Universal Ibogaine provides update on planned Clinical Trial Application process
Calgary, AB – TheNewswire - April 29, 2024 – Universal Ibogaine Inc. (TSXV:IBO) (“UI” or the “Company”), a life sciences company with a mission to research and deliver medicalized ibogaine-centered addiction care, is pleased to provide an update on its planned Clinical Trial Application (“CTA”) process. UI has engaged a new clinical research organization (“CRO”) to complete the process of compiling UI’s submission to Health Canada for approval to undertake a Canadian clinical trial focused on using ibogaine in the treatment of opioid use disorder(s).
Changemark Research + Evaluation Ltd. (“Changemark”) provides research and evaluation services in the areas of substance use, mental health, and Indigenous health and wellness. Changemark provides services to a wide range of privately and publicly funded institutions throughout Canada and the USA. Based in Vancouver, the Changemark team currently includes more than 150 specialized contractors located in seven Canadian provinces.
Nick Karos, UI CEO, noted “we are pleased to be partnering with Changemark with the goal of finalizing UI's study design in advance of the anticipated pre-clinical trial application meeting to be held with Health Canada, in order to complete the ultimate No Objections Letter process with Health Canada”.
Changemark expects the CTA submission project to have a timeframe of 4 to 6 months.
About Universal Ibogaine Inc.
UI is a life sciences company, with a mission to transform addiction treatment using medicalized ibogaine through a planned Canadian clinical trial focused on opioid use disorder, and ultimately to utilize that treatment protocol globally through planned future licensing agreements. UI is concurrently developing a state of the art holistic addiction treatment protocol at its Kelburn Recovery Centre (located near Winnipeg, Manitoba) that, which when paired with the planned ibogaine detox protocol, is intended to revolutionize the way we treat addiction and drastically improve the lives of individuals and families affected by addiction.
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CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS
This news release may contain forward-looking statements and information. Forward-looking information is frequently characterized by words such as "plans", “planned”, "expect", "project", "intends", “intended” "will", "believe", "anticipate", "estimate", "scheduled", "potential", or other similar words, or statements that certain events or conditions "may", "should" or "could" occur. The forward-looking statements and information are based on certain key expectations and assumptions made by UI at the date the statements are made. Although UI believes that the expectations and assumptions on which the forward-looking statements are based are reasonable, undue reliance should not be placed on the forward-looking statements because UI can give no assurance that they will prove to be correct.
Since forward-looking statements address future events and conditions, by their very nature they involve inherent risks and uncertainties. Actual results could differ materially from those currently anticipated due to a number of factors and risks, which include, but are not limited to, risks that required regulatory approvals are not obtained. The reader is cautioned that assumptions used in the preparation of such information, although considered reasonable by UI at the time of preparation, may prove to be incorrect and readers are cautioned not to place undue reliance on forward-looking information, which speaks only to conditions as of the date hereof. UI does not undertake any obligation to release publicly any revisions to forward-looking information contained herein to reflect events or circumstances that occur after the date hereof or to reflect the occurrence of unanticipated events, except as may be required under applicable securities laws.
Additional information identifying risks and uncertainties that could affect financial results and the Company is contained in the Company’s filings with Canadian securities regulators, which are available at www.sedar.com
For further information:
Nick Karos, CEO
Universal Ibogaine Inc.
612-309-3527
Nick.Karos@universalibogaine.com
Investor Relations: Dugan Selkirk, IR Manager
dugan.selkirk@universalibogaine.com
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