DMT – MJ Shareholders https://mjshareholders.com The Ultimate Marijuana Business Directory Fri, 04 Nov 2022 18:22:01 +0000 en-US hourly 1 https://wordpress.org/?v=6.5.3 Biomind Labs Announces Positive Initial Results From Its Phase II Trial on Its BMND01 Candidate for Treatment Resistant Depression https://mjshareholders.com/biomind-labs-announces-positive-initial-results-from-its-phase-ii-trial-on-its-bmnd01-candidate-for-treatment-resistant-depression/ Fri, 04 Nov 2022 18:22:01 +0000 https://www.cannabisfn.com/?p=2968019

Ryan Allway

November 4th, 2022

Psychedelics, Top News


TORONTO, November 04, 2022–(BUSINESS WIRE)–Biomind Labs Inc. (“Biomind Labs” or the “Company“) (NEO: BMND) (OTC: BMNDF) (FSE: 3XI), a leading biotech company focused on developing the next generation of pharmaceuticals to treat patients suffering from neurological and psychiatric disorders by scientifically harnessing the medicinal power of psychedelic molecules, is pleased to announce positive initial results from part I of its Phase II trial on its BMND01 candidate, a novel liquid inhaled formulation of N,N-Dimethyltryptamine (“DMT“) for Treatment-Resistant Depression (“TRD“).

“With the conclusion of the dosing sessions, 30 volunteers went through the activities of the proprietary clinical-experimental protocol developed by our scientific team, to verify the safety and tolerability of our novel DMT-based candidate BMND01 and protocol in healthy individuals. This is the world’s first in-lab study using an inhaled formulation of DMT, and the largest completed trial with this molecule. We are seeking to tackle one of the most concerning factors related to psychedelics as a potential novel treatment for mental health disorders, the long duration of the sessions. This trial aims to go through the full psychedelic experience in just 10 minutes. These successful first results bring strong potential for the next phase of the trial, which will address patients suffering from TRD”, commented Alejandro Antalich, CEO of Biomind Labs.

The trial, led by Professor Dráulio Araújo, Ph.D., has involved a dose exploration schedule ranging from 5 to 100 mg. No volunteer presented serious adverse events or clinical risk to the 11 different doses tested. “During the trial, we observed only a mild, transient and self-limited increase in blood pressure and heart rate of up to 30% compared to baseline values, with no clinical repercussions. This is a physiological increase comparable to moderate physical activity in healthy individuals”, commented Marcelo Falchi, M.D., Biomind Labs’ Head of the Psychiatric Research Unit, who sees excellent clinical potential and safety in DMT, “the only endogenous psychedelic molecule, which is already present in low concentrations in different organs of the human body”, said Marcelo Falchi, M.D.

The experimental design of this open-label ascending dose trial involved developing and implementing a proprietary clinical-experimental protocol based on the fundamentals of interventional psychiatry. This multidisciplinary approach combines a psychiatric procedure for dosing DMT associated with psychological support under strict clinical standards. “The model is intended to integrate into existing health systems globally, quickly and easily, positioning Biomind Labs’ BMND01 candidate at the frontier of accessible psychedelic medicine. By allowing the creation of specialized centers for the administration of DMT, it is possible to scale-up treatments without the need to train a whole new generation of mental health professionals”, concluded Alejandro Antalich, CEO of Biomind Labs.

The trial is registered at www.clinicaltrials.gov (NCT05573568).

About Biomind Labs Inc.

Biomind Labs is a biotech research and development company aimed at transforming biomedical sciences knowledge into novel pharmaceutical drugs and innovative nanotech delivery systems for a variety of psychiatric and neurological conditions. Through its acceleration platform, Biomind Labs is developing novel pharmaceutical formulations of the main psychedelic molecules DMT, 5-MeO-DMT and mescaline for treating a wide range of therapeutic indications. Biomind Labs’ focus is to provide patients access to affordable and modern-day treatments.

Cautionary Note Regarding Forward-Looking Statements

This press release contains statements that constitute “forward-looking information” (“forward-looking information”) within the meaning of the 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 document include, among others, statements relating to the Company’s ability to scientifically harness the medicinal power of psychedelic molecules to treat patients suffering from neurological and psychiatric disorders, any timeframes and possible results associated with the Company’s Phase II trial of the novel drug candidate BMND01; any statement regarding the creation of specialized centers for the administration of DMT; the Company’s ability to provide patients access to affordable and modern-day treatments; and other statements that are not historical facts.

By their nature, forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause our actual results, performance or achievements, or other future events, to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Such factors and risks include, among others: (a) the Company may require additional financing from time to time in order to continue its operations which may not be available when needed or on acceptable terms and conditions acceptable; (b) compliance with extensive government regulation; (c) domestic and foreign laws and regulations could adversely affect the Company’s business and results of operations; (d) the stock markets have experienced volatility that often has been unrelated to the performance of companies and these fluctuations may adversely affect the price of the Company’s securities, regardless of its operating peers; (e) adverse changes in the public perception of tryptamine-based treatments and psychedelic-based therapies; (f) the impact of COVID-19; and (g) 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.

The Company makes no medical, treatment or health benefit claims about the Company’s proposed products. The U.S. Food and Drug Administration, Health Canada or other similar regulatory authorities have not evaluated claims regarding tryptamine-based treatments, psychedelic-based therapies or other psychedelic compounds. The efficacy of such products has not been confirmed by approved research. There is no assurance that the use of psychedelic tryptamines, tryptamine derivatives or other psychedelic compounds can diagnose, treat, cure or prevent any disease or condition. Vigorous scientific research and clinical trials are needed. The Company has not yet completed commercial clinical trials for the use of its proposed products. Any references to quality, consistency, efficacy and safety of potential products do not imply that the Company verified such in commercial clinical trials or that the Company will complete such trials. If the Company cannot obtain the approvals or research necessary to commercialize its business, it may have a material adverse effect on the Company’s performance and operations.

The forward-looking information contained in this news release represents the expectations of the Company as of the date of this news release and, accordingly, is subject to change after such date. Readers should not place undue importance on forward-looking information and should not rely upon this information as of any other date. The Company undertakes no obligation to update these forward-looking statements in the event that management’s beliefs, estimates or opinions, or other factors, should change.

The Neo Exchange Inc. has neither approved nor disapproved the contents of this news release and is not responsible for the adequacy and accuracy of the contents herein.

View source version on businesswire.com: https://www.businesswire.com/news/home/20221104005328/en/

Contacts

Biomind Labs Inc.
Alejandro Antalich
Chief Executive Officer
Email: [email protected]
Tel: + 598 97 702500

This article was published by CFN Enterprises Inc. (OTCQB: CNFN), owner and operator of CFN Media, the industry’s leading agency and digital financial media network dedicated to the burgeoning CBD and legal cannabis industries. Call +1 (833) 420-CNFN for more information.

About Ryan Allway

Mr. Allway has over a decade of experience in the financial markets as both a private investor and financial journalist. He has been actively involved in the cannabis industry since its inception, covering public and private companies.


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Biomind Labs Announces Upgrade to the OTCQB® Venture Market in the United States https://mjshareholders.com/biomind-labs-announces-upgrade-to-the-otcqb-venture-market-in-the-united-states/ Thu, 17 Feb 2022 20:39:14 +0000 https://www.cannabisfn.com/?p=2937992

Ryan Allway

February 17th, 2022

Psychedelics, Top News


TORONTO, February 17, 2022–(BUSINESS WIRE)–Biomind Labs Inc. (“Biomind Labs” or the “Company“) (NEO: BMND) (OTC: CRSWF) (FSE: 3XI), a leading biotech company focused on innovation and research on endogenous tryptamines (biomolecules acting as psychoneuroplastogens) for the treatment of mental health disorders and beyond, is pleased to announce its successful upgrade from the OTC Pink to the OTCQB® Venture Market (the “OTCQB“), a United States trading platform that is operated by the OTC Markets Group Inc. The Company will continue to trade its common shares on the Neo Exchange Inc. (the “NEO“) under the symbol “BMND”. Biomind Labs will commence trading on the OTCQB as of market open today, under the symbol “CRSWF”.

Alejandro Antalich, Chief Executive Officer of Biomind Labs, said: “Trading on the OTCQB is another important milestone for Biomind Labs. It strengthens our strategy of enhancing our visibility, expanding our liquidity and diversifying our shareholder base on an established public market. As a verified market with efficient access for U.S. investors, we expect to build a strong shareholder base in the United States with a goal of achieving fair valuation. This announcement comes in the right moment, as we are preparing to submit Investigational New Drug (“IND“) applications to the U.S. Food and Drug Administration (the “FDA)”.

OTCQB is recognized by the United States Securities and Exchange Commission as an established public market. The OTCQB platform enables companies to provide current public information that investors need to analyze, value and trade a security. A large network of data distributors and media partners ensures that trade data, news and disclosure are available to broker-dealers, market data providers, and investors. On the OTCQB, investors get an exchange-comparable information experience, with convenient trading through their preferred broker or financial advisor, transparent pricing with real-time quotes, and trusted disclosure.

About Biomind Labs Inc.

Biomind Labs is a biotech research and development company aimed at transforming biomedical sciences knowledge into novel pharmaceutical drugs and innovative nanotech delivery systems for a variety of psychiatric and neurological conditions. Through its acceleration platform, Biomind Labs is developing novel pharmaceutical formulations of the main psychedelic molecules, DMT, 5-MeO-DMT and mescaline for treating a wide range of therapeutic indications. Biomind Labs’ focus is to provide patients access to affordable and modern-day treatments.

Cautionary Note Regarding Forward-Looking Statements

This press release contains statements that constitute “forward-looking information” (“forward-looking information”) within the meaning of the 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 document include, among others, statements relating to the ability of the Company’s innovation and research on endogenous tryptamines to possibly treat mental health disorders and beyond, the Company’s strategy of enhancing its visibility, expanding its liquidity, diversifying and building its shareholder base and achieving fair valuation, the Company’s IND application submissions to the FDA and other statements that are not historical facts.

By their nature, forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause our actual results, performance or achievements, or other future events, to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Such factors and risks include, among others: (a) the Company may require additional financing from time to time in order to continue its operations which may not be available when needed or on acceptable terms and conditions acceptable; (b) compliance with extensive government regulation; (c) domestic and foreign laws and regulations could adversely affect the Company’s business and results of operations; (d) the stock markets have experienced volatility that often has been unrelated to the performance of companies and these fluctuations may adversely affect the price of the Company’s securities, regardless of its operating peers; (e) adverse changes in the public perception of tryptamine-based treatments and psychedelic-based therapies; (f) the impact of COVID-19; and (g) 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.

The Company makes no medical, treatment or health benefit claims about the Company’s proposed products. The U.S. Food and Drug Administration, Health Canada or other similar regulatory authorities have not evaluated claims regarding tryptamine-based treatments, psychedelic-based therapies or other psychedelic compounds. The efficacy of such products has not been confirmed by approved research. There is no assurance that the use of psychedelic tryptamines, tryptamine derivatives or other psychedelic compounds can diagnose, treat, cure or prevent any disease or condition. Vigorous scientific research and clinical trials are needed. The Company has not yet completed clinical trials for the use of its proposed products. Any references to quality, consistency, efficacy and safety of potential products do not imply that the Company verified such in clinical trials or that the Company will complete such trials. If the Company cannot obtain the approvals or research necessary to commercialize its business, it may have a material adverse effect on the Company’s performance and operations.

The forward-looking information contained in this news release represents the expectations of the Company as of the date of this news release and, accordingly, is subject to change after such date. Readers should not place undue importance on forward-looking information and should not rely upon this information as of any other date. The Company undertakes no obligation to update these forward-looking statements in the event that management’s beliefs, estimates or opinions, or other factors, should change.

The NEO has neither approved nor disapproved the contents of this news release and is not responsible for the adequacy and accuracy of the contents herein.

This article was published by CFN Enterprises Inc. (OTCQB: CNFN), owner and operator of CFN Media, the industry’s leading agency and digital financial media network dedicated to the burgeoning CBD and legal cannabis industries. Call +1 (833) 420-CNFN for more information.

About Ryan Allway

Mr. Allway has over a decade of experience in the financial markets as both a private investor and financial journalist. He has been actively involved in the cannabis industry since its inception, covering public and private companies.


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Entheon Biomedical Announces the Approval of DMT Clinical Trial https://mjshareholders.com/entheon-biomedical-announces-the-approval-of-dmt-clinical-trial/ Thu, 03 Feb 2022 18:19:36 +0000 https://www.cannabisfn.com/?p=2937143

Vancouver, British Columbia–(Newsfile Corp. – February 03, 2022) – Entheon Biomedical Corp. (CSE: ENBI) (OTCQB: ENTBF) (FSE: 1XU1) (“Entheon” or the “Company”), a biomedical company focused on the research and development of psychedelic drugs and leading-edge biomarkers to provide personalized treatment of addiction disorders, announced today the approval by the local Dutch ethics committee of EBRX-101, a comprehensive phase I clinical trial evaluating the pharmacokinetics, pharmacodynamics and safety profile of N,N-dimethyltryptamine (DMT). The study will be conducted at the Centre for Human Drug Research, in Leiden, Netherlands, with patient screening scheduled to begin this month.

The EBRX-101 study is the core research focus of Entheon Rx™, one of the Company’s business divisions, which is focused on advancing the therapeutic potential of DMT and DMT-based drug analogues. The study will use an adaptive, randomized, double-blind, placebo-controlled design with a single ascending dose of intravenous DMT to be administered via continuous-controlled infusion to a population of otherwise healthy smokers. This phase 1 study will provide Entheon with essential safety and dosing data, providing the foundation for further research of DMT’s therapeutic potential.

“DMT’s unique metabolic and neuroprotective properties, together with its record of safe human use in the scientific literature, suggests that it is an ideal candidate for therapeutic administration,” says Dr. Andrew Hegle, Chief Science Officer of Entheon. “However, it is crucial that we thoroughly investigate the pharmacological properties and safety profile of infused DMT in a clinical setting, and fully characterize its effects on the central nervous system. These results will form the basis for Entheon’s phase 2 efficacy trials for nicotine cessation and the treatment of other substance use disorders.”

DMT is a classic hallucinogen, similar to LSD or psilocybin in that it exerts many of its subjective, visual, and potentially therapeutic effects via the brain’s serotonin system. DMT differs from the other serotonergic psychedelics in that it is naturally found in the body in trace amounts, and when given externally is rapidly metabolized, with subjective effects returning to baseline after roughly thirty minutes post- administration.

“Approval of this study is a significant achievement for the company, marking the culmination of months of rigorous work,” says Timothy Ko, CEO of Entheon. “In our estimation and based on our review of existing literature, EBRX-101 is the most comprehensive studies of DMT to date. This clinical trial will serve as a benchmark for further investigation into the development of DMT as a treatment for addiction disorders.”

About Entheon Biomedical Corp.

Entheon is a biomedical company focused on the research and development of psychedelic drugs and leading-edge biomarkers to provide personalized treatment of addiction disorders. Entheon is comprised of three divisions, Entheon RX™, focused on the development of therapeutic drugs, using N, N-dimethyltryptamine (DMT) as the pharmacological benchmark; Entheon ID™, focused on identification, analysis and predictive use of EEG biomarkers and genetics in the selection and management of drug treatment; and Entheon IQ™, focused on the development of treatment algorithms through the analysis of patient data. Subject to obtaining all requisite regulatory approvals and permits, Entheon intends to generate revenue through the sale of its DMT Products to physicians, clinics and licensed psychiatrists in the United States, certain countries in the European Union and throughout Canada.

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Algernon Pharmaceuticals Files for Clinical Trial and Ethics Approval for Phase 1 DMT Human Stroke Study https://mjshareholders.com/algernon-pharmaceuticals-files-for-clinical-trial-and-ethics-approval-for-phase-1-dmt-human-stroke-study/ Wed, 19 Jan 2022 17:55:14 +0000 https://www.cannabisfn.com/?p=2936668

Ryan Allway

January 19th, 2022

Psychedelics


VANCOUVER, British Columbia, Jan. 19, 2022 (GLOBE NEWSWIRE) — Algernon Pharmaceuticals Inc. (the “Company” or “Algernon”) (CSE: AGN) (FRANKFURT: AGW0) (OTCQB: AGNPF) a clinical stage pharmaceutical development company is pleased to announce that it has filed a combined Clinical Trials of Investigational Medicinal Products and Ethics Approval application, with the United Kingdom Medicines and Healthcare Products Regulatory Agency (“UK MHRA”). This was accomplished via the combined review service, which provides for a single application route for its planned Phase 1 clinical human study of AP-188 (“N,N-dimethyltryptamine” or “DMT”). DMT is a known psychedelic compound that is part of the tryptamine family.

The Company announced on November 19, 2021, that it had received positive feedback at a scientific advice meeting from the UK MHRA for its planned Phase 1 DMT Stroke study.

The primary focus of the Phase 1 DMT study is to investigate prolonged intravenous infusion of DMT, for durations which have never been clinically studied. The resulting data generated will help the Company to plan both its Phase 2 acute stroke and rehabilitation studies more effectively.

“We look forward to getting our DMT clinical stroke program started with our Phase 1 study at Hammersmith Medicines Research in the UK,” said Christopher J. Moreau CEO of Algernon Pharmaceuticals. “This study will provide important information on dosage and duration of our new DMT IV formula to help us better plan for our Phase 2 study where we plan to test the drug with both acute and recovering stroke patients.”

Phase 1 DMT Stroke Study Summary

The purpose of the study is to identify the safety, tolerability, and pharmacokinetics of DMT when administered as an intravenous bolus followed by prolonged infusion. The first part of the study will use a single-escalating dose design aimed at identifying the maximum sub-psychedelic dose, while the second part will test the effects of repeated administrations of this dose. There will be up to 96 healthy volunteers enrolled across the two parts of the study which will include both psychedelic experienced and psychedelic naïve patients.

About DMT

N,N-Dimethyltryptamine, or DMT, is a hallucinogenic tryptamine drug producing effects similar to those of other psychedelics like LSD, ketamine, psilocybin and psilocin. DMT occurs naturally in many plant species and animals including humans and has been used in religious ceremonies as a traditional spiritual medicine by indigenous people in the Amazonian basin. DMT can also be synthesised in a laboratory.

Algernon has filed provisional patents for new forms of DMT, in addition to formulation, dosage and method of use claims for ischemic stroke. The Company has also filed claims for combination therapy of DMT and stroke rehabilitation including Constraint Induced Movement Therapy.

About Algernon Pharmaceuticals Inc.

Algernon is a drug re-purposing company that investigates safe, already approved drugs, including naturally occurring compounds, for new disease applications, moving them efficiently and safely into new human trials, developing new formulations and seeking new regulatory approvals in global markets. Algernon specifically investigates compounds that have never been approved in the U.S. or Europe to avoid off label prescription writing.

CONTACT INFORMATION

Christopher J. Moreau
CEO
Algernon Pharmaceuticals Inc.
604.398.4175 ext 701

[email protected]
[email protected]
www.algernonpharmaceuticals.com.

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.

CAUTIONARY DISCLAIMER STATEMENT: No Securities Exchange has reviewed nor accepts responsibility for the adequacy or accuracy of the content of this news release. This news release contains forward-looking statements relating to product development, licensing, commercialization and regulatory compliance issues and other statements that are not historical facts. Forward-looking statements are often identified by terms such as “will”, “may”, “should”, “anticipate”, “expects” and similar expressions. All statements other than statements of historical fact, included in this release are forward-looking statements that involve risks and uncertainties. There can be no assurance that such statements will prove to be accurate and actual results and future events could differ materially from those anticipated in such statements. Important factors that could cause actual results to differ materially from the Company’s expectations include the failure to satisfy the conditions of the relevant securities exchange(s) and other risks detailed from time to time in the filings made by the Company with securities regulations. The reader is cautioned that assumptions used in the preparation of any forward-looking information may prove to be incorrect. Events or circumstances may cause actual results to differ materially from those predicted, as a result of numerous known and unknown risks, uncertainties, and other factors, many of which are beyond the control of the Company. The reader is cautioned not to place undue reliance on any forward-looking information. 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. The forward-looking statements contained in this news release are made as of the date of this news release and the Company will update or revise publicly any of the included forward-looking statements as expressly required by applicable law.

This article was published by CFN Enterprises Inc. (OTCQB: CNFN), owner and operator of CFN Media, the industry’s leading agency and digital financial media network dedicated to the burgeoning CBD and legal cannabis industries. Call +1 (833) 420-CNFN for more information.

About Ryan Allway

Mr. Allway has over a decade of experience in the financial markets as both a private investor and financial journalist. He has been actively involved in the cannabis industry since its inception, covering public and private companies.


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Entheon Biomedical Announces EEG Patent Application & Provides Research Update https://mjshareholders.com/entheon-biomedical-announces-eeg-patent-application-provides-research-update/ Thu, 16 Dec 2021 15:46:37 +0000 https://www.cannabisfn.com/?p=2936329

Ryan Allway

December 16th, 2021

Psychedelics


Vancouver, British Columbia–(Newsfile Corp. – December 16, 2021) – Entheon Biomedical Corp. (CSE: ENBI) (OTCQB: ENTBF) (FSE: 1XU1) (“Entheon” or the “Company“), a biomedical company focused on the research and development of psychedelic drugs and leading-edge biomarkers to provide personalized treatment of addiction disorders, is pleased to provide an update on its patent portfolio as well as nonclinical and clinical programs.

US Provisional Patent Filed

In furtherance of its program, the Company filed US Provisional Patent Application No. 63/283,051, titled “Detection of Therapeutic Psychedelic State,” as of November 23, 2021. The patent relates to improved technology for detection and maintenance of the optimal therapeutic psychedelic state, which Entheon intends to study through the monitoring of electroencephalogram (EEG) biomarkers in order to optimize the treatment of neuropsychiatric conditions.

“Entheon is proud to be making significant strides in its Entheon IQ™ program,” says Timothy Ko, Chief Executive Officer of Entheon. “With the filing of our provisional patent application, Entheon is building an IP foundation to better facilitate safe and precise use of psychedelics to deliver improved patient outcomes.”

In Vivo Toxicity Assays Completed

Further to the Corporate Update provided on November 24, 2021, the Company is pleased to announce further progress on its nonclinical program. In vivo toxicity assays have been completed with our CRO partner, with a final report expected in the coming weeks. Along with the previously completed in vitro assays, these studies serve as the benchmark for further preclinical work in 2022 and will contribute to regulatory submissions as the company advances its DMT program.

EBRX-101 on Track to Submit Regulatory Package for Human DMT Clinical Trial

The Company is pleased to confirm that it is on track to submit its regulatory package to the Dutch ethics committee in early 2022 for its upcoming human trial. EBRX-101, a study that will evaluate the pharmacodynamics, pharmacokinetics and safety of a target controlled intravenous infusion of N, N-dimethyltryptamine (DMT) in a population of healthy smokers.

About Entheon Biomedical Corp.

Entheon is a biomedical company focused on the research and development of psychedelic drugs and leading-edge biomarkers to provide personalized treatment of addiction disorders. Entheon is comprised of three divisions, Entheon RX™, focused on the development of therapeutic drugs, using N,N-dimethyltryptamine (DMT) as the pharmacological benchmark; Entheon ID™, focused on identification, analysis and predictive use of EEG biomarkers and genetics in the selection and management of drug treatment; and Entheon IQ™, focused on the development of treatment algorithms through the analysis of patient data. Subject to obtaining all requisite regulatory approvals and permits, Entheon intends to generate revenue through the sale of its DMT Products to physicians, clinics and licensed psychiatrists in the United States, certain countries in the European Union and throughout Canada.

For more information, please contact the Company at:

Entheon Biomedical Corp.
Joseph Cullen, Investor Relations
Telephone: +1 (778) 919-8615
[email protected]
https://entheonbiomedical.com/

For media inquiries, please contact Elizabeth Glassen of BlueSky Communications at:

BlueSky Communications
Elizabeth Glassen, Account Manager
Telephone: +1 (647) 309-0141
[email protected]

Cautionary Note on Forward-Looking Information

This news release contains forward‐looking statements and forward‐looking information within the meaning of applicable securities laws. These statements relate to future events or future performance. All statements other than statements of historical fact may be forward‐looking statements or information. More particularly and without limitation, this news release contains forward‐looking statements and information relating to the grant of the patent, if at all; timing and issuance of in vivo toxicity assay reports, the timing and submission of the regulatory package for EBRX-101, the commencement of certain pre-clinical studies and the expected timeline for results and other matters. The forward‐looking statements and information are based on certain key expectations and assumptions made by management of the Company, including, but not limited to, assumptions relating to the continued impact and status of COVID on the Company’s personnel and planned research activities, that general economic and political conditions will remain the same, stability in applicable law and regulations that the Company will receive the in vivo toxicity reports timeously, will be able to prepare the regulatory within the time frame expected, and that the Company will submit the EBRX-101 regulatory package within the expected timeframes. Although management of the Company believes that the expectations and assumptions on which such forward-looking statements and information are based are reasonable, undue reliance should not be placed on the forward‐looking statements and information since no assurance can be given that they will prove to be correct.

Forward-looking statements and information are provided for the purpose of providing information about the current expectations and plans of management of the Company relating to the future. Readers are cautioned that reliance on such statements and information may not be appropriate for other purposes, such as making investment decisions. Since forward‐looking statements and information address future events and conditions, by their very nature they involve inherent risks and uncertainties. Actual results could differ materially from those currently anticipated due to a number of factors and risks. These include, but are not limited to, a rise in the number of COVID cases globally, an adverse impact of COVID on the research activities of the Company and its research partners, the inability to prepare the IMPD submission within the time frame expected, difficulties in subject enrollment, initial screening or site initiation, delays to the Company’s planned clinical trial timeline as a result of other unknown uncertainties and adverse changes to applicable law and regulations. Accordingly, readers should not place undue reliance on the forward‐looking statements and information contained in this news release. Readers are cautioned that the foregoing list of factors is not exhaustive. The forward‐looking statements and information contained in this news release are made as of the date hereof and no undertaking is given to update publicly or revise any forward‐looking statements or information, whether as a result of new information, future events or otherwise, unless so required by applicable securities laws. The forward-looking statements or information contained in this news release are expressly qualified by this cautionary statement.

Neither the CSE nor the Investment Industry Regulatory Organization of Canada accepts responsibility for the adequacy or accuracy of this release.

This article was published by CFN Enterprises Inc. (OTCQB: CNFN), owner and operator of CFN Media, the industry’s leading agency and digital financial media network dedicated to the burgeoning CBD and legal cannabis industries. Call +1 (833) 420-CNFN for more information.

About Ryan Allway

Mr. Allway has over a decade of experience in the financial markets as both a private investor and financial journalist. He has been actively involved in the cannabis industry since its inception, covering public and private companies.


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Cybin Awarded Notice of Allowance from U.S. Patent and Trademark Office for CYB004 (Deuterated Psychedelic Tryptamine) for the Treatment of Anxiety Disorders https://mjshareholders.com/cybin-awarded-notice-of-allowance-from-u-s-patent-and-trademark-office-for-cyb004-deuterated-psychedelic-tryptamine-for-the-treatment-of-anxiety-disorders/ Wed, 15 Dec 2021 15:31:27 +0000 https://www.cannabisfn.com/?p=2936319

Ryan Allway

December 15th, 2021

Psychedelics


– Expands intellectual property portfolio and strengthens position as leading innovator in developing putative psychedelic compounds –

Cybin Inc. ( NEO:CYBN) ( NYSE American:CYBN) (“ Cybin” or the “ Company”), a biopharmaceutical company focused on progressing “Psychedelics to Therapeutics TM” today announced that it has been awarded a Notice of Allowance from the U.S. Patent and Trademark Office (“USPTO”) for patent application No. 17/394,038 related to CYB004, the Company’s investigational deuterated psychedelic tryptamine compound for the potential treatment of anxiety disorders. The allowed claims include other forms of deuterated psychedelic tryptamine, notably certain deuterated forms of DMT and  5-MeO-DMT. The patent, which is expected to expire in 2041 before consideration of any patent term extensions, covers composition of matter for the CYB004 drug substance as a putative new chemical entity.

“The receipt of this Notice of Allowance from the USPTO represents an important milestone in expanding our intellectual property portfolio progressing psychedelics to therapeutics for the countless patients in need, and strongly demonstrates the Company’s dedication to the discovery and development of differentiated psychedelic-based compounds for addressing mental health,” said Doug Drysdale, Chief Executive Officer of Cybin. “Once issued, this patent may have the opportunity to cover a broad range of claims supporting our IP in psychedelic medicine and further strengthen our emerging best-in-class position in this evolving industry.”

According to the U.S. National Institute of Mental Health, anxiety disorders are one of the most common mental illnesses in the U.S., affecting 40 million adults, or approximately 18% of the population every year1. Despite the availability of many prescription medicines, these treatments are not equally efficacious in all patients with up to 50% of patients with general anxiety disorder failing to respond to first line treatments2. Current standardized treatments for anxiety disorders also require chronic administration of medicines that have a long time to onset and present several potential side effects including weight gain, gastrointestinal disturbances, sexual dysfunction and withdrawal symptoms.

“CYB004 is a proprietary deuterated psychedelic tryptamine that has the potential to effectively treat anxiety disorders without the well-known side effects of the current treatment landscape,” concluded Drysdale.

Cybin continues to pursue multiple opportunities to secure and support its patent position for research and development evaluating deuterated tryptamines for future psychedelic-based treatments for mental illnesses.

About Cybin
Cybin is a leading ethical biopharmaceutical company, working with a network of world-class partners and internationally recognized scientists, on a mission to create safe and effective therapeutics for patients to address a multitude of mental health issues. Headquartered in Canada and founded in 2019, Cybin is operational in Canada, the United States, United Kingdom and Ireland. The Company is focused on progressing Psychedelics to Therapeutics™ by engineering proprietary drug discovery platforms, innovative drug delivery systems, novel formulation approaches and treatment regimens for mental health disorders. Patent filings described herein are held by Cybin IRL Limited, a wholly owned subsidiary of Cybin.

Cautionary Notes and Forward-Looking Statements
Certain statements in this press release constitute forward-looking information. All statements other than statements of historical fact contained in this press release, including, without limitation, statements regarding Cybin’s future, strategy, plans, objectives, goals and targets, and any statements preceded by, followed by or that include the words “believe”, “expect”, “aim”, “intend”, “plan”, “continue”, “will”, “may”, “would”, “anticipate”, “estimate”, “forecast”, “predict”, “project”, “seek”, “should” or similar expressions or the negative thereof, are forward-looking statements. Forward-looking statements in this news release include statements regarding the Company’s proprietary drug discovery platforms, innovative drug delivery systems, novel formulation approaches and treatment regimens to potentially treat psychiatric disorders.

These forward-looking statements are based on reasonable assumptions and estimates of management of the Company at the time such statements were made. Actual future results may differ materially as forward-looking statements involve known and unknown risks, uncertainties, and other factors which may cause the actual results, performance, or achievements of the Company to materially differ from any future results, performance, or achievements expressed or implied by such forward-looking statements. Such factors, among other things, include: implications of the COVID-19 pandemic on the Company’s operations; fluctuations in general macroeconomic conditions; fluctuations in securities markets; expectations regarding the size of the psychedelics market; the ability of the Company to successfully achieve its business objectives; plans for growth; political, social and environmental uncertainties; employee relations; the presence of laws and regulations that may impose restrictions in the markets where the Company operates; and the risk factors set out in the Company’s management’s discussion and analysis for the period ended September 30, 2021 and the Company’s listing statement dated November 9, 2020, which are available under the Company’s profile on www.sedar.com and with the U.S. Securities and Exchange Commission on EDGAR at www.sec.gov. Although the forward-looking statements contained in this news release are based upon what management of the Company believes, or believed at the time, to be reasonable assumptions, the Company cannot assure shareholders that actual results will be consistent with such forward-looking statements, as there may be other factors that cause results not to be as anticipated, estimated or intended. Readers should not place undue reliance on the forward-looking statements and information contained in this news release. The Company assumes no obligation to update the forward-looking statements of beliefs, opinions, projections, or other factors, should they change, except as required by law.

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

Neither the Neo Exchange Inc. nor the NYSE American LLC stock exchange have approved or disapproved the contents of this news release and are not responsible for the adequacy and accuracy of the contents herein.

1)

Bandelow B, Michaelis S. Epidemiology of anxiety disorders in the 21st century. Dialogues Clin Neurosci. 2015;17(3):327-335. doi:10.31887/DCNS.2015.17.3/bbandelow

2)

Ansara ED. Management of treatment-resistant generalized anxiety disorder. Ment Health Clin. 2020;10(6):326-334. Published 2020 Nov 5. doi:10.9740/mhc.2020.11.326

Source: Cybin Inc.

This article was published by CFN Enterprises Inc. (OTCQB: CNFN), owner and operator of CFN Media, the industry’s leading agency and digital financial media network dedicated to the burgeoning CBD and legal cannabis industries. Call +1 (833) 420-CNFN for more information.

About Ryan Allway

Mr. Allway has over a decade of experience in the financial markets as both a private investor and financial journalist. He has been actively involved in the cannabis industry since its inception, covering public and private companies.


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PharmaDrug Announces Clinical Research Collaboration with The Johns Hopkins University to Evaluate DMT in a Comparative Clinical Study https://mjshareholders.com/pharmadrug-announces-clinical-research-collaboration-with-the-johns-hopkins-university-to-evaluate-dmt-in-a-comparative-clinical-study/ Wed, 25 Aug 2021 16:01:27 +0000 https://www.cannabisfn.com/?p=2931578

Ryan Allway

August 25th, 2021

Psychedelics


Toronto, Ontario–(Newsfile Corp. – August 25, 2021) – PharmaDrug Inc. (CSE: PHRX) (OTC Pink: LMLLF) (“PharmaDrug” or the “Company“), a specialty pharmaceutical company focused on the research, development and commercialization of controlled-substances and natural medicines such as psychedelics, cannabis and naturally-derived approved drugs, is pleased to announce that the Company has entered into a Clinical Trial Agreement with The Johns Hopkins University (JHU) to conduct a clinical study comparing acute and enduring psychological and neural effects of N,N-Dimethyltryptamine (DMT) and an undisclosed, potently active comparator molecule. The principal investigator, Dr. Frederick S. Barrett, PhD, Associate Professor of Psychiatry and Behavioral Sciences, will be supported by Co-investigators Dr. Sandeep Nayak and Dr. Roland Griffiths; all from the JHU Center for Psychedelic and Consciousness Research.

The potential of psychedelic drugs to treat various neuropsychiatric indications is currently being explored in several human clinical trials. The dramatic mind-altering effects of these drugs is well known, and as such, a study volunteer’s expectancy may contribute to clinical outcomes. Such effects are considered classic study confounds and can lead to misinterpretation of efficacy signals. For example, this phenomenon was recently noted in a large, placebo-controlled study of LSD which found that those receiving LSD or placebo showed significant improvements in mood, anxiety, creativity and energy1. To address this common study design limitation and to assess the neuropsychiatric impact of DMT more fully, the Company has sponsored the submission of an Investigational New Drug (“IND”) application to the U.S Food and Drug Administration (“FDA”) which aims to compare the effects of DMT with another potently psychotropic drug.

The first part of the planned study will examine dose effects of DMT and the other test article. During the second part of the study, healthy subjects will be exposed to a maximum tolerated dose of each drug (as defined in part 1 of the study). During both parts of the study, investigators will carefully characterize any acute and persisting subjective, affective, cognitive, and neural dose-dependent effects for both drugs being evaluated. Much debate exists around the relative potential benefits of micro vs macro-doses for psychedelic compounds. Using a highly controlled approach, the currently planned clinical trial will go some way to answering this important question. Employing an extensive battery of psychological assessment tools, coupled with state-of-the-art functional MRI and EEG the JHU researchers endeavour to develop a more fulsome understanding of how DMT acts in the brain of healthy volunteers; with the ultimate goal of being able to apply this knowledge in tailoring the treatment of serious neuropsychiatric conditions.

This clinical research collaboration builds upon PharmaDrug’s existing strategy of focusing on establishing a better understanding of the basic mechanisms by which DMT exerts its effects in the brain and elsewhere in the body. By supporting world class talent with distinct expertise in early discovery and clinical use the Company will be optimally positioned to identify novel applications for DMT and unlock its full therapeutic potential. The Company intends to become a leader in advancing DMT as a prescription pharmaceutical, and as previously reported, is the first organization to receive orphan drug designation by the U.S. FDA for DMT in the prevention of ischemia-reperfusion injury in patients undergoing solid organ transplantation, which includes the liver, kidney, heart, and lungs. As a further example of PharmaDrug’s commitment to DMT development, the Company recently entered into a sponsored research agreement with the Terasaki Institute to evaluate the potential of novel DMT delivery systems for the treatment of primary open angle glaucoma, one of the leading causes of vision loss worldwide.

Daniel Cohen, CEO of PharmaDrug commented: “We are excited to collaborate and support Dr. Frederick Barrett to better understand DMT and its potential. The JHU Center for Psychedelic and Consciousness Research is a global leader in psychedelics clinical research, and we are very grateful to partner with them to achieve our objectives in expanding our pharmaceutical product pipeline for novel uses and delivery forms of DMT to treat unmet medical needs.”

Under the terms of the agreement, the Company has an exclusive option to obtain worldwide, royalty-bearing commercialization license to all rights, title, and interest that JHU may have or obtain in any invention that results from the clinical study.

About PharmaDrug Inc.

PharmaDrug is a specialty pharmaceutical company focused on the research, development and commercialization of controlled-substances and natural medicines such as psychedelics, cannabis and naturally-derived approved drugs. The Company owns 80% of Pharmadrug Production GmbH, a German medical cannabis distributor, with a Schedule I European Union narcotics license and German EuGMP certification allowing for the importation and distribution of medical cannabis to pharmacies in Germany and throughout the EU. The Company also owns 100% of Super Smart, a Dutch company building a modern adult use psychedelic retail business with an elevated and educational focus. PharmaDrug recently acquired Sairiyo Therapeutics, a biotech company that specializes in researching and reformulating established natural medicines with a goal of bringing them through regulatory and research driven clinical trials.

For further information, please contact:

Daniel Cohen, Chairman and CEO
[email protected]
(647) 202-1824

Caution Regarding Forward-Looking Information:

THE CANADIAN SECURITIES EXCHANGE HAS NOT REVIEWED NOR DOES IT ACCEPT RESPONSIBILITY FOR THE ADEQUACY OR ACCURACY OF THIS RELEASE.

This press release contains ‘forward-looking information’ within the meaning of applicable Canadian securities legislation. These statements relate to future events or future performance. The use of any of the words “could”, “intend”, “expect”, “believe”, “will”, “projected”, “estimated”, “potential”, “aim” and similar expressions and statements relating to matters that are not historical facts are intended to identify forward-looking information and are based on PharmaDrug Inc. (the “Company”) current belief or assumptions as to the outcome and timing of such future events. Forward-looking information is based on reasonable assumptions that have been made by the Company at the date of the information and is subject to known and unknown risks, uncertainties, and other factors that may cause actual results or events to differ materially from those anticipated in the forward-looking information. Given these risks, uncertainties and assumptions, you should not unduly rely on these forward-looking statements. The forward-looking information contained in this press release is made as of the date hereof, and Company is not obligated to update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as required by applicable securities laws. The foregoing statements expressly qualify any forward-looking information contained herein. Factors that could cause actual results to differ materially from those anticipated in these forward-looking statements are described under the caption “Risk Factors” in Company’s management’s discussion and analysis for the period of March 31, 2021 (“MD&A”), dated May 31, 2021, which is available on the Company’s profile at www.sedar.com.

This news release does not constitute an offer to sell or the solicitation of an offer to buy, and shall not constitute an offer, solicitation or sale in any state, province, territory or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state, province, territory or jurisdiction.

The Company’s securities have not been registered under the U.S. Securities Act of 1933, as amended (the “U.S. Securities Act”), or applicable state securities laws, and may not be offered or sold to, or for the account or benefit of, persons in the United States or “U.S. Persons”, as such term is defined in Regulations under the U.S. Securities Act, absent registration or an applicable exemption from such registration requirements. This press release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of the securities in the United States or any jurisdiction in which such offer, solicitation or sale would be unlawful.

References:

1) Szigeti B, Kartner L, Blemings A, Rosas F, Feilding A, Nutt DJ, Carhart-Harris RL, Erritzoe D. Self-blinding citizen science to explore psychedelic microdosing. Elife. 2021 Mar 2;10:e62878. doi: 10.7554/eLife.62878. PMID: 33648632; PMCID: PMC7925122.

This article was published by CFN Enterprises Inc. (OTCQB: CNFN), owner and operator of CFN Media, the industry’s leading agency and digital financial media network dedicated to the burgeoning CBD and legal cannabis industries. Call +1 (833) 420-CNFN for more information.

About Ryan Allway

Mr. Allway has over a decade of experience in the financial markets as both a private investor and financial journalist. He has been actively involved in the cannabis industry since its inception, covering public and private companies.


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PharmaDrug Forms Research Collaboration with Terasaki Institute for Novel Ocular Drug Formulation Program to Deliver DMT and Other Tryptamines to Treat Eye Disease https://mjshareholders.com/pharmadrug-forms-research-collaboration-with-terasaki-institute-for-novel-ocular-drug-formulation-program-to-deliver-dmt-and-other-tryptamines-to-treat-eye-disease/ Thu, 05 Aug 2021 15:30:19 +0000 https://www.cannabisfn.com/?p=2928470
  • Unlocking the potential of psychedelics, including DMT, and other tryptamines to treat the significant unmet medical needs of glaucoma patients
  • Partnering with world-renowned research institution brings validated drug delivery expertise in novel, controlled drug-release technologies

Toronto, Ontario–(Newsfile Corp. – August 5, 2021) – PharmaDrug Inc. (CSE: PHRX) (OTC Pink: LMLLF) (“PharmaDrug” or the “Company“), a specialty pharmaceutical company focused on the research, development and commercialization of controlled-substances and natural medicines such as psychedelics, cannabis and naturally-derived approved drugs, is pleased to announce that PharmaDrug has entered into a sponsored research agreement with the Terasaki Institute to develop a novel ocular drug delivery platform that aims to deliver psychedelic and tryptamine-based pharmaceuticals, such as N, N-dimethyltryptamine (“DMT”), for eye diseases.

PharmaDrug will focus on developing a novel ocular drug delivery platform to deliver DMT and other undisclosed tryptamines as a potential therapeutic solution in treating the significant unmet medical needs of glaucoma patients. Glaucoma is a disorder of the optic nerve that results in irreversible vision loss and is the second leading cause of blindness in the world, according to the World Health Organization. Glaucoma impacts more than 2.7 million people aged 40 or older in the United States and current treatments are known to have poor rates of compliance of up to 80% of patients. The global market for glaucoma was estimated by Market Scope at $4.8 billion in 2019 with the U.S. market representing $1.9 billion.

Although the exact etiology of primary open angle glaucoma remains poorly understood, and may be variable across patient subsets, it is generally accepted that the observed increase in intraocular pressure (IOP) correlates with progressive vision loss1. As such, currently available glaucoma treatments, most commonly formulated into eye drops, are designed to lower IOP. While these approaches provide partial improvement, they often result in side effects such as redness and stinging and require multiple daily applications; all of which diminish patient compliance.

Key regions of the eye that regulate fluid dynamics, including maintenance of healthy IOP, are known to be richly decorated with various serotonin receptor family members. Previous research has highlighted the role of serotonin receptor signaling in the regulation of IOP2-5. Tryptamines, often hallucinogenic above certain threshold concentrations, constitute a large collection of molecules that selectively act on multiple different serotonin receptors including 5-HT1A and 5-HT2A. Topical application of several different tryptamines have shown early promise in preclinical models of elevated IOP, however formulation, delivery, the potential for undesirable hallucinogenic side effects, and the controlled substances act of 1970 have all contributed to a lack of development of tryptamines to treat this serious threat to vision. PharmaDrug, working with the renowned Terasaki Research Institute, has entered into a sponsored research agreement that will evaluate multiple candidate tryptamines, including DMT in various preclinical models of glaucoma. Studies will include cell-based basic research, active pharmaceutical ingredient formulation, and exploitation of novel delivery technologies aimed at improving patient outcome by delivering the optimal drug in a convenient format that improves compliance and diminishes side effects.

The Terasaki Institute for Biomedical Innovation is a biotechnology institute which develops medical devices and cutting-edge protocols for a variety of diagnostic, monitoring and treatment applications. Their research platforms include work in biomaterials, cellular and tissue engineering, wearable biosensors and organs-on-a-chip, with specific expertise in novel polymer development.

“We are very excited to partner with the Terasaki Institute, a leader in the design and development of novel drug delivery technologies. This relationship will expedite our development plan and move us meaningfully closer to our goal of evaluating DMT and other tryptamines for various types of eye disease which require both a pharmacological and delivery solution to fill the significant treatment gap in glaucoma,” said Daniel Cohen, Chairman and CEO of PharmaDrug. “By aligning ourselves with thought leaders in the space we aim to tackle the worthy challenge of developing a novel delivery device that will provide sub-psychedelic quantities of candidate tryptamines to the front of the eye.”

Dr. Ali Khademhosseini, CEO of the Terasaki Institute commented: “At the Terasaki Institute we have a number of core competences in developing next generation medical technologies such as polymer-based formulations and wearables for drug delivery purposes. We have partnered with various pharmaceutical and biotechnology companies seeking to evolve their product offerings in treating significant unmet medical needs. PharmaDrug’s unique proposed solution to the challenges that are present in eye diseases is what motivates the Terasaki team to answer the call in developing a drug delivery system that would positively affect the millions of people who suffer with impaired vision and compromised quality of life. We are excited to be working with PharmaDrug and be a part of their journey in their quest to develop therapeutic solutions for eye disease.”

About PharmaDrug Inc.

PharmaDrug is a specialty pharmaceutical company focused on the research, development and commercialization of controlled-substances and natural medicines such as psychedelics, cannabis and naturally-derived approved drugs. The Company owns 80% of Pharmadrug Production GmbH, a German medical cannabis distributor, with a Schedule I European Union narcotics license and German EuGMP certification allowing for the importation and distribution of medical cannabis to pharmacies in Germany and throughout the EU. The Company also owns 100% of Super Smart, a Dutch company building a modern adult use psychedelic retail business with an elevated and educational focus. PharmaDrug recently acquired Sairiyo Therapeutics, a biotech company that specializes in researching and reformulating established natural medicines with a goal of bringing them through regulatory and research driven clinical trials.

For further information, please contact:

Daniel Cohen, Chairman and CEO
[email protected]
(647) 202-1824

Caution Regarding Forward-Looking Information:

THE CANADIAN SECURITIES EXCHANGE HAS NOT REVIEWED NOR DOES IT ACCEPT RESPONSIBILITY FOR THE ADEQUACY OR ACCURACY OF THIS RELEASE.

This news release may contain forward-looking statements and information based on current expectations. These statements should not be read as guarantees of future performance or results of the Company. Such statements involve known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to be materially different from those implied by such statements. Although such statements are based on management’s reasonable assumptions, there can be no assurance that such assumptions will prove to be correct. We assume no responsibility to update or revise them to reflect new events or circumstances. The Company’s securities have not been registered under the U.S. Securities Act of 1933, as amended (the “U.S. Securities Act”), or applicable state securities laws, and may not be offered or sold to, or for the account or benefit of, persons in the United States or “U.S. Persons”, as such term is defined in Regulations under the U.S. Securities Act, absent registration or an applicable exemption from such registration requirements. This press release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of the securities in the United States or any jurisdiction in which such offer, solicitation or sale would be unlawful. Additionally, there are known and unknown risk factors which could cause the Company’s actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking information contained herein, such as, but not limited to dependence on obtaining regulatory approvals; the ability to locate additional supply of medical cannabis, owning interests in companies or projects that are engaged in activities currently considered illegal under United States federal law; changes in laws; limited operating history, reliance on management, requirements for additional financing, competition, hindering market growth; regulatory and political change. All forward-looking information herein is qualified in its entirety by this cautionary statement, and the Company disclaims any obligation to revise or update any such forward-looking information or to publicly announce the result of any revisions to any of the forward-looking information contained herein to reflect future results, events or developments, except as required by law.

Forward-looking information is subject to known and unknown risks, uncertainties and other factors that may cause the actual results, level of activity, performance or achievements of the Company to be materially different from those expressed or implied by such forward-looking information. Such risks and other factors may include, but are not limited to: general business, economic, competitive, political and social uncertainties; general capital market conditions and market prices for securities; the actual results of the Company’s future operations; competition; changes in legislation affecting the Company; the ability to obtain and maintain required permits and approvals, the timing and availability of external financing on acceptable terms; lack of qualified, skilled labour or loss of key individuals; risks related to the COVID-19 pandemic including various recommendations, orders and measures of governmental authorities to try to limit the pandemic, including travel restrictions, border closures, non-essential business closures, service disruptions, quarantines, self-isolations, shelters-in-place and social distancing, disruptions to markets, economic activity, financing, supply chains and sales channels, and a deterioration of general economic conditions; and a deterioration of financial markets that could limit the Company’s ability to obtain external financing.

A description of additional risk factors that may cause actual results to differ materially from forward-looking information can be found in the Company’s disclosure documents on the SEDAR website at www.sedar.com. Although the Company has attempted to identify important factors that could cause actual results to differ materially from those contained in forward-looking information, there may be other factors that cause results not to be as anticipated, estimated or intended. Accordingly, readers should not place undue reliance on forward-looking information. Readers are cautioned that the foregoing list of factors is not exhaustive. Readers are further cautioned not to place undue reliance on forward-looking information 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.

The Company’s securities have not been registered under the U.S. Securities Act of 1933, as amended (the “U.S. Securities Act”), or applicable state securities laws, and may not be offered or sold to, or for the account or benefit of, persons in the United States or “U.S. Persons”, as such term is defined in Regulations under the U.S. Securities Act, absent registration or an applicable exemption from such registration requirements. This press release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of the securities in the United States or any jurisdiction in which such offer, solicitation or sale would be unlawful.

Forward-looking information contained in this press release is expressly qualified by this cautionary statement. The forward-looking information contained in this press release represents the expectations of the Company as of the date of this press release and, accordingly, are subject to change after such date. However, the Company expressly disclaims any intention or obligation to update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as expressly required by applicable securities law.

References:

  1. Weinreb RN, Leung CK, Crowston JG, Medeiros FA, Friedman DS, Wiggs JL, Martin KR. Primary open-angle glaucoma. Nat Rev Dis Primers. 2016 Sep 22;2:16067. doi: 10.1038/nrdp.2016.67. PMID: 27654570.
  2. May JA, McLaughlin MA, Sharif NA, Hellberg MR, Dean TR. Evaluation of the ocular hypotensive response of serotonin 5-HT1A and 5-HT2 receptor ligands in conscious ocular hypertensive cynomolgus monkeys. J Pharmacol Exp Ther. 2003 Jul;306(1):301-9. doi: 10.1124/jpet.103.049528. Epub 2003 Apr 3. PMID: 12676887.
  3. Sharif NA. Serotonin-2 receptor agonists as novel ocular hypotensive agents and their cellular and molecular mechanisms of action. Curr Drug Targets. 2010 Aug;11(8):978-93. doi: 10.2174/138945010791591278. PMID: 20426763.
  4. Najam A Sharif & Jesse A May (2011) Potential for serotonergic agents to treat elevated intraocular pressure and glaucoma: focus on 5-HT2 receptor agonists, Expert Review of Ophthalmology, 6:1, 105-120, DOI: 10.1586/eop.10.69
  5. Sharif NA, McLaughlin MA, Kelly CR. AL-34662: a potent, selective, and efficacious ocular hypotensive serotonin-2 receptor agonist. J Ocul Pharmacol Ther. 2007 Feb;23(1):1-13. doi: 10.1089/jop.2006.0093. PMID: 17341144.

This article was published by CFN Enterprises Inc. (OTCQB: CNFN), owner and operator of CFN Media, the industry’s leading agency and digital financial media network dedicated to the burgeoning CBD and legal cannabis industries. Call +1 (833) 420-CNFN for more information.

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Entheon Biomedical Announces DMT Drug Supply Agreement with Ofichem Group https://mjshareholders.com/entheon-biomedical-announces-dmt-drug-supply-agreement-with-ofichem-group/ Tue, 18 May 2021 14:57:46 +0000 https://www.cannabisfn.com/?p=2920467

Ryan Allway

May 18th, 2021

Psychedelics


Vancouver, British Columbia–(Newsfile Corp. – May 18, 2021) – Entheon Biomedical Corp. (CSE: ENBI) (OTCQB: ENTBF) (FSE: 1XU1) (“Entheon” or the “Company“), a biotechnology company focused on developing psychedelic medicines to treat addiction, announced it has entered into a drug-supply agreement (the “Agreement“) with Laboratorium Ofichem BV (“Ofichem” or “Ofichem Group”). Under the terms of the Agreement, Ofichem will supply Entheon with GMP quality N,N-dimethyltryptamine drug substances (“DMT“) for upcoming formulation, preclinical, clinical, and post-approval commercialization phases under the European Medicines Agency regulatory framework.

The Agreement, entered into May 4, 2021, will see Ofichem provide GMP DMT product as well as the required analytical data package for use in the previously announced phase 1 human clinical trial to be conducted by the Centre for Human Drug Research. Ofichem will also provide any additional DMT product that is required for an anticipated stability study. The phase 1 trial, to be conducted in the Netherlands, is scheduled to begin in Q4 2021.

“This supply agreement with Ofichem will enable the delivery of GMP-grade DMT for use in our upcoming human clinical trials and is a critical element to the success of the study. Ofichem’s significant experience in organic synthesis, analytical chemistry and drug development make them an ideal European partner for this initiative,” said Timothy Ko, Chief Executive Officer of Entheon. “We look forward to updating shareholders further as we advance through the preparation steps leading to the commencement of the clinical trial.”

“Headquartered in Ter Apel, The Netherlands, the Ofichem Group is active in more than 60 countries and boasts a portfolio of 45 in-house made active pharmaceutical ingredients. We consider it important to continue to engage with new partners. We are therefore pleased to provide our knowledge and commitment to quality for Entheon Biomedical’s clinical efforts,” said Dr. Weite Oldenziel, CEO of Ofichem Group.

The Company also announces that it has entered into a consulting agreement with Grant Galloway and Christopher Biggin dba Canna Cap Fund (“Canna Cap”) pursuant to which Canna Cap will provide investor communications and public relations services with existing shareholders, brokers, dealers and other investment professionals as to the Company’s current and proposed activities. The agreement is for an initial three (3) month term. Canna Cap will be compensated a monthly fee of USD $25,000.00 during the initial term.

About Entheon Biomedical Corp.

Entheon is a biotechnology research and development company committed to developing and commercializing a portfolio of safe and effective N,N-dimethyltryptamine based psychedelic therapeutic products (“DMT Products“) for the purposes of treating addiction and substance use disorders. Subject to obtaining all requisite regulatory approvals and permits, Entheon intends to generate revenue through the sale of its DMT Products to physicians, clinics and licensed psychiatrists in the United States, certain countries in the European Union and throughout Canada.

About Ofichem Group

For over 40 years the Ofichem Group has been working to improve health for humans and animals by providing high quality Active Pharmaceutical Ingredients. API’s that not only meet client’s needs but also comply with stringent health and safety regulations.

Ofichem’s mission is to help improve health in humans and animals and to do so we work in close collaboration with our clients, developing, manufacturing and sourcing API’s and distributing them across the globe. Ofichem’s teams work closely with our clients so that they can respond to market demands, meet country-specific regulations and develop their products for their specific purposes. We take our clients through the complete process of bringing an API to market, from development and production to regulation and distribution, so that in the end, together, we can make a difference to the health of humans and animals.

On Behalf of the Board of Directors,

“Timothy Ko”
Timothy Ko, CEO

For more information, please contact the Company at:
Entheon Biomedical Corp.
Joseph Cullen, Investor Relations
Telephone: +1 (778) 919-8615
[email protected]
https://entheonbiomedical.com/

For media inquiries, please contact Crystal Quast at:
Bullseye Corporate
Crystal Quast
Telephone: +1 (647) 529-6364
[email protected]

Cautionary Note on Forward Looking Information

This news release contains forward‐looking statements and forward‐looking information within the meaning of applicable securities laws. These statements relate to future events or future performance. All statements other than statements of historical fact may be forward‐looking statements or information. More particularly and without limitation, this news release contains forward‐looking statements and information relating to the supply agreement with Laboratorium Ofichem BV, the production and delivery of the DMT by Laboratorium Ofichem BV, the ability of the Company to obtain requisite permits, the commencement and execution of its clinical study, if at all and subsequent use of drug supply in forthcoming clinical trials, and other matters. The forward‐looking statements and information are based on certain key expectations and assumptions made by management of the Company. Although management of the Company believes that the expectations and assumptions on which such forward-looking statements and information are based are reasonable, undue reliance should not be placed on the forward‐looking statements and information since no assurance can be given that they will prove to be correct.

Forward-looking statements and information are provided for the purpose of providing information about the current expectations and plans of management of the Company relating to the future. Readers are cautioned that reliance on such statements and information may not be appropriate for other purposes, such as making investment decisions. Since forward‐looking statements and information address future events and conditions, by their very nature they involve inherent risks and uncertainties. Actual results could differ materially from those currently anticipated due to a number of factors and risks. These include, but are not limited to, the Company’s ability to raise further capital and the Company’s ability to obtain regulatory and exchange approvals. Accordingly, readers should not place undue reliance on the forward‐looking statements and information contained in this news release. Readers are cautioned that the foregoing list of factors is not exhaustive. The forward‐looking statements and information contained in this news release are made as of the date hereof and no undertaking is given to update publicly or revise any forward‐looking statements or information, whether as a result of new information, future events or otherwise, unless so required by applicable securities laws. The forward-looking statements or information contained in this news release are expressly qualified by this cautionary statement.

Neither the CSE nor the Investment Industry Regulatory Organization of Canada accepts responsibility for the adequacy or accuracy of this release.

This article was published by CFN Enterprises Inc. (OTCQB: CNFN), owner and operator of CFN Media, the industry’s leading agency and digital financial media network dedicated to the burgeoning CBD and legal cannabis industries. Call +1 (833) 420-CNFN for more information.

About Ryan Allway

Mr. Allway has over a decade of experience in the financial markets as both a private investor and financial journalist. He has been actively involved in the cannabis industry since its inception, covering public and private companies.


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Core One Labs’ Vocan Initiates Engineering and Design of a Proprietary Production System for Manufacturing of API-Grade DMT https://mjshareholders.com/core-one-labs-vocan-initiates-engineering-and-design-of-a-proprietary-production-system-for-manufacturing-of-api-grade-dmt/ Wed, 21 Apr 2021 15:15:40 +0000 https://www.cannabisfn.com/?p=2918915

Ryan Allway

April 21st, 2021

Psychedelics


VANCOUVER, British Columbia, April 21, 2021 (GLOBE NEWSWIRE) — Core One Labs Inc. (CSE: COOL), (OTC: CLABF), (Frankfurt: LD62, WKN: A2P8K3) (”Core One”) a life sciences research and technology company focused on bringing psychedelic medicines to market through novel delivery systems and psychedelic-assisted psychotherapy is pleased to announce its wholly owned subsidiary Vocan Biotechnologies Inc. (“Vocan”) has initiated the engineering and design of a proprietary enzymatic production system for the manufacturing of API-grade N,N-dimethyltryptamine (DMT). DMT, a naturally occurring psychedelic substance, is currently under clinical investigation for the treatment of certain mood disorders. The compound is a primary component of traditional South American entheogenic brews and is traditionally derived from the leaves of a variety of plants endemic to equatorial regions across the globe.

The Vocan team has outlined a genetic pathway that could result in potentially elevated levels of DMT biosynthesis compared to the naturally occurring production pathway in the plants from which the compound is commonly extracted. With further development the research team plans to construct a high-throughput production system based on the same recombinant enzyme fermentation platform the company is already developing for API-psilocybin. The addition of this biosynthetic target to its development pipeline will allow Vocan to broaden its offerings of clinical-quality psychedelic medicines and enable advancement of the therapeutic use of psychedelic substances in medicine.

This proprietary approach to DMT production will preserve the highly specific molecular structure of naturally occurring plant-derived DMT and allow the Company’s fermentative biosynthesis platform to be optimized for maximum DMT output at production scale. The team intends to accelerate the current development stage of its DMT production system within a few weeks in order to fast-track the first DMT provisional patent filling with the US Patent and Trademark Office. Early patent protection of its proprietary DNA sequences and enhanced-activity enzymes will ensure API-grade DMT can be manufactured by a repeatable and reliable process without any requirement for more costly chemical synthesis or cultivation, extraction, and purification from plant sources.

Core One’s research and development division, through the leadership of Dr. Robert Hancock, continues to achieve significant scientific milestones in the production of biosynthesized and stereochemically sound psychedelic compounds. There is a growing body of scientific research and empirical evidence surrounding the benefits of using various psychedelic compounds to treat mental health afflictions and Core One endeavours to support the scientific community by providing psychedelic compounds for their research at a fraction of the cost of other producers. We will continue to develop and expand our psychedelic product offerings, to provide the scientific research community with the compounds they need, and the successful engineering of enzymatic DMT is another example of how we can do this,” Stated Joel Shacker CEO of the Company.

About Core One Labs Inc.
Core One is a biotechnology research and technology life sciences enterprise focused on bringing psychedelic medicines to market through novel delivery systems and psychedelic assisted psychotherapy. Core One has developed a patent pending thin film oral strip (the “technology”) which dissolves instantly when placed in the mouth and delivers organic molecules in precise quantities to the bloodstream, maintaining excellent bioavailability. The Company intends to further develop and apply the technology to psychedelic compounds, such as psilocybin. Core One also holds an interest in medical clinics which maintain a combined database of over 275,000 patients. Through these clinics, the integration of its intellectual property, R&D related to psychedelic treatments and novel drug therapies, the Company intends to obtain regulatory research approval for the advancement of psychedelic-derived treatments for mental health disorders.

Core One Labs Inc.
Joel Shacker
Chief Executive Officer

Cautionary Disclaimer Statement:

The Canadian Securities Exchange has not reviewed and does not accept responsibility for the adequacy or accuracy of the content of this news release.

Information set forth in this news release contains forward-looking statements that are based on assumptions as of the date of this news release. These statements reflect management’s current estimates, beliefs, intentions, and expectations. They are not guarantees of future performance. The Company cautions that all forward-looking statements are inherently uncertain, and that actual performance may be affected by a number of material factors, many of which are beyond the Company’s control. Such factors include, among other things: risks and uncertainties relating to the Company’s limited operating history and the need to comply with strict regulatory regulations. Accordingly, actual and future events, conditions and results may differ materially from the estimates, beliefs, intentions and expectations expressed or implied in the forward-looking information. Except as required under applicable securities legislation, the Company undertakes no obligation to publicly update or revise forward-looking information.

In addition, psilocybin is currently a Schedule III drug under the Controlled Drugs and Substances Act (Canada) and it is a criminal offence to possess substances under the Controlled Drugs and Substances Act (Canada) without a prescription or authorization. Health Canada has not approved psilocybin as a drug for any indication. Core One does not have any direct or indirect involvement with illegal selling, production, or distribution of psychedelic substances in jurisdictions in which it operates. While Core One believes psychedelic substances can be used to treat certain medical conditions, it does not advocate for the legalization of psychedelics substances for recreational use. Core One does not deal with psychedelic substances, except within laboratory and clinical trial settings conducted within approved regulatory frameworks.

This article was published by CFN Enterprises Inc. (OTCQB: CNFN), owner and operator of CFN Media, the industry’s leading agency and digital financial media network dedicated to the burgeoning CBD and legal cannabis industries. Call +1 (833) 420-CNFN for more information.

Ryan Allway

About Ryan Allway

Mr. Allway has over a decade of experience in the financial markets as both a private investor and financial journalist. He has been actively involved in the cannabis industry since its inception, covering public and private companies.


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