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COMPASS Pathways presents largest ever study of psilocybin therapy, at American Psychiatric Association annual meeting

COMPASS Pathways presents largest ever study of psilocybin therapy, at American Psychiatric Association annual meeting

Positive data from phase IIb study shows potential of COMP360 psilocybin therapy
in treatment-resistant depression

COMPASS Pathways plc (Nasdaq: CMPS) (“COMPASS”), a mental health care company dedicated to accelerating patient access to evidence-based innovation in mental health, today presented positive data from the largest randomised, controlled, double-blind study of psilocybin therapy ever completed, at the American Psychiatric Association annual meeting in New Orleans*. The study showed that a single 25mg dose of COMP360 psilocybin, in combination with psychological support, was associated with a highly statistically significant reduction in depressive symptoms after three weeks (p<0.001), with a rapid and durable response for up to 12 weeks.

The randomised, controlled, double-blind phase IIb clinical trial was designed to understand the efficacy and safety of a single dose of investigational COMP360 psilocybin (25mg or 10mg), compared to 1mg in patients with treatment-resistant depression (TRD). 233 patients with TRD received either 1mg, 10mg or 25mg COMP360 psilocybin, in conjunction with psychological support from specially trained therapists. Symptoms of depression were assessed using the Montgomery-Åsberg depression rating scale (MADRS)**, a widely used and accepted scale for assessing depression; the MADRS assessments were made by an independent, blinded rater.

Key results:

  • Depression symptoms: patients who received a 25mg dose of COMP360 psilocybin with psychological support experienced a highly statistically significant reduction in symptoms of depression after three weeks: the difference between 25mg group and 1mg group was -6.6 on the MADRS* depression scale at week 3, p<0.001.
  • Durability: double the number of patients who received 25mg had a sustained response at week 12, compared to those who received 1mg (20.3% of patients in the 25mg group vs 10.1% in the 1mg group).
  • Tolerability: COMP360 psilocybin was generally well-tolerated. On the day of COMP360 administration, headache, nausea, and dizziness were the only adverse events where a dose-related increase in incidence was evident and there were no clinically significant differences between dose group in vital signs or clinical laboratory tests observed during the study.
  • Adverse events: In this study suicidal ideation and intentional self-injury were seen in all treatment groups (as is regularly observed in a TRD population), and the majority occurred more than a week after the psilocybin session. There was no mean worsening of suicidal ideation scores in any treatment group. Suicidal behaviours were reported at least 1 month after COMP360 administration for 3 non-responders in the 25mg arm.

David J Hellerstein MD, a Principal Investigator on the trial and Professor of Clinical Psychiatry at the Columbia University Irving Medical Center, said: “Treatment-resistant depression is one of the biggest challenges we face in psychiatry, and chances of success decreases with each treatment that a patient tries. It’s rare to see such positive outcomes of clinical trials in this disease area, which is why these results are so significant. I hope this represents a major step in finding new options for people living with treatment-resistant depression.”

Dr Guy Goodwin, Chief Medical Officer, COMPASS Pathways, said, “Our mission is all about developing mental health innovations through scientific evidence, which is why we’re so honoured to present the largest study of its kind at the APA. In this study, a significant number of patients experienced improvement in their symptoms of depression after just a single dose of 25mg psilocybin with psychological support, with effects lasting for up to three months of the study. We now need to continue our research to understand if this can be replicated in even larger trials.”

Hear Professor David Hellerstein talk about the study

-Ends-

*The safety and efficacy of COMP360 psilocybin therapy in treatment-resistant depression: Results from a phase IIb randomized controlled trial. Guy M. Goodwin, Susan C. Stansfield, David J. Hellerstein, Allan H. Young, Ekaterina Malievskaia. APA: Abstract Number: 5301 Session Title: Poster Session 6

**MADRS = Montgomery-Åsberg Depression Rating Scale; response = ≥50% decrease in MADRS total score from baseline; remission = MADRS total score ≤10; sustained response = patients meeting the MADRS response criteria from week 3 until week 12

About treatment-resistant depression (TRD)

More than 320 million people globally suffer with major depressive disorder (MDD)1, the leading cause of disability worldwide and one of the fastest growing mental health illnesses2. About a third of these patients – 100 million people – aren’t helped by existing therapies and suffer with treatment-resistant depression (TRD)3. As many as 30% of these attempt suicide at least once during their lifetime4,5. TRD carries two to three times the medical costs of a non-TRD MDD patient, and patients with TRD have a higher all-cause mortality compared with non-TRD MDD patients6. The TRD population is by definition more difficult to treat and more likely to relapse than patients with major depressive disorder. In 2018, COMPASS received FDA Breakthrough Therapy designation for its COMP360 psilocybin therapy for TRD.

About the COMP360 psilocybin therapy phase IIb study

This randomised, controlled, multicentre, double-blind phase IIb trial is the largest psilocybin therapy clinical trial ever conducted, with 233 patients from 10 countries in North America and Europe. 94% of the patients had no prior experience with psilocybin. The objective of the trial was to find the appropriate dose for a larger, pivotal phase III programme, which COMPASS expects to begin in 2022.

The trial assessed the safety and efficacy of COMP360 psilocybin therapy at three doses: 1mg, 10mg, 25mg. A total of 233 patients enrolled in the study and were randomised and blinded into three arms comprising 79 patients for each of the 25mg and 1mg doses, and 75 patients for the 10mg dose. Patients were followed up for 12 weeks. The trial used the Montgomery-Åsberg depression rating scale (MADRS), a widely used and accepted scale for assessing depression; assessments were made by an independent, blinded rater. The primary endpoint was the change in the MADRS total score from baseline to week 3.

About COMPASS Pathways              

COMPASS Pathways plc (Nasdaq: CMPS) is a mental health care company dedicated to accelerating patient access to evidence-based innovation in mental health. Our focus is on improving the lives of those who are suffering with mental health challenges and who are not helped by current treatments. We are pioneering the development of a new model of psilocybin therapy, in which our proprietary formulation of synthetic psilocybin, COMP360, is administered in conjunction with psychological support. COMP360 has been designated a Breakthrough Therapy by the US Food and Drug Administration (FDA), for treatment-resistant depression (TRD), and we have completed a phase IIb clinical trial of psilocybin therapy for TRD, in 22 sites across Europe and North America. This was the largest randomised, controlled, double-blind psilocybin therapy clinical trial ever conducted, and our topline data showed a statistically significant (p<0.001) and clinically relevant improvement in depressive symptom severity after three weeks for patients who received a single high dose of COMP360 psilocybin with psychological support. We are also running a phase II clinical trial of COMP360 psilocybin therapy for post-traumatic stress disorder (PTSD). COMPASS is headquartered in London, UK, with offices in New York and San Francisco in the US. Our vision is a world of mental wellbeing. www.compasspathways.com

Availability of other information about COMPASS Pathways

Investors and others should note that we communicate with our investors and the public using our website (www.compasspathways.com), our investor relations website (ir.compasspathways.com), and on social media (LinkedIn), including but not limited to investor presentations and investor fact sheets, US Securities and Exchange Commission filings, press releases, public conference calls and webcasts. The information that we post on these channels and websites could be deemed to be material information. As a result, we encourage investors, the media, and others interested in us to review the information that is posted on these channels, including the investor relations website, on a regular basis. This list of channels may be updated from time to time on our investor relations website and may include additional social media channels. The contents of our website or these channels, or any other website that may be accessed from our website or these channels, shall not be deemed incorporated by reference in any filing under the Securities Act of 1933.

Forward-looking statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. In some cases, forward-looking statements can be identified by terminology such as “may”, “might”, “will”, “could”, “would”, “should”, “expect”, “intend”, “plan”, “objective”, “anticipate”, “believe”, “contemplate”, “estimate”, “predict”, “potential”, “continue” and “ongoing,” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. Forward-looking statements include express or implied statements relating to, among other things, the safety or efficacy of COMP360 psilocybin therapy as a treatment for depression, COMPASS’s business strategy and goals, including its ability to launch and commercialise products, COMPASS’s ability to continue to advance its research or develop plans to bring its product candidates to patients, including COMP360, and COMPASS’s expectations regarding the benefits of its psilocybin therapy. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond COMPASS’s control and which could cause actual results, levels of activity, performance or achievements to differ materially from those expressed or implied by these forward-looking statements.

These risks, uncertainties, and other factors include, among others: preclinical research and clinical development is lengthy and uncertain, and therefore our preclinical studies and clinical trials may be delayed or terminated, or may never advance to or in the clinic; and those risks and uncertainties described under the heading “Risk Factors” in COMPASS’s annual report on Form 10-K filed with the US Securities and Exchange Commission (SEC) on 24 February 2022 and in subsequent filings made by COMPASS with the SEC, which are available on the SEC’s website at www.sec.gov. Except as required by law, COMPASS disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on COMPASS’s current expectations and speak only as of the date hereof.

Enquiries

Media: Amy Lawrence, amy@compasspathways.com, +44 7813 777 919
Investors: Stephen Schultz, stephen.schultz@compasspathways.com, +1 401 290 7324

References:

[1] WHO (2017). Depression and Other Common Mental Disorders Global Health Estimates [Online]. Available at: https://apps.who.int/iris/bitstream/handle/10665/254610/WHO-MSD-MER-2017.2-eng.pdf [Accessed 21 October 2021]
[2] WHO (2012). Depression: A Global Crisis [Online]. Available at: https://www.who.int/mental_health/management/depression/wfmh_paper_depression_wmhd_2012.pdf [Accessed 21 October 2021]
[3] Al-Harbi KS. Treatment-resistant depression: therapeutic trends, challenges, and future directions. Patient Preference and Adherence. 2012; 6: 369–388.
[4] Bergfeld IO, Mantione M, Figee M, Schuurman PR, Lok A, Denys D. Treatment-resistant depression and suicidality. Journal of Affective Disorders. 2018;235:362-367
[5] Dong M, Lu L, Zhang L, et al. Prevalence of suicide attempts in bipolar disorder: a systematic review and meta-analysis of observational studies. Epidemiology and Psychiatric Sciences. 2020;29:e63
[6] Gang L, Fife D, Wong G, Sheehan JJ, et al. All-cause mortality in patients with treatment-resistant depression: a cohort study in the US population. Annuals of General Psychiatry. 2019; 18:23.

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Braxia Scientific Receives Health Canada Special Access Program Approval to Provide Psilocybin-Assisted Therapy for Depression in Ontario

Braxia Scientific Receives Health Canada Special Access Program Approval to Provide Psilocybin-Assisted Therapy for Depression in Ontario

  • 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).

While this is Braxia Scientific’s first psilocybin-assisted therapy treatment approval using Health Canada’s SAP, which was amended January 5th, 2022 to include access to psychedelic compounds on a case-by-case basis outside of clinical trials, Braxia Scientific was the first to receive Health Canada approval for a multi-dose psilocybin-assisted therapy clinical trial in July 2021, dosing its first participant in November 2021. To date, the Company has provided psilocybin-assisted therapy to 16 individuals living with depression.

“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.

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CB Therapeutics granted a new patent that will help further provide eco-conscious avenues for psychedelic research

CB Therapeutics granted a new patent that will help further provide eco-conscious avenues for psychedelic research

CARLSBAD, Calif., May 19, 2022 (GLOBE NEWSWIRE) — CB Therapeutics (the “Company”), a biotechnology and precision fermentation company focused on using cellular agriculture to produce environmentally-friendly products for human health, has been granted a new patent covering the use of microorganisms to produce tryptamines and their analogs, such as psilocybin and various other molecules found in “magic” mushrooms. The patent marks yet another milestone for the Company in its journey to create safe, sustainable, and scalable compounds for various industries, researchers and clinicians.

This patent allows CB Therapeutics to own a production process that is the future of the psychedelic medicine industry. Almost all other methods to produce these molecules are costly, time-consuming or create significant amounts of toxic waste, CO2 and other byproducts that negatively impact the environment.

CB Therapeutics’ cellular agriculture platform enables the conversion of cheap feedstocks into high-value compounds. The result is a scalable and eco-conscious supply chain, carried out by precision fermentation, which is the future for various products and therapeutics, including the psychedelic medicine industry.

“Businesses and research institutions in the emerging psychedelic industry need to get serious about ESG now because once the industry is established, it will be too late. Right now is the time to provide services that adhere to this paradigm change and we are motivated to grow as an innovative player in the industry. Our company may be small but we are doing big things to make the biotechnology sector more environmentally sustainable,” says Sher Ali Butt, Co-Founder and CEO.

While patents tend to stir up controversy in regulated markets, they continue to be essential for small, innovative companies. They protect valuable IPs, which paves the way for smaller companies to work with large corporations, such as CB Therapeutics’ recent partnership, launching TryptageniX with atai Life Sciences. Easing the way for such partnerships could help diversify service offerings in the psychedelic space through collaboration.

“Increasing access to safe and sustainably produced therapeutics is more achievable than ever before through innovations in synthetic biology and precision fermentation. We are very proud to be at the forefront of this movement, and to be a part of a growing number of groups innovating in the psychedelic medicine space to unlock these powerful molecules for researchers and clinicians to help patients with unmet needs,” says Co-Founder, Jacob Vogan. “This is a ‘rising tide lifts all boats’ moment of societal benefit in accessing therapeutics through new sustainable processes.”

The CB Therapeutics team of researchers, executives and esteemed advisory board members are hopeful this will better standardize eco-conscious research into products for human health, including foods, cannabinoids and psychedelic medicines. Furthermore, with ethical considerations applied, this patent gives rise to new molecules and therapies that will be faster and cheaper than currently available, ultimately benefiting the hundreds of millions of people who suffer from mental illnesses globally.

About CB Therapeutics

CB Therapeutics produces high-value molecules, compounds, and rare ingredients from simple sugars utilizing yeast and the process of fermentation. Since its inception, CB Therapeutics has developed standardized biotechnology processes for producing natural molecules and their analogs for clinical research in psychedelic medicine, cannabinoid-based therapies, and food technologies. As a drug discovery platform with the ability to create a clean and secure supply of products, The Company’s partnership allows it to develop custom production process technologies to support and scale drug product manufacturing to meet clinical patient supply demands. In turn, this enables partners to move more swiftly through clinical development.

CB Therapeutics’ expertise in synthetic genomics and bio-engineering has significantly advanced its proprietary production platform of microorganisms, enzymes, and production processes. After more than four years of research and development, the CB Therapeutics team can produce a broad range of phytochemicals faster, utilizing fewer resources, at greater yields, and with more purity, consistency, and efficiency than competing platforms. CB Therapeutics operates from their new 16,000 sq. ft. fully-licensed commercial batch facility in southern California.

Contact Information

Media Contact:
Alana Armstrong
Dir. of Communications, Alan Aldous Inc.
Email: alana@alanaldous.com

Partnership Inquiries:
Sher Ali Butt
CEO, CB Therapeutics
Email: sher@cbthera.com

Follow CB Therapeutics on Twitter: @CBTherapeutics
Follow CB Therapeutics on Instagram: @cbthera

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Silo Pharma Announces Successful Dosing of Patients Suffering from Parkinson’s Disease in Psilocybin Study

Silo Pharma Announces Successful Dosing of Patients Suffering from Parkinson’s Disease in Psilocybin Study

Study is examining effects of Psilocybin on Inflammatory Markers

ENGLEWOOD CLIFFS, N.J., May 19, 2022 (GLOBE NEWSWIRE) —  Silo Pharma, Inc . (OTCQB: SILO), a development-stage biopharmaceutical company focused on the use of psychedelics as a therapeutic, today announces that it in conjunction with the University of California San Francisco (UCSF), researchers have successfully dosed patients suffering from Parkinson’s disease. As part of this study, the researchers are collecting blood samples to determine the effects of psilocybin on inflammatory markers of patients who have exhibited signs of Parkinson’s.

This study is taking place at The Translational Psychedelic Research (TrPR) Program at UCSF.  TrPR brings together scientists and care providers across disciplines to understand how psilocybin, LSD, ketamine, MDMA and related compounds impact the brain and other organ systems. The goal of TrPR is to accelerate progress towards impactful and accessible psychedelic treatments.

Eric Weisblum, CEO of Silo Pharma commented “Successful dosing and collection of blood samples from enrolled patients is an important milestone that demonstrates the progress being made in this study which seeks to examine the effects of Psilocybin as an Anti-inflammatory agent.. We are encouraged by the progress and look forward to the next cohort of patients receiving therapeutic treatment and sharing the analysis of these markers when data has been analyzed and completed.”

About Silo Pharma
Silo Pharma. Inc. is a development-stage biopharmaceutical company focused on merging traditional therapeutics with psychedelic research for people suffering from indications such as PTSD, Parkinson’s, and other rare neurological disorders. Silo’s mission is to identify assets to license and fund the research which we believe will be transformative to the well-being of patients and the health care industry. For more information, visit www.silopharma.com

Safe Harbor and Forward-Looking Statements
This news release contains “forward-looking statements” within the meaning of the “safe-harbor” provisions of the Private Securities Litigation Reform Act of 1995. These statements are identified by the use of words “could”, “believe”, “anticipate”, “intend”, “estimate”, “expect”, “may”, “continue”, “predict”, “potential” and similar expressions that are intended to identify forward-looking statements. Such statements involve known and unknown risks, uncertainties and other factors that could cause the actual results of Silo Pharma, Inc. (“Silo” or “the Company”) to differ materially from the results expressed or implied by such statements, including changes to anticipated sources of revenues, future economic and competitive conditions, difficulties in developing the Company’s technology platforms, retaining and expanding the Company’s customer base, fluctuations in consumer spending on the Company’s products and other factors. Accordingly, although the Company believes that the expectations reflected in such forward-looking statements are reasonable, there can be no assurance that such expectations will prove to be correct. The Company disclaims any obligations to publicly update or release any revisions to the forward-looking information contained in this presentation, whether as a result of new information, future events or otherwise, after the date of this presentation or to reflect the occurrence of unanticipated events except as required by law.

Investor Relations Contact:
Hayden IR
Brett Maas
646-536-7331
Email: brett@haydenir.com

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UK Member of Parliament Crispin Blunt to Inaugurate Psilocybin Cultivation Facility at Optimi Health Grand Opening

UK Member of Parliament Crispin Blunt to Inaugurate Psilocybin Cultivation Facility at Optimi Health Grand Opening

Blunt to speak on the importance of understanding psilocybin’s potential role in mental health, reducing barriers to continued research in psychedelic medicine

VANCOUVER, BC — Optimi Health Corp. (CSE: OPTI) (OTCQX: OPTHF) (FRA: 8BN) (“Optimi” or the “Company”), a homegrown, Canadian company producing natural, scalable, and accessible mushroom formulations for transformational human experiences, is pleased to announce that Crispin Blunt, Member for Reigate for the Conservative Party of the United Kingdom, will be appearing as a keynote speaker at the Grand Opening of the Company’s 20,000 square foot psilocybin cultivation facility in Princeton, British Columbia.

As Chair of the Conservative Drug Policy Reform Group, Blunt has been a vocal advocate for the rescheduling of psilocybin under current United Kingdom drug laws, with particular emphasis on the treatment of mental health conditions such as depression and cluster headaches.

Blunt’s efforts toward further psychedelic science included a House of Commons Speech in October of 2021, asking Prime Minister Boris Johnson if he were willing to “cut through the current barriers to research into psilocybin and similar compounds?”

“It is an honour for Optimi Health to welcome Crispin Blunt, MP, to our May 27 Grand Opening Ceremony,” said Bill Ciprick, CEO of Optimi Health. “Optimi’s founders, advisory board, and executive team are pleased to host such an internationally recognizable figure in the ongoing dialogue around therapeutic psilocybin. It is our hope that we are only at the beginning of a larger, global rescheduling of psychedelic substances for research and medicinal purposes, and that discussions such as those being had now continue in the halls and offices of government worldwide.”

Blunt will join the Optimi event after attending the 2022 Catalyst Summit in Kingston, Ontario where he has been invited to speak on international drug policy reform and regulation. Blunt served as the Minister of State for Prisons, Probation, Rehabilitation and Sentencing from 2010-2012.

“I am thrilled to be associated with some of the great work currently being undertaken by our friends in Canada,” said Blunt. “The push to raise the profile of these much-needed psychedelic therapies in continuity with drug policy reform is paramount to bringing relief to the millions of people suffering from severe mental health conditions and addictions issues across the world. I am very much looking forward to seeing Optimi Health’s contribution to these efforts.”

Mr. Blunt’s official biography can be found here.

GRAND OPENING

On May 27th, 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 facility tour to inaugurate its Princeton, BC facility. Those interested in attending in-person or via livestream should contact event organizer, Michael Kydd, at info@kyddergroup.com.

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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Albert Labs Granted Health Canada Licence

Albert Labs Granted Health Canada Licence

Albert Labs has been issued a Health Canada License enabling the possession, production, and delivery of psilocybin and other psychoactive controlled substances

May 16th 2022 – VANCOUVER, BRITISH COLUMBIA

Albert Labs International Corp. (CSE: ABRT) (FSE: VB50) (the “Company”), a research and drug development company using advanced culture technology to create pharmaceutical-quality medicines for mental health treatments, is pleased to report it has been granted a Health Canada License dated 05-05-2022 for its research and production facility in Burnaby, Canada. This approval permits the legal possession, production, assembly, sale, and delivery of psilocybin and other psychoactive controlled substances within the confines of the regulations governing controlled substances.

At the company’s research and production facility, Albert Labs cultivate, extract, and process pharmaceutical-grade natural psilocybin. Utilizing patent-pending technology, Albert Labs can optimize the consistency and standardization of natural psilocybin Active Pharmaceutical Ingredients (APIs) to meet regulatory compliance standards. With the issue of this license, Albert Labs has the ability to distribute API to Canada and, where import licenses exist, internationally. The licence will allow Albert Labs to supply product to its forthcoming Real World Evidence (RWE) trial in the UK, as well as distribute and sell API to other licensed customers. Under the Special Access Program (SAP) in Canada, Albert Labs is also able, once a medicinal product is approved, to provide health care professionals with medicines under prescribed conditions.

“This is an important milestone for Albert Labs; it firms up our supply chain and provides us with more market opportunities,” said Dr. Michael Raymont, CEO. He continued, “We have spent significant effort to develop our production technology, allowing us to cultivate and process the most consistent natural pharmaceutical psilocybin products in the industry. With this license, we now have the flexibility to produce and supply precursor APIs to our own operations in Europe and to explore sales to other customers in Canada and elsewhere.” Listen more to what Dr. Michael Raymont had to say here.

Dr. Raymont also endorsed Health Canada for its leadership in creating a favourable regulatory environment for advancing therapeutic uses for psilocybin. Dr. Raymont added, “The Canadian Government has created a beneficial environment for business to develop psychotherapeutic prescription drugs, which have the potential to help millions of sufferers with anxiety, depression and other mental health indications. Mental health issues can ruin lives, wreck families, and cost economies billions in lost productivity. It’s inspiring to see Canada as a leader in mental health R&D and treatments.”

Business of Albert Labs

Albert Labs is a clinical research and drug development enterprise, and its team of experts leverage advanced culture and extraction technologies to accelerate the development of effective mental health medicines. Through collaborations with research institutions, hospitals and government agencies, and by the use of expedited regulatory approval pathways, Albert Labs is able to rapidly assess candidate products for their potential as licensed medicines in the treatment of mental health illnesses.

Albert Labs’ first product, KRN-101, is believed to act on 5-HT2A receptors and is being investigated as a potential treatment for cancer-related anxiety. With over 15 million people thought to suffer from the condition and approximately 1 million new sufferers diagnosed each year, cancer-related distress represents an urgent and unmet need in mental health treatment. From this initial focus, Albert Labs will address broader mental health disorders, reported to affect over a billion people worldwide.

Albert Labs (CSE: ABRT) (FSE: VB50) recently executed a listing on the Canadian Securities Exchange (CSE) and filed a provisional patent for the scalable production of natural psilocybin medicine. You can find more details at albertlabs.com or watch a short “About Albert Labs” video here.

ON BEHALF OF THE BOARD OF DIRECTORS

Albert Labs International Corp.

Dr. Michael Raymont

Chief Executive Officer & Chairman

For further information please contact:
Email: press@albertlabs.com
Website: albertlabs.com
Canada: +1 778-819-0740
United Kingdom: +44 1625 324 960

Cautionary Statement

This news release includes forward-looking statements that are subject to assumptions, risks, and uncertainties. Statements in this news release that are not purely historical are forward-looking statements, including without limitation any statements concerning the Company’s intentions, plans, estimates, beliefs, or expectations regarding the future. Although the Company believes that any such intentions, plans, estimates, beliefs, and expectations in this news release are reasonable, there can be no assurance that any such intentions, plans, beliefs, and expectations will prove to be accurate.
The Company cautions readers that all forward-looking statements, including without limitation those relating to the Company’s future operations and business prospects, are based on assumptions none of which can be assured, and are subject to certain risks and uncertainties that could cause actual events or results to differ materially from those indicated in the forward-looking statements. Readers are advised to rely on their evaluation of such risks and uncertainties and should not place undue reliance on forward-looking statements.
Any forward-looking statements are made as of the date of this news release, and the Company assumes no obligation to update the forward-looking statements or to update the reasons why actual events or results could or do differ from those projected in the forward-looking statements. The Company assumes no obligations to update any forward-looking statements, whether as a result of new information, future events, or otherwise unless required by the applicable securities laws.

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Legal psilocybin therapy comes to Quebec

Numinus Wellness Receives Health Canada Special Access Program Applicant Approval to Provide Psychedelic-assisted Therapy Treatment

After several unsuccessful depression treatments, a patient in Quebec will finally get to try psilocybin therapy through the Special Access Program (SAP), marking the first legal psilocybin treatment in the province.

Numinus Wellness (NUMI) received Health Canada approval to administer the treatment at its Montreal clinic. It will be the company’s first treatment outside of a clinical trial setting.

Hopefully we’ll start seeing more wins like this thanks to TheraPsil, a non-profit that launched an initiative to make it easier for patients to access psilocybin through the SAP. 

The initiative, called Project Solace, will secure a safe supply of psilocybin from HAVN Life (HAVN) and other licensed dealers and collect data on treatment outcomes to support policy change. 

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Red Light Holland Successfully Imports 200 Psilocybin iMicrodose Packs, Sold in The Netherlands, Into Canada Under a Third Health Canada Approved Psilocybin Import Permit To cGMP Laboratory

Red Light Holland Successfully Imports 200 Psilocybin iMicrodose Packs, Sold in The Netherlands, Into Canada Under a Third Health Canada Approved Psilocybin Import Permit To cGMP Laboratory

  • Red Light Holland proudly exports a commercial sale of 3000 Grams (200 x 15g packs) of Psilocybin Truffles (Psilocybe Tampanensis) grown in the Company’s Farm in Horst, The Netherlands to its laboratory partner, CCrest Laboratories Inc., a cGMP pharmaceutical laboratory in Montreal, Canada
  • Red Light Holland has an established alliance with CCrest Laboratories Inc. in partnership with Shaman Pharma Corp., who have been listed by Health Canada as a Psilocybin supplier to the Special Access Program.
  • CCrest Laboratories will continue to perform stability tests and R&D towards creating a standardized consistent dose from naturally occurring psilocybin truffles.

Toronto, Ontario–(Newsfile Corp. – May 16, 2022) – Red Light Holland Corp. (CSE: TRIP) (FSE: 4YX) (OTC Pink: TRUFF) (“Red Light Holland” or the “Company“), an Ontario-based corporation engaged in the production, growth and sale of a premium brand of it’s Psilocybin magic truffles, is pleased to announce that it has completed the third export of the company’s freshly harvested high-grade psilocybe truffles, from the Netherlands to Canada, under a Health Canada psilocybin import permit awarded to CCrest Laboratories Inc. in partnership with Shaman Pharma Corp. CCrest Laboratories received 200 of Red Light Holland’s psilocybe truffles kits, a total of 3 kg (200 x 15g packs) of Psilocybin Truffles (Psilocybe Tampanensis) grown in the Company’s Farm in Horst, The Netherlands.

“I’m absolutely thrilled to have completed our third import and sale of our Psilocybin Truffles from the Netherlands to Canada to our partners CCrest Labs, who have been listed as a provider of Psilocybin for the Special Access Program by Health Canada,” said Todd Shapiro, CEO and Director of Red Light Holland. “We thought it was important to ship a large number of our actual iMicrodose packs to CCrest Labs this time, in case they could ever be used by patients through the Special Access Program. This is just another milestone for Red Light Holland and our loyal shareholders.”

“Our previous testing has shown that our truffles are suitable as a source of active pharmaceutical ingredients (“API”) for scientific and potentially medical and therapeutic purposes and we are excited to continue the testing and R&D with our partners at CCrest Labs,” said Sarah Haskes, CTIO of Red Light Holland. “We continue to move towards our goal of creating a standardized consistent dose from naturally occurring psilocybin truffles, which our market research shows people are interested in. This can potentially benefit both the recreational and medicinal markets and we continue our path to work within the careful means of the regulatory process with reliable partners in hopes of pushing for safe, responsible access to the company’s naturally occurring psilocybin by testing, learning and educating the public and hopefully Governments right here in Canada and across the world.”

CCrest Laboratories, a cGMP pharmaceutical laboratory in Montreal specializing in highly regulated narcotics, including psychedelics, holds a Health Canada Controlled Drugs and Substances License, and received federally issued import permits for the restricted drug Psilocybin. CCrest has also been listed as a provider of Psilocybin for the Special Access Program in Canada.

Shaman Pharma, working in conjunction with CCrest Laboratories, is developing cGMP compliant scientific methods and protocols of Quality Control, Analysis and Extraction, aimed at industrial-scale commercialization of medical purpose psychedelic substances in this emerging pharmaceutical sector. Together with Red Light Holland, the companies are setting the pace at which regulatory requirements are exceeded, opening a new realm of possibilities for disruptive healthcare innovation.

“This third shipment marks the continuation of the previously announced progress achieved between Red Light Holland and CCrest Labs,” commented Alex Grenier, CEO of Shaman Pharma and President of CCrest Laboratories. “Notable points are that we have a 100% success rate while increasing quantities, it looks promising for a certain maturity and scale in a supply chain that had not been achieved until now. We set out to demonstrate beyond any doubt that patients, and responsible adults in general, should be able to reliably and safely access psilocybin from natural sources. While much research remains, so far there doesn’t seem to be any impurities or toxins present that would disqualify a natural source. Actually, to us it is rapidly becoming more interesting to study than pure (synthetic) psilocybin. Simply put, it’s a richer platform for discovery, and we would hate to miss out on something that nature has potentially perfected.”

Making larger quantities available to the scientists enables deepening the research into the composition of the raw materials – the scientific protocols are now expanded for the detection and quantification of other active ingredients known to exist alongside psilocybin and psilocin, mainly the compounds norpsilocin, baeocystin, norbaeocystin and aeruginascin. While expected to be present in very small quantities, they could prove to have large modulation effects. This could arguably establish a new realm of possibilities beyond simple dosage of psilocybin, where a near infinite number of combinations exist between the various compounds.

About Red Light Holland

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

For additional information on the Company:

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

About Shaman Pharma Corp.

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

Forward-Looking Statements

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

Certain information set forth in this news release may contain forward-looking statements that involve substantial known and unknown risks and uncertainties, certain of which are beyond the control of Red Light Holland. Forward-looking statements are frequently characterized by words such as “plan”, “continue”, “expect”, “project”, “intend”, “believe”, “anticipate”, “estimate”, “may”, “will”, “potential”, “proposed” and other similar words, or statements that certain events or conditions “may” or “will” occur. These statements are only predictions. Readers are cautioned that the assumptions used in the preparation of such information, although considered reasonable at the time of preparation, may prove to be imprecise and, as such, undue reliance should not be placed on forward-looking statements. Forward looking statements include, but are not limited to: statements with respect to the evaluation and testing of the Company’s naturally occurring psilocybe truffles by CCrest Laboratories for scientific and medical purposes; the potential of the Company’s products being used for scientific and medical purposes; the potential of the Company’s products being used for Health Canada’s Special Access Program; the potential for Red Light Holland, CCrest Labs and Shaman Pharma to be disruptive in healthcare innovation; statements with respect to the Company’s expansion into the mental wellness pharmaceutical sector; the future sharing of the test results with the Company’s customers and shareholders; the future ability to create standardized dosages from naturally occurring products from psilocybin; and the Company’s ability to establish itself as the leader in the recreational psychedelics’ sector.

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

These statements involve known and unknown risks, uncertainties and other factors, which may cause actual results, performance or achievements to differ materially from those expressed or implied by such statements, including but not limited to: the inability of the Company to continue as a going concern; the inability of the Company to obtain all necessary governmental and/or other regulatory approvals, licenses, and permits necessary to operate and expand the Company’s facilities; the effect of regulatory and/or political change and its effect on the legislation and regulations surrounding the psychedelics industry; the negative perception of the medical-use and adult-use psilocybin industry; the inability of CCrest to complete the planned testing of the Company’s products; the inability of CCrest labs and Red Light Holland to advance standardized doses of psilocybin; the potential unviability of psilocybin for medical and/or scientific purposes; the potential to ever have the Company’s Truffles approved for patients under Health Canada’s Special Access Program the inability of the Company to continue its growth; the Company’s limited operating history; reliance on management; the Company’s requirements for additional financing; and competition for mental health and wellness investments.

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

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

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Mushroom case ruling sparks controversy

Supreme Court says MRU student’s magic mushroom assault defence was valid

In some highly controversial news, the Supreme Court of Canada decided that voluntary extreme intoxication is a valid defence for violent crimes.

The court ruled in favour of a student who attacked his professor while high on magic mushrooms and alcohol in 2018. They noted that he was in a state of “automatism” in which he was incapable of consciously controlling his behaviours, and therefore isn’t accountable.

“In Canada, two elements of fundamental justice are required for a person to be found guilty of a crime. They are a guilty action; and a guilty mind. Neither element is present when a person is in a state of automatism,” stated the court in a brief of the ruling.

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