February 2, 2021
Entheon Biomedical Corp. has provided an update on licence amendments issued to its clinical research organization, The Centre for Human Drug Research.
Entheon confirms that the CHDR, the Company’s Netherlands-based partner clinical research organization, has 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.
“These license amendments are another important step in the launch and execution of our Phase I clinical trial to assess the safety and tolerability of DMT in humans,” said Chief Executive Officer, Timothy Ko. “The ability to import and access clinical grade DMT is integral to the smooth operation of this process, which we are now one step closer to achieving.”
Entheon announced its clinical trial with the Leiden, Netherlands-based CHDR on December 1, 2020, and expects the trial to begin in Q4 2021.
About Entheon Biomedical Corp.
Entheon is a biotechnology research and development company committed to developing and commercializing a portfolio of safe and effective N,N-dimethyltryptamine based psychedelic therapeutic products (“DMT Products”) for the purposes of treating addiction and substance use disorders. Subject to obtaining all requisite regulatory approvals and permits, Entheon intends to generate revenue through the sale of its DMT Products to physicians, clinics and licensed psychiatrists in the United States, certain countries in the European Union and throughout Canada.
About the Centre for Human Drug Research (CHDR)
The Centre for Human Drug Research (CHDR) is an independent institute that specializes in cutting-edge technology and early-stage clinical drug research. CHDR utilizes the services of the GMP-compliant the Leiden University Medical Center (LUMC). The LUMC pharmacy prepares and delivers the pharmaceutical products, including investigational medicinal products.