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1 psilocybin therapy session = 12 months of therapy alone

Tryp Therapeutics Announces Results of First Patient Dosed in Its Phase II Clinical Trial for the Treatment of Binge Eating Disorder

Tryp Therapeutics (TRYP) and University of Florida initiated the first-ever psilocybin therapy study on binge eating disorder, and the results are already showing promise.

Just 4 weeks after receiving Tryp’s psilocybin formulation, TRP-8802, the first patient experienced:

  • Reduced overall anxiety
  • Reduced anxiety around food
  • Reduced compulsion to overeat
  • Improved self-image and confidence 
  • Significant weight loss

“We believe that the improvements witnessed in this patient following a single intervention with TRP-8802 in combination with tailored psychotherapy are on par with what might be possible in 12 months of extensive psychotherapy alone,” says Tryp’s Interim CEO and Chief Scientific Officer Jim Gilligan.

Researchers will follow up with the patient again in 8 weeks to see if the benefits are sustained. Up to 9 more patients will participate in the study as well.

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Optimi Health Finalizes Partnership and Psilocybin Supply Agreement With ATMA Journey Centers

Optimi Health Finalizes Partnership and Psilocybin Supply Agreement With ATMA Journey Centers

Strategic partnership will focus on improving regulatory outcomes in therapist training and safe supply of psilocybin

VANCOUVER, BC — Optimi Health Corp. (CSE: OPTI) (OTCQX: OPTHF) (FRA: 8BN) (“Optimi” or the “Company”), a homegrown, Canadian company producing natural, scalable, and accessible mushroom formulations for transformational human experiences, is pleased to announce that it has entered into an exploratory supply agreement with ATMA Journey Centers (“ATMA”), a privately held facilitator of psilocybin-assisted therapy and practitioner training services for palliative care and mental health conditions based in Calgary, Alberta.

The Company has finalized an agreement which will supply psilocybin products to ATMA for future therapist initiatives and supply requirements.

“Few organizations have made as significant a contribution in recent years to the evolving regulatory conversation around psilocybin-assisted therapy as ATMA Journey Centers,” said Bill Ciprick, CEO of Optimi Health. “Optimi is deeply gratified to be able to provide them with this test supply of natural psilocybin in order to facilitate research that may lead to better mental health services for healthcare workers while testing the potential to expand the scale of available psilocybin therapies.”

Optimi Health is looking forward to opportunities presented by this partnership with ATMA to advance the knowledge base of trained psychedelic therapists by providing learning experiences and real-world data derived from the direct administration of a natural psilocybin product.

Further, the Company views this and other early-phase trials and supply agreements as an opportunity to refine approaches and improve efficiencies around the commercial distribution and clinical applications of psilocybin in anticipation of more robust demand as clinical research improves regulatory outcomes for psychedelic medicine.

“The ability to conduct both experiential training for authorized therapists and the clinical trials that will allow us to provide these treatments to patients in need is dependent on a safe and consistent supply of high-grade psilocybin,” said David Harder, Co-CEO of ATMA Journey Centers. “This agreement is an important step toward ATMA’s goal of building a complete research and training infrastructure that will streamline further growth in these directions.”

Authorized parties interested in purchasing Optimi psilocybin and functional mushroom products are invited to contact sales@optimihealth.ca where a member of the sales team will respond within 24 hours.

ABOUT OPTIMI (CSE: OPTI) (OTCQX: OPTHF) (FRA: 8BN)

Optimi Health Corp. is a homegrown, Canadian success story producing and supplying natural, EU-GMP grade psilocybin and functional mushrooms that focus on the health and wellness markets. Built with the purpose of producing scalable, natural mushroom formulations for transformational human experiences, the Company’s goal is to be the number one trusted, compassionate supplier of safe, natural EU-GMP psilocybin throughout the world. With a vertically integrated approach, Optimi is engaged in the cultivation, extracting, processing and distribution of high quality functional and psychedelic mushroom products at its two facilities comprising a total of 20,000 square feet in Princeton, British Columbia.

ABOUT ATMA JOURNEY CENTERS

ATMA is pioneering a therapist-centered and therapist-driven business model for the psychedelic industry, by building the largest online community platform for psychedelic practitioners. Education, training, and business support services will all be accessible on one user friendly technology platform. ATMA’s philosophy of inclusivity will encourage more participation from healthcare professionals, which will in turn yield more data and experiences. Overall, this will lead to increased effectiveness and accessibility of psychedelic-assisted therapy. Beginning with a clear focus on psilocybin-assisted therapy, ATMA will be able to expand to other psychedelics as the regulatory environment also expands. ATMA provides a clear, guided path for healthcare professionals and clinics to build psychedelic-assisted therapies into their current practices.

FOR INTERVIEW REQUESTS OR FURTHER INFORMATION PLEASE CONTACT:

Michael Kydd
Investor Relations
Email: investors@optimihealth.ca
Phone: +1 (902) 880 6121
Web: https://optimihealth.ca

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Nova Mentis Receives Controlled Substances Export Approval From The U.S DEA For The Company’s Proprietary Psilocybin Drug NM 1001

Nova Mentis Receives Controlled Substances Export Approval From The U.S DEA For The Company’s Proprietary Psilocybin Drug NM 1001

Vancouver, British Columbia – June 7, 2022 – Nova Mentis Life Science Corp. (CSE: NOVA) (FSE: HN3Q) (OTCQB: NMLSF) (“NOVA” or the “Company”), a biotechnology company and global leader in first-in-class psilocybin-based therapeutics and complementary diagnostics for neuroinflammatory disorders is pleased to announce it received the required controlled substances export approval from the U.S. Drug Enforcement Administration (DEA). The Company’s proprietary psilocybin drug (NM-1001), has been received at the Toronto Institute of Pharmaceutical Technology (TIPT®) labs in Toronto, Canada to be used to formulate and manufacture psilocybin microdose capsules for a planned Phase 2A fragile X syndrome clinical study.

“NOVA is excited to have completed the successful import of our proprietary psilocybin drug (NM-1001) into Canada. This allows us to move forward with the formulation and final production of microdose capsules in preparation for our clinical trial application submission to Health Canada. Our science team has delivered promising preclinical results and we look forward to continuing to advance our research program to demonstrate the important role that microdose therapy may play in the treatment of autism spectrum disorder and FXS,” stated Will Rascan, President & CEO of Nova Mentis Life Science Corp.

Earlier this year, NOVA announced that a very low microdose formulation of the Company’s proprietary psilocybin drug (NM-1001) significantly modulated behavioural and cognitive defects, such as recognition memory, in a genetic model of FXS.

About Nova Mentis Life Science Corp.
Nova Mentis Life Science Corp. is a Canadian-based biotechnology company and global leader in developing diagnostics and psilocybin-based therapeutics for neuroinflammatory disorders. Nova is the first biotech company to achieve orphan drug designation in both the United States and European Union for the use of psilocybin in the treatment of Fragile X Syndrome (FXS).

Our goal is to diagnose and treat debilitating chronic conditions that have unmet medical needs, such as autism spectrum disorder (ASD) and FXS.

For further information on the Company, please visit 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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Red Light Holland Psilocybin Truffles, Sold in The Netherlands, Complete First Stability Test Under a Health Canada Approved cGMP Laboratory

Red Light Holland Psilocybin Truffles, Sold in The Netherlands, Complete First Stability Test Under a Health Canada Approved cGMP Laboratory

  • Red Light Holland’s iMicrodose packs containing Psilocybe Tampanensis Truffles, produced in the Netherlands, tested at CCrest Laboratories, under a Health Canada approved Psilocybin license.
  • Red Light Holland and CCrest Laboratories continue to demonstrate their strong commitment to the highest standards for naturally occurring Psilocybin products.
  • Red Light Holland has an established alliance with CCrest Laboratories Inc. in partnership with Shaman Pharma Corp., who have been listed by Health Canada as a Psilocybin supplier to the Special Access Program.

Toronto, Ontario–(Newsfile Corp. – June 6, 2022) – Red Light Holland Corp. (CSE: TRIP) (FSE: 4YX) (OTC Pink: TRUFF) (“Red Light Holland” or the “Company“), an Ontario-based corporation engaged in the production, growth and sale of a premium brand of magic truffles, is pleased to announce that it has received a report from the first stability test conducted on the company’s Psilocybin Truffles sold in the Netherlands. This report was focused on optimizing shelf life and the long-term quality of the product. The report confirmed Red Light Holland’s iMicrodose packs containing tampanensis truffles have a psilocybin equivalent content to be 1.23 mg/gram one week after opening the truffles. This baseline measurement will help in future studies to research Psilocybin content over longer periods of time which will be crucial in any potential clinical use of naturally occurring Psilocybin. The report also confirmed the importance of keeping fresh truffles refrigerated after opening them, which Red Light Holland currently mentions on all iMicrodose packs sold.

The testing performed by CCrest Laboratories in Montreal, Canada demonstrates the Company’s commitment to standardization, research and development in hopes of being able to advocate to Health Canada that their farm grown truffles could be an option of naturally occurring psychedelics for those patients in need under the new Special Access Program (“SAP”). CCrest Laboratories, Red Light Holland’s partner, has been listed as a provider of Psilocybin via SAP, if and when requests are made by health practitioners and all Government approvals are met.

“Step by step we continue to move towards a standardized consistent dose of naturally occurring psilocybin truffles that can potentially benefit all legal markets,” said Todd Shapiro, CEO and Director of Red Light Holland. “As far as we know our truffles are the first to go through such rigorous testing which shows our commitment to increasing scientific knowledge of these natural products and having the best products on the market. The legal market in the Netherlands and the market opening in Oregon next year are focused on naturally occurring Psilocybin which our market research shows many people prefer over synthetics – so it’s exciting that Red Light Holland with the help of Shaman Pharma is working towards giving people what they want. We hope other governments around the world will follow to legalize the responsible use of a substance that has been used by many civilizations for thousands of years.”

“Working with natural Psilocybin is exciting and we continue to learn and progress our methods of discovery,” said Alex Grenier, CEO of Shaman Pharma and President of CCrest Laboratories.

Red Light Holland’s partner, CCrest Laboratories will continue to perform stability tests and R&D towards creating a standardized consistent dose from naturally occurring psilocybin truffles.

Red Light Holland continues to establish itself as a leader in the recreational sector and push for legal, responsible, and safe access to natural psychedelic truffles/mushrooms while Scarlette Lillie Science and Innovation pursues research and development, technology, and applied science.

About Red Light Holland

Red Light Holland is an Ontario-based corporation engaged in the production, growth and sale (through existing Smart Shops operators and an advanced e-commerce platform) of a premium brand of magic truffles.

For additional information on the Company:

Todd Shapiro
Chief Executive Officer & Director
Tel: 647-643-TRIP (8747)
Email: todd@redlight.co
Website: www.RedLight.co

About Shaman Pharma Corp.

Shaman Pharma is a federally registered Canadian corporation with the mission to power outstanding psychedelic life science innovation. Accelerating time-to-market through its portfolio of assets, Shaman launches and consolidates revenue-driven pharma-biotech life sciences ventures focused on supplying psychedelic drugs & novel active ingredients.

Forward-Looking Statements

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.

Certain information set forth in this news release may contain forward-looking statements that involve substantial known and unknown risks and uncertainties, certain of which are beyond the control of Red Light Holland. Forward-looking statements are frequently characterized by words such as “plan”, “continue”, “expect”, “project”, “intend”, “believe”, “anticipate”, “estimate”, “may”, “will”, “potential”, “proposed” and other similar words, or statements that certain events or conditions “may” or “will” occur. These statements are only predictions. Readers are cautioned that the assumptions used in the preparation of such information, although considered reasonable at the time of preparation, may prove to be imprecise and, as such, undue reliance should not be placed on forward-looking statements. Forward-looking statements include, but are not limited to: statements with respect to the Company creating a standardized consistent dose from naturally occurring psychoactive truffles; statements with respect to Health Canada’s Special Access Program, including the Company’s expectations with respect to exceeding any potential regulatory standards set by such program; statements with respect to further evaluation and testing of the Company’s naturally occurring psilocybe truffles by CCrest Laboratories for scientific and medical purposes; the potential of the Company’s products being used for scientific and medical purposes; the potential of the Company’s products being used for Health Canada’s Special Access Program; and the Company’s ability to establish itself as the leader in the recreational psychedelics sector.

Forward-looking information is based on a number of key expectations and assumptions made by Red Light Holland, including without limitation: the COVID-19 pandemic impact on the Canadian economy and Red Light Holland’s business, and the extent and duration of such impact; no change to laws or regulations that negatively affect Red Light Holland’s business; there will be a demand for Red Light Holland’s products in the future; no unanticipated expenses or costs arise; the Company will be able to continue to develop products that are allowed to be imported and sold under Health Canada’s import permit; and the partnership with Shaman Pharma Corp. will help Red Light Holland to achieve its business goals. Although the forward-looking information contained in this news release is based upon what the Company believes to be reasonable assumptions, it cannot assure investors that actual results will be consistent with such information.

These statements involve known and unknown risks, uncertainties and other factors, which may cause actual results, performance or achievements to differ materially from those expressed or implied by such statements, including but not limited to: the inability of the Company to continue as a going concern; the inability of the Company to obtain all necessary governmental and/or other regulatory approvals, licenses, and permits necessary to operate and expand the Company’s facilities; the effect of regulatory and/or political change and its effect on the legislation and regulations surrounding the psychedelics industry including SAP; negative perception of the medical-use and adult-use psilocybin industry; the inability of CCrest to complete the planned testing of the Company’s products; the inability of the Company to create a standardized dose; the potential unviability of psilocybin for medical and/or scientific purposes; the inability for the company to use their psilocybin in any potential clinical use of naturally occurring Psilocybin; the inability for the Company to continue product development and research and development; the inability of the Company to continue its growth; the Company’s limited operating history; reliance on management; the Company’s requirements for additional financing; and competition for mental health and wellness investments.

Readers are cautioned that the foregoing list is not exhaustive. Readers are further cautioned not to place undue reliance on forward-looking statements, as there can be no assurance that the plans, intentions or expectations upon which they are placed will occur. Such information, although considered reasonable by management at the time of preparation, may prove to be incorrect and actual results may differ materially from those anticipated.

Forward-looking statements contained in this news release are expressly qualified by this cautionary statement and reflect the Company’s expectations as of the date hereof and are subject to change thereafter. The Company undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, estimates or opinions, future events or results or otherwise or to explain any material difference between subsequent actual events and such forward-looking information, except as required by applicable law.

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Women-focused psilocybin study for depression

A New Clinical Trial in South Africa Aims to Study the Effect of Psilocybin on HIV Positive Women with Major Depressive Disorder

Women are nearly twice as likely to be diagnosed with depression than men, but they’re often underrepresented in clinical trials.

Additionally, individuals with chronic illnesses like HIV often suffer from depression as well, which can make them less likely to adhere to their medications.

That’s why Cannsun Medicinal Global is investigating psilocybin as a treatment for depression in women who are HIV-positive.

The phase 2 trial received approval and will begin next month in South Africa.

“It is vitally important to have a deeper understanding of how women respond to medical treatment for major depression versus men in order to develop psychedelic therapies and treatment protocols for women that have clinically significant outcomes that are safe and effective,” says Donaghue Woodman, the company’s Head of R&D and Chief Medical Information Officer.

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Nirvana Life Sciences Announces Positive Results for Addiction Relapse Prevention from Their Latest Pre-Clinical Psychedelic Drug Study

Nirvana Life Sciences Announces Positive Results for Addiction Relapse Prevention from Their Latest Pre-Clinical Psychedelic Drug Study

Psilocybin reduced reinstatement of heroin-seeking behavior when administered immediately after a memory retrieval task in rats

Vancouver, British Columbia–(Newsfile Corp. – June 2, 2022) – Nirvana Life Sciences Inc. (CSE: NIRV) (Nirvana or the “Company”), a Canadian-based life sciences company focused on developing novel therapeutic products derived from psychedelics to produce non-addictive solutions for opioid addiction treatment and ongoing pain management, in conjunction with Integrative Therapy Discovery (ITD) Labs in Italy, have released comprehensive data on a scientific study that aims in determining the effects that psilocybin has on the heroin-addicted brain.

The study was carried out by Dr. Massimo Nabissi from the School of Pharmacy Section of Experimental Medicine, University of Camerino in Camerino, Italy. The preclinical study evaluated the effect of psilocybin on in-vitro rat brain cell line models and an in-vivo rat model on heroin self-administration and reinstatement of heroin seeking behavior following memory retrieval tests. Drug self-administration is regarded as a gold-standard preclinical model of addiction and substance-use disorders. The aim of the project was threefold and are as follows.

  • To evaluate the effect of psilocybin in modulating heroin molecular pathways in in vitro rat brain cell line models
  • To evaluate the effect of psilocybin on heroin self-administration (in vivo results)
  • To evaluate the effect of psilocybin on reinstatement of heroin seeking following memory retrieval test (in vivo results)

Gene Analysis was performed by the Clariom S Assay tool. This machine serves as a next generation transcriptome-wide gene-level expression profiling tool, which allows for the fastest, simplest and most scalable path to generating actionable results. Based on industry-leading microarray technology, the novel rat Clariom S Assay provides extensive coverage of all known well-annotated genes, compatibility with clinical sample types, scalable formats, and flexible data analysis software. The GeneChip™ Rat Genome 230 2.0 Assay was used to evaluate gene expression levels and in cell lines that were treated with heroin and psilocybin and with psilocybin in combination with heroin.

The immortalized rat hypothalamus cells (RCHT-1) were derived from the hypothalamus of a four-month-old Fisher Rat. The hippocampal cells (H19-7) derived from the rats’ hippocampi were treated daily with heroin and psilocybin, alone or in combination. After 48 hours, cell lines were collected for RNA extraction and gene array analysis. For each of the comparisons indicated, an electronic file was created that includes differentially expressed transcripts that were identified in both H19-7 and RCTH-1 cells with extended annotations. A second file was created that made comparisons evidencing only the transcript differences where the Ct (or cell type) value was highly different as a final analysis. For each of these data sets, only the genes whose expression was reverted by psilocybin and in the treatments consisting of heroin plus psilocybin were selected. Moreover, only the genes whose expression was psilocybin dose dependent were considered. In summary, the potential candidate genes whose expression in heroin treatment was reverted by psilocybin and evidenced in the electronic file reports were selected.

The effect of heroin and psilocybin in reducing cell viability was evaluated in HT19-7 and RCHT-1 cell lines by daily administration. Cells were treated for 48 hours with either heroin or psilocybin or with a combination of heroin with psilocybin and then were analyzed. The percentage of cell viability was evaluated by a cell viability assay whose results showed a dose-dependent heroin effect in the RCHT-1 cell line with specific IC50 values. While in HT19-7 cell lines, no cytotoxic effects were observed at the concentrations used. Regarding psilocybin, similar results were obtained in cell lines with specific IC50 values and with both RCHT-1 and HT19-7 cell lines. To gain further insight, heroin was combined with psilocybin at varying doses to evaluate the optimal combination for transcriptional study. The results showed that when used together at varying dosages, the combinations were not cytotoxic in either of the two cell lines.

The study goes on to show how treatment with psilocybin effected self-administered heroin use via lever presses along with the overall effect that psilocybin combined with heroin had on certain behavioral models in both male and female Wistar rat populations. A preliminary experiment aimed at testing the efficacy of psilocybin to prevent heroin relapse following cue memory reconsolidation was also conducted. Altogether, these results suggest that psilocybin decreased reinstatement of heroin seeking in female rats. As a final analysis, the gene data evidenced in the study was subjected to a comprehensive academic wide search of available current littérature and, although information regarding a correlation with psilocybin and opioid addiction was available, a transcriptome analysis for heroin and psilocybin and their co-combination has never been previously investigated. As a result, the data presented in this study can be extremely useful for determining a better understanding of dependent doses and the molecular mechanisms involved in the potential modulation of heroin (or opioids in general) addiction and dependence.

In summary, the information contained within the study dealing with relapse prevention is new and groundbreaking evidence in the field of pharmaceutical addictions medicine and chemotherapy. This type of comprehensive study, which constitutes concrete scientific evidence-based data, is at the heart of Nirvana Life Sciences’ business objective which is to develop and seek FDA approval for therapeutic formulations and novel pharmaceuticals.

Dr. Sazzad Hossain, CSO of Nirvana, states, “Our research team has over 100 years of combined academic and applied experience in the field of psychedelic science. I’m excited to see what they can do with this new information.”

About Nirvana Life Sciences Inc.

Nirvana Life Sciences Inc. has been founded with a simple objective of researching and developing non-addictive pain management and relapse prevention products that can provide healthier outcomes for patients who live with chronic pain and/or have battled with addiction. Nirvana believes that using naturally sourced psychedelics in novel formulations holds the promise of delivering non-addictive solutions that are effective in managing pain and addiction. Nirvana’s team, consisting of leading researchers from around the globe, will develop therapies that have the potential of freeing millions from addiction and saving society billions of dollars annually.

For further information:

Bruce Clark- CEO
info@nirvanalifescience.com
Phone: 604-401-8100

Forward-Looking Statements

This news release contains certain forward-looking statements and forward-looking information (collectively referred to herein as “forward- looking statements”) within the meaning of Canadian securities laws including, without limitation, statements with respect to the future investments by the Company. All statements other than statements of historical fact are forward-looking statements. Undue reliance should not be placed on forward-looking statements, which are inherently uncertain, are based on estimates and assumptions, and are subject to known and unknown risks and uncertainties (both general and specific) that contribute to the possibility that the future events or circumstances contemplated by the forward-looking statements will not occur. Although the Company believes that the expectations reflected in the forward-looking statements contained in this press release, and the assumptions on which such forward-looking statements are made, are reasonable, there can be no assurance that such expectations will prove to be correct. Readers are cautioned not to place undue reliance on forward-looking statements included in this document, as there can be no assurance that the plans, intentions or expectations upon which the forward-looking statements are based will occur. By their nature, forward-looking statements involve numerous assumptions, known and unknown risks and uncertainties that contribute to the possibility that the predictions, forecasts, projections and other forward-looking statements will not occur, which may cause the Company’s actual performance and results in future periods to differ materially from any estimates or projections of future performance or results expressed or implied by such forward-looking statements. The forward-looking statements contained in this news release are made as of the date hereof and the Company does not undertake any obligation to update publicly or to revise any of the included forward-looking statements, except as required by applicable law. The forward-looking statements contained herein are expressly qualified by this cautionary statement.

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Psyence Group Corporate Update

Psyence Group Corporate Update

Highlights:

  • Partnership with CRO Clerkenwell Health to design and deliver Psyence’s UK clinical trial progressing; exclusive licensing agreement with Filament Health
  • Clive Ward-Able has been appointed as Medical Director, Head of Research & Development and Early Commercialization for Psyence
  • ISO22000 certified commercial psilocybin production facility and lab upgraded
  • Received an import permit from Health Canada on behalf of Psilo Scientific
  • GOODMINDTM, functional mushroom product, launched online and in-store, sale through 300 stores of one of Africa’s largest coffee retail chains
  • CAD 1.273 million private placement received and being closed
  • Exploring capital market initiatives in UK, hires Investment Bank

TORONTO, ON/ June 02, 2022 / Psyence Group Inc. (CSE: PSYG | OTCQB: PSYGF) (“Psyence” or the “Company”) is pleased to provide the following corporate update on its three strategic focus areas namely: Psyence Therapeutics, Psyence Production and Psyence Function. The Psyence Group develops and provides innovative, safe, and effective psychedelic and nature-centered solutions for mental health and palliative care.

Psyence Therapeutics

Psyence is designing market-leading clinical trials in the field of palliative care, which will initially be conducted in the United Kingdom.

Psyence has partnered with a leading psychedelic Contract Research Organisation (CRO) Clerkenwell Health, to design and deliver the clinical trial, focused on assessing the safety and efficacy of psilocybin-assisted psychotherapy for the treatment of adjustment disorder due to an incurable cancer diagnosis versus psychotherapy alone.

The UK’s “Guardian Online” reported on May 9, 2022 that Clerkenwell Health “hopes to “make the UK a world leader in psychedelics research and Europe’s first facility for psychedelic drug trials will open in London”. The article noted that “the first trials, planned in collaboration with the Toronto-based biotechnology company Psyence, will focus on the use of psilocybin for the treatment of adjustment disorder – an emotional or behavioural reaction to a stressful event in someone’s life – in people with terminal diagnoses.”

Psyence recently concluded an exclusive licensing agreement with Filament Health Corp, a clinical-stage natural psychedelic drug development company, in April 2022. Filament has previously received authorisation from the FDA and Health Canada to enter into Phase I and Phase II human clinical trials for this drug candidate, PEX010. Under the terms of the agreement, Filament will license its proprietary botanical drug candidate PEX010 (25mg), and the associated intellectual property, to Psyence for use in Psyence’s upcoming clinical trials. The license grants Psyence exclusivity in the UK for the indications of anxiety and depression, and associated ailments, within the context of palliative care.

In addition, Psyence appointed Dr. Clive Ward-Able as Medical Director, Head of Research & Development and Early Commercialization for Psyence in December 2021. Based in Toronto Canada, Dr. Ward-Able has degrees in both Pharmacy and Medicine and over thirty years’ experience in the pharmaceutical industry, within R&D, medical affairs, marketing and sales. The majority of his experience is in the medical aspects of the commercialization of a pharmaceutical product, with expertise and direct involvement in designing and conducting clinical trials.

The Psyence Therapeutics team also contributes to scientific research; Psyence’s Dr. Amza Ali, MD,  (Chief Medical Officer) and Dr. Justin Grant, PhD, MBA, (Chief Scientific Officer) co-authored the peer-reviewed publication “Psychedelics: Alternative and Potential Therapeutic Options for Treating Mood and Anxiety Disorders,” which was published in the journal “Molecules” April 19, 2022.

Psyence Production

Psyence operates one of the first and only federally licensed commercial psilocybin production facilities in the world. Its production facility, located in Southern Africa, is ISO22000 certified and is licensed to cultivate and export psilocybin mushrooms for the legal, global medical market and commercial medical research market.

In March 2022 Psyence received an import permit from Health Canada on behalf of Psilo Scientific and is preparing to send mushrooms to Canada for analysis and extraction. Psyence has also received an import permit from the Portuguese regulators for the Cooperativa de Ensino Superior Politécnico e Universitário (CESPU) in Portugal and will be providing mushrooms for their extraction methodology development. Psyence is in the process of obtaining the necessary permissions to commence with the export process to these partners.

Psyence has recently concluded an upgrade to its production facility. A new structure has expanded the overall controlled workspace and further secures the facility. The structure also serves to protect the current assets including the spore and substrate unit, laboratory and fruiting facility. The covering will help Psyence decrease its energy costs through providing better insulation. It has been designed to enable a more flexible and cost -effective expansion of the facility in the future to match the expected growth in demand for natural psilocybin.

The laboratory has also been expanded as part of this upgrade. This expansion enables Psyence to have the capability and equipment to undertake in-process testing on site, as well as to generate Certificates of Analysis (COAs) and undertake testing of the end product. It also provides the space for Psyence to undertake crude extraction and testing at the facility. Our extraction partners will then process the crude extract into an active pharmaceutical ingredient (API). There are multiple benefits to on-site extraction including increased product shelf life and reduced transport costs. Psyence mycologist, Neil Van Rij, and his Quality Assurance team are currently receiving training on the new equipment and expect to be fully functional by the end of June 2022.

Psyence Function

Psyence Function is focused on the development, distribution and sales of legal over-the-counter non-psilocybin containing functional mushroom nutraceuticals.

Psyence’s first non-psilocybin containing functional mushroom product, GOODMINDTM was launched online in 2021 through its South African based joint venture, Good Psyence. Good Psyence launched the GOODMINDTM product on the digital platform http://www.foragoodmind.com that was registered and developed by Psyence’s joint venture partner, Goodleaf, solely for the sale of such products. GOODMINDTM is also distributed through the digital platforms of Goodleaf, Takealot (South Africa’s leading online retailer) and Wellness Warehouse online as well as Wellness Warehouse stores. Wellness Warehouse is a leading distributor and retailer of natural and organic products in South Africa. GOODMINDTM’s water-soluble functional mushroom sachets, which blend with coffee and other beverages, are available for sale through 300 stores of one of Africa’s largest coffee retail chains, Vida e Caffè.

Corporate Update

The Company is pleased to announce that the non-brokered private placement as announced on December 2, 2021 has yielded approximately CAD 1.273 million of subscriptions and is in the process of closing.

The Company has identified the UK as an investor market for mental wellness and has engaged Hannam & Partners as Corporate Advisors in the UK to assist in exploring capital market opportunities to access a broader pool of UK and European investors.  Hannam & Partners, our Corporate Advisors, are also working with Psyence to investigate a potential dual listing in the UK. As part of this dual listing exercise the Company conducted a thorough legal exercise.  The Company obtained legal opinions from local counsel registered in each jurisdiction in which the Company currently operates for the purpose of confirming the lawfulness of the Company’s activities currently carried on in each jurisdiction.  Each local legal adviser was required to address their legal opinion to UK legal counsel (having significant experience in proceeds of crime and anti-money laundering offences), for the purpose of confirming that such activities are suitable for investment by UK persons and such investment would be unlikely to amount to an offence in England under the Proceeds of Crime Act 2002 and relevant anti-money laundering legislation.  Based upon the legal opinions obtained, including the opinion of UK legal counsel, the directors of the Company are satisfied that the current activities of the Group do not pose such a risk.

In light of the challenging small cap and global equity markets as a whole, the Company has put into place cash preservation strategies to reduce operational expenditure across the business, including executive remuneration reductions and accruals.

 “Psyence’s progress continues to strengthen our company’s focused strategy,” says Dr. Neil Maresky, Psyence Chief Executive Officer. “As we execute on our plans as detailed in this corporate update, and continue to focus on operational efficiencies, we believe Psyence will achieve its milestones and in doing so deliver shareholder value.”

ABOUT PSYENCE GROUP: www.psyence.com

Psyence is a life science biotechnology company listed on the Canadian Securities Exchange (CSE: PSYG) and quoted on the OTCQB (OTCQB: PSYGF), with a focus on natural psychedelics. Psyence works with natural psilocybin products for the healing of psychological trauma and its mental health consequences in the context of palliative care. Our name “Psyence” combines the words psychedelic and science to affirm our commitment to producing psychedelic medicines developed through evidence-based research.

Informed by nature and guided by science, we built and operate one of the world’s first federally licensed commercial psilocybin mushroom cultivation and production facilities in Southern Africa. Our team brings international experience in both business and science and includes experts in mycology, neurology, palliative care, and drug development.  We work to develop advanced natural psilocybin products for clinical research and development.

Our key divisions, Psyence Production, Psyence Therapeutics and Psyence Function, anchor an international collaboration, with operations in Canada, the United Kingdom, Southern Africa, and a presence in the United States and Australia.

Contact Information

Katherine Murphy, Investor Relations
Email: ir@psyence.com
Media Inquiries: media@psyence.com
General Information: info@psyence.com

FORWARD LOOKING STATEMENTS:

Certain statements in this news release related to Psyence Group Inc and its subsidiaries (collectively the “Company“) are forward-looking statements and are prospective in nature. Forward-looking statements are not based on historical facts, but rather on current expectations and projections about future events and are therefore subject to risks and uncertainties which could cause actual results to differ materially from the future results expressed or implied by the forward-looking statements. These statements generally can be identified by the use of forward-looking words such as “may”, “should”, “could”, “intend”, “estimate”, “plan”, “anticipate”, “expect”, “believe” or “continue”, or the negative thereof or similar variations. Forward-looking statements in this news release include statements regarding the approval of clinical trial applications by the relevant regulatory authorities, the receipt of all regulatory approvals for the Company’s import and export activities, the appetite for investment into the psychedelic and mental wellness sector by UK and European investors, the fulfilment of the conditions required to achieve Company milestones, the effectiveness of the Company’s operational efficiency measures and the resultant creation of shareholder value. These forward-looking statements are based on a number of assumptions, including the assumptions that the Company’s applications will be successful, the Company’s research and development efforts will yield favourable results sufficient for product commercialisation and that there will be demand in the market for the Company’s current product offering internationally. There are numerous risks and uncertainties that could cause actual results and the Company’s plans and objectives to differ materially from those expressed in the forward-looking information. These risks and uncertainties include demand for the Company’s securities being less than anticipated, fluctuations in the price the Company’s common shares, and the Company not raising the amount expected, or any funds at all. Actual results and future events could differ materially from those anticipated in such information. These and all subsequent written and oral forward-looking information are based on estimates and opinions of management on the dates they are made and are expressly qualified in their entirety by this notice. Except as required by law, the Company does not intend to update these forward-looking statements.

The Company makes no medical, treatment or health benefit claims about the Company’s proposed products. The U.S. Food and Drug Administration, Health Canada or other similar regulatory authorities have not evaluated claims regarding psilocybin, psilocybin analogues, or other psychedelic compounds or nutraceutical products. The efficacy of such products has not been confirmed by approved research. There is no assurance that the use of psilocybin, psilocybin analogues, or other psychedelic compounds or nutraceuticals can diagnose, treat, cure or prevent any disease or condition. Vigorous scientific research and clinical trials are needed. The Company has not conducted clinical trials for the use of its proposed products. Any references to quality, consistency, efficacy, and safety of potential products do not imply that the Company verified such in clinical trials or that the Company will complete such trials. If the Company cannot obtain the approvals or research necessary to commercialize its business, it may have a material adverse effect on the Company’s performance and operations.

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Braxia Scientific Presents Positive Preliminary Findings from Phase II Randomized, Multi-Dose Clinical Trial of Psilocybin-Assisted Therapy for Treatment Resistant Depression

Braxia Scientific Presents Positive Preliminary Findings from Phase II Randomized, Multi-Dose Clinical Trial of Psilocybin-Assisted Therapy for Treatment Resistant Depression

TORONTO, June 2, 2022 / Braxia Scientific Corp. (“Braxia Scientific”, or the “Company”), (CSE: BRAX) (OTC: BRAXF) (FWB: 4960), a medical research company with clinics providing and advancing innovative ketamine and psilocybin treatments for depression and related mental health disorders, is pleased to announce positive preliminary results from the first Health Canada Approved, Phase II, randomized clinical trial to evaluate the feasibility, safety, tolerability, and efficacy of multi-dose psilocybin-assisted therapy for Treatment-Resistant-Depression. The preliminary results were presented at the “From Research to Reality Conference” in Toronto, May 27-28, 2022.

Positive Preliminary Results Highlights

Braxia Scientific’s ongoing multi-dose psilocybin trial effectively demonstrated the feasibility of Braxia’s proprietary psilocybin-assisted therapy protocol with high rates of recruitment and retention with adequate tolerability and safety.
Clinically meaningful improvements in depression severity observed (as measured by the MADRS1) with complete analysis of antidepressant efficacy and secondary outcomes pending. This trial will be completed by December 2022 at which point the full analysis will be completed and submitted for publication.
Preliminary results indicate strong feasibility with adequate recruitment including 159 individuals who were referred to the study.
Retention – 93% of participants retained to primary endpoint.
Safety – No serious adverse events and zero suicide attempts to date.
Tolerability – majority of adverse effects resolving within 24 hours of each dose and 87% of participants requesting to receive a second dose.
Feasibility of Braxia Institute psychedelic therapy training program demonstrated through recruiting, retaining, and training group of multi-disciplinary independently licensed therapists that continue to serve as therapists as part of Braxia’s psilocybin trial. Group of therapists consists of psychiatrists, primary care therapists, psychotherapists and spiritual care.
(1) Symptoms of depression were assessed using the Montgomery-Åsberg depression rating scale (MADRS), a widely used and accepted scale for assessing depression.

“These results clearly show that we have the infrastructure, expertise and personnel to effectively and safely provide psilocybin-assisted therapy. Dr. Joshua Rosenblat, Chief Medical and Scientific Officer, Braxia Scientific, and Principal Investigator. “While these preliminary results are highly encouraging, they also provide us with additional guidance as we evaluate and optimize our clinical protocols in delivering innovative, psychedelic treatments to patients with treatment resistant depression. These results also reinforce the potential value of the clinical infrastructure we have established to target new innovative treatments.”

Dr. Roger McIntyre, President and CEO, Braxia Scientific, “In addition to our ongoing trial that enables us to provide access to this treatment today, we are excited by the prospect these results with psilocybin may offer patients with treatment resistant depression, an area in need of therapeutic innovation. In addition to guiding professionals internationally on the safe and effective implementation of ketamine, Braxia Scientific is also conducting highly rigorous clinical research with psilocybin, ketamine, and related agents with the aim to provide eligible persons with innovative treatments that work rapidly and are safe to administer.”

Accessing Psilocybin and Ketamine in Canada

Braxia Scientific is a leader in providing access to innovative rapid acting treatments such as ketamine and psilocybin for people living with treatment resistant depression. Braxia Scientific was the first to receive Health Canada approval for a multi-dose psilocybin-assisted therapy clinical trial in July 2021, and dosed its first participant in November 2021. This ongoing clinical trial provides Canadians with immediate access to psilocybin for treatment resistant depression.

Recently, Braxia Scientific also recently announced its among the first to receive approval for psilocybin-assisted therapy treatment approval in Ontario using Health Canada’s Special Access Program (SAP). The SAP was amended January 5th, 2022 to include access to psychedelic compounds on a case-by-case basis outside of clinical trials.

Canadians interested in applying to the SAP, to participate in clinical trials or to qualify for other treatments, such as IV and oral Ketamine for the treatment of depression, may contact the medical team at Braxia Health (the Canadian Rapid Treatment Centre of Excellence https://crtce.com).

About Braxia Scientific Corp.

Braxia Scientific is a medical research company with clinics that provide innovative ketamine treatments for persons with depression and related disorders. Through its medical solutions, Braxia aims to reduce the illness burden of brain-based disorders, such as major depressive disorder among others. Braxia is primarily focused on (i) owning and operating multidisciplinary clinics, providing treatment for mental health disorders, and (ii) research activities related to discovering and commercializing novel drugs and delivery methods. Braxia seeks to develop ketamine and derivatives and other psychedelic products from its IP development platform. Through its wholly owned subsidiary, the Canadian Rapid Treatment Center of Excellence Inc., Braxia currently operates multidisciplinary community-based clinics offering rapid-acting treatments for depression located in Mississauga, Toronto, Ottawa, and Montreal.

ON BEHALF OF THE BOARD

“Dr. Roger S. McIntyre”

Dr. Roger S. McIntyre

Chairman & CEO

FOR FURTHER INFORMATION PLEASE CONTACT:

Braxia Scientific Corp.

Tel: 416-762-2138

Email: info@braxiascientific.com

Website: www.braxiascientific.com

The CSE has not reviewed and does not accept responsibility for the accuracy or adequacy of this release.

Forward-looking Information Cautionary Statement

This news release contains forward-looking statements within the meaning of applicable securities laws. All statements that are not historical facts, future estimates, plans, programs, forecasts, projections, objectives, assumptions, expectations, or beliefs of future performance are “forward-looking statements.”

Forward-looking statements include statements about the intended promise of ketamine-based treatments for depression and the potential for ketamine to treat other emerging psychiatric disorders, such as Bipolar Depression. Such forward- looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results, events, or developments to be materially different from any future results, events or developments expressed or implied by such forward-looking statements. Such risks and uncertainties include, among others, the failure of ketamine, psilocybin and other psychedelics to provide the expected health benefits and unanticipated side effects, dependence on obtaining and maintaining regulatory approvals, including acquiring and renewing federal, provincial, municipal, local or other licenses and engaging in activities that could be later determined to be illegal under domestic or international laws. Ketamine and psilocybin are currently Schedule I and Schedule III controlled substances, respectively, under the Controlled Drugs and Substances Act, S.C. 1996, c. 19 (the “CDSA”) and it is a criminal offence to possess such substances under the CDSA without a prescription or a legal exemption. Health Canada has not approved psilocybin as a drug for any indication, however ketamine is a legally permissible medication for the treatment of certain psychological conditions. It is illegal to possess such substances in Canada without a prescription.

These factors should be considered carefully, and readers are cautioned not to place undue reliance on such forward-looking statements. Although the Company has attempted to identify important risk factors that could cause actual actions, events or results to differ materially from those described in forward-looking statements, there may be other risk factors that cause actions, events or results to differ from those anticipated, estimated or intended. Additional information identifying risks and uncertainties that could affect financial results is contained in the Company’s filings with Canadian securities regulators, including the Amended and Restated Listing Statement dated April 15, 2021, which are available at www.sedar.com. There can be no assurance that forward-looking statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in forward-looking statements.

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CaaMTech Collaboration Proves Diversity in Magic Mushroom Chemistry

CaaMTech Collaboration Proves Diversity in Magic Mushroom Chemistry

A new paper published by The Leibniz Institute for Natural Product Research in collaboration with CaaMTech reveals the complex chemistry of magic mushrooms

Scientists at The Leibniz Institute for Natural Product Research and Infection Biology working in collaboration with CaaMTech and UMASS Dartmouth recently reported new results illustrating the diverse chemistry of magic mushrooms. These results were recently published in the journal ChemBioChem in a paper titled “Genetic survey of Psilocybe natural products.”  The publication highlights numerous findings about the chemical composition of psilocybin-containing Psilocybe “magic” mushrooms including the discovery of aeruginascin in new species of mushrooms and the presence of terpene compounds.  The research highlights the chemical variability across different kinds of magic mushrooms and further underscores that different mushrooms have different properties and effects on account of that chemical variability.

Psilocybe “magic” mushrooms’ best known component, psilocybin, is a prodrug of the potent 5-HT2A agonist and powerful psychedelic compound, psilocin. However, psilocybin co-exists in these mushrooms with other less-studied, structurally similar compounds whose roles and pharmacological properties are poorly understood.  The authors of “Genetic survey of Psilocybe natural products” browsed the genomes of five species (P. azurescens, P. cubensis, P. cyanescens, P. mexicana, and P. serbica) to “​​understand more profoundly common and species-specific metabolic capacities.”  This comparison demonstrated the genetic diversity between different species of magic mushrooms, confirming a difference in their biosynthetic machinery.

The work revealed far greater metabolic diversity in Psilocybe mushrooms than previously reported. Among the findings was the metabolic production of aeruginascin (the N-trimethyl analogue of psilocybin, previously found in only three species of mushrooms including P. cubensis) in two new species of mushrooms: P. cyanescens and P. mexicana.  Additionally, the researchers found, for the first time ever in Psilocybe mushrooms, the presence of terpenes – a class of compounds responsible for some of the entourage effects in cannabis.

“Despite six decades of research on magic mushrooms, it is surprising that knowledge on the global set of Psilocybe natural products is virtually non-existent,”  said Prof. Dr. Dirk Hoffmeister, author on the paper and head of the Research Group Pharmaceutical Microbiology at The Leibniz Institute for Natural Product Research and Infection Biology in Jena, Germany. “It has been truly amazing for our team to discover that a diversity of potentially bioactive molecules is genetically encoded in the magic mushrooms.”

In light of recent efforts to legalize and decriminalize Psilocybe magic mushrooms, “Genetic survey of Psilocybe natural products” further highlights the unmet need for a more complete understanding of the mushrooms’ chemical composition and metabolome.  For example, the delayed paralytic effects known as Wood Lovers Paralysis caused by some species of Psilocybe magic mushrooms has yet to be explained.

“Five years ago magic mushrooms were treated as psilocybin sources without regard to the other compounds,” said Dr. Andrew Chadeayne, CEO of CaaMTech. “By changing the focus from mushrooms to molecules, we’re discovering the importance of many previously overlooked compounds.”

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Lennham Pharmaceuticals Announces Issuance of U.S. Patent Covering Methods of Administering Psilocybin and Psilocin

Lennham Pharmaceuticals Announces Issuance of U.S. Patent Covering Methods of Administering Psilocybin and Psilocin

  • Patent claims cover methods of administering psilocybin and psilocin to patients having reduced monoamine oxidase A activity
  • New patent expires in 2041
  • Given implications to patient safety, Lennham’s discoveries are likely to cover information in the label of any future psilocybin- or psilocin-based product or structurally related compounds

May 31, 2022 10:03 AM Eastern Daylight Time

CONCORD, Mass.–(BUSINESS WIRE)–Lennham Pharmaceuticals, a start-up focused on the creative use of deuterium chemistry to improve the metabolic and pharmacological profile of existing compounds, today announced that the United States Patent & Trademark Office (USPTO) issued U.S. Patent No. 11,344,564 with an expiration date of December 2041. This patent covers methods of treating neurological or psychiatric disorders in patients having reduced monoamine oxidase A (MAO-A) activity by administering a below-normal dose of psilocybin or psilocin.

“Lennham has discovered that certain patient populations have traits that may affect the metabolism and, consequently, the pharmacological effects of psilocybin and its active metabolite, psilocin, at the site of action in the CNS”Tweet this

“Lennham has discovered that certain patient populations have traits that may affect the metabolism and, consequently, the pharmacological effects of psilocybin and its active metabolite, psilocin, at the site of action in the CNS,” said Bradford C. Sippy, Founder of Lennham. “Although glucoronidation is psilocin’s primary metabolic route systemically, metabolism by MAO-A plays a much greater role at the site of action. The use of psilocybin or psilocin in patients having an MAO-A deficiency requires a new approach to administration of those products. Our newly issued patent covers methods of using psilocybin and psilocin in these patient populations, which we believe will be incorporated into the eventual labeling for any psilocybin- or psilocin-based product.”

About Psilocybin
Psilocybin is a well-known, naturally occurring chemical in certain mushrooms that is known to produce hallucinogenic (psychedelic) effects in humans when consumed. It is currently being evaluated as a potential treatment for treatment-resistant depression1 and major depressive disorder, among other diseases and conditions.

About Lennham Pharmaceuticals, Inc.
Lennham is a privately held, life sciences company focused on the creative application of deuterium chemistry to highly utilized and well-characterized compounds. Founded in 2019, Lennham’s unique approach to deuteration has enabled it to rapidly develop a pipeline of product candidates, including deuterium-enriched forms of psilocybin, caffeine, and testosterone.

For more information please visit www.lennham.com or contact info@lennham.com.

References

  1. Carhart-Harris R, et al. Trial of Psilocybin versus Escitalopram for Depression. N Engl J Med. 2021 Apr 15;384(15):1402-1411

Contacts

Media:
Corey MacGregor
Chief Business Officer
Lennham Pharmaceuticals
Corey.macgregor@lennham.com
(978) 254-3201