CALGARY, AB, Jan. 14, 2022 /CNW/ - Universal Ibogaine Inc.
(TSXV: IBO) ("UI" or the "Company") a life sciences
company with a mission to develop and deliver medicalized
ibogaine-centered addiction care, is pleased to introduce its
contract research organization ("CRO") partners who will
enable UI's planned clinical trial in Canada to be conducted, subject to the
required approval by Health Canada. UI is currently working with
its CRO partners to finalize UI's study design in advance of an
anticipated pre-clinical trial application meeting to soon be held
with Health Canada.
UI has selected Intrinsik Corp. ("Intrinsik"), an
internationally recognized regulatory affairs consulting firm, to
provide regulatory strategy and support for the preparation and
submission of UI's Canadian Clinical Trial Application
("CTA"), as well as follow-up and monitoring if a No
Objection Letter ("NOL") is received from Health Canada.
Intrinsik is comprised of an experienced team who have driven
hundreds of successful clinical trials and investigational new drug
applications and have collectively contributed to more than 20 new
drug marketing applications. The group has over 25 regulatory
affairs professionals based in its Canadian headquarters located in
the greater Toronto area, and
unparalleled expertise and experience related to Central Nervous
System Disorders (CNS: the therapeutic area to which addiction and
mental health disorders belong).
Support for the development of the substance of the CTA package,
as well as ultimately the operation of the clinical trial itself,
is being provided by the world-class team at CATO Research Canada
Inc. ("CATO SMS"). The CATO SMS team of experts have
over 30-years' experience optimizing the design and execution of
clinical trials for life sciences companies such as UI. CATO SMS
has successfully conducted over 500 clinical trials in over 25
countries and have enrolled more than 60,000 patients at over 5,500
sites.
The CATO SMS engagement team, along with UI's team, involves a
variety of experts in Canada, the
US and Europe, providing critical
expertise ranging from clinical study designs to biostatistics to
clinical operations (e.g., patient recruitment, study startup,
budgeting, site management, data management, etc.). CATO SMS'
contributions will also include the analysis and synthesis of
proprietary real-world data and evidence ( "RWD" and
"RWE", respectively) stemming from the application of
ibogaine for the treatment of opioid use disorder in approximately
200 patients who have been treated in Cancun, Mexico by UI's licensing partner -
Clear Sky Recovery Cancun SA de CV. UI believes that the
presentation of RWD and RWE as part of the CTA package will
strengthen the application, particularly the preliminary claim to
safety, and is aligned with emerging guidance by regulators, such
as the US Food and Drug Administration ("FDA"), to
acknowledge and incorporate RWD and RWE in clinical development,
and generally in evidence-based medicine.
Finally, UI is lining up prominent academic and medical centres
to support the CTA to Health Canada, as well as potentially serve
as sites to undertake the ultimate clinical trial. Notably, UI has
engaged the research office of a leading Canada-based academic and teaching institution
in the therapeutic area of addiction to support the design of the
study protocol and generate interest in trial site selection.
Nick Karos - Universal
Ibogaine CEO
Nick Karos (CEO) noted "Our
engagement with Health Canada to date has clearly highlighted the
road UI must take to provide practitioners and patients access to
authorized ibogaine in Canada to
treat opioid use disorder. The conduct of clinical trials is a very
precise business requiring solid partnerships with the right
expertise and players, and Universal Ibogaine is pleased that we
have now secured these partnerships. We are confident that that
with our partners expertise, we will move towards our goal of
conducting clinical trials with Health Canada."
About Universal Ibogaine Inc.
UI is a life sciences company, with a mission to develop and
acquire a network of addiction treatment clinics throughout
Canada, and to eventually use
ibogaine as a primary modality for the interruption and ideally
cessation of addictions: primarily opioids such as oxycodone,
heroin, fentanyl, as well as alcohol, cocaine, and other
stimulants.
As such, UI concurrently plans to clinically develop ibogaine, a
plant derived substance, as an authorized addiction interruption
medicine for the treatment of Opioid Use Disorder. A Clinical
Trial Application to Health Canada is being developed to undertake
clinical trials in Canada, aimed
at proving the safety and efficacy of the use of ibogaine for this
purpose. In the longer term, and once approved as planned, UI
will introduce ibogaine into the addiction treatment protocols to
be used in its future facilities.
NEITHER THE TSX VENTURE EXCHANGE NOR ITS REGULATION SERVICES
PROVIDER (AS THAT TERM IS DEFINED IN THE POLICIES OF THE TSX
VENTURE EXCHANGE) ACCEPTS RESPONSIBILITY FOR THE ADEQUACY OR
ACCURACY OF THIS RELEASE.
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", "expect", "project",
"intend", "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. 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.
Related Links
https://universalibogaine.com
SOURCE Universal Ibogaine Inc.