In his opening speech at the Catalyst Psychedelics Summit, Canadian Senator Larry Campbell shared his fascinating (yet slightly disturbing) experience with microdosing.
The 74-year-old politician had been suffering from depression and PTSD for ages when his mental health suddenly started improving out of nowhere.
When Larry told his wife the good news, she admitted that she’d been spiking his morning coffee with a bit of psilocybin for the past two weeks 😲
While we don’t condone drugging people without their knowledge, her experiment revealed some important anecdotal evidence – the benefits that Larry experienced must have been from the psilocybin itself and not a result of the placebo effect!
Health Canada approval is for a patient with the indication of Major Depressive Disorder, in the absence of terminal medical illness or end of life distress.
Approval marks Braxia’s first Special Access Program (SAP) approval for use of psilocybin in Ontario.
To date Braxia’s experienced therapists have delivered psilocybin-assisted therapy treatments to 16 individuals with depression through its proprietary clinical trial commenced late 2021.
TORONTO, May 20, 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 other innovative treatments for people living with depression and related mental health disorders. Braxia Scientific is pleased to announce that Health Canada has approved the Company’s application to the Special Access Program (“SAP”) to provide psilocybin-assisted psychotherapy for a patient with Major Depressive Disorder in Ontario, through its wholly owned subsidiary Canadian Rapid Treatment Centre of Excellence (CRTCE).
“Being among the first to begin delivering psilocybin-assisted therapy treatments in Canada last year through our clinical trial, we have developed and optimized the infrastructure, including rigorous training for our therapists through our Braxia Institute, to provide a positive patient experience while optimizing outcomes, said Dr. Joshua Rosenblat, Chief Medical and Scientific Officer, Braxia Scientific. “To our knowledge, this is the first Health Canada SAP approval for psilocybin-assisted therapy for a person with Major Depressive Disorder in Ontario. My patient and I are extremely grateful for this opportunity to access this promising treatment. Health Canada was very responsive to this request, promptly providing the Letter of Authorization. This rapid approval stands in contrast to the previously required Section 56 exemptions that could take years to fully process. Allowing use of the SAP will be incredibly beneficial for patients in need of this treatment that are unable to receive it through psychedelic clinical trials.”
“Since opening our first clinic in 2018, in Toronto, Canada, our focus has been on creating a true centre of excellence for people living and suffering with depression to gain access to the most effective treatments. Our ability to deliver psilocybin-assisted therapy is an important step in our journey to achieving our vision of finding a cure for depression, said Dr. Roger McIntyre, Chairman and CEO, Braxia Scientific. “The experience of our therapists who have already delivered this novel treatment in multiple doses to multiple patients in our ongoing psilocybin trial, combined with data we’ve collected to date and expect to read out in the coming weeks, provides an excellent opportunity for new applicants to receive access to the most advanced clinical protocols and care to achieve best outcomes in this field. In addition to providing access to innovative treatments for depression, Braxia Scientific is a leader in comprehensive research, development and best- practices implementation of psilocybin, ketamine and related agents”
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.
ATMA signs non-binding Letters of Intent to access over 10 clinical sites across Canada in collaboration on the largest psilocybin trial to date.
CALGARY, AB, May 10, 2022 /CNW/ – ATMA Journey Centers Inc. (“ATMA”), an Alberta-based company focused on the international delivery of its innovative psychedelic-assisted therapy solutions, announced the submission of its N-500 Phase II Psilocybin Clinical Trial to Health Canada today. This trial is aimed at studying the potential relief of COVID-19-associated mental health concerns in healthcare professionals, as well as analyzing healthcare professionals’ firsthand evaluation of the effectiveness of psilocybin psychotherapy in application.
The primary objective of the trial is to assess the capacity of psilocybin to improve the overall mental health of healthcare providers. While enduring the pandemic has been difficult for all Canadians, healthcare providers have had the immense challenge of helping patients cope with the both the direct and indirect physical and psychological burdens of COVID-19. Using a variety of self-administered tests, including the Quick Inventory of Depressive Symptomatology Self-report 16-item (QIDS-SR16), the Generalized Anxiety Disorder 7-item (GAD-7), and the Burnout Assessment Tool (BAT), healthcare providers will assess their anxiety, depression, and occupational burnout levels before and after consuming psilocybin under the guidance of a licenced medical practitioner. The outcome of this objective will provide real-world data as to the effectiveness of psilocybin. As a secondary exploratory objective, participants will complete an assessment of their psilocybin experience to inform the potential utility of psilocybin in a clinical setting, from the perspective of a healthcare provider.
While an N-500 trial is an enormous undertaking, it is necessary in order to assess the efficacy of psilocybin in treating healthcare professionals struggling with mental health issues during and post-COVID-19, especially therapists who embody the role of ‘the healer’. Further, by experiencing the efficacious effects of psilocybin firsthand, therapists will be able to offer experiential insights into psilocybin-assisted therapy, thus providing valuable contributions to the future of this field. When combined with psychotherapy, therapists may begin to develop an appreciation of psilocybin’s usefulness in other applications of treatment-resistant mental illness.
In addition to the primary and secondary outcomes of this Phase II trial, this trial represents an opportunity unlike any other; many participants will be therapists that have previous training in psychedelic medicine, or are undergoing an experiential journey in combination with a psilocybin-assisted therapy training program. ATMA will be running its Psilocybin-assisted Therapy Training Program concurrent to this trial, allowing for the cross participation of healthcare professionals interested in pursuing the path of psychedelic-assisted therapy in the near future. Healthcare professionals will be able to participate as test subjects, facilitators, or both. For more on ATMA’s training programs, visit https://academy.atmajourney.com/
David Harder, ATMA Co-CEO, explains that “the need for qualified, certified therapists is becoming increasingly evident as we see that these medicines must be given in protocols of pre- and post-treatment counselling. Understanding the holistic nature of psilocybin therapy may prove more effective when the training includes an experiential component.” The clinical trial and Psilocybin-assisted Therapy Training Program will be open to interested healthcare professionals on both sides of the Canada-United States border.
In planning to expand from a local to national initiative, ATMA has signed Letters of Intent (LOIs) with multiple organizations that have the appropriate clinical facilities and staff to support this Canada-wide clinical trial. Having local support sites will ensure that the trial will service healthcare professionals from coast-to-coast in a logistical and efficient manner. David Harder adds, “We welcome more physician, clinician, and clinic participation in this historic collaboration of the largest psilocybin clinical trial to date. Physicians, clinicians, and clinics looking to explore psilocybin-assisted therapy as part of their future service offerings could benefit greatly from this trial.”
It is important for ATMA to collaborate with multiple capable organizations across Canada in order to conduct and maintain the integrity of this large Phase II clinical trial, as well as larger subsequent clinical trials. ATMA is pleased to have established such like-minded partnerships in an effort to bring these trials to healthcare professionals across Canada, allowing for individuals to participate locally without a travel burden added to their already busy schedules.ABOUT ATMA JOURNEY CENTERS INC.
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. Our 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, we 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.
SOURCE ATMA Journey Centers Inc
For further information: MEDIA CONTACT: David Harder, Co-CEO, ATMA Journey Centers Inc., david@atmajourney.com
CHICAGO and TORONTO, May 10, 2022 (GLOBE NEWSWIRE) — Wesana Health Holdings Inc.(“Wesana” or the “Company”) (CSE: WESA; OTCQB: WSNAF), a data-driven life sciences company focused on developing the novel therapies of tomorrow and delivering new care paradigms today, is pleased to announce that following the completion of a successful Pre-IND meeting with the United States Food and Drug Administration (“FDA”), the Company is expanding its lead indication for SANA-013 to Major Depressive Disorder (“MDD”) and exploring other complementary orphan indications.
Consistent with the positive feedback received from FDA, Wesana will accelerate the development of SANA-013 by initiating a Phase 1b/2a human study for MDD in H1 2023. In contrast to the prior development pathway for SANA-013 with TBI associated depression as the lead indication, the revised development pathway would allow the Company to bypass the healthy patient population study and research an MDD affected patient population directly as part of a Phase 1b/2a study.
Wesana’s SANA-013 is designed to deliver a novel depression treatment protocol that includes a single high dose of psilocybin followed by a maintenance regimen of a non-hallucinogenic dose of psilocybin combined with cannabidiol (CBD). The low, non-hallucinogenic dose of psilocybin in combination with CBD is being developed for MDD and other indications so that affected people can benefit from a chronic, at-home use proposition.
Daniel Carcillo, Wesana’s founder and Chief Executive Officer, said, “Given the positive written feedback from FDA regarding SANA-013, we are extremely excited to begin developing meaningful clinical data for our novel formulation and protocol. We believe SANA-013 provides Wesana distinct advantages compared to other companies exploring psilocybin, as they are primarily focused on delivering large in-clinic doses of psilocybin on an intermittent basis and therefore are not optimally positioned to treat conditions such as MDD that likely will require some kind of chronic dosing.”
MDD is a chronic, recurring, and debilitating mental disorder leading it to be one of the most burdensome illnesses on a global scale. Patients suffering from MDD are frequently and significantly impaired from an occupational and social function standpoint resulting in severe economic costs. With approximately 264 million people suffering from depression globally, according to World Health Organization data in 2020, the market size is currently estimated to grow at a CAGR of 3.9% to US$16 billion by 2026.1
About Wesana Health
Wesana Health helps people transcend barriers in mental health and performance. We innovate in care development through our therapies and patent-pending protocols, and in care delivery through activating a new multidisciplinary, technology-supported clinical model. Learn more at www.wesanahealth.com.
On behalf of the Board of Directors: Daniel Carcillo, Chief Executive Officer Phone: (773) 236-7972
Cautionary Note Regarding Forward-Looking Information
This news release contains “forward-looking information” within the meaning of applicable securities laws with respect to the Company, including, but not limited to: the Company’s future operations and clinical trials, including initiation of a Phase 1b/2a study for MDD in H1 2023. as part of a revised accelerated development pathway; and any other statement that may predict, forecast, indicate or imply future plans, intentions, levels of activity, results, financial position, operational or financial performance or achievements. Often, but not always, forward-looking information can be identified by the use of words such as “plans”, “expects”, “is expected”, “budget”, “scheduled”, “estimates”, “forecasts”, “intends”, “anticipates”, “will”, “projects”, or “believes” or variations (including negative variations) of such words and phrases, or statements that certain actions, events, results or conditions “may”, “could”, “would”, “might” or “will” be taken, occur or be achieved. Except for statements of historical fact, information contained herein constitutes forward-looking information. Forward-looking information is not a guarantee of future performance and is based upon a number of estimates and assumptions of management at the date the statements are made.
Certain assumptions that influence the successful initiation of a Phase 1b/2a study for MDD in H1 2023 as part of an expanded development pathway include: (i) the Company’s capital will be sufficient to execute the expanded (or any) development pathway; (ii) the broadened indication and the future clinical trials are going to be acceptable to the FDA; (iii) the Company and its consultants can efficiently and timely address any additional correspondence, submission of additional materials or information pursuant to any ongoing requests as they may arise resulted from the broadened indication; and (v) additional pre-clinical studies required for MDD will be commenced and completed on a timely basis and results will be supportive and as anticipated.
Although management believes that the anticipated future results, performance or achievements expressed or implied by the forward-looking statements are based upon reasonable assumptions and expectations, the reader should not place undue reliance on forward-looking statements because they involve assumptions, known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of the Company to differ materially from anticipated future results, performance or achievements expressed or implied by such forward-looking statements. Certain risk factors include but are not limited to there being no assurance as to the Company’s ability to continue as a going concern; there being no assurance as to the Company’s ability to raise additional funding to finance its operations; the detrimental impact of future losses and negative cash flow from operations; requirements for additional capital; lack of product or service revenue; research and development of drugs targeting the central nervous system being particularly difficult; failure to comply with health and data protection laws and regulations; delays in pre-clinical and clinical testing resulting in delays in commercializing; inability to file investigational new drug applications or clinical trial applications to commence clinical trials in a timely manner; difficulty enrolling patients in clinical trials; competition from other biotechnology and pharmaceutical companies; violations of laws and regulations resulting in repercussions; psychedelic inspired drugs possibly never being approved as medicines; regulatory or political change; reliance on third parties to plan, conduct and monitor preclinical studies and clinical trials; requirements of commercial scale and quality manufactured drug supply; negative results from pre-clinical and clinical trials or studies of others; unfavourable publicity or consumer perception; not achieving publicly announced milestones; reliance on the capabilities and experience of key executives and scientists; disruptions due to acquisitions or collaborations; risk of product liability claims; COVID-19; litigation; conflicts of interest; limited operating history; general economic, market and business conditions and other risk factors including those found in the Company’s management’s discussion and analysis for the year ended December 31, 2021 and the Company’s annual information form dated September 3, 2021 filed on the Company’s profile on SEDAR at www.sedar.com and discussed in the Company’s other public filings available on SEDAR.
Forward-looking information is provided and made as of the date of this news release and the Company does not undertake any obligation to revise or update any forward-looking information other than as required by applicable law.
1 Source: 2020, October. “Depression Treatment Market By Drug Type (Antidepressants, Antipsychotics) By Application (Major Depressive Disorder (MDD), Bipolar Disorder), By End-User (Hospitals, NGOs, Mental Health Centers), By Distribution Channel, and By Region, Forecasts to 2027.” Emergen Research, https://www.emergenresearch.com/industry-report/depression-treatment-market
Wesana Health (WESA) is considering selling all assets related to client care (like its network of ketamine clinics and mental health software) to focus solely on drug development.
Plus, Nova Mentis is recruiting both autisitc and neurotypical patients for an observational study that will lead to a psilocybin microdosing study.
If you want to contribute to psychedelic research from home, check out Johns Hopkins’ online surveys on psychedelics and breathwork for anxiety, depression, and PTSD.
A Maastricht University study found that a single dose of 5-MeO-DMT (the psychedelic found in toad venom and several plants) improved subjects’ scores for life satisfaction, depression, anxiety, and mindfulness.
The changes were seen 1 day after the dose and persisted for 4 weeks.
Higher levels of ego dissolution were linked with greater improvements in scores (so, the more intense the trip, the more beneficial).
A separate survey found that ~80% of people with depression or anxiety reported improvements in symptoms following a dose of 5-MeO-DMT.
Some companies that are researching 5-MeO-DMT include GH Research (GHRS), Biomind Labs (BMND), and Mindset Pharma (MSET).
Biomind Labs (BMND) dosed the first subject in a Phase I trial /IIa clinical trial on DMT for treatment-resistant depression.
Over the next 4 months, 30 healthy patients who have never done psychedelics will receive 2 doses of inhalable DMT. Researchers will assess the safety of the drug, as well as behavioral and brain effects before continuing with Phase II.
Can you imagine trying DMT as your first psychedelic?
TORONTO–(BUSINESS WIRE)– Cybin Inc. (NEO:CYBN) (NYSE American:CYBN) (Cybin or the Company), a biopharmaceutical company focused on progressing “Psychedelics to TherapeuticsTM”, today announced that it has partnered with Clinilabs Drug Development Corporation (“Clinilabs”), a global, full-service contract research organization with deep expertise in central nervous system drug development, to carry out the Company’s Phase 1/2a clinical trial of CYB003, a proprietary deuterated psilocybin analog. CYB003 will be the first psilocybin analog to be evaluated in Phase 1/2a development for the treatment of major depressive disorder (“MDD”).
“We are delighted to partner with the Clinilabs team as we progress this important program toward a first-in-human Phase 1/2a trial. Clinilabs brings a unique combination of scientific and operational experience and deep expertise in clinical research across a range of psychiatric, neurological and substance use disorders,” said Doug Drysdale, Chief Executive Officer of Cybin. “Clinilabs is ideally suited to help us accelerate the regulatory pathway for this promising treatment candidate and ultimately, to effectively treat those suffering with MDD.”
In multi-species preclinical studies, CYB003 demonstrated significant advantages over classic psilocybin including, less variability in plasma levels, faster onset of action, shorter duration of effect and potentially better tolerability for an overall better outcome for patients. Cybin recently announced the completion of its IND-enabling in vivo preclinical studies of CYB003. Data from these studies support the advancement toward an investigational new drug (“IND”) filing with the U.S. Food and Drug Administration (“FDA”) for the Phase 1/2a clinical trial. Cybin intends to submit an IND to the FDA in the second quarter of 2022 and expects to initiate the Phase 1/2a trial in mid-2022.
“Approximately one-third to one-half of people with MDD demonstrate an inadequate response to antidepressant drug treatment. Treatment options for these patients currently are limited to dose escalation, switching or combining antidepressants, or augmentation therapy, often with unsatisfactory results,” said Dr. Gary Zammit, President & CEO of Clinilabs. “It is a privilege to be working with Cybin, an innovator in the development of novel psychedelic therapeutics, to conduct its first-in-human clinical trial of CYB003. This trial is designed to assess the efficacy and safety of CYB003 in patients with MDD and is among the first to evaluate a standardized psychedelic treatment regimen in this patient population.”
About CYB003 CYB003 is derived from psilocybin, which is part of a family of molecules called indolamines that include more common neurotransmitters, such as serotonin. Psilocybin is dephosphorylated to form its metabolite, psilocin, which can cross the blood-brain-barrier. Given its structural similarity to serotonin, psilocin can easily activate the serotonin 5-HT2A receptor. CYB003 is a deuterated psilocybin analog that has the potential to effectively treat major depressive disorder and alcohol use disorder.
About Clinilabs Drug Development Corporation Clinilabs Drug Development Corporation is the only global, full-service contract research organization (CRO) focused exclusively on central nervous system (“CNS”) drug development. With deep expertise in CNS, we are committed to the development of medicines that treat a range of psychiatric, neurological and substance use disorders, as well as rare and ultra-rare CNS diseases. Clinilabs partners with pharmaceutical and biotechnology companies to deliver a complete, first-in-human to Phase 3 spectrum of high quality, timely, and cost-effective clinical drug development services, with the shared goal of speeding new CNS medicines to market. We are process-driven yet structured to be nimble, providing personalized service that meets the needs of customers and projects of all sizes. Clinilabs has conducted more than 675 CNS clinical trials in our 21-year history and played a pivotal role in the approval of 19 new therapies across 10 CNS indications to help transform the lives of patients worldwide.
About Cybin Cybin is a leading ethical biopharmaceutical company, working with a network of world-class partners and internationally recognized scientists, on a mission to create safe and effective therapeutics for patients to address a multitude of mental health issues. Headquartered in Canada and founded in 2019, Cybin is operational in Canada, the United States, United Kingdom and Ireland. The Company is focused on progressing Psychedelics to Therapeutics by engineering proprietary drug discovery platforms, innovative drug delivery systems, novel formulation approaches and treatment regimens for mental health disorders.
Cautionary Notes and Forward-Looking Statements Certain statements in this press release constitute forward-looking information. All statements other than statements of historical fact contained in this press release, including, without limitation, statements regarding Cybin’s future, strategy, plans, objectives, goals and targets, and any statements preceded by, followed by or that include the words “believe”, “expect”, “aim”, “intend”, “plan”, “continue”, “will”, “may”, “would”, “anticipate”, “estimate”, “forecast”, “predict”, “project”, “seek”, “should” or similar expressions or the negative thereof, are forward-looking statements. Forward-looking statements in this news release include statements regarding the Company’s proprietary drug discovery platforms, innovative drug delivery systems, novel formulation approaches and treatment regimens to potentially treat psychiatric disorders.
These forward-looking statements are based on reasonable assumptions and estimates of management of the Company at the time such statements were made. Actual future results may differ materially as forward-looking statements involve known and unknown risks, uncertainties, and other factors which may cause the actual results, performance, or achievements of the Company to materially differ from any future results, performance, or achievements expressed or implied by such forward-looking statements. Such factors, among other things, include: implications of the COVID-19 pandemic on the Company’s operations; fluctuations in general macroeconomic conditions; fluctuations in securities markets; expectations regarding the size of the psychedelics market; the ability of the Company to successfully achieve its business objectives; plans for growth; political, social and environmental uncertainties; employee relations; the presence of laws and regulations that may impose restrictions in the markets where the Company operates; and the risk factors set out in the Company’s management’s discussion and analysis for the period ended December 31, 2021 and the Company’s listing statement dated November 9, 2020, which are available under the Company’s profile on www.sedar.com and with the U.S. Securities and Exchange Commission on EDGAR at www.sec.gov. Although the forward-looking statements contained in this news release are based upon what management of the Company believes, or believed at the time, to be reasonable assumptions, the Company cannot assure shareholders that actual results will be consistent with such forward-looking statements, as there may be other factors that cause results not to be as anticipated, estimated or intended. Readers should not place undue reliance on the forward-looking statements and information contained in this news release. The Company assumes no obligation to update the forward-looking statements of beliefs, opinions, projections, or other factors, should they change, except as required by law.
Cybin makes no medical, treatment or health benefit claims about Cybin’s proposed products. The U.S. Food and Drug Administration, Health Canada or other similar regulatory authorities have not evaluated claims regarding psilocybin, psychedelic tryptamine, tryptamine derivatives or other psychedelic compounds. The efficacy of such products has not been confirmed by approved research. There is no assurance that the use of psilocybin, psychedelic tryptamine, tryptamine derivatives or other psychedelic compounds can diagnose, treat, cure or prevent any disease or condition. Rigorous scientific research and clinical trials are needed. Cybin 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 Cybin verified such in clinical trials or that Cybin will complete such trials. If Cybin cannot obtain the approvals or research necessary to commercialize its business, it may have a material adverse effect on Cybin’s performance and operations.
Neither the Neo Exchange Inc. nor the NYSE American LLC stock exchange have approved or disapproved the contents of this news release and are not responsible for the adequacy and accuracy of the contents herein.
Steve struggled with depression for 30 years. Traditional antidepressants numbed both his highs and lows, leaving him feeling like a “functional zombie”.
Things finally changed when he volunteered for a psilocybin trial at Imperial College London.
“With the first dose, I felt joy like I’ve never experienced – and more like myself than I’ve ever felt… It took from not knowing myself at all to having a sense of what my place was in the greater scheme of things,” he said.
The second dose was much more challenging, but “therapeutically more useful,” as it forced him to deal with suppressed emotions.
“The drug gives us part of a healing process. It exposes you to different possibilities – another way of being,” Steve explains.
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