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Optimi Health Completes Expansion of On-site Analytical Laboratory

Optimi Health Completes Expansion of On-site Analytical Laboratory

Lab’s completion brings Company closer to full commercialization.

VANCOUVER, BC — Optimi Health Corp. (CSE: OPTI) (OTCQX: OPTHF) (FRA: 8BN) (“Optimi” or the “Company”), is pleased to announce that it has completed a planned expansion of the on-site analytical laboratory at its Princeton, British Columbia facility.

The on-site lab is purpose built inside one of Optimi’s EU-GMP capable 10,000 square foot, state-of-the-art indoor growing facilities dedicated to the cultivation of safe, high-quality psychedelic and functional mushrooms. Optimi Chief Science Officer, Justin Kirkland, will oversee the Company’s analytical operations.

“Our analytical lab will prove a completely consistent dosage on natural psilocybin products that will meet stringent FDA and EU-GMP standards,” said Kirkland. “We will measure and ensure integrity, ongoing stability, and accuracy in all of our natural psilocybin and psychedelic formulations and are finalizing our Standard Operating Procedures to meet Health Canada and international standards.”

The newly enlarged analytical laboratory will operate as a division of Optimi Labs Inc., a wholly owned subsidiary of Optimi Health, and is designed both for research into the company’s proprietary formulations and extraction methods and to be utilized by clients and partners and approved companies to conduct investigations into molecular discovery with restricted psychedelic compounds.

Optimi CEO Bill Ciprick says that the lab expansion is a critical component of the Company’s planned revenue strategy.

“While Optimi’s main focus remains the cultivation of a safe, scalable supply of natural EU-GMP psilocybin, we realize that operationalizing a future for psychedelic science in which the largest number of authorized patients have access to these medicines requires a more robust research infrastructure than currently exists, particularly in light of the current levels of interest and demand from so many entities across the space. This laboratory is our contribution to that future,” added Ciprick.

Alongside its primary objective of becoming a tier one ingredient supplier of naturally cultivated psilocybin mushrooms and extracts, the Company intends to develop efforts on third parties requiring supplementary facilities and analytical support in drug discovery processes as well as for single and multi-site clinical trials.

In a press release issued by the Company on Monday, May 9, Optimi applauded Health Canada’s May 6 Notice to Stakeholders emphasizing the “importance of drug quality and Good Manufacturing Practices (GMP)” regarding “the proposed use of psilocybin mushrooms in clinical trials, or as a drug accessed through the Special Access Program (SAP).”

“We commend Health Canada for making quality assurance and GMP compliance a necessity in all clinical and observational protocols moving forward,” said Ciprick. “With our analytical capacity now in place, we look forward to helping industry suppliers validate their product and meet the demand for GMP grade psilocybin.”

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

Optimi Health 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 to produce scalable, natural mushroom formulations for transformational human experiences, the Company’s goal is to be the number one trusted, compassionate supplier of safe, natural GMP grade psilocybin across the world. With a vertically integrated approach, Optimi intends to cultivate, extract, process and distribute high quality functional and psychedelic mushroom products at its two facilities comprising a total of 20,000 square feet in Princeton, British Columbia.

To fully investigate the science of mushrooms, the Company has received a research exemption under Health Canada Food and Drug Regulations (FDR) for the use of Psilocybin and Psilocin for scientific purposes via its wholly owned subsidiary Optimi Labs Inc. Optimi has also been granted a dealer’s license under Canada’s Narcotic Control Regulations governing possession, distribution, sale, laboratory analysis of and research and development of Psilocybin and Psilocin formulations. Optimi is committed to expert cultivation and quality production subject to and in accordance with the terms of all applicable laws and governing regulations to ensure safe, superior Canadian fungi production.

FOR INTERVIEW REQUESTS OR FURTHER INFORMATION PLEASE CONTACT:

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

FORWARD‐LOOKING STATEMENTS

This news release contains forward‐looking statements and forward‐looking information within the meaning of Canadian securities legislation (collectively, “forward‐looking statements”) that relate to Optimi’s current expectations and views of future events. Any statements that express, or involve discussions as to, expectations, beliefs, plans, objectives, assumptions or future events or performance (often, but not always, through the use of words or phrases such as “will likely result,” “are expected to,” “expects,” “will continue,” “is anticipated,” “anticipates,” “believes,” “estimated,” “intends,” “plans,” “forecast,” “projection,” “strategy,” “objective,” and “outlook”) are not historical facts and may be forward‐looking statements and may involve estimates, assumptions and uncertainties which could cause actual results or outcomes to differ materially from those expressed in such forward‐looking statements. No assurance can be given that these expectations will prove to be correct and such forward‐looking statements included in this news release should not be unduly relied upon. These statements speak only as of the date of this news release. In particular and without limitation, this news release contains forward‐ looking statements pertaining to activities proposed to be conducted under the Company’s dealer’s license and associated business related to Psilocybin and Psilocin and Optimi’s plans, focus and objectives.

Forward‐looking statements are based on a number of assumptions and are subject to a number of risks and uncertainties, many of which are beyond Optimi’s control, which could cause actual results and events to differ materially from those that are disclosed in or implied by such forward‐looking statements. Such risks and uncertainties include, but are not limited to, the impact and progression of the COVID‐19 pandemic and other factors set forth under “Forward‐Looking Statements” and “Risk Factors” in the Company’s Annual information Form dated January 12, 2022, and other continuous disclosure filings available under Optimi’s profile at www.sedar.com. Optimi undertakes no obligation to update or revise any forward‐looking statements, whether as a result of new information, future events or otherwise, except as may be required by law. New factors emerge from time to time, and it is not possible for Optimi to predict all of them or assess the impact of each such factor or the extent to which any factor, or combination of factors, may cause results to differ materially from those contained in any forward‐looking statement.

Any forward‐looking statements contained in this news release are expressly qualified in their entirety by this cautionary statement.

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Activists arrested at DEA protest

Protestors of psilocybin ban arrested at DEA headquarters

At least 17 activists were arrested for protesting at the DEA headquarters. The purpose of the protest was to raise awareness about the DEA’s obstruction of access to psilocybin therapy, which should be legal for terminally ill patients through the Right to Try (RTT) laws.

“There is urgent need for the DEA to accommodate RTT and enable access (to psilocybin). This demonstration shines the bright light of public concern and outrage on this agency’s conduct,” says Kathryn Tucker, the attorney behind the litigation.

PDF of article

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Science-backed psychedelic experiences

Leveraging over 20 years of psychedelic research, Beckley Foundation is launching a psilocybin-focused holistic wellbeing company called Beckley Retreats.

Starting this September, Beckley Retreats will offer a self-development program that includes:

  • 4 weeks of virtual preparation
  • A 5-day retreat in Jamaica with 2 psilocybin ceremonies and tons of holistic healing practices
  • 6 weeks of virtual integration to encourage new habits and thought patterns

Led by certified psychotherapists and doctors, the retreat combines Indigenous wisdom with modern science to create an unparalleled experience.

Learn more and reserve your spot here.

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ATMA Submits Phase II Clinical Trial Application, Assessing Psilocybin Efficacy in Healthcare Professionals Suffering From COVID-19-related Mental Wellness Challenges

ATMA Submits Phase II Clinical Trial Application, Assessing Psilocybin Efficacy in Healthcare Professionals Suffering From COVID-19-related Mental Wellness Challenges

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

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Mycrodose Therapeutics Successfully Delivers Both Macro and Microdose Levels of Psilocin Using Core Drug Delivery Technologies

Mycrodose Therapeutics Successfully Delivers Both Macro and Microdose Levels of Psilocin Using Core Drug Delivery Technologies

Mycrodose Therapeutics showed the ability to synthesize and stabilize psilocin in their laboratory for use in their IP-protected drug delivery systems. The company successfully delivered in vitro both macro and microdose levels of psilocin through human skin using their patch and lozenge technologies.

Mycrodose Therapeutics (“Mycrodose”), a leading US pharmaceutical company specializing in the development of advanced drug delivery (ADD) technologies utilizing DEA Schedule I & III drugs and other compounds, announced today their successful in vitro pre-clinical research study showing the ability to synthesize and stabilize psilocin, the active pharmaceutical ingredient (API), in-vitro through human skin using their proprietary transdermal patch and lozenge technology. Mycrodose’s in vitro studies also showed that the company’s technologies were able to deliver both macro and microdose levels of psilocin into circulation.

“With the upgrade to our in vitro penetration test setup, we are now researching transdermal drug delivery beyond the 1-day patch, extending up to one-week delivery,” says Frank Kochinke, Chief Science Officer, Mycrodose Therapeutics. “However, thinking the opposite way, larger doses within a shorter time interval, essentially macrodosing is potentially possible. Our preliminary results suggest that larger doses, such as a standard macrodose, of psilocin can be delivered via our proprietary transdermal and transmucosal technologies. The technological hurdles that remain are to convert the exciting results into a 2-year shelf-life product. To accomplish that we are enhancing our analytical capabilities and implementing stability-indicating assays as well as using upgraded LC/MS equipment to research psilocin’s metabolites and degradation products. These are needed to be prepared for our projected clinical studies evaluating the prototypes for several indications in large mental and general health market segments,” Kochinke continued.

Mycrodose Therapeutics’ preclinical results show that the active compound psilocin, both extracted from psilocybin mushrooms and synthesized at Mycrodose’s laboratory to cGMP standards, can be stabilized before being delivered transdermally and transmucosally, through the company’s controlled and sustained-release drug delivery technology.

“We have successfully synthesized psilocin, developed a psilocin transdermal drug delivery system and performed in vitro permeation studies with our semi-automatic permeation instrument. We utilized human skin for in-vitro studies, which is donated from local surgery centers and dermatomed in-house. It is important to note all of the aforementioned processes were done in-house, at our research facility.” says Bryan Arrayales, Director of R&D, Mycrodose Therapeutics.

With respect to the instability of psilocin, Mycrodose Therapeutics is currently on track to further stabilize psilocin inside its respective drug delivery systems to increase the APIs shelf life. Through rigorous studies, Mycrodose is able to deliver micro and macro amounts of psilocin giving the company multiple treatment options with respect to patient demand.

The results of the research further show that the company’s ability to control and sustain the delivery of psilocin is possible by increasing or decreasing permeation rates through human skin. The research also showed that a larger dose, a macro dose level, of psilocin can be delivered effectively using the company’s patch and lozenge technology.

Future plans of the company include the synthesis of LSD to be used in the development of an LSD transdermal and sublingual drug delivery system.

About Mycrodose Therapeutics

Mycrodose Therapeutics Inc. is a U.S.-based pharmaceutical company headquartered in San Diego, California specializing in the development of advanced drug delivery systems utilizing DEA Schedule I & III drugs and other compounds to treat cancer related conditions, mental health, and cognitive degenerative diseases. Mycrodose’s state-of-the-art laboratory includes a transdermal department with full in-vitro and analytical capacities that allows for all intellectual property and proprietary data to remain in-house. The company believes that its IP-Protected Sustained Microdosing Technology™ is a smarter and safer approach to delivering pharmaceutical compounds to patients of all ages and allows for an expandable and scalable business model.

For more information about Mycrodose Therapeutics, please contact:

Patrick Eckstrom

Chief Operating Officer

Mycrodose Therapeutics

Email: Patrick@MycrodoseThera.com

Phone: 1-619-494-1367

Website: www.MycrodoseThera.com

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Creso Pharma’s wholly-owned psychedelics subsidiary, Halucenex Life Sciences Inc. secures import permit from Health Canada

Creso Pharma’s wholly-owned psychedelics subsidiary, Halucenex Life
Sciences Inc. secures import permit from Health Canada

Highlights:

  • Import permit allows for one kilogram of dried Jamaican grown psilocybe cubensis to be imported from Grogenex JA Ltd. (“Grogenex”)
  • Grogenex is a specialist consulting partner for licenced producers operating in thecannabis and psychedelics sectors
  • Imported psilocybe cubensis will be used to refine extraction and formulation techniques for drug development
  • Importing psilocybe cubensis will provide Halucenex with sufficient inventory while thereis an ongoing bottleneck in supply
  • Shipment expected to be completed before the end of the month
  • Work towards planned phase II clinical trial continues – anticipated commencement in Q2
  • Trial has the potential to unlock large market opportunity for Creso Pharma and access to the global PTSD therapeutics sector which is expected to grow to US$10.5Bn in value by 2025i

Creso Pharma Limited (ASX:CPH, OTC:COPHF, FRA:1X8) (‘Creso Pharma’ or ‘the Company’) is pleased to advise that its wholly-owned, Canadian based psychedelics company, Halucenex Life Sciences Inc. (“Halucenex”) has been awarded a permit to import one kilogram psilocybe cubensis by Health Canada. The psilocybe cubensis will be used for ongoing R&D initiatives.

Halucenex will utilise the permit to import one kilogram of dried Jamaican grown psilocybe cubensis from Grogenex JA Ltd. (“Grogenex”), which equates to 20g of psilocybin. Grogenex is a specialist consulting partner for licenced producers in the cannabis and psychedelics sector. Grogenex is comprised of a specialist growing team from multiple provinces and countries, with expertise in various styles of cultivation from large scale commercial to small batch craft. Separately, Halucenex and Grogenex have entered into a non-material consultation and supply agreement (“Agreement”), under which the Company has paid CAD$22,750 with an additional CAD$22,750 payable on the day tarting material for R&D purposes will be shipped to Halucenex; after which event, the Agreement
will end.

The Company expects to complete the import of psilocybe cubensis by the end of this month which will be used for ongoing R&D initiatives. The Company intends to give further consideration to entering into future natural psilocybin offtake agreements in due course, including potentially with Grogenex.

Importing the psilocybe cubensis provides Creso Pharma with the opportunity to establish a relationship with Grogenex that may provide access to Jamaican mushroom genetics and products.

This also has the potential to streamline future import initiatives for the Company and secure future additional supply of psilocybe cubensis as required.

Commentary:

CEO and Managing Director William Lay said: “Securing the import permit from Health Canada allows the Company to access a supply of dried psilocybe cubensis during a period where there is strong demand and a bottleneck on supply. “Further, establishing a relationship with Grogenex for the import of psilocybe cubensis will broaden
Halucenex’s exposure to different psilocybe cubensis strains for R&D initiatives and we are confident that this will build on our ongoing understanding of how to best leverage the substance for a range of potential benefits.”

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Wesana Health Outlines Accelerated Drug Development Pathway

Wesana Health Outlines Accelerated Drug Development Pathway

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

Investor Relations:
Keenan Gentry
Email: IR@wesanahealth.com
Phone: 702-329-8038

Media Contacts:
Isadora Forman
Email: media@wesanahealth.com
Phone: 917-653-4613

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

Primary Logo

Source: Wesana Health

Released May 10, 2022

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“Minor” Magic Mushroom Compound Crystal Structure Solved

“Minor” Magic Mushroom Compound Crystal Structure Solved

While psilocybin continues to receive attention as the active ingredient in magic mushrooms, CaaMTech scientists have continued filling the unmet need for fundamental scientific understanding of the “other” alkaloids.  In collaboration with the Manke Lab at the University of Massachusetts Dartmouth, CaaMTech published “The crystal structure of baeocystin” in Acta Crystallographica Section E. The paper reports the crystal structure of the compound baeocystin, an understudied naturally-occurring tryptamine present in most psilocybin magic mushrooms, for the very first time.

Psilocybin, a chemical compound found in psychedelic magic mushrooms, has received a tremendous amount of attention for its potential to treat numerous intractable health conditions. So much so that “psilocybin” and “magic mushrooms” have often and incorrectly been referred to interchangeably.  Psilocybin belongs to a class of compounds known as tryptamines, which closely resemble the neurotransmitter serotonin (5-hydroxytryptamine or 5-HT).  This structural similarity allows psilocybin to fit into and agonize serotonin receptors including the 5-HT2A receptor subtype responsible for elucidating psychedelic experiences.  But psilocybin is not the only tryptamine present in magic mushrooms.

Baeocystin, a zwitterionic alkaloid and analog of psilocybin, is another tryptamine that naturally occurs in most psilocybin mushrooms.  Baeocystin was first synthesized in 1959 and was isolated from the mushroom Psilocybe baeocystis in 1967. Still, relatively little is known about  baeocystin and little scientific research has been conducted due to a lack of access to pure, well-characterized material.  As co-author Alexander Sherwood wrote in a 2020 Journal of Natural Products paper, “…few studies have been conducted to evaluate pharmacological activity of these tryptamines, largely due to lack of availability of the compounds.”

“It is always exciting to solve the structure of a natural product,” said Dr. David R. Manke, Professor at UMass Dartmouth. “and even more so when it is one that has such great potential as a therapeutic.”

In an appearance on the Joe Rogan Podcast, famed mycologist Paul Stamets reported consuming pure baeocystin in the presence of a physician and further reported no psychedelic experience.  “I was ready for liftoff. I was hoping for liftoff, I know what liftoff feels like, and I didn’t get it,” said Stamets of the experience.  Baeocystin’s hydrolysis product and metabolite norpsilocin – which CaaMTech previously crystallographically characterized – was shown by Dr. Sherwood to be a full agonist of the 5-HT2A receptor but does not induce a head twitch response (HTR) in mice.

By solving the crystal structure of baeocystin, CaaMTech scientists have completed fundamental research required to understand baeocystin’s effects. Further determination of the biological effects of baeocystin and its metabolites could provide researchers with key findings necessary to better understand the role of the psychedelic experience in therapeutic benefit and whether non-psychedelic tryptamines may offer unique benefits of their own.

“CaaMTech continues to fill the unmet need for chemical precision when studying compositions such as magic mushrooms,” said Dr. Andrew Chadeayne, CEO of CaaMTech. “We are grateful to work with dedicated scientists Dr. Sherwood and Dr. Manke in filling the unmet need for pure, well-characterized compounds.”

A ball and stick model of the chemical structure of baeocystin
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Optimi Health Applauds Health Canada’s Position on Drug Quality and Goods and Manufacturing Practices (GMP) for Psilocybin

Optimi Health Applauds Health Canada’s Position on Drug Quality and Goods and Manufacturing Practices (GMP) for Psilocybin

“Sets the right tone, right standard, and right policy”: Optimi Health CEO, Bill Ciprick

VANCOUVER, BC — Optimi Health Corp. (CSE: OPTI) (OTCQX: OPTHF) (FRA: 8BN) (“Optimi” or the “Company”) CEO, Bill Ciprick, issued a statement today in response to Health Canada’s May 6 Notice to Stakeholders “regarding the proposed use of psilocybin mushrooms in clinical trials, or as a drug accessed through the Special Access Program (SAP).”

Ciprick says the Notice published by Health Canada’s Office of Legislative and Regulatory Affairs Controlled Substances Directorate was welcomed by Optimi, specifically around the “importance of drug quality and Good Manufacturing Practices (GMP).”

As a tier one ingredient provider and product leader, Optimi’s operational footprint includes 20,000 square feet of state-of-the-art, technologically advanced aeroponics facilities dedicated to the cultivation of EU-GMP grade psilocybin and functional mushrooms.

While the Company is uniquely positioned to be a world leader in the cultivation and supply of natural, scalable, and accessible psilocybin, Ciprick believes Health Canada’s message is one that benefits every industry supplier.

“Health Canada’s message sets the right tone, right standard, and right policy when it comes to building a sustainable industry backed by hard, evidence-based, science-driven clinical research that is paramount to the health and wellbeing of Canadians,” said Ciprick.

He added:

“Over the last year, Optimi has embarked on a transformational journey that has seen our company become a world leader in the supply of natural, EU-GMP grade psilocybin and functional mushrooms. Every member of our team shares our commitment to making possible a future whereby natural psychedelic alternatives aid in the treatment of a wide variety of addictions and mental health conditions.

From Optimi’s founders to the hardworking employees cultivating our supply, we have always believed that the surest path to a regulated safe supply of medical psilocybin in Canada lies in the standards of a fully licensed, GMP facility. For these reasons, Optimi applauds and endorses Health Canada’s announcement and will continue to invest in the future of natural psychedelic alternatives and solutions that pioneer the future of addictions and mental health.”

Last week, the Company announced that a requested Amendment to its Controlled Substances Dealer’s Licence had been granted by Health Canada, permitting it to possess a quota of up to 5,000kg of dried psilocybin mushrooms – the equivalent of 10kg of psilocybin – and 100g of psilocin.

On May 27, the Company will be welcoming guests and dignitaries from the psychedelic business space, the medical and public health fields, local and national politics, and the Indigenous community for a grand opening event and reception to inaugurate its Princeton, BC facility.

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

Optimi Health 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 to produce scalable, natural mushroom formulations for transformational human experiences, the Company’s goal is to be the number one trusted, compassionate supplier of safe, natural GMP grade psilocybin across the world. With a vertically integrated approach, Optimi intends to cultivate, extract, process and distribute high quality functional and psychedelic mushroom products at its two facilities comprising a total of 20,000 square feet in Princeton, British Columbia.

To fully investigate the science of mushrooms, the Company has received a research exemption under Health Canada Food and Drug Regulations (FDR) for the use of Psilocybin and Psilocin for scientific purposes via its wholly owned subsidiary Optimi Labs Inc. Optimi has also been granted a dealer’s license under Canada’s Narcotic Control Regulations governing possession, distribution, sale, laboratory analysis of and research and development of Psilocybin and Psilocin formulations. Optimi is committed to expert cultivation and quality production subject to and in accordance with the terms of all applicable laws and governing regulations to ensure safe, superior Canadian fungi production.

FOR INTERVIEW REQUESTS OR FURTHER INFORMATION PLEASE CONTACT:

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

FORWARD‐LOOKING STATEMENTS

This news release contains forward‐looking statements and forward‐looking information within the meaning of Canadian securities legislation (collectively, “forward‐looking statements”) that relate to Optimi’s current expectations and views of future events. Any statements that express, or involve discussions as to, expectations, beliefs, plans, objectives, assumptions or future events or performance (often, but not always, through the use of words or phrases such as “will likely result,” “are expected to,” “expects,” “will continue,” “is anticipated,” “anticipates,” “believes,” “estimated,” “intends,” “plans,” “forecast,” “projection,” “strategy,” “objective,” and “outlook”) are not historical facts and may be forward‐looking statements and may involve estimates, assumptions and uncertainties which could cause actual results or outcomes to differ materially from those expressed in such forward‐looking statements. No assurance can be given that these expectations will prove to be correct and such forward‐looking statements included in this news release should not be unduly relied upon. These statements speak only as of the date of this news release. In particular and without limitation, this news release contains forward‐ looking statements pertaining to activities proposed to be conducted under the Company’s dealer’s license and associated business related to Psilocybin and Psilocin and Optimi’s plans, focus and objectives.

Forward‐looking statements are based on a number of assumptions and are subject to a number of risks and uncertainties, many of which are beyond Optimi’s control, which could cause actual results and events to differ materially from those that are disclosed in or implied by such forward‐looking statements. Such risks and uncertainties include, but are not limited to, the impact and progression of the COVID‐19 pandemic and other factors set forth under “Forward‐Looking Statements” and “Risk Factors” in the Company’s Annual information Form dated January 12, 2022, and other continuous disclosure filings available under Optimi’s profile at www.sedar.com. Optimi undertakes no obligation to update or revise any forward‐looking statements, whether as a result of new information, future events or otherwise, except as may be required by law. New factors emerge from time to time, and it is not possible for Optimi to predict all of them or assess the impact of each such factor or the extent to which any factor, or combination of factors, may cause results to differ materially from those contained in any forward‐looking statement.

Any forward‐looking statements contained in this news release are expressly qualified in their entirety by this cautionary statement.