DMT FIRST-MOVER ADVANTAGE
Pre-Clinical Trial Approved and Ready to Go!
The time is right for potentially life-changing DMT research to move forward as substance use disorder patients await safer and more effective treatments – and Entheon Biomedical (CSE:ENBI, OTC:ENTBF) is at the forefront of the movement to provide novel, groundbreaking solutions.
Why DMT? Well tolerated with few adverse effects, pure DMT is the ideal molecule for advancing new models of psychedelic-assisted therapy.
DMT is unique among hallucinogens in that it is endogenous in the human body – and while other drugs in the class produce intense effects that last up to 12 hours, the effects of DMT are much shorter in duration and more easily controlled, making it an ideal therapeutic candidate.
Yet, achieving first-mover advantage for Entheon Biomedical means conducting the necessary research – and the company is quickly making strides in that regard. Not long ago, Entheon confirmed that CHDR, the company’s Netherlands-based partner clinical research organization, received an amendment to its opioid license, enabling it to possess and conduct research with DMT.
The opioid license amendment enables the CHDR to accommodate Entheon’s upcoming clinical study, designed to evaluate the pharmacodynamics, pharmacokinetics and safety of a target-controlled IV infusion of DMT in humans.
In addition, CHDR’s partner pharmacy, LUMC, has received its import permit to receive DMT, for testing and formulation work, from Entheon’s Canadian manufacturing partner, Psygen Labs Inc.
But of course, clinical research wouldn’t be possible without the mandated regulatory approval in place – and Entheon Biomedical is moving quickly to get the clearance it needs to move forward with its planned groundbreaking DMT pre-clinical trials.
And in fact, the company just announced that it has received ethics approval for an upcoming pre-clinical study to be conducted by the clinical research organization, Science in Action, an Israeli-based lab specializing in pre-clinical in vivo and in vitro R&D services.
As we’ve learned, Science in Action has indeed confirmed that it has received ethics approval for an in vivo non-GLP toxicology study of N, N Dimethyltryptamine (DMT). Both Entheon and Science in Action have applied for requisite permits in order to export, receive and research DMT drug product.
The objective of the study will be to determine the acute toxicity of IV doses of DMT in a 14-day in vivo study. The study is being performed in advance of the company’s human studies to evaluate DMT’s pharmacodynamic, pharmacokinetic and safety profile in order to better characterize DMT’s functional central nervous system effects and its impact on subjective experience, which is a crucial first step in properly understanding its potential as a pharmacotherapeutic in the treatment of addiction disorders. – coming up soon as the human studies are anticipated to be conducted in Q4 of this year.
“We are very excited to begin working with the acclaimed team at Science in Action in order to further characterize the toxicology profile of DMT in preparation for upcoming human trials,” said Chief Executive Officer of Entheon, Timothy Ko.
With the ethics approval now obtained, Entheon is one step closer to initiating pre-clinical work in order to further advance DMT’s profile as a therapeutic candidate to treat substance-use disorders – and a giant leap toward achieving the coveted first-mover status.
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On Sept 30th, 2020, in connection with our agreement with Entheon Biomedical Corp, we received $250,000USD to Gold Standard Media LLC. This was for a 4 month agreement. Wallace Hill Partners LTD on September 26, 2020 purchased 750,000 common shares at CAD0.10. On Feb 3rd, 2021, in connection with our agreement with Entheon Biomedical Corp, we received $300,000USD to Gold Standard Media LLC.