-class strategic partners, advisors and a strong leadership team with a proven track record of success in drug development, business development and capital markets. Our goal is to advance the development of panaceAI™, our drug repurposing artificial intelligence platform, and our clinical product pipeline with ketamine and psilocybin in the treatment of Parkinson’s Disease, depression, pain, traumatic brain injury and stroke.
Learn more at: pharmather.com and follow us on Facebook, Twitter and LinkedIn.

For more information, please contact:
Fabio Chianelli
Chief Executive Officer
Pharmather Inc.
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” and similar expressions and statements relating to matters that are not historical facts are intended to identify forward-looking information and are based on the Company’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 U.S. Food and Drug Administration (“FDA”) approval under an Orphan Drug Designation (“ODD”) and investigational new drug (“IND”) to conduct a Phase II clinical study, market opportunities in Parkinson’s Disease and levodopa-induced dyskinesia associated with Parkinson’s Disease (“LID-PD”), ketamine programs towards human clinical studies under the FDA regulatory pathway and product developments. 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 30, 2020 (“MD&A”), dated October 1, 2020, which is available on the Company’s profile at www.sedar.com.

References:

  1. 360iResearch 2020.
  2. UA Clinical Trial to Repurpose Ketamine for Parkinson’s Patients.
  3. US20190060254A1— Compositions and methods for treating motor disorders.
  4. Bartlett, et al, 2020. Preclinical evidence in support of repurposing sub-anesthetic ketamine as a treatment for L-DOPA-induced dyskinesia. Experimental Neurology. Volume 333.
  5. Bartlett, M.J., Joseph, R.M., LePoidevin, L.M., Parent, K.L., Laude, N.D., Lazarus, L.B., Heien, M.L., Estevez, M., Sherman, S.J., Falk, T., 2016. Long-term effect of sub-anesthetic ketamine in reducing L-DOPA-induced dyskinesias in a preclinical model.
  6. Sherman, S.J., Estevez, M., Magill, A.B., Falk, T., 2016. Case reports showing a long-term effect of subanesthetic ketamine infusion in reducing L-DOPA-induced dyskinesias. Case Rep. Neurol. 8, 53–58.
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Nova Mentis Life Science Acquisition Target, Pilz Bioscience Corp, Provides Corporate Update

November 11, 2020 6:00 am Published by 

Novamentis

Vancouver, British Columbia – November 11, 2020 – Nova Mentis Life Science Corp. (CSE: NOVA) (FSE: HN3Q) (OTCPK: LIBFF) (“NOVA” or the “Company”) is pleased to announce that its pending acquisition target, Pilz Bioscience Corp. (“Pilz”), has provided a corporate update.

Dr. Marvin S. Hausman MD, Chairman and Chief Scientific Officer of Pilz commented: “We are very pleased with the progress that we have made to date in advancing our scientific research mandate relating to our investigations into Autism Spectrum Disorder (ASD) and the potential for psilocybin and tryptamine-based compounds to be used in the treatment of this unmet medical need.”   He continued: “To this end, we have accomplished a number of initial milestones which, we believe, will assist in setting the stage for our future scientific and commercial advancement.”
Achievements to date include:

Pilz Sponsored Cell Study:

  • The goal for this initial study was to test Psilocybin and Psilocin for cellular bioavailability in a preclinical bioassay.
  • It was found that both Psilocin and Psilocybin had antioxidant capacity, with Psilocin being superior to Psilocybin.
  • Psilocin clearly showed a significant cellular antioxidant protection of red blood cells, as it robustly reduced the intracellular oxidative stress in the CAP-e bioassay.

Master Services Agreement:

  • Pilz entered into a Master Services Agreement (MSA) with Comac Medical Ltd. (“Comac”).  Comac is an international clinical research/site management company based in Sophia, Bulgaria that is engaged in clinical trial monitoring, bioanalysis, GxP auditing, and biometrics.
  • Comac will assist Pilz in designing and performing pharmacokinetic and Phase 1 clinical studies, as well as assist in European regulatory filings for drug approval.

Initiation of Pre-Clinical Study in Autism Spectrum Disorder:

  •  Dr. Viviana Trezza at Roma Tre University (Rome, Italy) has developed a rat model that allows the evaluation of the relationship between altered brain function in Autism Spectrum Disorder and behavior.
  • This unique animal model assists in unraveling the relationship between altered brain function in ASD and behavior and will allow Pilz to test its new psychedelic pharmaceutical compounds.
  • An initial non-treatment behavioral study was completed in September, 2020, and collected biologic samples are undergoing molecular and bacteriologic analysis. The results from these state-of-the-art analytics will be used to develop a unique proprietary diagnostic and therapeutic paradigm, titled the “Pilz ASD Correlate.” This “ASD Correlate” will be used in preclinical and clinical models to test the therapeutic application of the psilocybin and tryptamine derivatives under development, as well as personalize individual ASD therapy.

Proprietary Psilocybin Manufacturing Agreement:

  • Pilz entered into a psilocybin and tryptamine derivative manufacturing agreement with a U.S. based pharmaceutical company with over 800 employees.
  • Pilz is working closely with the manufacturing chemists to design a proprietary synthetic pathway that will allow possible patent filing.
  • Pilz will have complete and sole ownership of the Drug Master File (DMF) which will be used for regulatory submission prior to commencing human clinical trials.  Initial jurisdictions under consideration include the United States, Canada, and the European Union.
  • NonGMP psilocybin is being manufactured for shipment to Dr. Trezza’s lab in Italy to start treatment of ASD afflicted rats in a scientifically accepted research study. All export and import licenses are being readied for shipment of this schedule 1 controlled research drug.

Upcoming Deliverables and Milestones for Q4, 2020:

  • The initial phase of the behavioral pre-clinical ASD study at Roma Tre University has been completed and Pilz is awaiting molecular, biochemical and bacteriologic results from its contracted labs, Microbiome Insights, University of British Columbia, Vancouver, Canada and Thermo Fisher Scientific, Vienna, Austria. A deep learning artificial intelligence program for ASD will be developed that integrates inflammation, oral/gut/brain axis, and behavior.
  • A rat ASD preclinical study with treatment and control groups has been designed and psilocybin dosage amounts will be established using the currently manufactured Pilz psilocybin. Behavioral modification and side effects will also be assessed.

 

Pharmacokinetic studies are being designed and the data will lay the groundwork for potential Pilz regulatory submissions for human research.

NOVA’s pending acquisition of Pilz is subject to requisite regulatory approval, as applicable, and receipt of requisite approval of Pilz shareholders.

About Pilz Bioscience Corp.

Pilz Bioscience Corp. (“Pilz”) is a biotechnology company developing medicinal psychedelics for neuroinflammatory conditions with a significant cognitive component and high unmet therapeutic needs. The initial focus is on Autism Spectrum Disorder (ASD). The company intends to leverage a unique systems-level scientific approach that integrates inflammation, oral/gut/brain axis, and behavior. Pilz aims to lead the global effort in design of effective and comprehensive diagnostic/monitoring programs and first-in-class therapeutics.
https://pilzbioscience.com/

About Nova Mentis Life Science Corp.

Nova Mentis Life Science Corp. (formerly Liberty Leaf Holdings Ltd.) is a Canadian-based, public company whose focus is to build and support a diversified portfolio of health and wellness businesses. Key holdings include its wholly-owned subsidiary, Nova Mentis Biotech Corp., a R&D driven company focused on exploring the anti-inflammatory effects of psilocybin in underexplored metabolic indications such as obesity and diabetes – Just Kush Enterprises, an Okanagan BC based, Health Canada Standard Licensed facility focused on the cultivation of premium, small batch Kush dominant cultivars.

For further information on the Company, please visit https://www.novamentis.ca or email info@novamentis.ca

On Behalf of the Board
Will Rascan, President & CEO
Nova Mentis Life Science Corp.
Phone: 778-819-0244
Toll Free: 1-833-542-5323
Twitter: @novamentislsc
Instagram: @novamentislsc
Facebook: @novamentislsc

Neither the Canadian Securities Exchange nor its Market Regulator (as that term is defined in the policies of the Canadian Securities Exchange) accepts responsibility for the adequacy or accuracy of this release.

This news release contains statements that constitute “forward-looking statements.” Such forward looking statements involve known and unknown risks, uncertainties and other factors that may cause Nova Mentis Life Science’s actual results, performance or achievements, or developments in the industry to differ materially from the anticipated results, performance or achievements expressed or implied by such forward-looking statements. Forward looking statements are statements that are not historical facts and are generally, but not always, identified by the words “expects,” “plans,” “anticipates,” “believes,” “intends,” “estimates,” “projects,” “potential” and similar expressions, or that events or conditions “will,” “would,” “may,” “could” or “should” occur.

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Health Canada Approves MAVIRET® 8-Week Treatment Duration for Treatment-Naïve Patients with Genotype 3 Compensated Cirrhosis

  • MAVIRET® (glecaprevir/pibrentasvir) is the only 8-week oral treatment approved for all Hepatitis C virus (HCV) Genotypes.1
  • MAVIRET is indicated for the treatment of chronic HCV infection in adults and adolescent patients 12 to 18 years of age.1
  • MAVIRET is available and reimbursed across **

 

MONTREAL (Quebec), November 10, 2020 – AbbVie (NYSE: ABBV), a global, research and development- based biopharmaceutical company announced today that Health Canada has approved a label change for MAVIRET® (glecaprevir/pibrentasvir tablets) to include Treatment-Naïve Genotype 3 patients with compensated cirrhosis.1 With this change, the recommended treatment duration for ALL individuals* with chronic hepatitis C virus (HCV) infection who are treatment naïve, genotypes 1-6 with/or without compensated cirrhosis is 8 weeks.

 

“I witness the destructive effects hepatitis C has on patients, our community and healthcare system. At the Ottawa Hospital, we see thousands of people on a yearly basis with a variety of liver diseases.

Having access to effective HCV treatment options that cover all hepatitis C genotypes is a game

changer,” said Dr. Curtis Cooper, Director, The Ottawa Hospital and Regional Hepatitis Program. “We now have an opportunity to eliminate this deadly virus with testing, treatment and care in shorter periods of time also available for patients with Genotype 3”

 

Health Canada first approved MAVIRET in August 2017. MAVIRET is a once-daily ribavirin-free treatment for adults and adolescent patients 12 to 18 years of age with chronic hepatitis C virus infection across all major HCV genotypes (GT1-6).2 It is an 8-week, pan-genotypic treatment for patients without cirrhosis and who are new to treatment.*

 

MAVIRET’s efficacy and safety were evaluated in nine phase II-III clinical trials, in over 2300 patients with genotype 1, 2, 3, 4, 5 or 6 HCV infection and with compensated liver disease (with or without cirrhosis). 1

 

“AbbVie is committed to eliminating hepatitis C by 2030 and sees this objective as a national public health priority. Through meaningful partnerships, we are working to find sustainable solutions that allow more patients to be screened, linked to care, and treated sooner,” said Denis Hello, Vice-President and General Manager AbbVie Canada.

 

 

About Hepatitis C

An estimated 250,000 people in Canada are living with chronic hepatitis C but as many as 44% are not aware that they have it.3 Left undiagnosed and untreated, chronic hepatitis C can lead to cirrhosis, liver cancer or liver failure. Currently, hepatitis C is the leading indication for liver transplant in Canada.4 AbbVie supports a range of efforts to help elevate and prioritize HCV elimination because we know achieving the shared goal of elimination by 2030 will take more than medicine. It will take transparent and collaborative partnerships with all stakeholders – industry, healthcare providers, healthcare systems, patient groups and their support networks. Joint efforts and maximizing the time we have left will enable us to reach this goal.

 

 

About AbbVie

AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology,

women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.ca and www.abbvie.com. Follow @abbviecanada on Twitter or find us on Facebook, LinkedIn and Instagram.

 

– 30 –

Media:

Kim Hogan AbbVie Canada 514-832-7288

kim.hogan@abbvie.com

 

* The safety and efficacy of MAVIRET in patients less than 12 years of age have not been established. MAVIRET exposures in HCV-infected patients 12 to 18 years were comparable to those in HCV-infected adults; however, the safety and efficacy of MAVIRET in patients 12 to 18 years infected with HCV genotype 5 or 6 and/or with compensated cirrhosis and/or

previously treated with a regimen containing NS5B inhibitor have not been studied.

** Please refer to your province’s or Territory’s specific reimbursement criteria.

1 AbbVie Corporation MAVIRET (glecaprevir/pibrentasvir tablets) Product Monograph. Date of Preparation: August 16, 2017. Date of Revision: October 30, 2020.

2CADTH Canadian Drug Expert Committee Recommendation –

Final. www.cadth.ca/sites/default/files/cdr/complete/SR0523_Maviret_complete-Jan-25-18.pdf. Accessed September 2020. 3Canadian Network on Hepatitis C (CanHepC). Blueprint to inform hepatitis C elimination efforts in Canada. https://www.canhepc.ca/sites/default/files/media/documents/blueprint_hcv_2019_05.pdf Accessed September 2020.4The 4Canadian Liver Foundation. www.liver.ca/how-you-help/advocate/. Accessed September 2020.

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Novamind Supports Oregon Measure 109 to Responsibly Expand Patient Access to Psilocybin Therapy

Not for distribution to U.S. Newswire Services or for dissemination in the United States. Any failure to comply with this restriction may constitute a violation of U.S. Securities laws.

TORONTO, ON / ACCESSWIRE / November 10, 2020 / Novamind Ventures Inc. (“Novamind”), a leading mental health and wellness company specialized in psychedelic-assisted psychotherapy, today announced its support for the recently passed Measure 109 in the State of Oregon, a citizen initiative to establish the first regulated and licensed program for psilocybin therapy in the United States.

“The passage of Measure 109 is a major milestone in the movement to regulate psychedelic medicine, and it paves the way for patients in Oregon and beyond to access psilocybin therapy in a safe and legal manner,” said Yaron Conforti, Chief Executive Officer and Director of Novamind. “We support responsible and measured initiatives to expand access to psychedelic medicine and look forward to working with healthcare professionals and key stakeholders in Oregon to contribute to The Psilocybin Mushroom Service Program for the ultimate benefit of patients seeking safe and regulated access to alternative mental health therapies.”

Novamind has clinical expertise in psychedelic-assisted psychotherapy that can enable the planning and execution of psilocybin treatments in Oregon, and across the country. Novamind clinicians are widely recognized for participation in leading clinical trials examining psychedelics, as well as their capabilities in delivering safe, legal experiences for patients utilizing ketamine in the United States. Cedar Psychiatry by Novamind, based in Utah, has administered over 3,000 ketamine-assisted psychotherapy treatments since 2016 across its four clinics in the State.

With the passing of Measure 109, the Oregon Health Authority is now authorized to create a program, subject to a two-year development timeline, that permits licensed service providers to administer psilocybin-producing mushroom and fungi products to individuals 21 years of age or older. Psilocybin will not be available commercially or for home-based use, and strict regulations ensure psilocybin will only be used in settings under the supervision of trained facilitators.

About Novamind

Novamind is building a global network of clinics, retreats and research sites to serve the regulated psychedelics industry. With our wholly-owned subsidiaries, Cedar Psychiatry and Cedar Clinical Research, Novamind is dedicated to providing access to safe and legal psychedelic experiences, while advancing research for psychedelic medicine.

For more information visit www.novamind.ca.

Contact Information

Novamind
Yaron Conforti, CEO and Director
T: +1 (647) 953 9512
E: contact@novamind.ca

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COMPASS Pathways joins the Psychiatry Consortium in a collaboration to accelerate drug discovery in mental health care

COMPASS Pathways plc (Nasdaq: CMPS), a mental health care company dedicated to accelerating patient access to evidence-based innovation in mental health, has joined the Psychiatry Consortium, an international collaboration to accelerate drug discovery and development in areas of urgent, unmet medical need.

The Psychiatry Consortium, managed by Medicines Discovery Catapult, is a strategic collaboration of leading medical research charities and pharmaceutical companies focusing on the challenge of identifying and validating novel drug targets to address the unmet therapeutic needs of people living with mental health conditions. COMPASS Pathways will work alongside Psychiatry Consortium members and academic partners to advance research projects, providing support through access to funding, expertise, and commercialisation know-how. The Psychiatry Consortium seeks project proposals from the global psychiatric research community via biannual open calls for applications – the next call for applications will open in January 2021.

Dr Gary Gilmour, Director of Preclinical Research, COMPASS Pathways, said, “The scale of today’s mental health crisis is huge, and is getting bigger every day. The Psychiatry Consortium is bringing leading experts and resources together to speed up and reinvigorate the drug discovery process, and we are proud to be part of it. By working towards a common goal, we can bring evidence-based innovations to the people who need them, as quickly as possible.”

About COMPASS Pathways

COMPASS Pathways plc (Nasdaq: CMPS) is a mental health care company dedicated to accelerating patient access to evidence-based innovation in mental health. Our focus is on improving the lives of those who are suffering with mental health challenges and who are not helped by current treatments. We are pioneering the development of a new model of psilocybin therapy, in which our proprietary formulation of synthetic psilocybin, COMP360, is administered in conjunction with psychological support. COMP360 has been designated a Breakthrough Therapy by the US Food and Drug Administration (FDA), for treatment-resistant depression (TRD), and we are currently conducting a phase IIb clinical trial of psilocybin therapy for TRD, in 20 sites across Europe and North America. We are headquartered in London, UK, with offices in New York, USA. Our vision is a world of mental wellbeing. www.compasspathways.com

About the Psychiatry Consortium

The Psychiatry Consortium is a strategic collaboration of leading medical research charities and pharmaceutical companies focusing on the challenge of identifying and validating novel drug targets to address the unmet therapeutic needs of the people living with mental health conditions. The Psychiatry Consortium is managed by Medicines Discovery Catapult and supported by Wellcome. www.psychiatryconsortium.org

Forward-looking statements

This press release includes certain disclosures that contain “forward-looking statements,” including, without limitation, statements regarding COMPASS’s expectations of its future working relationship with Psychiatry Consortium. Factors that could cause actual results to differ include, but are not limited to, risks and uncertainties related to the ability of Psychiatry Consortium to undertake or advance its research projects. Forward-looking statements contained in this announcement are made as of this date, and COMPASS undertakes no duty to update such information except as required under applicable law.

Enquiries

COMPASS Pathways
Tracy Cheung, tracy@compasspathways.com, +44 7966 309024
Amy Lawrence, amy@compasspathways.com, +44 7813 777919

Westwicke (for investor enquiries)
Stephanie Carrington, stephanie.carrington@westwicke.com, +1 646 277 1282

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Vireo Health Celebrates Fifth Anniversary of First New York Cannabis Harvest with Expansion Plan in Fulton County

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CANADIAN RAPID TREATMENT CENTER OF EXCELLENCE OPENS SECOND LOCATION

Clinic effectively addresses the unmet need of depression and suicide

Mississauga, Ontario – Monday, November 9, 2020 – The Canadian Rapid Treatment Center of Excellence (the “CRTCE”) announces today the opening of a new clinic in downtown Toronto. Both the existing Mississauga clinic and newly opened Toronto clinic (the “CRTCE Clinics”) address the unmet need of depression and suicide through novel ketamine therapy treatment.

“These CRTCE Clinics address the unmet need of depression and suicide,” said Dr. Joshua Rosenblat, Medical Director, CRTCE. “Ketamine therapy is highly effective in treating people with severe depression where other treatments have proven to be ineffective. During the COVID-19 pandemic, the need for effective treatment have become exponentially critical.”

The first of its kind in Canada, the CRTCE multidisciplinary outpatient clinical research facility has specialized in providing breakthrough rapid onset treatments for depression, including but not limited to intravenous ketamine and intranasal esketamine. These therapies aid patients suffering from several treatment-resistant conditions such as major depressive disorder and/or bipolar disorder.

“In just two and a half years we have administered more than 2000 infusions for over 300 patients. Many of these patients have experienced substantial relief for what often can be debilitating depression and suicidal thinking,” said Kevin Kratiuk, Vice President of Operations, CRTCE. “Many of our patients regain their quality of life, their families, and their livelihood”.

To obtain treatment, patients must be referred to one of the CRTCE Clinics by family physicians, psychiatrists, or nurse practitioners. Patients with PTSD and OCD are considered on a case by case basis. Kratiuk continued, “The additional clinic will expand our capacity to help significantly more people affected by depression”.

The new Toronto clinic is located at Avenue and Dupont in Toronto. “The opening of our second CRTCE site in Ontario provides an opportunity for us to address the suffering associated with depression and provide patients a hopeful and innovative treatment avenue. Moreover, our second center represents a venue for us to conduct ongoing research on new treatments for depression to improve the quality of patient’s lives affected by these common and debilitating disorders in Canada,” said Dr. Roger McIntyre, CEO Champignon Brands Inc., Professor of Psychiatry and Pharmacology University of Toronto.

Background

Founded in July 2018, Canadian Rapid Treatment Center of Excellence (CRTCE) (https://www.crtce.com/) is an all-Canadian company operating two clinics in the Greater Toronto Area. Along with companies AltMed Capital Corp. and Apotheosis Scientific, CRTCE provides a platform for treatment development identification of and implementation breakthrough derivatives of ketamine and psychedelics, and innovative delivery platforms for the purpose of treating medical disorders like depression, post-traumatic stress disorder (PTSD) as well as substance and alcohol use disorder.

The CRTCE’s Intravenous Ketamine Infusion Therapy aims to aid those suffering from several treatment-resistant conditions. The clinic provides a comfortable environment focused on the safety and success of each individual patient.

Media contact: Victoria Ollers, vollers@dartincom.ca, 416-822-2288

Posted on

Novamind to Introduce Novel Psychedelic Treatment Protocol in Online Workshop

Not for distribution to U.S. Newswire Services or for dissemination in the United States. Any failure to comply with this restriction may constitute a violation of U.S. Securities laws.

TORONTO, ON / ACCESSWIRE / November 9, 2020 / Novamind Ventures Inc. (”Novamind”), a mental health and wellness company specialized in psychedelic-assisted psychotherapy, is pleased to announce that it will be hosting an online event introducing Emotion-Focused Ketamine-Assisted Psychotherapy (”EF-KAP”) on November 9th, 2020, from 9:00 AM – 4:30 PM EST. EF-KAP is a treatment protocol combining emotion-focused therapy and ketamine-assisted psychotherapy, developed by Adele Lafrance, PhD and Reid Robison, MD, MBA, Chief Medical Officer of Novamind, who will host the online workshop.

“We are excited to introduce EF-KAP to our peers in the mental health community. Dr. Robison and I are passionate about advancing psychedelic-assisted therapy protocols and our research suggests that EF-KAP has the potential to help patients who have not responded to standard mental health treatments,” commented Dr. Adele Lafrance.

EF-KAP is the first psychedelic-assisted psychotherapy treatment protocol to be introduced by Novamind’s clinical research division, Cedar Clinical Research from its base in Springville, Utah. As a treatment model, with a focus on increasing patients’ overall skill and confidence with emotion processing, EF-KAP aims to provide lasting symptom relief from a range of mental health conditions, including anorexia nervosa and major depressive disorder.

This workshop will introduce participants to recent research from Cedar Clinical Research in support of EF-KAP, including the foundations of emotion science and emotion-focused interventions. Participants will learn the structure of the model (preparation sessions, dosing sessions and psychotherapeutic integration sessions). Strategies to increase supportive caregiver involvement will also be reviewed, including sample scripts and guidelines around dosing support and integration work. Finally, vignettes and videos will be presented to illustrate the preparation, ketamine dosing and adjunctive-psychotherapy sessions that make up the model.

For more information please visit
https://www.eventbrite.ca/e/emotion-focused-ketamine-assisted-psychotherapy-ef-kap-registration-116430459639.

About Novamind
Novamind is building a global network of clinics, retreats and research sites to serve the regulated psychedelics industry. We provide access to safe, legal psychedelic experiences, while advancing research for psychedelic medicine. For more information visit www.novamind.ca.

Contact Information

Novamind
Yaron Conforti, CEO and Director
T: +1 (647) 953 9512
E: contact@novamind.ca

Posted on

Entheon Announces Completion of Amalgamation and Final Approval from the Canadian Securities Exchange

Original Source – Newsfile Corp.

Vancouver, British Columbia–(Newsfile Corp. – November 5, 2020) – Entheon Biomedical Corp. (CSE: MPV) (formerly, MPV Exploration Inc.) (“Entheon” or the “Company“) is pleased to announce that further to its news releases dated July 2, 2020, September 10, 2020 and October 28, 2020, the Company has completed the previously announced business combination with Entheon Holdings Corp. (formerly, Entheon Biomedical Corp.) and has received final approval to list the Resulting Issuer Shares (as defined below) on the Canadian Securities Exchange (“CSE“) pursuant to the amalgamation agreement (the “Amalgamation Agreement“) dated June 30, 2020, as amended, among the Company, Entheon Holdings Corp. and 1254912 B.C. Ltd.

Entheon will list 34,353,688 common shares (the “Resulting Issuer Shares“) on the CSE and the Resulting Issuer Shares are expected to begin trading on or about November 12, 2020 (the “Trading Resumption Date“) under the symbol “ENBI”.

Further Disclosure

Trading in the common shares of the Company was halted by the CSE on July 2, 2020 following the announcement of the Amalgamation Agreement and is expected to remain halted until the Trading Resumption Date.

Further, a total of 1,988,500 common share purchase warrants of the Company issued in connection with the Company’s Initial Public Offering in April 2018 (the “Warrants“) have been assigned a new CUSIP number and ISIN number, being 29383X111 and CA29383X1116, respectively, expected to be made eligible on or about November 10, 2020, with each Warrant now exercisable for one Resulting Issuer Share at a price of $0.90 per share until April 20, 2021.

For further information with respect to the Transaction and the business of Entheon, please refer to the listing statement of Entheon dated November 12, 2020 and posted under the Company’s issuer profile on SEDAR at www.sedar.com.

About Entheon Biomedical Corp.

Entheon is a biotechnology research and development company committed to developing and commercializing a portfolio of safe and effective Dimethyltryptamine based psychedelic therapeutic products (“DMT Products“) for the purposes of treating addiction and substance use disorders. Subject to obtaining all requisite regulatory approvals and permits, Entheon intends to generate revenue through the sale of its DMT Products to physicians, clinics and licensed psychiatrists in the United States, certain countries in the European Union and throughout Canada.

For more information, please contact the Company at:

Entheon Biomedical Corp.
Timothy Ko
Telephone: +1 (604) 562-3932
info@entheonbiomedical.com
https://entheonbiomedical.com/

For media inquiries, please contact Crystal Quast at:

Bullseye Corporate
Crystal Quast
Telephone: +1 (647) 529-6364
Quast@BullseyeCorporate.com

Original Source 
https://www.newsfilecorp.com/release/67606

Cautionary Note on Forward Looking Information

This news release contains forward‐looking statements and forward‐looking information within the meaning of applicable securities laws. These statements relate to future events or future performance. All statements other than statements of historical fact may be forward‐looking statements or information. More particularly and without limitation, this news release contains forward‐looking statements and information relating to the commencement of trading of the Resulting Issuer Shares on the CSE, and other matters. The forward‐looking statements and information are based on certain key expectations and assumptions made by management of the Company. Although management of the Company believes that the expectations and assumptions on which such forward-looking statements and information are based are reasonable, undue reliance should not be placed on the forward‐looking statements and information since no assurance can be given that they will prove to be correct. Forward-looking statements and information are provided for the purpose of providing information about the current expectations and plans of management of the Company relating to the future. Readers are cautioned that reliance on such statements and information may not be appropriate for other purposes, such as making investment decisions. Since forward‐looking statements and information address future events and conditions, by their very nature they involve inherent risks and uncertainties. Actual results could differ materially from those currently anticipated due to a number of factors and risks. These include, but are not limited to, the Company’s ability to raise further capital and the Company’s ability to obtain regulatory and exchange approvals. Accordingly, readers should not place undue reliance on the forward‐looking statements and information contained in this news release. Readers are cautioned that the foregoing list of factors is not exhaustive. The forward‐looking statements and information contained in this news release are made as of the date hereof and no undertaking is given to update publicly or revise any forward‐looking statements or information, whether as a result of new information, future events or otherwise, unless so required by applicable securities laws. The forward-looking statements or information contained in this news release are expressly qualified by this cautionary statement. Neither the CSE nor the Investment Industry Regulatory Organization of Canada accepts responsibility for the adequacy or accuracy of this release.