Ketamine One Subsidiary KGK Science Contracted to Support a Ketamine Clinical Trial in the United States
2021年10月6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 its wholly-owned contract research organization, KGK
Science Inc. (“
KGK” or the
“
CRO”), has recently been contracted by a third
party to develop the protocol and Informed Consent Form
(“
ICF”) to support its Institutional Review Board
application. The engagement of the Company’s CRO by the third party
is related to a ketamine clinical trial that is being planned to be
conducted by a clinic operator within its medical facilities
located in Miami, Florida.
The third party is a provider of digital
therapeutics for the psychedelic and mental health sectors. It will
be one of the first companies to collect certain data points and
seek to understand how ketamine can potentially resolve issues in
the brain through a process called neuroplasticity. The required
protocol and ICF for the clinical trial in association with the
third party are being developed by KGK in accordance with the
guidelines of the International Council for Harmonisation of
Technical Requirements for Pharmaceuticals for Human Use. KGK’s
work will result in a cover letter to support the clinical trial
that is being planned to go through an alternate route to the more
traditional Investigational New Drug application.
The purpose of the study will be to obtain
objective data to support the belief that the proper dosing and
administration of intravenous (“IV”) Ketamine
treatments can result in neuroplasticity and sustainable relief
from depression, with or without PTSD. Study patients are proposed
to each receive four ketamine infusions. In association with the
third party, the clinic operator is proposing that the
ketamine-centered study will measure patients before, during, and
after their IV Ketamine infusions.
Management Commentary
“We at KGK feel privileged to have been
contracted to complete this interesting work. I view the third
party as a pioneer in the pursuit of obtaining tangible proof of
patient claims about the effectiveness of IV ketamine treatments.
If the third party and its partner can record sustainable changes
in brain electroencephalograms that correlate strongly to patient
outcomes, then they could be on their way to making this protocol a
new standard of care. Ultimately, this could lead to bringing more
joy into the lives of the millions of people who suffer from a
range of insidious psychiatric disorders,” said Najla Guthrie,
President & CEO of KGK.
ABOUT KGK SCIENCE
Founded in 1997, KGK is a leading North American
contract research organization based in London, Ontario that
primarily provides high-quality clinical research trials with a
focus on the nutraceutical, cannabis and emerging psychedelic
industries. The business has successfully helped hundreds of
companies with custom designed clinical trials and claim
substantiation strategies to move products into global markets.
KGK’s other existing service lines include expert regulatory
support and compliance solutions, participant recruitment, research
support services and consulting services. On an approximate basis,
the business to date has produced 150 publications, executed over
400 clinical trials across more than 40 indications, amassed 25,000
participants in its database and collected 10 million data
points.
ABOUT KETAMINE ONE
KetamineOne Capital Limited (formerly Myconic
Capital Corp.) 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. Currently, Ketamine One has a network of 16 clinics
across North America, with plans to further consolidate the highly
fragmented industry. KGK Science Inc. is the Company’s wholly-owned
contract research division, which places it at the forefront of
premium clinical research based on the subsidiary’s 24-year 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
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