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!
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.
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.
MindBio Therapeutics is aiming to develop a “smart drug delivery technology” that can use patient data to determine an optimal microdose for each individual.
Here’s a fun way to bond with grandma…
Mindset Pharma (MSET) filed a patent for psilocybin microdoses that have potential to treat Alzheimer’s disease and ADHD.
The compounds may promote cognitive benefits without the liability of a psychedelic experience, making them suitable for “fragile population groups” like children and the elderly, according to the company’s Chief Scientific Officer.
Evidence suggests that microdosing improves cognitive function and memory. This kit could take the benefits up a notch.👇🏽
Ixtlan Bioscience, a private Israeli company, filed a US patent for a microdosing kit that can be used at home to treat Alzheimer’s, brain damage, and neuronal disorders.
The kit includes:
Who knows, maybe this time next year, it’ll be the trending gift to put under the tree. 🎄
MindMed (MNMD) is collaborating with universities in Switzerland and the Netherlands to study the effects of microdosing LSD on adults with ADHD. Patients will be assessed on symptoms of inattention, impulsivity, and hyperactivity after microdosing twice a week for six weeks.
“The study builds on the growing evidence demonstrating LSD has the potential to improve mood and selective cognitive processes,” says the company’s new CEO, Robert Barrow, who was appointed this week.
Nova Mentis (NOVA) and Mycrodose Therapeutics successfully created a transdermal patch that delivers Nova’s psilocybin formulation through the skin. The companies aim to use the patch to administer microdoses to autistic patients to treat cognitive impairments.
This method could be administered at home to reduce medical costs for families and save time for overworked medical professionals.
TORONTO, December 14, 2021 — PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a clinical-stage psychedelics biotech company, is pleased to announce that it has successfully completed its first research study evaluating MicroDose-MN™, a proprietary microneedle (“MN”) patch for the intradermal delivery of psychedelics, in delivering lysergic acid diethylamide (“LSD”). These results provide support to file for an IND application with the FDA to conduct Phase 2 clinical studies in 2022 with LSD for various indications.
The aim of PharmaTher’s research program was to develop a suitable prototype of MicroDose-MN™ patch for transdermal (intradermal) drug delivery to confirm compatibility and suitability to deliver LSD. The research program scope included, full characterization of LSD conjugated on the microneedle patch backbone, establishment and demonstration of the loading capacity for LSD, and release rate evaluations for the LSD conjugated materials using appropriate models that will be used to support the Company’s IND application with the FDA in the future.
The Company’s research program with LSD conjugated microneedles have been successfully fabricated, optimized, and characterized. Both structural aspects and ex-vivo skin insertion assessments of the LSD conjugated microneedles have demonstrated successful fabrication and acceptable performance. The incorporation of LSD into microneedles without issue and the ability to demonstrate complete ex vivo skin model release over several days demonstrates potential for larger doses and modified release profiles. With these results, the Company believes it has an acceptable prototype for completing IND-enabling studies with the aim to conduct clinical studies in 2022. Details of the research program will be published in a scientific journal.
The Company believes that its MicroDose-MN™ patch for delivering LSD and other psychedelics may enable flexible drug load capacity and combinations, controlled released delivery, and be able to present desired pharmacokinetic and safety profiles. In addition, the MicroDose-MN™ patch for psychedelics aims to empower patients to dose their medication remotely, safely and conveniently rather than under supervision by a healthcare provider at a certified medical office or hospital. To achieve this, the Company will incorporate anti-tampering and anti-abuse features that would parallel the approach used for the tamper-resistant transdermal fentanyl patch.
The Company is completing its evaluation of MicroDose-MN™ with 3,4-methylenedioxy-methamphetamine (“MDMA”) and N, N-dimethyltryptamine (“DMT”) and expects to provide results before the end of this year and pursue clinical studies in 2022.
The Company is actively engaged in partnering discussions for the use of its microneedle patch system to deliver psychedelics including, but not limited to, MDMA, LSD, DMT, ibogaine and mescaline. As such, PharmaTher offers potential partners a differentiated and validated delivery system for psychedelics, desired pharmacokinetic profiles, intellectual property protection, cGMP microneedle patches for IND-enabling and clinical studies, and a clear clinical pathway towards clinical studies in 2022.
About PharmaTher Holdings Ltd.
PharmaTher Holdings Ltd. (OTCQB: PHRRF) (CSE: PHRM) is a clinical-stage psychedelics biotech company focused on the research, development and commercialization of novel uses, formulations and delivery methods of psychedelics, such as ketamine, to treat mental health, neurological and pain disorders. PharmaTher is currently advancing an FDA approved phase 2 clinical study with ketamine to treat Parkinson’s disease and is developing a novel microneedle patch for the intradermal delivery of psychedelics and infectious disease treatments.
Learn more at: PharmaTher.com and follow us on Twitter and LinkedIn.
For more business development opportunities or 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.
Vancouver, British Columbia – TheNewswire – December 13, 2021 – Blackhawk Growth Corp. (CSE:BLR); (CNSX:BLR.CN); (OTC:BLRZF); (Frankfurt:0JJ) (“Blackhawk”), is pleased to provide an update on its clinical trials for both of its wholly-owned subsidiaries MindBio Therapeutics PTY Ltd. (“MindBio”) and Digital Mind Technology PTY Ltd. (“Digital Mind”).
MindBio Clinical Trial Update
MindBio is accelerating its clinical trial program and is now fully funded for its Phase II clinical trial for microdosing of psychedelics in late-stage cancer patients. MindBio will be one of only a handful companies that is progressing to a Phase II clinical trial in the psychedelics sector.
The now fully funded Phase II clinical trial will examine the effects of Psychedelic Microdosing Assisted Meaning Centred Psychotherapy (PMA-MCP) in advanced stage cancer patients.
The ground-breaking Phase II trial will examine the feasibility, acceptability and safety of a randomised, double-blind, placebo-controlled trial comparing Psychedelic Microdosing Assisted Meaning Centred Psychotherapy (PMA-MCP) to placebo in advanced stage cancer patients. This trial will help to evaluate whether PMA-MCP provides benefits in advanced stage cancer patients in regard to quality of life, their spiritual well-being, anxiety, depression, hopelessness, and attitudes towards death.
At each quarterly reporting, the intellectual property protection will be discussed and managed between the University of Auckland and MindBio. A qualified medical officer, psychotherapists, and a study nurse will also be appointed for patient therapy and safety.
In addition, MindBio also has the necessary funding to start the development of a second Phase II microdosing depression trial. This will involve the analysis of Phase I trial data, expected to be completed in Q1 2022, which will inform the trial design for Phase II trials for the development of investigator materials and the development of trial protocol documentation.
A pharmacogenomic (liver enzyme genotyping) and pharmacokinetic analyses will also be conducted to help understand the individual variability of response to LSD observed in Phase I study data (see Vizeli et al 2021 Scientific Reports). Furthermore, biomarker analysis will be used to determine potential candidate biomarkers for Phase 2 trials (e.g. mRNA).
MindBio has budgeted to start scientific research to objectively determine the effectiveness of psychedelic microdosing on individuals. This includes developing a platform to ensure time critical requirements of microdosing, personalised algorithms used for optimising microdosing to suit a given individual, artificial intelligent toos for data analytics for studying the impact of therapy on the patient’s mood state, and more.
Digital Mind Technology
Digital Mind has successfully completed a pilot randomized controlled trial with 69 patients of an online mindfulness-based program for people diagnosed with melanoma1. Led by leading scientist Dr. Lahiru Russell, Digital Mind is launching a fully funded Phase I clinical trial of mindfulness-based digital programs for people requiring pain management to avoid or reduce the impact on mental health. The clinical trials will start in Q1, 2022 and will be fully compliant with the Food and Drug Administration’s (FDA) protocols.
Results of Digital Mind’s completed pilot randomized controlled trial showed that psycho-educational interventions can decrease anxiety and health-related distress, and prompt positive change in coping with illness. Improving awareness of thoughts may be a therapeutic approach to reduce worrisome and unhelpful thoughts, which underlie fear of disease that can lead to depression and other mental health problems.
This awareness is an essential component of mindfulness-based interventions in which one is aware of any thoughts, feelings, bodily sensations and surrounding environment occurring moment-by-moment. In this state of awareness, thoughts and feelings are experienced as passing events in the mind, instead of a reflection of oneself or reality. This detached self-observation allows individuals to reflect on situations and respond in more adaptive ways, instead of reacting in an automatic, habitual pattern.
Online and digital based interventions are more easily accessible, available at any time to people in their own environment, enable people to work at their own pace and have the option to remain anonymous. Digital Mind’s Phase I clinical trial will build on the results of the pilot trial and protocols to help develop digital platforms (mobile, smart watch, and web) that provides clinically proven mindfulness-based digital programs to help patients deal with pain that ultimately reduces the impact on their mental health conditions. These clinical programs have the potential to be provided to patients via health professionals in a clinical setting.
“MindBio has taken a significant leap forward”, said Frederick Pels, CEO of Blackhawk Growth. “A fully funded Phase II clinical trial puts the research and progress of MindBio in the top echelon of the booming psychedelic sector. Combined with the addition of Digital Mind and its fully funded Phase I clinical trial, it truly displays the strength and growth of our Company’s psychedelic and life science portfolio. I look forward to updating shareholders as these initiatives progress and as we work hard to unlock substantial value for our shareholders.”
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, LeichtMind Clinics, Noble Hemp, Spaced Food, NuWave Foods, MindBio Therapeutics and Digital Mind Technology.
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
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 future operations of Digital Mind Technology Pty Ltd. and MindBio Therapeutics Pyy 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.
