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XPhyto provides progress update on Psychedelic Medicine Programs and Novel Compounds Milestone

XPhyto provides progress update on Psychedelic Medicine Programs and Novel Compounds Milestone

Vancouver, Canada, and Uttenweiler, Germany (February 22, 2022) – XPhyto Therapeutics Corp. (CSE:XPHY / OTC:XPHYF / FSE:4XT) (“XPhyto” or the “Company”) is pleased to provide an update on its wholly owned subsidiary XPhyto Laboratories Inc. (“XPhyto Labs”). XPhyto Labs’ psychedelic medicine programs based in Edmonton, Canada, are focused on a multi-pronged approach to psychedelic medicine including GMP drug synthesis, proprietary drug delivery systems, novel psychedelic analogue engineering, and clinical validation.

Psychedelic Medicine – Canada

Through its exclusive contract R&D collaboration with Applied Pharmaceutical Innovation (“Applied”), first announced on February 3, 2021, XPhyto Labs is pursuing the application of psychedelic compounds as impactful solutions to mental health-related conditions.

Based on a systematic literature review, the Company identified mescaline (3,4,5-trimethoxyphenethylamine) as a promising candidate for the treatment of a broad range of mental disease states such as depression, anxiety, PTSD, and addiction, as well as cluster headaches. XPhyto and Applied developed a repeatable two-step reaction process with a yield greater than 60% and purity exceeding 99%, which is ideal for clinical use. Analytical methods were developed and validated and to date approximately 60 g of GMP grade mescaline has been manufactured for clinical trial evaluation.

With respect to mescaline drug delivery, XPhyto is focused on formulations designed to avoid common negative side-effects and provide precise and predictable dosage forms for clinical use. Mescaline is a naturally occurring psychedelic compound found in certain cacti, most notably peyote, San Pedro, and Peruvian Torch. These cacti are typically consumed via ingestion which has been associated with gastro-intestinal discomfort, nausea, and a lack of dosing predictability. The Company is pursuing a novel drug delivery system designed to prevent these common negative side-effects and complications; however, due to sensitivity related to intellectual property, further details cannot be disclosed at this time. The Company will announce further details in due course.

In addition to GMP mescaline synthesis and drug delivery, the Canadian operations are also focused on the design and synthesis of novel “2nd generation” psychedelic analogues. The Company has successfully developed and manufactured two promising novel compounds with properties designed to increase bioavailability. Intellectual property related information will be disclosed in due course.

XPhyto and Applied are developing a mescaline clinical trial strategy and are currently in the planning process for a robust Phase I clinical trial to commence in late 2022 to evaluate the safety and dosing parameters for mescaline-based treatment employing a proprietary drug delivery system. Details will be provided as decisions are finalized over the coming months.

“We see a lot of potential therapeutic value in psychedelic compounds for their ability to positively influence neural networks through growth and reorganization,” said Prof. Dr. Löbenberg, XPhyto director and founder and director of the Drug Development and Innovation Centre, University of Alberta. “Our focus is to develop production methodology for GMP manufacturing, proprietary drug formulations with precise, predictable and efficient API delivery for clinical investigation and therapeutic use of novel next-generation psychedelic compounds.”

Psychedelic Medicine – Germany

In addition to operations in Canada and in collaboration with a major German university, the Company is pursuing the development of industrial scale production methodology for GMP psilocybin through an advanced biosynthesis process focused on the insertion of genes from the psilocybin mushroom into certain bio-organisms. Gene insertion is complete and the micro-organisms are now producing psilocybin. The Company will announce further details in due course.

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MAPS receives Innovation Passport for MDMA therapy 🎉

MAPS is Granted Innovation Passport in United Kingdom for MDMA as an Adjunct to Therapy for PTSD

The Innovation Passport will make MDMA therapy for PTSD widely available in the UK, as rapidly as possible!

The Multidisciplinary Association for Psychedelic Studies (MAPS) found that 88% of patients had a reduction in PTSD symptoms after three MDMA sessions in conjunction with trauma-focused therapy. 

The organization was granted an Innovation Passport for the treatment – a UK designation that speeds up the timeline for approval of innovative medicines for life-threatening conditions (similar to Breakthrough Therapy Designations in the US, which the treatment received in 2017).

Multidisciplinary Association for Psychedelic Studies – MAPS

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Mydecine Partners with Combat Stress to Treat Post-Traumatic Stress Disorder in Veterans

Mydecine Partners with Combat Stress to Treat Post-Traumatic Stress Disorder in Veterans

Study further supports the expansion of clinical trials of MYCO-001 for the treatment of PTSD among the Veteran population

DENVER, Jan. 24, 2022 (GLOBE NEWSWIRE) — Mydecine Innovations Group (NEO: MYCO) (OTC: MYCOF) (FSE: 0NFA) (“Mydecine” or the “Company”), a biotechnology and digital technology company aiming to transform the treatment of mental health and addiction disorders, today announced a partnership with Combat Stress (Combat Stress) and the King’s College London to utilize psilocybin as part of a psychoactive-assisted psychotherapy treatment for post-traumatic stress disorder (PTSD) in veterans. Combat Stress will be one of several sites for Mydecine’s upcoming clinical trials.

Combat Stress is the leading charity aiding veterans’ mental health in the United Kingdom, providing treatment and support to former servicemen and women for over a century. They provide a range of online, community, outpatient and residential specialist mental health services to veterans with complex mental health issues related to their military service.

Professor Dominic Murphy, Head of Research at Combat Stress and President of the UK Psychological Trauma Society, has been named a Principal Investigator for the study which will utilize Mydecine’s lead psilocybin drug candidate, MYCO-001, as an adjunct to psychotherapy to treat severe PTSD in veterans that has otherwise been resistant to traditional forms of therapy. Data collected from the study will further advance Mydecine’s drug development pipeline and their ability to bring a much needed novel treatment to market.

“I am truly excited to be leading this study at Combat Stress,” stated Professor Murphy. “We know that the gold standard treatments for PTSD, provided by Combat Stress and other organizations, work for most veterans. However, for a minority, their symptoms do not improve. This collaboration offers great potential for research focused on new, innovative therapeutics that offer significant opportunities to bring hope to those veterans still living with the trauma of their military experiences.”

Mydecine Chief Medical Officer, Dr. Rakesh Jetly, said, “The team is thrilled to be conducting studies within the veteran population where the help is needed most. During my 31 years as a medical officer and psychiatrist in the Canadian Armed Forces, I have seen first hand the impact PTSD has on our vets and their families. Sadly, many soldiers and veterans do not respond to the evidence-based treatments readily available to them and the search is on for new safe and effective treatments. Our troops fight and sacrifice together, so it only makes sense that we help them heal together.”

Mydecine CEO, Josh Bartch, said, “This partnership serves as another significant opportunity to expand our clinical trials and deliver on our mission to develop safe and effective alternative medicine people can trust. There is a big unmet need when it comes to treating PTSD and other mental health conditions, especially within the veteran population, and this partnership demonstrates the strong progress we continue to make in bringing psychoactive-assisted psychotherapies to the forefront of the market and bring hope for all those struggling with these conditions.”

Stay up to date and sign-up for Mydecine’s newsletter by scrolling to the bottom of this page.

About Mydecine Innovations Group

Mydecine Innovations Group™ (NEO:MYCO) (OTC:MYCOF) (FSE:0NFA) is a biotechnology and digital technology company developing innovative first-and-second-generation novel therapeutics for the treatment of mental health and addiction through world-class technology and drug development infrastructure. Mydecine Innovations Group was founded in 2020 on the guiding principle that there is a significant unmet need and lack of Innovations in the mental health and treatment environments. Mydecine Innovations Group is dedicated to efficiently developing innovative therapeutics to treat PTSD, depression, anxiety, addiction, and other mental health disorders. Mydecine Innovations Group’s business model combines clinical trials and data outcome, technology, scientific and regulatory expertise with a focus on psychedelic therapy underpinned by other novel molecules with differentiated therapeutic potential. By collaborating with some of the world’s foremost authorities connected by best practices, Mydecine Innovations Group aims to responsibly fast-track the development of new medicines across its platforms, seeking to effectively treat and ultimately change the way we treat mental health disorders. Mydecine Innovations Group’s vision is to bridge the current gap between what the cognitive healthcare system currently provides with the needs of the patients. Mydecine Innovations Group is headquartered in Denver, Colorado, USA, with international offices in Leiden, Netherlands.

Learn more at: www.mydecine.com and follow the company on Twitter, Instagram, and LinkedIn.

For more information, please contact:

Investor & Media Contact
Morgan Kervitsky, Director of Marketing
(720) 689-4638
contact@mydecineinc.com

On behalf of the Board of Directors:
Joshua Bartch, Chief Executive Officer
contact@mydecineinc.com

For further information about Mydecine Innovations Group, Inc., please visit the Company’s profile on SEDAR at www.sedar.com or visit the Company’s website at www.mydecine.com.

This news release contains forward-looking information within the meaning of Canadian securities laws regarding the Company and its business, which relate to future events or future performance and reflect management’s current expectations and assumptions. Often but not always, forward-looking information can be identified by the use of words such as “expect”, “intends”, “anticipated”, “believes” or variations (including negative variations) of such words and phrases, or state that certain actions, events or results “may”, “could”, “would” or “will” be taken, occur or be achieved. Such forward-looking statements reflect management’s current beliefs and are based on assumptions made by and information currently available to the Company. Readers are cautioned that these forward-looking statements are neither promises nor guarantees, and are subject to risks and uncertainties that may cause future results to differ materially from those expected including, without limitation, risks regarding the COVID-19 pandemic, the availability and continuity of financing, the ability of the Company to adequately protect and enforce its intellectual property, the Company’s ability to bring its products to commercial production, continued growth of the global adaptive pathway medicine, natural health products and digital health industries, and the risks presented by the highly regulated and competitive market concerning the development, production, sale and use of the Company’s products. Although the Company has attempted to identify important factors that could cause actual results to differ materially from those contained in forward-looking information, there may be other factors that cause results not to be as anticipated, estimated or intended. There can be no assurance that such information will prove to be accurate, as actual results and future events could differ materially from those anticipated in such information. These forward-looking statements are made as of the date hereof and the Company does not assume any obligation to update or revise them to reflect new events or circumstances save as required under applicable securities legislation.

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Source: Mydecine Innovations Group Inc.

Released January 24, 2022

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Numinus Announces Key Milestones in MAPS-Sponsored MDMA-Assisted Therapy for PTSD Clinical Trial

Numinus Announces Key Milestones in MAPS-Sponsored MDMA-Assisted Therapy for PTSD Clinical Trial

Numinus Wellness (NUMI) is enrolling patients for a multi-site study on MDMA for PTSD, which will be sponsored by the Multidisciplinary Association for Psychedelic Studies (MAPS). The study received approval from both Health Canada and the Institutional Ethics Review Board.

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MDMA works better than antidepressants

Latest Trials Confirm the Benefits of MDMA – the Drug in Ecstasy – for Treating PTSD

Plus, the effects are long-lasting!

A recent analysis found that, on average, patients who received MDMA-assisted therapy experienced a 22 point reduction in PTSD scores, whereas daily antidepressants only reduced scores by 6 to 14 points. 

One year after receiving the treatments, patients still reported benefits:

  • 84% reported improved feelings of well-being
  • 71% had fewer nightmares
  • 69% had less anxiety
  • 66% had improved sleep

Why is it so effective? MDMA reduces feelings of intense anxiety, allowing patients to open up and work through traumatic memories without fear.

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Reboot your brain 

‘Magic’ Mushrooms, Ecstasy, Other Psychedelics Could Become Legal in California

Marcus Capone, a former Navy SEAL who was battling PTSD, finally got his life back after travelling to Mexico for an ibogaine treatment. 

He instantly felt like a huge weight had been lifted, as if his brain “was rebooted like a new operating system.”

“You can’t hide from the medicine. It’s going to reach down and it’s going to pull out everything that is affecting you,” he explains.

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Ibogaine is a psychedelic substance found in the root  bark of the iboga tree! Learn more here.

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MAPS and Vine Ventures Pioneer Novel Regenerative Funding Structure to Infuse Psychedelic-Assisted Therapy Research and Access With Timely $70 Million

MAPS and Vine Ventures Pioneer Novel Regenerative Funding Structure to Infuse Psychedelic-Assisted Therapy Research and Access With Timely $70 Million

Vine Ventures and MAPS formed a $70M special purpose vehicle called the Regenerative Financing Vine to fund MDMA research for PTSD and promote patient access.

Multidisciplinary Association for Psychedelic Studies – MAPS
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Ketamine One Partners with Cognetivity Neurosciences in Collaborative Clinical Study on Depression and PTSD

Ketamine One Partners with Cognetivity Neurosciences in Collaborative Clinical Study on Depression and PTSD

VANCOUVER, British Columbia, Dec. 02, 2021 (GLOBE NEWSWIRE) — KetamineOne Capital Limited (“Ketamine One” or the “Company”) (NEO: MEDI) (OTC: KONEF) (FRA: 6FC), a company focused on consolidating medical clinics and becoming a North American leader in mental health treatments, is pleased to announce that it is entering into a collaborative partnership with Cognetivity Neurosciences Ltd. (CSE: CGN; OTCQB: CGNSF; FWB: 1UB) (“Cognetivity”) to study and develop assessments for depression and post-traumatic stress disorder (“PTSD”).

In the initial stage of the partnership, Cognetivity and Ketamine One will partner on two separate clinical studies, one for depression and the second for PTSD. Protocols for both studies have received Institutional Review Board (“IRB”) approval and patient recruitment is expected to occur in early 2022. Ketamine One’s wholly owned subsidiary, KGK Science Inc., will lead the study, while Cognetivity will lead the analysis.

Ketamine One is a next-generation health and wellness company focused on transforming the treatment of mental health by providing ketamine-assisted therapy and psychedelic medicines. Based in Canada and operating clinics throughout North America, the firm is dedicated to building the critical infrastructure needed to provide potentially breakthrough and life-changing treatments for conditions such as anxiety, PTSD, chronic pain and addiction.

Cognetivity’s Integrated Cognitive Assessment (“ICA”) technology has already been deployed throughout Ketamine One’s network of clinics in North America after the two companies entered into a commercial agreement earlier this year. In the latest phase of their collaboration, the ICA will be used to monitor changes in patients’ cognitive ability as they undergo ketamine-assisted treatment for depression and PTSD.

The clinical studies will add to the extensive body of data validating the ICA’s use as a cognitive testing tool. It has already been widely deployed in clinical care, from North America and the Middle East to clinics in the UK’s National Health Service. The project will also generate novel intellectual property regarding the ICA’s predictive and long-term monitoring capabilities – not only on a stand-alone basis, but in combination with additional variables, including data from wearable devices, to support the creation of dedicated new products for specialist care in the areas of depression and PTSD.

It is well documented that there is vast potential for improvement in the treatment of such conditions. According to the World Health Organization, mental health disorders account for 28% of the global burden of disability-adjusted life years among non-communicable diseases – more than cardiovascular disease or cancer. Every year, more than 12 billion working days are lost due to mental health conditions, costing the global economy USD 16 trillion in economic output between 2011 and 2030. The global market for PTSD therapeutics is expected to reach USD 3.1 billion by 20271, with the global market for the treatment of anxiety disorders and depression predicted to exceed 13 billion by the same year2.

Management Commentary

“We’re delighted to be extending our relationship with Cognetivity through this exciting new research project,” said Adam Deffett, Interim CEO of Ketamine One. “Depression and PTSD are sadly very common conditions and existing approaches to treating them leave a lot to be desired. With the crucial involvement of the ICA, this study will further demonstrate the power of our therapies as we pursue our goal of changing how mental health is treated across North America.”

Also commenting on the announcement, Dr. Sina Habibi, CEO of Cognetivity, said, “It’s great to be working with Ketamine One on these clinical studies. We are very excited about obtaining high-quality clinical validation data on the use of the ICA to assess and monitor patients with depression and PTSD, and developing exciting new technology to better serve this huge market. These disease areas represent important use cases for the ICA beyond its core application as a device for dementia detection and diagnosis, and the fact that it can transition so smoothly into this new space confirms the strength of its fundamental capabilities and the ongoing global need for much-improved cognitive testing across a huge number of areas.”

ABOUT COGNETIVITY NEUROSCIENCES LTD.

Cognetivity is a technology company that has created a cognitive testing platform for use in medical, commercial and consumer environments. Cognetivity’s ICA uses Artificial Intelligence and machine learning techniques to help detect the earliest signs of cognitive impairment by testing the performance of large areas of the brain. The ICA is currently available for clinical use in the USA, UK and Europe, with regulatory approval for other regions planned for 2022.

For more information, please visit: www.cognetivity.com or contact: info@cognetivity.com.

ABOUT KETAMINE ONE

KetamineOne Capital Limited (formerly Myconic Capital Corp.) is a company focused on consolidating medical clinics and becoming a North American leader in mental health treatments. It is working to provide the critical infrastructure needed to develop and deliver breakthrough mental health treatments. Currently, Ketamine One has a network of clinics across North America, with plans to further consolidate the highly fragmented industry. KGK Science Inc. is the Company’s wholly owned contract research division, which places it at the forefront of premium clinical research based on the subsidiary’s history and extensive experience in pharmaceuticals, cannabis, and the emerging psychedelic medicine industries. As a collective enterprise, Ketamine One is dedicated to helping solve the growing need for safe and accessible mental health therapy.

On behalf of:

KETAMINE ONE

“Adam Deffett“
Adam Deffett, Interim CEO

For further information, please contact:

Nick Kuzyk, Investor Relations
Tel: 1-844-PHONE-K1 (1-844-746-6351)
Email: IR@ketamine.one
Web: www.ketamine.one
Twitter: @KetamineOne

Notice Regarding Forward-Looking Information:

This news release contains forward-looking statements including but not limited to statements regarding the Company’s business, assets or investments, as well other statements that are not historical facts. Readers are 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 based will occur. By their nature, forward-looking statements involve numerous assumptions, known and unknown risks and uncertainties, both general and specific, that contribute to the possibility that the predictions, forecasts, projections and other forward-looking statements will not occur, which may cause 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. These assumptions, risks and uncertainties include, among other things, the state of the economy in general and capital markets in particular, investor interest in the business and prospects of the Company.

The forward-looking statements contained in this news release are made as of the date of this news release. Except as required by law, the Company disclaims any intention and assumes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable securities law. Additionally, the Company undertakes no obligation to comment on the expectations of, or statements made, by third parties in respect of the matters discussed above.
Endnotes

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INTERESTED IN WORKING WITH KETAMINE ONE?

If you’re interested in being a financial partner, clinic partner, or community advocate, we’d love to talk. partners@ketamine.one