Numinus has received approvals from Health
Canada and the Institutional Ethics Review Board
VANCOUVER, BC, Jan. 19,
2022 /CNW/ - Numinus Wellness Inc. ("Numinus" or
the "Company") (TSX: NUMI), a leader in psychedelics-focused
mental healthcare, is pleased to announce that it has completed key
steps to prepare to enroll participants at its clinics
participating in "A multi-site open-label extension study of
MDMA-assisted psychotherapy for PTSD (MAPPUSX)", sponsored by the
Multidisciplinary Association for Psychedelic Studies (MAPS).
The Canadian study sites, which will continue to study the
safety of MDMA-assisted therapy in treating severe PTSD, under the
leadership of MAPS Public Benefit Corporation (MAPS PBC) as study
sponsor, have recently received regulatory authorization from
Health Canada, ethical approval from an Institutional Review Board
(IRB) and a Section 56 exemption from the Controlled Drug and
Substance Act (Canada), which will
allow the use of MDMA throughout the duration of the clinical
trial.
"We are thrilled that our talented team of doctors and
researchers at Numinus are helping pave the path forward to greater
access to safe psychedelic-assisted psychotherapy with this study
further evaluating the safety of MDMA-assisted therapy in treating
severe PTSD," says Payton Nyquvest,
Founder and CEO, Numinus. "This is an exciting next step in the
MAPPUSX study, happening at our clinics in both British Columbia and Quebec, and we look forward to how this work
supports expanded collaboration with MAPS in the future."
Numinus will host the Canadian sites for MAPPUSX, managed
through Numinus' two recently acquired, purpose-designed clinics,
allowing for quick completion of the Canadian segment of the
MAPS-sponsored trial.
"The recent approvals from Health Canada and the IRB, coupled
with our clinics in Montreal and
Vancouver already being
regulatorily compliant, allow us to quickly conduct this phase of
the research at these sites," said Dr. Joe
Flanders, VP, Psychology, Numinus and therapist for the
Montreal site of the trial. "I'm
proud to be a part of this study alongside our clinical and
research teams as we work towards examining the important findings
around MDMA-assisted therapy for PTSD and, ultimately, translating
research findings into mainstream clinical practice."
The trial will be open to eligible participants who were
previously enrolled in the placebo arm of the parent study (MAPP1)
or who were not able to receive treatment due to COVID-19
restrictions.
NOTE
The safety of MDMA-assisted therapy is currently under
investigation. It has not yet been approved by Health Canada or the
U.S. Food and Drug Administration (FDA), does not work for
everyone, and carries risks even in therapeutic settings. These
statements are no guarantee of future Health Canada or FDA approval
or availability of MDMA-assisted therapy. These statements
necessarily involve known and unknown risks and uncertainties,
which may cause actual outcomes to differ materially from
projections.
About Numinus
Numinus Wellness (TSX: NUMI) helps people to heal
and be well through the development and delivery of innovative
mental health care and access to safe, evidence-based
psychedelic-assisted therapies. The Numinus model - including
psychedelic production, research and clinic care - is at the
forefront of a transformation aimed at healing rather than managing
symptoms for depression, anxiety, trauma, pain and substance use.
At Numinus, we are leading the integration of psychedelic-assisted
therapies into mainstream clinical practice and building the
foundation for a healthier society.
Learn more at www.numinus.com and follow us on
LinkedIn, Facebook, Twitter, and Instagram.
About MAPS
Founded in 1986, MAPS is a 501(c)(3) non-profit research and
educational organization that develops medical, legal, and cultural
contexts for people to benefit from the careful uses of
psychedelics and marijuana. MAPS is sponsoring the most advanced
psychedelic therapy research in the world: Phase 3 clinical trials
of MDMA-assisted therapy for PTSD. Since its founding, MAPS has
raised over $130 million for
psychedelic and marijuana research and education and has earned
both the Guidestar Platinum Seal of Transparency and a 4-Star
Rating from Charity Navigator. Learn more at
maps.org
ABOUT MAPS PUBLIC BENEFIT CORPORATION (MAPS PBC)
MAPS Public Benefit Corporation (MAPS PBC) catalyzes healing and
well-being through psychedelic drug development, therapist training
programs, and sales of prescription psychedelics while prioritizing
public benefit above profit. Founded in 2014, MAPS PBC is a wholly
owned subsidiary of the Multidisciplinary Association for
Psychedelic Studies (MAPS), a 501(c)(3) non-profit organization.
Learn more at www.mapspublicbenefit.org
Forward-looking statements
This press release contains forward-looking
statements within the meaning of applicable securities
laws. All statements that are not historical facts, including
without limitation, statements regarding future estimates, plans,
programs, forecasts, projections, objectives, assumptions,
expectations or beliefs regarding future performance are
"forward-looking statements". Forward-looking statements can
be identified by the use of words such as "expects", "does not
expect", "is expected", , "intends", "anticipates", "does not
anticipate", "believes" or variations of these words, expressions
or statements, that certain actions, events or results "may",
"could", "would", "might" or "will be" taken, will occur or will be
realized. Such forward-looking statements involve risks,
uncertainties and other known and unknown factors that could cause
actual results, events or developments to differ materially from
the results, events or developments expected and expressed or
implied in such forward-looking statements. These risks and
uncertainties include, but are not limited to, dependence on
obtaining and maintaining regulatory approvals, including the
acquisition and renewal of federal, provincial, municipal, local or
other licenses, and any inability to obtain all necessary
government authorizations, licenses and permits to operate and
expand the Company's facilities; regulatory or policy changes
such as changes in applicable laws and regulations, including
federal and provincial legalization, due to fluctuations in public
opinion, industry perception of integrative mental health,
including the use of psychedelic-assisted therapy, delays or
inefficiencies or any other reason; any other factor or
development likely to hamper the growth of the market; the
Company's limited operating and profitability track
record; dependence on management; the Company's need for
additional financing and the effects of financial market conditions
and other factors on the availability of
capital; competition, including that of more established
and better funded competitors; the continued impact of the
COVID-19 pandemic; and the need to build and maintain alliances and
partnerships, including with research and development companies,
customers and suppliers. These factors should be carefully
considered, and readers are cautioned not to place undue reliance
on forward-looking statements. Despite the Company's efforts
to identify the main risk factors that could cause actual measures,
events or results to differ materially from those described in
forward-looking statements, other risk factors may cause measures,
events or developments to materially differ from those anticipated,
estimated or intended. There can be no assurance that
forward-looking statements will prove to be accurate, as
actual results and future events could differ materially from those
anticipated in forward-looking statements. The Company does
not undertake to revise forward-looking statements, even if new
information becomes available as a result of future events, new
facts or any other reason, except as required by applicable
laws.
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SOURCE Numinus Wellness Inc.