(TheNewswire)
Vancouver, British Columbia – TheNewswire - December 13, 2021 –Blackhawk Growth Corp. (CSE:BLR ) ; (CNSX:BLR.CN); (OTC:BLRZF);( Frankfurt:0JJ) (“ Blackhawk ”), ispleased to provide an update on its clinical trials for both of itswholly-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 andis 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 toa Phase II clinical trial in the psychedelics sector.
The now fully funded Phase II clinical trial will examine the effects of PsychedelicMicrodosing Assisted Meaning Centred Psychotherapy (PMA-MCP) inadvanced stage cancer patients.
The ground-breaking Phase II trial will examine thefeasibility, acceptability and safety of a randomised, double-blind,placebo-controlled trial comparing Psychedelic Microdosing AssistedMeaning Centred Psychotherapy (PMA-MCP) to placebo in advanced stagecancer patients. This trial will help to evaluate whether PMA-MCPprovides benefits in advanced stage cancer patients in regard toquality of life, their spiritual well-being, anxiety, depression,hopelessness, and attitudes towards death.
At each quarterly reporting, the intellectual propertyprotection will be discussed and managed between the University ofAuckland and MindBio. A qualified medical officer, psychotherapists,and a study nurse will also be appointed for patient therapy andsafety.
In addition, MindBio also has the necessary funding tostart the development of a second Phase II microdosing depressiontrial. This will involve the analysis of Phase I trial data, expectedto be completed in Q1 2022, which will inform the trial design forPhase II trials for the development of investigator materials and thedevelopment of trial protocol documentation.
A pharmacogenomic (liver enzyme genotyping) andpharmacokinetic analyses will also be conducted to help understand theindividual variability of response to LSD observed in Phase I studydata (see Vizeli et al 2021 Scientific Reports). Furthermore,biomarker analysis will be used to determine potential candidatebiomarkers for Phase 2 trials (e.g. mRNA).
MindBio has budgeted to start scientific research toobjectively determine the effectiveness of psychedelic microdosing onindividuals. This includes developing a platform to ensure timecritical requirements of microdosing, personalised algorithms used foroptimising microdosing to suit a given individual, artificialintelligent toos for data analytics for studying the impact of therapyon the patient’s mood state, and more.
Digital Mind Technology
Digital Mind has successfullycompleted a pilot randomized controlled trial with 69 patients of anonline mindfulness-based program for people diagnosed withmelanoma 1 . Led by leading scientist Dr. Lahiru Russell, Digital Mindis launching a fully funded Phase I clinical trial ofmindfulness-based digital programs for people requiring painmanagement to avoid or reduce the impact on mental health. Theclinical trials will start in Q1, 2022 and will be fully compliantwith the Food and Drug Administration’s (FDA) protocols.
Results of Digital Mind’s completed pilot randomizedcontrolled trial showed that psycho-educational interventions candecrease anxiety and health-related distress, and prompt positivechange in coping with illness. Improving awareness of thoughts may bea therapeutic approach to reduce worrisome and unhelpful thoughts,which underlie fear of disease that can lead to depression and othermental health problems.
This awareness is an essential component ofmindfulness-based interventions in which one is aware of any thoughts,feelings, bodily sensations and surrounding environment occurringmoment-by-moment. In this state of awareness, thoughts and feelingsare experienced as passing events in the mind, instead of a reflectionof oneself or reality. This detached self-observation allowsindividuals to reflect on situations and respond in more adaptiveways, instead of reacting in an automatic, habitual pattern.
Online and digital based interventions are more easilyaccessible, available at any time to people in their own environment,enable people to work at their own pace and have the option to remainanonymous. Digital Mind’s Phase I clinical trial will build on theresults of the pilot trial and protocols to help develop digitalplatforms (mobile, smart watch, and web) that provides clinicallyproven mindfulness-based digital programs to help patients deal withpain that ultimately reduces the impact on their mental healthconditions. These clinical programs have the potential to be providedto patients via health professionals in a clinical setting.
“Mind Bio has taken asignificant leap forward”, said Frederick Pels, CEO of BlackhawkGrowth. “A fully funded Phase II clinical trial puts the researchand progress of MindBio in the top echelon of the booming psychedelicsector. Combined with the addition of Digital Mind and its fullyfunded Phase I clinical trial, it truly displays the strength andgrowth of our Company’s psychedelic and life science portfolio. Ilook forward to updating shareholders as these initiatives progressand as we work hard to unlock substantial value for ourshareholders.”
About Blackhawk Growth
Blackhawk is an investment holding company looking tocreate substantial value for its shareholders through the acquisitionand development of high growth companies. It has focused itsinvestments in the health, cannabis and cannabidiol industries in bothCanada and the United States. Its portfolio of companies includes SacPharma, LeichtMind Clinics, Noble Hemp, Spaced Food, NuWave Foods,MindBio Therapeutics and Digital Mind Technology.
The Company diligently posts updates through videosfrom the official company YouTube channel https://www.youtube.com/channel/UCs4f2tt3yAvOGhNLjgNOy-A
Please join the conversation on our Blackhawk groupsupporter’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 ExecutiveOfficer
(403)-991-7737
Cautionary NoteRegarding Forward-Looking Statement
All statements in this pressrelease, other than statements of historical fact, are “forward-looking information”with respect to the Company within the meaning of applicablesecurities laws, including with respect to future operations ofDigital Mind Technology Pty Ltd. and MindBio Therapeutics Pyy Ltd TheCompany provides forward-looking statements for the purpose ofconveying information about current expectations and plans relating tothe future and readers are cautioned that such statements may not beappropriate for other purposes. By its nature, this information issubject to inherent risks and uncertainties that may be general orspecific and which give rise to the possibility that expectations,forecasts, predictions, projections or conclusions will not prove tobe accurate, that assumptions may not be correct and that objectives,strategic goals and priorities will not be achieved. These risks anduncertainties include but are not limited those identified andreported in the Company’s public filings under the Company’s SEDARprofile at www.sedar.com. Although the Company has attempted toidentify important factors that could cause actual actions, events orresults to differ materially from those described in forward-lookinginformation, there may be other factors that cause actions, events orresults not to be as anticipated, estimated or intended. There can beno assurance that such information will prove to be accurate as actualresults and future events could differ materially from thoseanticipated in such statements. The Company disclaims any intention orobligation to update or revise any forward-looking information,whether as a result of new information, future events or otherwiseunless required by law.
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