Ketamine One Launching Two Inaugural Research Studies
2021年10月14日 - 4:00PM
KetamineOne Capital Limited (“Ketamine One” or the
“Company”) (NEO: MEDI) (OTC: KONEF) (Frankfurt: MY0), a
company focused on consolidating medical clinics and becoming a
North American leader in mental health treatments, is pleased to
announce that it will be launching a single arm, open label study
of patients with post-traumatic stress disorder
(“
PTSD”) who are undergoing the proprietary
physical therapy program at the Company’s IRP Health clinics (the
“
PTSD Study”) as well as an observational,
single-arm, pilot study aimed at collecting objective biometric
data and validated psychiatric instrument measures of efficacy in
patients with depression symptoms who are receiving IV ketamine
infusion therapy (the “
Depression Study”)
(collectively, the “
Research Studies”). The
Research Studies will be conducted across multiple Ketamine One
clinic locations in Canada and the United States and are both
expected to begin in the month of November.
The PTSD Study is designed to occur over the
twelve weeks of IRP Health’s physical therapy program, which
includes exercise therapy, physiotherapy and pain neurophysiology
education. The participants, most of whom are veterans and first
responders, will be adults with PTSD who are also experiencing some
form of pain that is musculoskeletal in origin. The program is
meant to alleviate both pain and PTSD symptoms over the study
period. The PTSD study will be observational in nature and will
gather symptom data using validated patient reported questionnaires
as well as objective sleep and biometric data. The protocol and
information consent form (“ICF”) for the PTSD
Study have been submitted to the Institutional Review Board
(“IRB”) and are currently under review. Ketamine
One’s wholly owned subsidiary, KGK Science Inc., will lead the
study, including building the database and conducting training,
among other tasks.
The protocol and ICF for the Depression Study
are currently being finalized and is expected to be submitted to
the IRB in the near future. The trial is expected to begin in late
November, subject to the operational capacity of the Company’s
medical clinics. The purpose of the Depression Study is to
investigate ketamine as a fast-onset treatment for depression given
that the duration of the relief from symptoms varies in patients
with most requiring a booster within 4-6 weeks. Specifically, there
is currently no way for physicians to predict a relapse, therefore
patients may fully relapse before they are able to receive a
booster dose. The Depression Study will look to correlate the
efficacy of treatments with objective measures that have been
suggested in the past to be predictive of efficacy. Its aim is to
identify patterns in the data that are predictive of relapse and
may be used to inform the development of an algorithm to determine
the optimal timing for physicians to administer booster doses of
ketamine to patients based on their objective biometric data.
Management Commentary
“The launch of these inaugural studies by
Ketamine One is a great milestone for our Company and a clear
demonstration of the synergies being created between the
subsidiaries of KGK Science and IRP Health. These studies represent
full collaboration between all our divisions - KGK, IRP Health and
our ketamine clinic network. Our mental health platform is enabling
us to explore important topics and seek to find the answers to
long-standing questions about the efficacy of IV ketamine
treatments and how to improve treatment outcomes,” said Adam
Deffett, Interim CEO of Ketamine One. “Our hope is that both the
PTSD Study and the Depression Study yield significant results,
which enable not only our clinicians but those in other clinics as
well as to improve the patient experience and alleviate chronic
pain, depression and other interrelated issues,” added Mr.
Deffett.
ABOUT KETAMINE ONE
KetamineOne Capital Limited is a company focused
on consolidating medical clinics and becoming a North American
leader in mental health treatments. It is working to provide the
critical infrastructure needed to develop and deliver breakthrough
mental health treatments. Ketamine One has a network of clinics
across North America, with plans to further consolidate the highly
fragmented industry. KGK Science Inc., the Company’s wholly owned,
contract research division also places the company at the forefront
of premium clinical research based on its long history and
extensive experience in pharmaceuticals, cannabis, and the emerging
psychedelic medicine industries. As a collective enterprise,
Ketamine One is dedicated to helping solve the growing need for
safe and accessible mental health therapy.
On behalf of:
KETAMINE ONE
"Adam Deffett"Adam Deffett, Interim CEO
For further information, please contact:
Nick Kuzyk, Investor RelationsTel:
1-844-PHONE-K1 (1-844-746-6351)Email: IR@ketamine.one Web:
www.ketamine.one Twitter: @KetamineOne
Notice Regarding Forward-Looking
Information:
This news release contains forward-looking
statements including but not limited to statements regarding the
Company’s business, assets or investments, as well other statements
that are not historical facts. Readers are cautioned not to place
undue reliance on forward-looking statements, as there can be no
assurance that the plans, intentions or expectations upon which
they are based will occur. By their nature, forward-looking
statements involve numerous assumptions, known and unknown risks
and uncertainties, both general and specific, that contribute to
the possibility that the predictions, forecasts, projections and
other forward-looking statements will not occur, which may cause
actual performance and results in future periods to differ
materially from any estimates or projections of future performance
or results expressed or implied by such forward-looking statements.
These assumptions, risks and uncertainties include, among other
things, the state of the economy in general and capital markets in
particular, investor interest in the business and future prospects
of the Company.
The forward-looking statements contained in this
news release are made as of the date of this news release. Except
as required by law, the Company disclaims any intention and assumes
no obligation to update or revise any forward-looking statements,
whether as a result of new information, future events or otherwise,
except as required by applicable securities law. Additionally, the
Company undertakes no obligation to comment on the expectations of,
or statements made, by third parties in respect of the matters
discussed above.
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