Wesana Health (WESA) may expand the indication of its psilocybin formulation after meeting with the FDA. In addition to treating anxiety related to traumatic brain injury, it could also target depression. A $3M private placement will fund phase Ib/IIa depression study next year.
“For the first time we find that psilocybin works differently from conventional antidepressants — making the brain more flexible and fluid, and less entrenched in the negative thinking patterns associated with depression,” says Imperial College London researcher David Nutt.
A new brain imaging study found that psilocybin increases brain network integration, whereas a common antidepressant, escitalopram, had no impact on brain network organization.
fMRI scans showed that psilocybin reduces activity in the default mode network (DMN), a region associated with introspection that’s often overactive in patients with depression, causing negative fixations about one’s self and the future.
The DMN became more connected with other regions like the salience network and the executive network, which are often impaired in patients with depression (as well as autism and OCD).
Essentially, this helps “open up” the brain, breaking rigid and restrictive patterns.
These findings may explain why psilocybin outperformed escitalopram in treating depression.
Vancouver, British Columbia – TheNewswire – April 04, 2022 – Blackhawk Growth Corp. (CSE:BLR) (CNSX:BLR.CN) (OTC:BLRZF) (Frankfurt:0JJ) (the “Company” or “Blackhawk”) is pleased to announce that MindBio Therapeutics Pty. Ltd. (“MindBio”) has entered its 80th and final patient into its Phase 1 clinical trial microdosing LSD (Lysergic Acid Diethylamide) in the largest safety trial of its kind ever to have been completed.
The global depression drugs market reached a value of US $12.7 Billion in 2020.1 MindBio is targeting this market with the most promising innovation in treating depression that has occurred since the invention of traditional modern anti-depressant medications in the mid 1980s.
Despite the investment in these traditional anti-depressant medications and their prescription by doctors and psychiatrists all over the world, the mental health crisis and prevalence of depression and related mood disorders has escalated with one of the leading causes of death in young people, being suicide.2
MindBio has also started preparation work for two Phase 2 Clinical Trials including the design of psychedelic microdosing formulations that can subsequently be manufactured under Good Manufacturing Practices (GMP) standards for use both commercially and in Clinical Trials.
MindBio is working towards creating a safe and effective microdosing regimen using psychedelics that can be prescribed by doctors to patients in the primary health care system. In larger doses, LSD is a hallucinogenic drug that substantially changes cognition, thinking, mood and perception, however in much smaller “microdoses”, the medicine is subperceptual, meaning that patients can take the drug without noticing its hallucinogenic effects, but still receive the medicinal benefit and get on with their normal day.
The results of this important clinical trial will form the basis for advancing the commercialization of a psychedelic microdosing regimen for safe use in the community.
In addition, Blackhawk contines to move forward on the spinout of Mindbio from Blackhawk. It has set a number of key dates for the transaction, including a proposed meeting date of shareholders to approve the spinout of June 20, 2022. Further details regarding the spinout and the meeting will be made available in an information circular mailed to shareholders of record, and posted under the profile for Blackhawk on SEDAR (www.sedar.com). Completion of the spinout remains subject to the receipt of shareholder, regulatory and court approvals.
“MindBio wants to be the first to market with a highly effective psychedelic microdosing treatment regimen and the completion of each clinical trial milestone drives us closer towards achieving our goal of changing the course of mental health treatment forever,” said Frederick Pels, CEO of Blackhawk Growth. “With progress continuing, I expect significant value to be realized once MindBio has spun out. I look forward to updating our shareholders as we make progress.”
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 Sac Pharma, Terp Wholesale, LeichtMind Clinics, Noble Hemp, Spaced Food, Stable Foods, and MindBio Therapeutics, Digital Mind Therapeutics as well as an equity position in Gaia Grow Corp. (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 the spinout 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.
Copyright (c) 2022 TheNewswire – All rights reserved.
Vancouver, British Columbia, Canada – April 2, 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”) through a research arrangement with Neuro-Zone Srl, (“Neuro-Zone”) based in Bresso, Italy, has achieved positive results from its in vitro biological assay (“bioassay”) development studies (“bioassay studies”); furthering the Company’s patent pending psychedelic bioactive compounds that could lead to groundbreaking drug formulations for Alzheimer’s Disease (AD), Parkinson’s Disease (PD), Major Depressive Disorder (Depression) and Stroke, (collectively “targeted diseases” or “neurological indications”).
Bioassay studies are one of the most important tools in new drug discovery and development as they identify whether a compound or, in Akome’s research scenarios, bioactive compounds, have the desired effect on targeted disease pathways.
Neuro-Zone’s bioassay studies have, to date, focused on confirming the relationship between the plant bioactives covered in Akome’s United States Patent and Trademark Office (USPTO) patent submissions, (namely AKO001, AKO002, AKO003 and AKO004 (see Company press releases dated June 19, 2021, May 6, 2021, July 21, 2021, and July 26, 2021, respectively), and the underlying neuropathological mechanisms related to conditions such as AD, PD, Depression and Stroke.
Neuro-Zone’s bioassay studies have allowed researchers to assess the effect of Akome’s plant bioactives on various biological targets associated with the neurological indications in question. Positive results emerging from the bioassay studies indicate that Akome’s plant bioactives possess the desired biological effects against Alzheimer’s Disease neuropathological mechanisms, as well as against other neuroinflammatory processes.
Using these positive results Akome and Neuro-Zone are actively mapping out the next stages in the Company’s drug development process.
“The positive results from these studies have demonstrated that Akome is making significant steps towards developing groundbreaking drug formulations that can be used to treat neurological diseases. This is great news for the tens of millions of people who are affected by Alzheimer’s, Parkinson’s, Depression and Stroke, across the globe” stated Joel Shacker, the Company’s CEO.
About Neuro-Zone
Neuro-Zone is a functional service company supporting drug discovery and research projects in the fields of inflammation and age-related pathologies, including underlying mechanisms of common brain diseases. With their added value deep scientific knowledge and cutting-edge technological platforms, Neuro-Zone studies the cell-cell interactions and biological activity of the Company’s new candidate drugs and provide understanding on the role of the microenvironment in the complex disease scenarios.
About Core One Labs Inc.
Core One Labs is a life sciences biotechnology research and development company focused on bringing psychedelic medicines to market through the development and production of psychedelic compounds, the advancement of psychedelic assisted treatments, and the integration of novel delivery systems technology.
The Company has a multi-faceted business approach and incorporates several complementary lines of businesses and units in establishing itself as an industry leader in the rapidly growing and emerging psychedelics market space.
Core One, through its wholly owned subsidiary Vocan Biotechnologies Inc., has developed and filed for patent protection of a proprietary psilocybin production system using engineered bacteria. It is also the holder of 4 provisional patents for the development of psychedelic-based pharmaceutical formulations targeting neurological and mental health disorders, under its 100% owned subsidiary Akome Biotech Ltd., and 3 provisional patents under its other 100% owned subsidiary, Awakened Biosciences Inc., for additional synthetic technologies for psilocybin and psilocin production methods.
In addition to the development of psychedelics and psychedelic compounds, Core One holds an interest in four medical clinics which maintain a combined database of more than 275,000 patients. Through its clinics the Company intends to integrate a roll out of its intellectual property related to psychedelic technologies and participate in the advancement of psychedelic-based 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.
CHICAGO and TORONTO, March 22, 2022 (GLOBE NEWSWIRE) — Wesana Health Holdings Inc. (“Wesana” or the “Company”) (CSE: WESA; OTCQB: WSNAF), a data-driven life sciences company focused on developing the novel therapies of tomorrow and delivering new care paradigms today, has announced data from an animal study, conducted by an independent global laboratory services provider in a validated model of depression.
Results of the study showed that administration of imipramine given three weeks following a psilocybin loading dose provided an additional 39% further improvement in depressive behaviors from that of psilocybin loading dose alone. Furthermore, a second administration of imipramine given four weeks after a psilocybin loading dose provided an even greater reduction (45%) in depressive behaviors.
“These results demonstrate that psilocybin has the ability to potentiate the effects of antidepressant medications,” said Mark Wingertzahn, Wesana Chief Scientific Officer. “These data could signal a shift in how we develop future clinical treatments for depression using both psilocybin and anti-depressants to optimize outcomes.”
While there are a number of available therapies to treat depression, only 60%–70% of patients respond to antidepressant therapy. Of those who do not respond, 10%–30% exhibit treatment-resistant symptoms1, highlighting the need for additional therapeutic options. Further, despite the established importance of treating depression, only 44% of TBI patients with major depressive disorder received antidepressants or counseling2. Of those treated, there is limited evidence supporting the efficacy of antidepressants in the treatment of post-TBI depression3. These new findings suggest that combination therapy could provide more consistent and robust effects over time.
“I’m proud of the work my team has done to continue investigating the full potential of psilocybin alone and in combination with other medications in order to one day provide tailored medication regimens that have an optimized benefit:risk profile,” added Daniel Carcillo, Wesana Founder and Chief Executive Officer. “I look forward to further investigations to address the massive need in our communities today.”
Additionally, The Company has entered into an engagement letter with MDM Worldwide for the provision of market awareness and investor relations services. The engagement has a six-month term at a rate of US$8,000 per month and upon completion, the issuance of 25,000 Restricted Stock Units (“RSUs”). MDM Worldwide is a digital communications agency that develops and manages online engagement strategies to connect companies with their stakeholders. MDM specializes in working with clients in the technology, healthcare and life sciences spaces.
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1 Al-Harbi KS. Treatment-resistant depression: therapeutic trends, challenges, and future directions. Patient preference and adherence. 2012;6:369-388.
2 Bombardier CH, Fann JR, Temkin NR, Esselman PC, Barber J, Dikmen SS. Rates of major depressive disorder and clinical outcomes following traumatic brain injury. JAMA. 2010;303(19):1938-45.
3 Robert S. Traumatic brain injury and mood disorders. Ment Health Clin. 2020;10(6):335-345.
About Wesana Health.
Wesana Health helps people transcend barriers in mental health and performance. We innovate in care development through our therapies and patent-pending protocols, and in care delivery through activating a new multidisciplinary, technology-supported clinical model. Learn more at www.wesanahealth.com.
Investor Relations:
Keenan Gentry
Email: IR@wesanahealth.com
Phone: 702-329-8038
Media Contacts:
Isadora Forman
Email: media@wesanahealth.com
Phone: 917-653-4613
Forward-Looking Information and Statements
This news release contains “forward-looking information” within the meaning of applicable securities laws relating to future partnerships, collaborative research and the focus of the Company’s business. Any such forward-looking statements may be identified by words such as “expects”, “anticipates”, “intends”, “contemplates”, “believes”, “projects”, “plans” and similar expressions. Readers are cautioned not to place undue reliance on forward-looking statements. These statements should not be read as guarantees of future performance or results. 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 regarding the participation in, or success of, partnerships or collaborative research or that the Company will continue its business as described above. The Company assumes no responsibility to update or revise forward-looking information to reflect new events or circumstances or actual results unless required by applicable law. Readers are encouraged to refer to the Listing Statement filed on Company’s profile on SEDAR at www.sedar.com for information as to the risks and other factors which may affect the Company’s business objectives and strategic plans.
Source: Wesana Health
Released March 22, 2022
Peyote has the longest documented use of any psychedelic, yet we don’t see many companies researching its properties.
That’s because the psychedelic cactus is endangered – the 13-year growth cycle can’t keep up with the rate of harvesting.
Lophos Pharmaceuticals is developing a sustainable cultivation technique that could reduce the long growth cycle to just 3 years, preserving the species and accelerating research.
The CEO of Lophos says that peyote could help treat obesity, addiction, anxiety, and depression, with a strong potential for microdosing.
About 60% of patients with chronic pain also suffer from a second condition like depression or anxiety.
A University of Tasmania researcher predicts that ketamine therapy will have a “dual beneficial effect” on both pain and mental health.
Other chronic pain experts share this belief. “The domains of pain, anxiety and depression are all connected. If you treat one, another often gets better,” according to researcher Dr. David Borsook.
The hypothesis will be put to the test in an upcoming study of 30 chronic pain patients, which received a $80K grant from the Clifford Craig Foundation.
MindBio Therapeutics invested NZ$2.3M to fast-track its research on microdosing LSD for depression and end-of-life distress in late-stage cancer patients.
After finding its DMT formulation to be well-tolerated, Small Pharma (DMT) is launching two new trials this year.
One will assess how DMT interacts with SSRIs in patients with depression and the other will compare the drug’s effects when administered through muscles versus veins.
The company has also developed a form of DMT that lasts longer than the typical 30 minute trip, but is still much shorter than a psilocybin or LSD trip.
Biomind Labs (BMND) is taking the opposite approach. The company reduced a DMT trip to just 10-15 minutes by making a formulation that’s inhalable.
Biomind’s formulation will be assessed in a Phase II trial for treatment-resistant depression, which just received approval by the Brazilian Institutional Review Board.
We’re eager to see if the length of the trip makes a difference!
Novamind (NM) began a Phase II trial on psilocybin for depression, which is sponsored by the non-profit Usona Institute.
