KetamineOne Capital Limited (LSE:CAPD) revealed that its wholly-owned contract research organization, KGK Science Inc., 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 Vancouver, British Columbia-based company said that KGK Science’s engagement 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,” said the company. 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.
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“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,” said KetamineOne.
KGK’s work will result in a cover letter to support the clinical trial that is being planned as 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 post-traumatic stress disorder (PTSD).
The company revealed that study patients will 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,” KGK Science CEO Najla Guthrie said in a statement.
“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,” Guthrie added.
Ketamine One (NEO:MEDI.AQN) is a company focused on consolidating medical clinics and becoming a North American leader in mental health treatments. The recent addition of KGK Science Inc. as the company’s contract research division also places the company at the forefront of clinical research based on its 24-year history and experience in pharmaceuticals, cannabis, and emerging psychedelic medicine industries.
Contact the author Uttara Choudhury at uttara@proactiveinvestors.com
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