IBO:CC - Universal Ibogaine provides update on planned Clinical Trial Application process
(TheNewswire)
Calgary, AB – TheNewswire - April 29, 2024 – Universal Ibogaine Inc.( TSXV:IBO ) (“ UI ” or the “ Company ”), a life sciences company with amission to research and deliver medicalized ibogaine-centeredaddiction care, is pleased to provide an update on its plannedClinical Trial Application (“ CTA ”) process. UI has engaged a newclinical research organization (“ CRO ”) to completethe process of compiling UI’s submission to Health Canada forapproval to undertake a Canadianclinical trial focused on using ibogaine in the treatment of opioiduse disorder(s).
Changemark Research + Evaluation Ltd. (“ Changemark ”)provides research and evaluation services in the areas of substanceuse, mental health, and Indigenous health and wellness. Changemarkprovides services to a wide range of privately and publicly fundedinstitutions throughout Canada and the USA. Based in Vancouver, theChangemark team currently includes more than 150 specializedcontractors located in seven Canadian provinces.
Nick Karos, UI CEO, noted “we are pleased to bepartnering with Changemark with the goal of finalizing UI's studydesign in advance of the anticipated pre-clinical trial applicationmeeting to be held with Health Canada, in order to complete theultimate No Objections Letter process with Health Canada”.
Changemark expects the CTA submission project to have atimeframe of 4 to 6 months.
About UniversalIbogaine Inc.
UI is a life sciences company, with a mission totransform addiction treatment using medicalized ibogaine through aplanned Canadian clinical trial focused on opioid use disorder, andultimately to utilize that treatment protocol globally through plannedfuture licensing agreements. UI is concurrently developing a state of the art holisticaddiction treatment protocol at its Kelburn Recovery Centre (locatednear Winnipeg, Manitoba) that, which when paired with the plannedibogaine detox protocol, is intended to revolutionize the way we treataddiction and drastically improve the lives of individuals andfamilies affected by addiction.
NEITHER THE TSXVENTURE EXCHANGE NOR ITS REGULATION SERVICES PROVIDER (AS THAT TERM ISDEFINED IN THE POLICIES OF THE TSX VENTURE EXCHANGE) ACCEPTSRESPONSIBILITY FOR THE ADEQUACY OR ACCURACY OF THISRELEASE.
CAUTIONARY STATEMENTREGARDING FORWARD-LOOKING STATEMENTS
?This news release may containforward-looking statements and information. Forward-lookinginformation is frequently characterized by words such ?as"plans", “planned”, "expect","project", "intends", “intended”"will", "believe", "anticipate","estimate", "scheduled",??"potential", or other similar words, or statementsthat certain events or conditions "may", "should"or ??"could" occur. The forward-looking statements andinformation are based on certain key expectations ?and assumptionsmade by UI at the date the statements are made. Although UI believesthat the expectations and assumptions on which the forward-?lookingstatements are based are reasonable, undue reliance should not beplaced on the forward-?looking statements because UI can give noassurance that they will prove to be correct.
Since ?forward-looking statementsaddress future events and conditions, by their very nature theyinvolve ?inherent risks and uncertainties. Actual results coulddiffer materially from those currently anticipated ?due to a numberof factors and risks, which include, but are not limited to, risksthat required ?regulatory approvals are not obtained. The reader iscautioned that assumptions used in the ?preparation of suchinformation, although considered reasonable by UI at the time of?preparation, may prove to be incorrect and readers are cautionednot to place undue reliance on ?forward-looking information, whichspeaks only to conditions as of the date hereof. UI does not?undertake any obligation to release publicly any revisions toforward-looking information contained ?herein to reflect events orcircumstances that occur after the date hereof or to reflect theoccurrence ?of unanticipated events, except as may be required underapplicable securities laws. ?
Additional information identifying risks anduncertainties that could affect financial results and the Company iscontained in the Company’s filings with Canadian securitiesregulators, which are available at www.sedar.com
For furtherinformation:
Nick Karos, CEO
Universal Ibogaine Inc.
612-309-3527
Nick.Karos@universalibogaine.com
InvestorRelations: Dugan Selkirk,IR Manager
dugan.selkirk@universalibogaine.com
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