(TheNewswire)
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 subsidiaryMindBio Therapeutics Pty Ltd (“ MindBio ”) is developing a new microdosingformula using LSD (Lysergic Acid Diethylamide) to treat MajorDepressive Disorder (“MDD”).
MindBio aims to develop psychedelic microdosingformulations that can subsequently be manufactured under GoodManufacturing Practices (GMP) standards for subsequent use in bothcommercially and in Clinical Trials. The principal aim is to develop aLSD microdosing formulation suitable for home use. The feasibility ofdelivery systems will be confirmed as part of the overall works. Thesuccess of the formulations developed will be assessed againststandard GMP criteria for dose homogeneity and stability with the aimof a minimum shelf-life of 6 months.
The prevalence of MDD is extraordinarily high andgrowing. In 2019, the National Institute of Mental Health estimatedthat 19.4 million people suffered at least one major depressiveepisode in the United States(www.nimh.nih.gov/health/statistics/major-depression). MindBio is directly targeting MDD in one ofits Phase 2 clinical trials microdosing LSD to create breakthroughtreatments for this debilitating mental health condition.
LSD is a hallucinogenic drug that has a profound impacton cognition, thinking, perception and mood. MindBio is developing anovel medicinal treatment using a microdose formula of LSD. Thebenefit of microdoses is the effects of the drug can be sub-perceptualand the patient can conveniently get on with their day immediatelyafter taking the drug without noticing its hallucinogenic effects.
MindBio recently received feedback from its Phase 1clinical trial independent Data and Safety Monitoring Committee thatthe clinical trial is approved to continue after a successfulsix-month safety review of its use of LSD in healthy participants. After its positive safety review, MindBio is progressing thedevelopment and enhancement of its microdose formulation of LSD in aform for commercial distribution and use.
The new microdose formula will be adapted in the Phase2 clinical trials and assessed utilizing MindBio’s proprietarytechnology which will be used to determine an optimal microdose forpatients.
Health Canada Announces SignificantAmendment to Special Access Programme
Blackhawk commends Health Canada’s leadership ontheir recent amendments to the Special Access Programme ( SAP ), which will now allow physiciansto request patient access to psychedelic treatments, includingpsilocybin-assisted therapy.
The amendments under the SAP came into effect as ofJanuary 5, 2022, as published in the Canada Gazette, and allowsphysicians to request psychedelic treatments on behalf of theirpatients, on a case-by-case basis, for serious treatment-resistant orlife- threatening conditions. This significantamendment has the potential to provide numerous Canadians strugglingwith serious mental health afflictions with alternative therapieswhere traditional treatments have failed, or where other treatmentsare unsuitable or are unavailable in Canada.
Canada’s SAP was designed with the purpose ofallowing people access to new, potentially life-saving medicationsbefore they are formally approved for routine use in healthcare,however prior to today’s milestone amendment, psychedelicmedications have been ineligible for Special Access Programmeapplications. The regulatory amendment will enable Canadian physiciansto apply for psychedelic therapies in a similar process as to howother investigational medications are accessed prior to formal drugapproval.
The amendment to SAP by Health Canada is an historicmilestone in Canada’s approach to treating mental health conditionsand signifies a growing recognition of the important and growing bodyof research that supports the efficacy of psychedelics andpsychedelic-assisted therapies in treating mental health afflictions.According to Health Canada, access to psychedelic treatments will beprovided where there is sufficient data to support the safety andefficacy of the targeted drug for a patient’s specificcondition.
“This is an important development for MindBio”,said Frederick Pels, CEO of Blackhawk Growth Corp. “ HealthCanada’s recent amendment to the Special Access Program, has thepotential to improve the lives of numerous Canadians suffering frommental health afflictions, including major depression, end-of-lifeanxiety and even addictions and historical traumas. It also providesdoctors and their patients a safe, legal and regulated process forproviding alternative treatments to mental health patients thatdesperately seek alternatives to otherwise failing contemporarymodalities.”
Chief Financial OfficerAppointment
Zula Kropivnitski has resigned as the Company's ChiefFinancial Officer for personal reasons, effectively immediately. TheBoard of Directors and management would like to thank Ms. Kropivnitskifor her contributions to the Company and wish her every success in herfuture endeavours.
The Company is pleased to announce that Heidi Gutte hasbeen appointed Chief Financial Officer of the Company. Ms. Guttespecializes in providing corporate finance, financial reporting,consulting, taxation and other accounting services to both smallbusinesses as well as public companies in various industries. She alsoassists in many aspects of clients' administration, corporatecompliance and other activities.
Ms. Gutte earned her bachelor's degree of computerengineering from the University of Applied Sciences in Brandenburg,Germany. She holds the professional designation of charteredprofessional accountant (CPA, CGA), and is a member of CharteredProfessional Accountants of B.C. and Canada. Ms. Gutte has hadextensive experience as a controller and CFO ofnumerous publicly traded and private corporations in severalindustries.
About MindBioTherapeutics Pty Ltd. (“MindBio”)
MindBio is a clinical-stage drug development companythat is pioneering psychedelic microdosing research and is advancingemerging therapies to treat a range of debilitating health conditionssuch as depression, anxiety, chronic pain, cognitive impairment andPTSD (posttraumatic stress disorder).
In a world’s first clinical trial of its kind,MindBio is currently conducting Phase 1 clinical trials, that is over50% complete, at a tier 1 university in a safety study of 80participants microdosing LSD to patients. The study has receivedregulatory approval and government funding for the importing of LSD,laboratory work using the drug and approvals for participants to beprescribed the drug; and then patients take the drug at home as theywould any other medication. Approvals have also been received for twophase 2 clinical trials involving microdosing LSD in late-stage cancerpatients experiencing end-of-life distress.
MindBio is also pioneering the development of microdoseformulations and a range of technology and artificial intelligenceapplications to ensure the safe dosage, use and administration ofpsychedelic medicines in the community. Early indications show thatLSD is tolerated well in microdoses and has a lower side effectprofile than the currently prescribed antidepressant drugs. MindBiohas a detailed roadmap to conduct further clinical trials, includingwith other psychedelic substances, and a clear plan to bring newlycreated intellectual property to market and commercialization.
For more information, please visit https://mindbiotherapeutics.com .
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 TERPWholesale, Sac Pharma, LeichtMind Clinics, Noble Hemp, Spaced Food,NuWave Foods, MindBio Therapeutics and Digital Mind Technology, aswell as an equity position in Gaia Grow (CSE:GAIA).
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
fred@ blackhawkgrowth.com
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 transaction and futureoperations of MindBio Therapeutics Pty Ltd. The Company providesforward-looking statements for the purpose of conveying informationabout current expectations and plans relating to the future andreaders are cautioned that such statements may not be appropriate forother purposes. By its nature, this information is subject to inherentrisks and uncertainties that may be general or specific and which giverise to the possibility that expectations, forecasts, predictions,projections or conclusions will not prove to be accurate, thatassumptions may not be correct and that objectives, strategic goalsand priorities will not be achieved. These risks and uncertaintiesinclude but are not limited those identified and reported in theCompany’s public filings under the Company’s SEDAR profile atwww.sedar.com. Although the Company has attempted to identifyimportant factors that could cause actual actions, events or resultsto 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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