Posted on

Is this why ketamine helps with depression?

Perception study may explain promising depression therapy

Our brains are constantly making predictions about the world around us based on learned associations – if we hear sirens, we expect to see an ambulance. 

A recent study by University of Wisconsin–Madison researchers found that ketamine blocks the chemical signals that allow us to make predictions.

Why is this beneficial?

Many disorders are rooted in poor predictions. For instance, patients with depression often predict that the worst case scenario is bound to happen. 

“Blocking the negative predictions that are prominent in depressed patients could be how ketamine helps,” explains the school’s psychology and neuroscience professor.

PDF of article

Posted on

Core One Labs’ Akome Biotech Signs Research Agreement with University of Barcelona, Faculty of Pharmacy and Food Sciences

Core One Labs’ Akome Biotech Signs Research Agreement with University of Barcelona, Faculty of Pharmacy and Food Sciences

Vancouver, British Columbia, Canada – January 26, 2022 – Core One Labs Inc. (CSE: COOL), (OTC: CLABF), (Frankfurt: LD6, WKN: A3CSSU) (the “Company” or “Core One”) is pleased to announce that its wholly owned subsidiary Akome Biotech Ltd. (“Akome”) has signed a consulting agreement with the Universitat de Barcelona (the “University of Barcelona” or the “University”), Faculty of Pharmacy and Food Sciences, Laboratory of Medicinal Chemistry, of Barcelona, Spain.

By virtue of this agreement, Professor Maria Carmen Escolano, a full professor at the University’s Unit of Medicinal Chemistry in the Faculty of Pharmacy and Food Sciences, and her team will provide technical guidance for the in vitro development of Akome’s psychedelic based bioactive compounds targeting Major Depressive Order, Stroke, Parkinson’s Disease and Alzheimer’s Disease.

The University of Barcelona, Faculty of Pharmacy and Food Sciences, Laboratory of Medicinal Chemistry, has been selected by Akome as the successful candidate organization to provide technical guidance for the necessary in vitro studies of its proposed pharmaceutical psychedelic drug formulations.

Conducting in vitro studies is essential in the development of any new pharmaceutical drug. In vitro studies determine whether a pharmaceutical candidate produces the desired changes on cell cultures as an early indicator of efficacy. These studies are usually completed quickly and are designed based on information already presented in the provisional patents that have been filed by Akome.

Professor Escolano received her PhD from the University of Barcelona in 1993. Upon completion, she undertook research posts at the University College of London and Kingston University (UK) working in the synthesis of complex molecules with biological interest. Professor Escolano currently serves as a full professor at the Unit of Medicinal Chemistry in the Faculty of Pharmacy and Food Sciences, a post she has occupied for the last 14 years.

Professor Escolano leads the medicinal research group at the Universitat de Barcelona. The focus of this research group is the pharmacology of neurodegenerative diseases. Professor Escolano and her group have conducted in vitro development of multiple candidate substances for the treatment of neurological conditions. Professor Escolano is a renowned authority in the field, with over 95 publications in textbooks and peer-reviewed scientific journals. Akome is looking forward to the advancement of its pipeline of bioactive compounds specifically those targeting the neurodegenerative diseases, Parkinson’s and Alzheimer’s.

“We are excited to announce our contract with the University of Barcelona, Faculty of Pharmacy and Food Sciences, Laboratory of Medicinal Chemistry,” stated Joel Shacker CEO of the Company.  “Professor Escolano and her team have an enormous amount of experience, and knowledge of the targeted diseases, and the research acumen that will allow Core One to efficiently move forward with the more in-depth in vitro and in vivo studies that are necessary in effectively mapping out development of pre-clinical trials.”

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

FOR MORE INFORMATION, PLEASE CONTACT:

info@core1labs.com

1-866-347-5058

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.

Posted on

BetterLife Receives FDA Response On Its Pre-IND Application For Major Depressive Disorder (MDD) Treatment With BETR-001

BetterLife Receives FDA Response On Its Pre-IND Application For Major Depressive Disorder (MDD) Treatment With BETR-001

VANCOUVER, British Columbia, Jan. 20, 2022 (GLOBE NEWSWIRE) — BetterLife Pharma Inc. (“BetterLife” or the “Company”) (CSE: BETR / OTCQB: BETRF / FRA: NPAU ), an emerging biotech company focused on the development and commercialization of 2nd-generation non-hallucinogenic psychedelic analogs for the treatment of neuropsychological disorders, is pleased to announce it has received a written response from the U.S. Food and Drug Administration (FDA) to its pre-investigational new drug (pre-IND) application for the treatment of MDD with BETR-001. BETR-001 (2-bromo-LSD, formerly TD-0148A) is a non-hallucinogenic derivative of lysergic acid diethylamide (LSD) and is currently undergoing IND-enabling non-clinical studies and GMP manufacturing for clinical trials. The FDA response is in general agreement with the Company’s planned program for the development of BETR-001 and provided guidance regarding the BETR-001 IND-enabling non-clinical toxicology studies, its manufacturing strategy, and initial proposed clinical trial parameters.

“We are very pleased with the outcome of the BETR-001 pre-IND meeting with the FDA. The response from the FDA confirms that our current program will support the filing of BETR-001’s IND application and initiation of human clinical trials by the third quarter of this year. Being a non-hallucinogenic derivative of LSD makes BETR-001 a unique molecule with therapeutic potential for the treatment of debilitating psychiatric and neurological disorders with high unmet need, such as major depressive disorders and cluster headaches. Our team is fully dedicated to start the human clinical trials in the United States by early second half of this year,” said BetterLife’s Chief Executive Officer, Dr. Ahmad Doroudian.

About BetterLife Pharma

BetterLife Pharma Inc. is an emerging biotechnology company primarily focused on developing and commercializing two compounds, BETR-001 and BETR-002, to treat neuro-psychiatric and neurological disorders.

BETR-001 (formerly TD-0148A), which is in preclinical and IND-enabling studies, is a non-hallucinogenic and non-controlled LSD derivative in development and it is unique in that it is unregulated and therefore can be self-administered. BetterLife’s synthesis patent for BETR-001 eliminates regulatory hurdles and its pending patent for composition and method of use covers treatment of depression, cluster headaches, post-traumatic stress disorder and other neuro-psychiatric and neurological disorders.

BETR-002 (formerly TD-010), which is in preclinical and IND-enabling studies, is based on honokiol, the active anxiolytic ingredient of magnolia bark. BetterLife’s pending method of use and formulations patent covers treatment of anxiety related disorders including benzodiazepine dependency.

BetterLife also owns a drug candidate for the treatment of viral infections such as COVID-19 and is in the process of seeking strategic alternatives for further development.

For further information, please visit BetterLife Pharma .

Contact Information

David Melles, Investor Relations Manager
Email: David.Melles@blifepharma.com
Phone: 1-778-887-1928

Cautionary Note Regarding Forward-Looking Statements

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.

Primary Logo

News Provided by GlobeNewswire via QuoteMedia

Posted on

Microdosing eases depression

Wesana Health Announces Positive Findings From Animal Study on Novel Depression Treatment Protocol Combining Psilocybin and Cannabidiol

In a preclinical animal model, Wesana Health (WESA) found that a single high dose of psilocybin rapidly improved depressive behaviours for 14 days. A regimen of psilocybin microdoses and CBD was able to sustain the results and reduced depressive behaviours by an additional 64%.

Let’s keep the microdosing evidence coming!

PDF of article

Posted on

Blackhawk’s MindBio Therapeutics to Develop Psychedelic Medicine in Microdoses Ready for Commercial Use to Treat Major Depressive Disorder

Blackhawk’s MindBio Therapeutics to Develop Psychedelic Medicine in Microdoses Ready for Commercial Use to Treat Major Depressive Disorder

Vancouver, British Columbia – TheNewswire – January 17, 2021 – Blackhawk Growth Corp. (CSE:BLR) (CNSX:BLR.CN) (OTC:BLRZF) (Frankfurt:0JJ) (the “Corporation” or “Blackhawk”) is pleased to announce that its wholly-owned subsidiary MindBio Therapeutics Pty Ltd (“MindBio”) is developing a new microdosing formula using LSD (Lysergic Acid Diethylamide) to treat Major Depressive Disorder (“MDD”).  

MindBio aims to develop psychedelic microdosing formulations that can subsequently be manufactured under Good Manufacturing Practices (GMP) standards for subsequent use in both commercially and in Clinical Trials. The principal aim is to develop a LSD microdosing formulation suitable for home use. The feasibility of delivery systems will be confirmed as part of the overall works. The success of the formulations developed will be assessed against standard GMP criteria for dose homogeneity and stability with the aim of a minimum shelf-life of 6 months.

The prevalence of MDD is extraordinarily high and growing. In 2019, the National Institute of Mental Health estimated that 19.4 million people suffered at least one major depressive episode in the United States (www.nimh.nih.gov/health/statistics/major-depression).  MindBio is directly targeting MDD in one of its Phase 2 clinical trials microdosing LSD to create breakthrough treatments for this debilitating mental health condition.  

LSD is a hallucinogenic drug that has a profound impact on cognition, thinking, perception and mood. MindBio is developing a novel medicinal treatment using a microdose formula of LSD.  The benefit of microdoses is the effects of the drug can be sub-perceptual and the patient can conveniently get on with their day immediately after taking the drug without noticing its hallucinogenic effects.  

MindBio recently received feedback from its Phase 1 clinical trial independent Data and Safety Monitoring Committee that the clinical trial is approved to continue after a successful six-month safety review of its use of LSD in healthy participants.  After its positive safety review, MindBio is progressing the development and enhancement of its microdose formulation of LSD in a form for commercial distribution and use.

The new microdose formula will be adapted in the Phase 2 clinical trials and assessed utilizing MindBio’s proprietary technology which will be used to determine an optimal microdose for patients.  

Health Canada Announces Significant Amendment to Special Access Programme

Blackhawk commends Health Canada’s leadership on their recent amendments to the Special Access Programme (SAP), which will now allow physicians to request patient access to psychedelic treatments, including psilocybin-assisted therapy.

The amendments under the SAP came into effect as of January 5, 2022, as published in the Canada Gazette, and allows physicians to request psychedelic treatments on behalf of their patients, on a case-by-case basis, for serious treatment-resistant or life-threatening conditions. This significant amendment has the potential to provide numerous Canadians struggling with serious mental health afflictions with alternative therapies where traditional treatments have failed, or where other treatments are unsuitable or are unavailable in Canada.

Canada’s SAP was designed with the purpose of allowing people access to new, potentially life-saving medications before they are formally approved for routine use in healthcare, however prior to today’s milestone amendment, psychedelic medications have been ineligible for Special Access Programme applications. The regulatory amendment will enable Canadian physicians to apply for psychedelic therapies in a similar process as to how other investigational medications are accessed prior to formal drug approval.

The amendment to SAP by Health Canada is an historic milestone in Canada’s approach to treating mental health conditions and signifies a growing recognition of the important and growing body of research that supports the efficacy of psychedelics and psychedelic-assisted therapies in treating mental health afflictions. According to Health Canada, access to psychedelic treatments will be provided where there is sufficient data to support the safety and efficacy of the targeted drug for a patient’s specific condition.

“This is an important development for MindBio”, said Frederick Pels, CEO of Blackhawk Growth Corp. “Health Canada’s recent amendment to the Special Access Program, has the potential to improve the lives of numerous Canadians suffering from mental health afflictions, including major depression, end-of-life anxiety and even addictions and historical traumas. It also provides doctors and their patients a safe, legal and regulated process for providing alternative treatments to mental health patients that desperately seek alternatives to otherwise failing contemporary modalities.”

Chief Financial Officer Appointment

Zula Kropivnitski has resigned as the Company’s Chief Financial Officer for personal reasons, effectively immediately. The Board of Directors and management would like to thank Ms. Kropivnitski for her contributions to the Company and wish her every success in her future endeavours.

The Company is pleased to announce that Heidi Gutte has been appointed Chief Financial Officer of the Company. Ms. Gutte specializes in providing corporate finance, financial reporting, consulting, taxation and other accounting services to both small businesses as well as public companies in various industries. She also assists in many aspects of clients’ administration, corporate compliance and other activities.

Ms. Gutte earned her bachelor’s degree of computer engineering from the University of Applied Sciences in Brandenburg, Germany. She holds the professional designation of chartered professional accountant (CPA, CGA), and is a member of Chartered Professional Accountants of B.C. and Canada. Ms. Gutte has had extensive experience as a controller and CFO of numerous publicly traded and private corporations in several industries.

About MindBio Therapeutics Pty Ltd. (“MindBio”)

MindBio is a clinical-stage drug development company that is pioneering psychedelic microdosing research and is advancing emerging therapies to treat a range of debilitating health conditions such as depression, anxiety, chronic pain, cognitive impairment and PTSD (posttraumatic stress disorder).

In a world’s first clinical trial of its kind, MindBio is currently conducting Phase 1 clinical trials, that is over 50% complete, at a tier 1 university in a safety study of 80 participants microdosing LSD to patients. The study has received regulatory approval and government funding for the importing of LSD, laboratory work using the drug and approvals for participants to be prescribed the drug; and then patients take the drug at home as they would any other medication. Approvals have also been received for two phase 2 clinical trials involving microdosing LSD in late-stage cancer patients experiencing end-of-life distress.

MindBio is also pioneering the development of microdose formulations and a range of technology and artificial intelligence applications to ensure the safe dosage, use and administration of psychedelic medicines in the community. Early indications show that LSD is tolerated well in microdoses and has a lower side effect profile than the currently prescribed antidepressant drugs. MindBio has a detailed roadmap to conduct further clinical trials, including with other psychedelic substances, and a clear plan to bring newly created intellectual property to market and commercialization.

For more information, please visit https://mindbiotherapeutics.com.

About Blackhawk Growth

Blackhawk is an investment holding company looking to create substantial value for its shareholders through the acquisition and development of high growth companies. It has focused its investments in the health, cannabis and cannabidiol industries in both Canada and the United States. Its portfolio of companies includes TERP Wholesale, Sac Pharma, LeichtMind Clinics, Noble Hemp, Spaced Food, NuWave Foods, MindBio Therapeutics and Digital Mind Technology, as well as an equity position in Gaia Grow (CSE:GAIA).

The Company diligently posts updates through videos from the official company YouTube channel https://www.youtube.com/channel/UCs4f2tt3yAvOGhNLjgNOy-A  

Please join the conversation on our Blackhawk group supporter’s telegram group at https://t.me/Blackhawkgrowthcorp and visit us online at https://www.blackhawkgrowth.com.

For further information please contact:

Frederick Pels, Chief Executive Officer

(403)-991-7737

fred@blackhawkgrowth.com

Cautionary Note Regarding Forward-Looking Statement

All statements in this press release, other than statements of historical fact, are “forward-looking information” with respect to the Company within the meaning of applicable securities laws, including with respect to transaction and future operations of MindBio Therapeutics Pty Ltd. The Company provides forward-looking statements for the purpose of conveying information about current expectations and plans relating to the future and readers are cautioned that such statements may not be appropriate for other purposes. By its nature, this information is subject to inherent risks and uncertainties that may be general or specific and which give rise to the possibility that expectations, forecasts, predictions, projections or conclusions will not prove to be accurate, that assumptions may not be correct and that objectives, strategic goals and priorities will not be achieved. These risks and uncertainties include but are not limited those identified and reported in the Company’s public filings under the Company’s SEDAR profile at www.sedar.com. Although the Company has attempted to identify important factors that could cause actual actions, events or results to differ materially from those described in forward-looking information, there may be other factors that cause actions, events or results not to be as anticipated, estimated or intended. There can be no assurance that such information will prove to be accurate as actual results and future events could differ materially from those anticipated in such statements. The Company disclaims any intention or obligation to update or revise any forward-looking information, whether as a result of new information, future events or otherwise unless required by law.

Posted on

Filament Health and Cybin Therapeutics Announce Licensing Agreement

Filament Health and Cybin Therapeutics Announce Licensing Agreement

Filament will license PEX010, its proprietary botanical psilocybin drug candidate, to Cybin Therapeutics for use in two upcoming Phase II clinical trials awaiting Health Canada approval

Vancouver, British Columbia, January 14, 2022  – Filament Health Corp. (OTCQB:FLHLF) (NEO:FH) (FSE:7QS) (“Filament” or the “Company”), a clinical-stage natural psychedelic drug development company, today announced that it has entered into a licensing agreement with Cybin Therapeutics (“CT”), a private therapeutic bioscience company on a mission to discover and develop psilocybin assisted therapeutic protocols to treat mild mood disorders and addictions. Under the agreement, Filament will license PEX010, its botanical psilocybin drug candidate, to CT for two upcoming Phase II clinical trials addressing depression and alcohol use disorder with an additional two planned for 2022. The financial terms were not disclosed.

CT filed a Clinical Trial Application (CTA) to Health Canada for the first trial in 2021, and anticipates its depression study to begin in the second quarter of 2022. Both trials will be led by Dr. Reg Peters and Dave Phillips. Dr. Reg Peters has been involved in advocacy for compassionate use of psilocybin for palliative patients, including as a medical advisor to Therapsil. Mr. Dave Phillips, Training Advisor to Therapsil and a highly experienced psilocybin-assisted therapist, will lead the therapy component of the trials along with an experienced clinical team at Cybin Therapeutics’ purpose-built clinic.

“This agreement with Cybin Therapeutics demonstrates Filament’s ability to license our technology and facilitate our partners’ trials,” said Filament Chief Executive Officer, Benjamin Lightburn. “Our mission is to support the treatment of mental health conditions through the discovery and delivery of exclusively-natural psychedelic medicines, and we are proud to aid CT’s efforts. We view this as the first of many agreements in a long partnership.”

Josh Taylor, Cybin Therapeutics Founder, said “We are excited to advance our mission of creating psilocybin-based therapies for a number of treatment areas. Filament’s unique, all-natural drug candidates combined with our experienced team, we believe, create an ideal environment for creating research-based protocols, formulations, and outcomes for healing.”

BUSINESS DEVELOPMENT

Due to strong commercial demand for Filament’s unique proprietary drug candidates, the Company has engaged business development professionals to meet inbound requests and begin commercial outreach. Andry Tjahyana joins as Vice President, Business Development, bringing more than 25 years’ relevant experience. Filament has also engaged Thomas Ryan, Rob Grundy, and Christine Verstraate from NavigatorBIO, who bring a combined 65 years of pharmaceutical industry sales experience. 

ABOUT FILAMENT HEALTH (OTCQB:FLHLF) (NEO:FH) (FSE:7QS)

Filament Health is a clinical-stage natural psychedelic drug development company. We believe that safe, standardized, naturally-derived psychedelic medicines can improve the lives of many, and our mission is to see them in the hands of everyone who needs them as soon as possible. Filament’s platform of proprietary intellectual property enables the discovery, development, and delivery of natural psychedelic medicines for clinical development. We are paving the way with the first-ever natural psychedelic drug candidates.

Learn more at www.filament.health and on Twitter, Instagram and LinkedIn

ABOUT CYBIN THERAPEUTICS

Cybin Therapeutics (“CT”), is a private therapeutic bioscience company established in 2019, on a mission to develop psilocybin-assisted therapeutic protocols and natural formulations to treat mild mood disorders and addictions. Cybin Therapeutics works with healthcare specialists who together form a dynamic clinical team with the ability to carry out studies and clinical trials for Cybin Therapeutics and it’s future partners looking to conduct psilocybin based studies and trials. 

Learn more at www.cybintherapeutics.com.

MEDIA RELATIONS

Anna Cordon, Director of Communications
778.245.9067
anna@filament.health

Cybin Therapeutics
604.318.0458
info@cybintherapeutics.com

INVESTOR RELATIONS CONTACT

KCSA Strategic Communications
Tim Regan/Adam Holdsworth
347.487.6788
KCSA-investor-relations@filament.health

FORWARD LOOKING INFORMATION

Certain statements and information contained herein may constitute “forward-looking statements” and “forward-looking information,” respectively, under Canadian securities legislation. Generally, forward-looking information can be identified by the use of forward-looking terminology such as, “expect”, “anticipate”, “continue”, “estimate”, “may”, “will”, “should”, “believe”, “intends”, “forecast”, “plans”, “guidance” and similar expressions are intended to identify forward-looking statements or information. Forward-looking statements herein include, but are not limited to, statements regarding the benefits of psilocin as compared to psilocybin. The forward-looking statements are not historical facts, but reflect the current expectations of management of Filament regarding future results or events and are based on information currently available to them. Certain material factors and assumptions were applied in providing these forward-looking statements. Forward-looking statements regarding the Company are based on the Company’s estimates and are subject to known and unknown risks, uncertainties and other factors that may cause the actual results, levels of activity, performance or achievements of Filament to be materially different from those expressed or implied by such forward-looking statements or forward-looking information, including results of the clinical trial. 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. Accordingly, readers should not place undue reliance on forward-looking statements and forward-looking information. Filament will not update any forward-looking statements or forward-looking information that are incorporated by reference herein, except as required by applicable securities laws.

Posted on

MYND Life Sciences Announces Collaborative Research Agreement with the University of British Columbia

MYND Life Sciences Announces Collaborative Research Agreement with the University of British Columbia

MYND’s Second CRA focuses on Novel Therapies for Neurological Diseases of the Brain

VANCOUVER, BC, Jan. 12, 2022 /CNW/ – MYND Life Sciences Inc.  (“MYND” or the “Company“) (CSE: MYND) (OTC: MYNDF) a biopharmaceutical research and development company creating innovative precision medicines for patients with relentless neurological diseases, today announced that it has entered into Collaborative Research Agreement (the “Agreement”) with the University of British Columbia (“UBC”) focussing on Novel Therapies for Neurological Diseases.

MYND is creating safe and effective precision medicines based on proprietary technologies, targeting intractable diseases affecting the Central Nervous System, aiming to improve the standard of care for patients. This research seeks to test new compounds, including Psilocybins which may modify neurological diseases. Through 38 Health Canada licenses issued under their Section J exemptions of the Food and Drug Act issued to the UBC Laboratory, MYND possesses the enviable ability to examine the unique actions of analogues of Psilocybin. The focus is to develop, validate and patent the ability of Psilocybin-based drugs to modify outcomes in disease.

“We are very excited to announce our second Collaborative Research Agreement focussing on diseases of the brain,” stated Dr. Lyle Oberg, MYND‘s Chief Executive Officer. “We have a unique opportunity to improve the wellness and quality of life of millions of people and families torn apart by the tragedy of dementia and other debilitating diseases of the Central Nervous System. The MYND management team has a wealth of scientific, clinical and operational experience, and is well networked within the pharmaceutical industry. The Psilocybin sector is rapidly transitioning to become a pharmaceutical industry and MYND holds a unique position within the sector in terms of  building upon our unique intellectual property and a valuable portfolio of related patents”,”

The Company has a broad development pipeline, including advancing clinical programs, such as novel biomarkers for depression and MYND is expecting results from its pivotal trial to validate these biomarkers. Through its subsidiary MYND Diagnostics INC., this includes conducting an adaptive dose finding single phase 2b clinical trial funded by the Australian Government of the efficacy and safety of psilocybin assisted psychotherapy (“PAP”) in the treatment of people diagnosed with treatment resistant depression (“TRD”) in collaboration with clinical researchers at Monash University. Furthermore, MYND anticipates entering clinic trials with three additional programs in the course of 2022/2023. After progressing to clinical proof of concept, MYND will continue to have the option to enter into partnerships for late-stage development and commercialization.

“We are continuing to translate our innovative approaches, while maintaining our scientific excellence,” stated Dr. Wilfred Jefferies, Chief Science Officer at MYND. “We have unique technologies with differentiating potential and access to state-of-the-art facilities. This funding will allow us to accelerate our research dramatically leading to more rapid translation of our studies. This is a really exciting time for MYND and our team.”

DEPARTURE OF AN OFFICER OF THE COMPANY

MYND’s Chief Operating Officer, Jordan Cleland, is moving on from the company to pursue other professional opportunities effective the end of day, January 11, 2022. Cleland was MYND’s first hire in August of 2020 and provided operations set up and support in the formative months of the company. Cleland’s duties will be assumed by Dr. Chahaat Singh who will assume the role of Operations and Research Manager with MYND. Dr. Singh has a Ph.D. in Medical Genetics, a M. Sc. In Microbiology, and brings a wealth of research experience to the position.  Singh has biotech industry experience with the firms IMTech and Panacea and recently co-authored an article in the Lancet dealing with Alzheimer’s Disease. Mynd would like to thank Mr. Cleland for his dedication to the company and wishes him well in his future endeavours.

ABOUT MYND LIFE SCIENCES INC.

MYND Life Sciences Inc. is a medical biotech drug research and development company focused on neuro-pharmaceutical and novel psilocybin drug development, diagnostics and vaccines. MYND is developing new biological entities (NBEs) and new chemical entities (NCEs) and differentiates itself from other (bio)pharmaceutical companies by unique molecular concepts for the applications of Psilocybins for overcoming disease. The Company is advancing pharmaceuticals through rigorous science and clinical trials, while diligently patenting and safeguarding its intellectual property. For more information and to subscribe to MYND’s mailing list, please visit https://myndsciences.com/contact/.

CONTACT INFORMATION

Dr. Lyle Oberg, MD, CEO
Email: ir@myndsciences.com
Web: www.myndsciences.com

Forward-Looking Statements

This news release contains forward-looking statements and information within the meaning of applicable securities legislation. Often, but not always, forward-looking statements and information can be identified by the use of words such as “plans”, “expects” or “does not expect”, “is expected”, “estimates”, “intends”, “anticipates” or “does not anticipate”, or “believes”, or variations of such words and phrases or state that certain actions, events or results “may”, “could”, “would”, “might” or “will” be taken, occur or be achieved. Forward-looking statements or information involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of MYND to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements or information contained in this release.  

Risks, uncertainties and other factors involved with forward-looking information could cause actual events, results, performance, prospects and opportunities to differ materially from those expressed or implied by such forward-looking information. The Canadian Securities Exchange has not reviewed and does not accept responsibility for the adequacy or accuracy of the content of this news release.

None of the securities issued in connection with the Offering will be registered under the United States Securities Act of 1933, as amended (the “1933 Act”), and none of them may be offered or sold in the United States absent registration or an applicable exemption from the registration requirements of the 1933 Act. This press release shall not constitute an offer to sell or a solicitation of an offer to buy nor shall there be any sale of the securities in any state where such offer, solicitation, or sale would be unlawful.

SOURCE Mynd Life Sciences Inc.

Posted on

Psilocybin + CBD 🧠

Wesana Health Granted US FDA Pre-IND Meeting for SANA-013

The majority of patients with traumatic brain injury (TBI) also experience depression, and patients with severe TBI-related depression are 5x more likely to attempt suicide.

Wesana Health (WESA) is planning a study to see if the condition can be treated with one large dose of psilocybin in a clinic, followed by “self-administered maintenance doses” of psilocybin and CBD to sustain the benefits.

Researchers believe the treatment will promote neuroplasticity and neurogenesis while reducing neuroinflammation.

PDF of article

Posted on

PharmaTher Provides Update on Product Pipeline and Expected Milestones for 2022

PharmaTher Provides Update on Product Pipeline and Expected Milestones for 2022

Focused on becoming a leader in the development and commercialization of specialty ketamine prescription-based products
Expected milestones for 2022 include initiating Phase 3 clinical study for ketamine to treat Parkinson’s disease (KETLID); completing Phase 2 clinical study for ketamine to treat ALS (KETALS); completing observational study with ketamine and betaine for depression and pain (KETABET); initiating Phase 2 clinical study for ketamine microneedle patch (KETAPATCH); and seeking FDA approval for Ketamine Hydrochloride Injection USPproduct (KETARX)

​TORONTO, December 21, 2021 — PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a company focused on the development and commercialization of specialty ketamine prescription-based products, is pleased to provide a product pipeline update and expected milestones for 2022.

Fabio Chianelli, Chief Executive Officer of PharmaTher, said, “2021 proved to be a foundational year for PharmaTher as we achieved a number of milestones which have paved the way for an exciting 2022 in unlocking ketamine’s therapeutic potential for treating Parkinson’s disease and ALS, the development of our ketamine hydrochloride injection USP product and our ketamine microneedle patch as a potential next-generation therapeutic solution for mental health, neurological and pain disorders.  We are now in a position both operationally and financially to seek FDA approval for KETARX, our ketamine prescription product, and to enter clinical studies for KETAPATCH, our ketamine patch product, in 2022.”

Project KETLID:  Ketamine for Levodopa-Induced Dyskinesia in Parkinson’s Disease

The Company’s Phase 2 clinical trial (ClinicalTrials.gov Identifier: NCT04912115)  to evaluate the safety, efficacy and pharmacokinetics of ketamine in the treatment of levodopa-induced dyskinesia (“LID”) in patients with Parkinson’s disease is currently ongoing and the Company now expects topline results in Q1-2022. Positive Phase 2 clinical results will allow the Company to request a meeting with the FDA to discuss its plan and obtain an agreement to move to a Phase 3 clinical study under the 505(b)2 regulatory pathway by Q3-2022.

PharmaTher has an exclusive license agreement with the University of Arizona for the intellectual property protecting the potential use of ketamine to treat movement disorders.  The possible therapeutic effect of low-dose ketamine on LID was noted in a retrospective analysis of Parkinson’s disease patients who received ketamine for pain relief. During this analysis, it was observed that the patients experienced an improvement in LID lasting several weeks beyond treatment [Sherman et al, 2016]. These results were corroborated in a test of low-dose ketamine in a rodent LID model, and this possible effect has also been examined in a controlled study [Bartlett et al, 2016].

Project KETALS:  Ketamine for Amyotrophic Lateral Sclerosis (ALS or Lou Gehrig’s Disease)       

An Investigator-initiated IND application has been submitted and it is expected the FDA will accept the IND to proceed to a clinical study for ketamine to treat ALS patients within the next 30 days.  Patient enrollment is targeted for Q1-2022.  On August 3rd, 2021, the Company was granted orphan drug designation by the FDA for ketamine to treat ALS.

PharmaTher has an exclusive license agreement with the University of Kansas for the intellectual property protecting the potential use of ketamine to treat ALS. Ketamine has the potential to effectively increase the life expectancy of those with ALS at any stage and slow the progressive loss of muscle associated with poor outcomes of the disease. The University of Kansas Medical Center researchers and inventors of the potential use of ketamine to treat ALS, Dr. Richard J. Barohn, M.D., John A. Stanford, Ph.D., and Dr. Matthew Macaluso, D.O., have made the promising discovery that ketamine can be administered as an effective treatment for ALS. In addition, unpublished and patent-pending preclinical research has shown that the administration of ketamine preserves muscle function in advancing ALS and increases life expectancy when given in the early stages of muscle decline.

Project KETABET: Ketamine and Betaine Combination Formulation

The Company is supporting an Investigator-lead observational study to evaluate the impact of betaine anhydrous on the unwanted ketamine side effects seen post ketamine treatment for subjects with depression.  The Company now expects results to be reported in early Q1-2022.  Based on the results, the Company will advance the KETABET program with its microneedle patch for clinical studies in the H2-2022.

PharmaTher has an exclusive license agreement with the National Health Research Institutes for the development and commercialization of a patented combination formulation of FDA-approved ketamine and betaine. KETABET has been shown in research to enhance the antidepressant effect while having the potential to reduce the known negative side effects of ketamine significantly.  The combination of ketamine and betaine anhydrous produced more robust antidepressant-like responses than their individual effects and that the combination blocked the psychotomimetic effects of ketamine [Lin, Jen-Cheng et al., 2016].

Project KETAPATCH: Ketamine Microneedle Patch

In collaboration with The Queen’s University of Belfast (“QUB”), led by Professor Ryan Donnelly, the Company has successfully completed the evaluation of a patented hydrogel-forming microneedle patch to deliver Ketamine and KETABET as a potential next-generation treatment for neuropsychiatric, neurodegenerative and pain disorders.  This de-risking milestone supports the Company’s expansion in finalizing IND-enabling studies and the clinical manufacturing scale up with LTS Lohmann, a leader in transdermal delivery systems, to support FDA and international regulatory submissions.  Validation and tech transfer activities to support clinical studies are in progress and the Company expects to conduct clinical studies in H2-2022.

PharmaTher has an exclusive license agreement with QUB for the development and commercialization of a patented hydrogel-forming microneedle delivery technology developed by Professor Ryan Donnelly to support PharmaTher’s product and clinical development initiatives with ketamine and psychedelics.  Professor Donnelly’s lab successfully completed research and published a paper titled “Hydrogel-forming microneedle arrays as a therapeutic option for transdermal esketamine delivery” validating the delivery of esketamine, the S(+) enantiomer of ketamine, in a novel microneedle patch which may overcome the drawbacks associated with ketamine administration in an intravenous or nasal spray format [Courtenay, Aaron J et al., 2020].

Project KETARX: Ketamine Prescription (Rx) Product

The Company is developing its own Ketamine Hydrochloride Injection USP product as part of its plans to support the Company’s future Phase 3 clinical studies and its commercialization plans in the U.S. via a supplemental Abbreviated New Drug Application (“sANDA”) with the FDA for use in anesthesia and procedural sedation.  The Company expects to file for its sANDA in Q4-2022 for commercialization in the U.S. and international markets thereafter.

PharmaTher has entered into an agreement with Alcami Corporation, a global pharmaceutical contract development and manufacturing organization with extensive experience in cGMP sterile fill-finish products and handling of controlled substances, for the clinical and commercial manufacturing for the Company’s KETARX project. The Company expects to form partnerships with research labs, ketamine clinics and pharmaceutical companies that are: seeking a secure supply of cGMP ketamine and ketamine products for current portfolios; exploring alternative dose forms for multiple existing indications; and requiring support to develop and eventually commercialize specific ketamine products for new indications.  In addition, the Company will enter the market with KETARX targeting ketamine’s FDA approved label for anesthesia and procedural sedation.

About PharmaTher Holdings Ltd.

​PharmaTher Holdings Ltd. (OTCQB: PHRRF) (CSE: PHRM) is focused on the research, development and commercialization of specialty ketamine prescription-based products including KETAPATCH, a  ketamine microneedle patch for mental health, neurological and pain disorders, and KETARX, a ketamine hydrochloride injection USP product for anesthesia and procedural sedation. Learn more at PharmaTher.com, Twitter and LinkedIn.

For more information about PharmaTher, please contact:

Fabio Chianelli
Chief Executive Officer
PharmaTher Holdings Ltd.
Tel: 1-888-846-3171
Email: info@pharmather.com
Website: www.pharmather.com

Neither the Canadian Securities Exchange nor its Regulation Services Provider have reviewed or accept responsibility for the adequacy or accuracy of this release.

Cautionary Statement

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”, “may” and similar expressions and statements relating to matters that are not historical facts are intended to identify forward-looking information and are based on PharmaTher Holdings Ltd. (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 August 31, 2021 (“MD&A”), dated October 27, 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.