The Trial is to be Conducted in Association with a Clinic Operator in its Facilities Located in Miami, Florida
Vancouver, British Columbia, October 6, 2021 / Globe Newswire / – 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.
“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:
Adam Deffett, Interim CEO
For further information, please contact:
Nick Kuzyk, Investor Relations
Tel: 1-844-PHONE-K1 (1-844-746-6351)
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