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Treating meth addiction and brain damage

Revive Therapeutics Provides Update on Psychedelics Clinical Product Pipeline

Revive Therapeutics (RVV) is partnering with the University of Wisconsin-Madison to conduct two exciting new psilocybin studies.

One study will research the effect of psilocybin on traumatic brain injury (TBI) and strokes, expanding on preclinical findings that psilocybin improved cognitive function in mice with TBI.

Revive will also conduct a Phase 1/2 clinical study to determine psilocybin’s impact on adults with methamphetamine use disorder. Both studies will begin patient enrollment by the end of the year.

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Seelos Therapeutics Announces Mid-Year 2021 Business and Clinical Update

Seelos Therapeutics Announces Mid-Year 2021 Business and Clinical Update

NEW YORK, Aug. 9, 2021 /PRNewswire/ — Seelos Therapeutics, Inc. (Nasdaq: SEEL), a clinical-stage biopharmaceutical company focused on the development of therapies for central nervous system disorders and rare diseases, today announced its mid-year 2021 business and clinical update.

“In the first half of 2021, the Seelos team continued to execute at a very high level. Part 1 of the SLS-002 study demonstrated rapid antidepressant and anti-suicidal effects with a well-tolerated safety profile. We have begun the placebo-controlled Part 2 of this registration directed study and plan to enroll in up to 30 sites,” said Raj Mehra Ph.D., Chairman and CEO of Seelos. “The SLS-005 IV trehalose program’s pivotal study in ALS, which was accepted into the HEALEY ALS Platform Trial at Harvard, plans to commence dosing patients in the third quarter as well. We have begun additional in vivo studies with our gene therapy program SLS-004 after demonstrating its capability of reducing alpha-synuclein expression targeting Parkinson’s disease, and we continue to evaluate additional indications for both SLS-002 and SLS-005.”

In the first half of 2021, Seelos achieved several major clinical and financial milestones and continued to make progress on its multiple clinical stage development programs.

Seelos Business Update

As of the end of Q2, Seelos had $87.2mm of cash. It currently has no outstanding debt.

In January, Seelos raised $33.5 million in net proceeds in an offering of common stock. The company raised an additional $65 million in net proceeds in another offering of common stock. Proceeds were used for the full repayment of Seelos’ prior convertible promissory notes and the remainder is for general corporate purposes and to advance the development of its product candidates.

Also in January, Seelos was selected as one of 17 companies included in the world’s first psychedelic Exchange Traded Fund (ETF), the Horizons Psychedelic Stock Index Fund, which trades on Canada’s NEO exchange and, in June, Seelos was included in the Defiance Next Gen Altered Experience ETF, the first U.S. listed Exchange Traded Fund (ETF) focused on psychedelics, which began trading on May 28th.

In February, Seelos announced an amendment of its agreement with Vyera Pharmaceuticals AG for the development of SLS-002 (intranasal racemic ketamine) to repurchase in cash 9% of the royalties payable on any future net sales of SLS-002.

In April, Seelos announced a Strategic Device Partnership with AptarGroup, Inc. for the co-exclusive use and supply of Aptar Pharma’s Bidose (BDS) Liquid System device for SLS-002 in the investigational development programs for the treatment of suicidality, depression, and Post-Traumatic Stress Disorder (PTSD) and under the terms of the agreement, Seelos has certain rights to add other undisclosed indications to the Strategic Device Partnership.

Seelos was added to the Russell 2000®, Russell 3000®, and Russell Microcap® Indexes at the end of June, as part of the 2021 Russell US Indexes Reconstitution.

Seelos Clinical Update

SLS-002 (intranasal racemic ketamine)

  • Data for Part 1, the open-label cohort, of the registration directed study for Acute Suicidal Ideation and Behavior in patients with Major Depressive Disorder demonstrated a significant treatment effect plus a well-tolerated safety profile.
  • In early July, dosing of Part 2, the double-blind, placebo-controlled cohort of the study commenced. A super-majority of the trial sites are in various stages of onboarding.
  • On June 15th, Seelos completed a Type C meeting with the FDA to discuss the regulatory pathway for the SLS-002 program.

SLS-005 (IV trehalose)

  • Seelos was issued a patent from the Australian Patent Office covering the parenteral administration of SLS-005  in multiple neurodegenerative indications.
  • A Notice of Allowance was received from the Japanese Patent Office covering the parenteral administration of SLS-005 in treating oculopharyngeal muscular dystrophy (OPMD).
  • SLS-005 received European Orphan Drug designation for ALS.
  • In the third quarter, Seelos is expected to commence dosing of a pivotal Phase IIb/III trial in amyotrophic lateral sclerosis (ALS) as part of the HEALEY ALS Platform Trial led by Harvard Medical School at Massachusetts General Hospital at several dozen trial sites across the U.S.

SLS-004 (Parkinson’s disease gene therapy programs)

  • In vivo data was released in early July demonstrating down-regulation of SNCA mRNA and protein-expression from a study of SLS-004 in an in-vivo rodent model utilizing CRISPR-dCas9 gene therapy technology.
  • Additional studies have commenced to explore efficacy of SLS-004 in the induced Parkinsonism in an in vivo rodent model.

If you or a loved one are having thoughts of suicide, please seek immediate medical help, go to your nearest emergency room, or call the National Suicide Prevention Lifeline at 1-800-273-8255.

Forward Looking Statements

Statements made in this press release, which are not historical in nature, constitute forward-looking statements for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. These statements include, among others, those regarding enrollment in Seelos’ Part 2 of the SLS-002 registration directed study focused on patients with major depressive disorder (the “SLS-002 Study”), and the planned dosing of patients in the SLS-005 IV trehalose program’s pivotal study in ALS (with SLS-002 Study, collectively, the “Studies”). These statements are based on Seelos’ current expectations and beliefs and are subject to a number of risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Risks associated with Seelos’ business and plans described herein include, but are not limited to, the risk of not successfully executing its preclinical and clinical studies, or continuing the Studies, and not gaining marketing approvals for its product candidates, the risk that prior clinical results may not be replicated in future studies and trials (including the risk that the clinical results from the Studies are not replicated, or the risk that the clinical results from the SLS-002 Study are materially different from the topline clinical results of Part I of the SLS-002 Study), the risks that clinical study results may not meet any or all endpoints of a clinical study and that any data generated from such studies may not support a regulatory submission or approval, the risks associated with the implementation of a new business strategy, the risks related to raising capital to fund its development plans and ongoing operations, risks related to Seelos’ current stock price, risks related to the global impact of COVID-19, as well as other factors expressed in Seelos’ periodic filings with the U.S. Securities and Exchange Commission, including its most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, even if subsequently made available by us on our website or otherwise. We do not undertake any obligation to update, amend or clarify these forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws.

Contact Information:

Anthony Marciano
Head of Corporate Communications
Seelos Therapeutics, Inc. (Nasdaq: SEEL)
300 Park Avenue
New York, NY 10022
(646) 293-2136
anthony.marciano@seelostx.com
https://seelostherapeutics.com/
https://twitter.com/seelostx
https://www.linkedin.com/company/seelos

SOURCE Seelos Therapeutics, Inc.

Related Links

https://seelostherapeutics.com

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Silo Wellness Brings Marley One Mushrooms to the U.K. Market through Distribution Agreement with LocoSoco Limited

Silo Wellness Brings Marley One Mushrooms to the U.K. Market through Distribution Agreement with LocoSoco Limited

TORONTO, Aug. 05, 2021 (GLOBE NEWSWIRE) — Silo Wellness Inc. (“Silo Wellness” or the “Company”) (CSE: SILO) (OTCQB: SILFF) (FRA: 3K70), a leading global psychedelics company, today announced a nationwide distribution partnership with Essex-based U.K. brand distributor LocoSoco Group Plc (“LocoSoco”) (DIMA: AV), pursuant to a distribution agreement dated August 4, 2021 (the “Distribution Agreement”). The Distribution Agreement stipulates LocoSoco as the exclusive U.K. distributor for Silo Wellness’ full portfolio of Marley One branded mushroom products.

This partnership announcement comes on the heels of Silo Wellness’ launch of Marley One, the first global functional and psychedelic mushroom consumer brand, created in collaboration with the family of legendary musician Bob Marley. The Distribution Agreement cements a solid route to market for Marley One products that can keep pace with consumer demand across the region. Silo Wellness is also the first global psychedelics company to access the nationwide network of a large-scale distributor to reach consumers across the U.K. at mainstream retail stores.

“Since the launch of Marley One, we’ve been vetting potential partners to help us bring the powerful health and wellness benefits of functional mushrooms to the U.K., where consumer interest in these products is on the rise, and psychedelic products as regulations allows,” said Douglas K. Gordon, Chief Executive Officer, Silo Wellness. “In LocoSoco, we’ve found a uniquely structured distribution network and like-minded collaborator who shares not only our dynamic vision for the mushroom category but also our principles around community building and value sharing at every point in the supply chain. We think the industry at large will benefit from the synergies of these two established, publicly-traded companies working in sync.”

LocoSoco will distribute the full line of Marley One mushroom products, beginning with the brand’s initial five functional mushroom tinctures, to independent retailers, buying groups, health food stores, online retailers and influencers and their e-commerce affiliates, across the United Kingdom. The exclusive distribution by LocoSoco is based on a minimum commitment of orders with a value of US $1.4M of Marley One products. The Agreement reflects consumer demand for mushroom-based wellness products and the market potential for functional mushrooms in particular, which constituted a GBP £18,409 million, or US$25,415 million market globally, in 2020, according to Mordor Intelligence. The global psychedelic drugs market at large is projected to reach US$6.85 billion by 2027, growing at a CAGR of 16.3% over the next eight years, according to Data Bridge Market Research.

The initial portfolio of Marley One mushroom products is a range of functional mushroom tinctures with unique blends highlighting the brand’s connection to Jamaica. Marley One mushroom tinctures include species such as cordyceps, lion’s mane, chaga, reishi and turkey tail that offer a range of distinct health and wellness benefits, from improved immunity and gut health to cognitive function and sleep enhancement. The Company intends to launch a psychedelic mushroom product line under the Marley name later this year, to be followed by additional functional mushroom products including gummies, capsules and cosmetics. LocoSoco will be the sole distributor of Marley products across the U.K.

“We are thrilled to align with Silo Wellness, a company catalyzing growth in the burgeoning functional mushroom industry, to build a strategic route to market for their iconic Marley One product portfolio,” said James Perry, Founder and Chief Executive Officer of LocoSoco. “We are extremely selective with who we choose to partner with, and we’re proud to leverage our unique network of local and independent retailers to support a future-thinking, sustainable and ethical brand like Marley One in gaining access to consumers and communities across the U.K.”

For more information about Silo Wellness, please visit https://www.silowellness.com/. To buy Marley One products outside of the U.K., please visit https://marleyone.com/ and visit https://locoso.co/marley-one for U.K. sales.

ABOUT SILO WELLNESS
Silo Wellness is a growth-oriented holding company focused on functional mushroom and psychedelic opportunities that benefit from a unified ecosystem and exceptional leadership. Founded in 2018 and headquartered in Toronto, Silo Wellness has operations in Jamaica and Oregon. Silo Wellness is a publicly-traded company on the Canadian (CSE: SILO) and Frankfurt (FRA: CK70) exchanges and trading on the OTCQB Venture Market (OTCQB: SILFF).

Silo Wellness offers a diverse and growing portfolio of functional mushroom products, psychedelic wellness retreats in Jamaica and Oregon, cultivation of psychedelic mushrooms and truffles in Jamaica, development of a brick-and-mortar smart shop in Jamaica, and intellectual property, focused initially on the commercialization of its metered-dosing psilocybin nasal spray.

In March 2021, Silo Wellness announced a multi-year licensing agreement with the family of legendary musician Bob Marley for the exclusive worldwide rights to brand, market and sell a distinct product line of functional and psychedelic mushrooms. The Marley One line of functional mushrooms is available at www.marley.one.

For more information about Silo Wellness, please visit www.silowellness.com.

For further information, please contact:

Silo Wellness Media Relations:
hello@trailblaze.co

Silo Wellness Investor Relations:
(778) 383-6740
ir@silowellness.com

ABOUT LOCOSOCO GROUP PLC

LocoSoco builds technology to profit from creating sustainable communities. We work with community partners to turn community assets into eco-enterprises enabling them to generate additional revenues whilst supporting the transition to sustainable alternatives.

Community partners have the opportunity to engage with their local community on sustainability, whilst also earning additional revenue for themselves, their businesses and causes.
LocoSoco Group Plc listed on the Austrian Wiener Borse Direkt Market in February 2019.

CAUTIONARY NOTE REGARDING FORWARD-LOOKING INFORMATION: This news release contains “forward-looking information” and “forward-looking statements” (collectively, “forward-looking statements”) within the meaning of the applicable Canadian securities legislation. All statements, other than statements of historical fact, are forward-looking statements and are based on expectations, estimates, and projections as at the date of this news release. Any statement that involves discussions with respect to predictions, expectations, beliefs, plans, projections, objectives, assumptions, future events or performance (often but not always using phrases such as “expects”, or “does not expect”, “is expected”, “anticipates” or “does not anticipate”, “plans”, “budget”, “scheduled”, “forecasts”, “estimates”, “believes” or “intends” or variations of such words and phrases or stating that certain actions, events or results “may” or “could”, “would”, “might” or “will” be taken to occur or be achieved) are not statements of historical fact and may be forward-looking statements. In this news release, forward-looking statements relate, among other things, to: the Distribution Agreement, the distribution partnership with LocoSoco and the business plans of Silo Wellness. Forward-looking statements are necessarily based upon a number of estimates and assumptions that, while considered reasonable, are subject to known and unknown risks, uncertainties, and other factors which may cause the actual results and future events to differ materially from those expressed or implied by such forward-looking statements. Such factors include, but are not limited to: general business, economic, competitive, political and social uncertainties and the potential impact of COVID-19. There can be no assurance that such statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Readers should not place undue reliance on the forward-looking statements and information contained in this news release. Silo Wellness assumes no obligation to update the forward-looking statements of beliefs, opinions, projections, or other factors, should they change, except as required by law.

NEITHER THE CANADIAN SECURITIES EXCHANGE NOR ITS REGULATION SERVICES PROVIDER ACCEPTS RESPONSIBILITY FOR THE ADEQUACY OR ACCURACY OF THIS RELEASE.

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PsyBio Therapeutics Adds NMDA Receptor Antagonists and Associated Analogues into its Intellectual Property Portfolio

PsyBio Therapeutics Adds NMDA Receptor Antagonists and Associated Analogues into its Intellectual Property Portfolio

PsyBio has filed a new provisional patent and is initiating preclinical studies aimed at treating neurologic and psychologic conditions

COCONUT CREEK, Fla, Aug. 4, 2021 /CNW/ – PsyBio Therapeutics Corp. (TSXV: PSYB) (OTCQB: PSYBF) (“PsyBio” or the “Company“), an intellectual property driven biotechnology company developing novel formulations of psychoactive medications produced by genetically modified bacteria and other innovative mediums for the potential treatment of mental health challenges and other neurological disorders, has initiated a new program to study N-methyl-D-aspartate (“NMDA“) receptor antagonists and associated analogs for potential activity against a variety of human health conditions.

The Company has filed a new provisional patent application with the United States Patent and Trademark Office entitled NMDA Receptor Antagonist-Containing Compositions and Methods of Treatment. The addition of NMDA receptor antagonists with pending patent protection is highly focused on the potential improvement of neurological conditions including traumatic brain injury, other neurological deficits, addiction as well as other psychological conditions.

NMDA receptor antagonists play an important role in the health and function of neurons and have been implicated by a number of studies to be strongly involved with exitotoxicity and also associated with promoting synaptic plasticity. Research also indicates that some NMDA receptor antagonists also interact with nicotinic acetylcholine receptors leading to the release of neurotransmitters. Many compounds in this class have been approved by the United States Food and Drug Administration (“FDA“) as anesthetics and are under evaluation for other indications within the brain.

The scientific discovery, clinical pharmacology and drug development team at PsyBio has identified NMDA receptor antagonists and their analogues for their role in promoting neuroplasticity as potential therapeutic targets for a wide variety of disease indications. PsyBio continues utilizing its resources to rapidly develop and test new drug candidates in anticipation of launching future clinical trials.

“PsyBio is distinctively positioned as one of the leading biotechnology companies sponsoring commercial development of new therapeutic targets for myriad human health conditions,” stated Evan Levine, PsyBio’s Chief Executive Officer. “The Company is actively screening drug candidates across a variety of medical indications and will utilize its regulatory experience to submit proposals for human clinical trials based upon those preclinical studies to the FDA and other regulatory bodies. The Company retains expertise across a wide range of pharmaceutical discovery and development including synthetic biology, molecular engineering, neurobiopsychology, translational medicine and clinical pharmacology and is leveraging this ability to work towards shepperding new therapeutics to treat unmet medical needs.”

“PsyBio has unique expertise in clinical pharmacology and is actively expanding its portfolio of drug candidates and remains particularly interested in advancing therapeutic understanding and potential treatment of neurologic and psychologic conditions,” stated Dr. Michael Spigarelli, PsyBio’s Chief Medical Officer. “The advantages of utilizing compounds, exhibiting previously known neurological or psychological effect, to harness the opportunity to develop potential therapeutics more rapidly than previously conceived.”

PsyBio’s intellectual property portfolio now includes six pending provisionals and one pending non-provisional patent application.

About PsyBio Therapeutics Corp.

PsyBio Therapeutics is an intellectual property driven biotechnology company developing novel formulations of psychoactive medications for the potential treatment of neurologic and psychologic conditions. The team has extensive experience in drug discovery based on synthetic biology and metabolic engineering as well as clinical and regulatory expertise progressing drugs through human studies and regulatory protocols. Research and development is currently ongoing for NMDA receptor antagonists.

Cautionary Note Regarding Forward-Looking Statements

This press release contains statements that constitute “forward-looking information” (“forward-looking information“) within the meaning of applicable Canadian securities legislation. All statements, other than statements of historical fact, are forward-looking information and are based on expectations, estimates and projections as at the date of this news release. Any statement that discusses predictions, expectations, beliefs, plans, projections, objectives, assumptions, future events or performance (often but not always using phrases such as “expects”, or “does not expect”, “is expected”, “anticipates” or “does not anticipate”, “plans”, “budget”, “scheduled”, “forecasts”, “estimates”, “believes” or “intends” or variations of such words and phrases or stating that certain actions, events or results “may” or “could”, “would”, “might” or “will” be taken to occur or be achieved) are not statements of historical fact and may be forward-looking information. Forward looking-statements in this press release include statements regarding: the ability of PsyBio to develop novel formulations to potentially treat neurologic and psychologic conditions and other disorders; and the ability of PsyBio to launch clinical trials.

In disclosing the forward-looking information contained in this press release, the Company has made certain assumptions, including that: PsyBio will be successful in protecting its intellectual property; PsyBio will be successful in discovering new valuable target molecules; PsyBio will file its initial pre-Investigational New Drug (“IND”)  Application request and IND Application within anticipated timeframes; PsyBio will be successful in obtaining IND Applications and will be able to obtain all necessary approvals for clinical trials; PsyBio will be successful in launching clinical trials; PsyBio’s technology will be safe and effective; and that drug development involves long lead times, is very expensive and involves many variables of uncertainty. Although the Company believes that the expectations reflected in such forward-looking information are reasonable, it can give no assurance that the expectations of any forward-looking information will prove to be correct. Known and unknown risks, uncertainties, and other factors which may cause the actual results and future events to differ materially from those expressed or implied by such forward-looking information. Such factors include, but are not limited to: compliance with extensive government regulations; domestic and foreign laws and regulations adversely affecting PsyBio’s business and results of operations; decreases in the prevailing process for psilocybin and nutraceutical products in the markets in which PsyBio operates; the impact of COVID-19; and general business, economic, competitive, political and social uncertainties. Accordingly, readers should not place undue reliance on the forward-looking information contained in this press release. Except as required by law, the Company disclaims any intention and assumes no obligation to update or revise any forward-looking information to reflect actual results, whether as a result of new information, future events, changes in assumptions, changes in factors affecting such forward-looking information or otherwise.

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

The TSX Venture Exchange (“TSXV“) has neither approved nor disapproved the contents of this news release. Neither the TSXV nor its Regulation Services Provider (as that term is defined in the policies of the TSXV) accepts responsibility for the adequacy or accuracy of this release.

SOURCE PsyBio Therapeutics Corp.

For further information: Evan Levine, CEO, PsyBio Therapeutics Corp., t: 513.449.9585, e: ir@psybiolife.com; Investor Enquiries: Valter Pinto / Tim Regan, KCSA Strategic Communications, t: 212.896.1254, e: valter@kcsa.com

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Mark Haden, Psychedelic Medicine Expert, Joins Clearmind Medicine’s Advisory Board

Mark Haden, Psychedelic Medicine Expert, Joins Clearmind Medicine’s Advisory Board

Initial Focus on MEAI ClinicalTrial Protocol

TORONTO,Aug. 3, 2021 — Clearmind Medicine Inc. (CSE: CMND) (“Clearmind” or the”Company“), a psychedelic medicine biotech company focused onthe discovery and development of novel psychedelic-derived therapeutics tosolve widespread and undertreated health problems, announces that Mark Hadenhas joined the Company’s Scientific Advisory Board (the “SAB”). The SAB’sinitial focus will be providing guidance on the Company’s request for anInvestigational New Drug review from the US Food and Drug Administration (“FDA”)for MEAI, for treating Alcohol Use Disorder (“AUD”).

Arecognized leader in the field, Mr. Haden has spent his career working toadvance the use of psychedelics in medicine. He currently serves as director ofclinical research at Psygen Industries, a manufacturer of pharmaceutical-gradepsychedelic drug products for clinical research and therapeutic applicationsand is an adjunct professor at the University of British Columbia School ofPopulation and Public Health.

Mr.Haden has substantial research experience, including a leadership role in thePRIME study (Psilocybin Research Investigating Medical Efficacy), whichexplores psilocybin as an adjunct in the treatment of substance use disorders,and he has spent 10 years as the chairman and executive director of MAPS Canada(Multidisciplinary Association for Psychedelic Studies), an organization hefounded. He has also dedicated over 25 years to working directly with patientsthrough the Vancouver Coastal Health Addiction Services at the Pacific SpiritCommunity Health Centre.

Heis a frequent keynote speaker on the topic of psychedelics and has beenpublished in a number of journals, including the Canadian Journal of PublicHealth, International Journal of Drug Policy, Encyclopedia of Public Health,Harm Reduction Journal, Open Medicine, Journal of Psychoactive Drugs, and theJournal of Studies on Alcohol and Drugs. He was also instrumental in helpingthe Health Officers Council of British Columbia develop their position papers,lectures and presentations on issues regarding the regulation of illegal drugs.

“Markis an important addition to our SAB. He is one of the world’s leading advocatesfor the legalization of psychedelics and a strong proponent of their medicinalvalue. His research into psychedelics and their potential to treat addictionparallels the work we are doing to develop therapies to manage AUD, and I amconfident that his contribution to our efforts to secure FDA approval for MEAI willbe invaluable,” commented Adi Zuloff-Shani, Ph.D., CEO of Clearmind.

Mr.Haden noted, “Clearmind’s innovative approach to harnessing the propertiesof psychedelics to create therapeutics for mental health issues has thepotential to change millions of lives around the world. I have spent my careeron a similar quest, and I am delighted to facilitate this effort in any way Ican. I very much look forward to working with the talented team at Clearmind aswell as the other distinguished members of the advisory board.”

AboutClearmind Medicine Inc.

Clearmindis a psychedelic pharmaceutical biotech company focused on the discovery anddevelopment of novel psychedelic-derived therapeutics to solve widespread and underservedhealth problems, including alcohol use disorder. Its primary objective is to researchand develop psychedelic-based compounds and attempt to commercialize them asregulated medicines, foods or supplements.

TheCompany’s intellectual portfolio currently consists of two patent families. Thefirst, “Binge Behavior Regulators”, has been granted in the U.S.,Europe, China and India, with pending divisional applications in Europe and theU.S. The second, “Alcohol Beverage Substitute”, has been approved for aEuropean patent, with pending applications in the U.S., China and India. TheCompany intends to seek additional patents for its compounds whenever warrantedand will remain opportunistic regarding the acquisition of additional intellectualproperty to build its portfolio.

Sharesof Clearmind are listed for trading on the Canadian Securities Exchange underthe symbol “CMND.”

For further information, please contact:

Investor Relations,

Email:invest@clearmindmedicine.com

Telephone: (778) 400-5347

General Inquiries,

Info@Clearmindmedicine.com

www.Clearmindmedicine.com

FORWARD-LOOKING STATEMENTS:

Thisnews release may contain forward-looking statements and information based oncurrent expectations. These statements should not be read as guarantees offuture performance or results. Such statements involve known and unknown risks,uncertainties and other factors that may cause actual results, performance orachievements to be materially different from those implied by such statements.Such statements include submission of the relevant documentation within therequired timeframe to the satisfaction of the relevant regulators and raisingsufficient financing to complete the Company’s business strategy. There is nocertainty that any of these events will occur. Although such statements arebased on management’s reasonable assumptions, there can be no assurance thatsuch assumptions will prove to be correct. We assume no responsibility toupdate or revise them to reflect new events or circumstances.

Investinginto early-stage companies inherently carries a high degree of risk, andinvestment into securities of the Company shall be considered highlyspeculative.

Thispress release shall not constitute an offer to sell or the solicitation of anoffer to buy, nor shall there be any sale of the securities in any province inwhich such offer, solicitation or sale would be unlawful.

Neitherthe Canadian Securities Exchange (the “CSE”) nor its Regulation ServicesProvider (as that term is defined in the policies of the CSE) acceptsresponsibility for the adequacy or accuracy of this release.

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Taking Health Canada to court

Health Canada dragging feet on approving magic mushrooms for therapeutic use, patients and advocates say

To date, Health Canada has granted legal exemptions to 19 healthcare professionals and 32 terminally-ill patients so they can legally use psilocybin in clinical settings. The patients have reported life-changing results, yet at least 119 patients are still awaiting exemptions to gain access to the therapy, and experts are beginning to see the lengthy process as an ethical issue.

TheraPsil, a Victoria non-profit, has hired lawyers to take action against Health Canada and Health Minister Patty Hajdu through the federal court. TheraPsil’s efforts will hopefully speed up the application process and bring justice to patients who are desperate for psilocybin therapy.

 

 

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Exotic shrooms coming to a city near you

HAVN LIFE SIGNS AGREEMENT TO ENABLE EXPORT OF PSILOCYBIN INTO CANADA, THE US AND EUROPE

HAVN Life Sciences (HAVN) can now export Jamaican-grown psilocybin to Canada, the US, and Europe.

HAVN signed into an agreement with P.A. Benjamin Manufacturing Company, a Jamaican pharmaceutical company that will produce naturally-derived psilocybin at a GMP compliant facility. HAVN aims to be leader in the psychedelic supply chain by supplying researchers, patients, and companies across the globe with natural psilocybin.

 

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Diamond Therapeutics Hires Industry Veteran David Brown, PhD, to Further Advance Formulation of Psilocybin

Brown will lead Diamond’s pharmaceutical development activities

TORONTO, July 26, 2021 /CNW/ – Diamond Therapeutics Inc. (“Diamond”), a drug development company focused on low-dose psychedelic therapies for use in the treatment of mental health, today announced the appointment of David Brown, PhD, as vice president, pharmaceutical development.

Brown has an impressive track record of experience, having held senior positions at leading pharmaceutical companies, including Patheon, Teva and Impopharma. He has developed numerous dosage forms, including complex and high barrier-to-entry drug-device combination products, for multiple global markets. His broad expertise includes program management; he has successfully taken projects from pipeline selection and project concept through to commercialization. Brown completed his PhD in pharmaceutics at the School of Pharmacy, University of London.

“With the global mental health crisis and lack of effective treatment options, the unique characteristics of psychedelics offer the promise of bringing exciting new options to patients with unmet needs,” says Brown.

“I am delighted to join Diamond’s impressive leadership team to work with highly regarded experts and partners.”

At Diamond, Brown will be heading cutting-edge research and development regarding the formulation of low-dose psychedelics for pharmaceutical uses and the synthesis of novel compounds.

He will work closely with leading pharmaceutical manufacturer Dalton Pharma Services, which has an exclusive worldwide partnership with Diamond to provide cGMP psilocybin and other compounds to support clinical trials, research, and future commercial opportunities.

Dalton is one of only a few Canadian companies to successfully manufacture cGMP psilocybin for prospective use in regulatory submissions. The material already produced is sufficient for Diamond’s needs for its own clinical trials and research.

Dalton is Health Canada approved, FDA inspected and works in accordance with  International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines.

Brown’s work with Dalton will be instrumental to Diamond as it prepares to begin its clinical trial programs with low-dose psilocybin in the United States and Canada.

“We at Diamond are thrilled to have David join the team. The level of expertise he brings in developing pharmaceutical products will be key to accelerating our drug development efforts,” says Judy Blumstock, CEO of Diamond. 

About Diamond Therapeutics
Diamond Therapeutics is a psychedelic drug development company based in Toronto. Our mission is to develop new and better therapies for mental health conditions by unlocking the promise of psychedelic compounds. Diamond is focused on sub-perceptual, non-hallucinogenic treatments that hold potential for use across a broad patient cohort — maximizing the positive impact better drugs can have on the global mental health crisis. To learn more about Diamond, visit www.diamondthera.com.

About Dalton Pharma Services
Dalton Pharma Services is a leading North American cGMP pharmaceutical organization providing integrated drug discovery, development and manufacturing services. We are FDA inspected, Health Canada approved and bring over 30 years of experience to every project. We deliver fully integrated solutions with an emphasis on speed, flexibility and quality. Our integrated services all at one location help us to be adaptable, flexible and cost-effective. To learn more about our history and capabilities, please visit http://www.dalton.com.

SOURCE Diamond Therapeutics Inc.

For further information: Rebecca Brown, rebecca@diamondthera.com

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The legal magic mushroom that no one is talking about (yet)

The Other Magic Mushroom: Why a Canadian Startup Is Suddenly Interested in the Fungus From Super Mario

The iconic Super Mario mushrooms can actually help you level up?

As countless companies study the benefits of psilocybin mushrooms, Psyched Wellness is focusing on a different type of magic mushroom. The famous red and white spotted mushrooms are called Aminita muscaria, or fly agaric mushrooms, and they actually contain a psychoactive compound called muscimol.

Muscimol targets GABA-A receptors, whereas psilocybin targets serotonin receptors, so the experience and benefits are a bit different from typical magic mushrooms. While there isn’t much research on muscimol’s benefits, Psyched Wellness is changing this.

Psyched Wellness is in the process of making an Amanita muscaria extract to treat sleep disorders, stress, and physical pain. The company hopes to have an over-the-counter tincture for sale by mid-2022. Amanita muscaria mushrooms are legal in many countries including the US, so it will be much easier and cheaper to study their benefits and bring a product to market.