Entheon Biomedical Announces CRO Agreement with CHDR for Phase 1 Clinical Trial; Centre for Human Drug Research Led DMT Study to Start in 2021
Vancouver, British Columbia--(Newsfile Corp. - December 1, 2020) - Entheon Biomedical Corp. (CSE: ENBI) (FSE: 1XU1) ("Entheon" or the "Company"), a biotechnology company focused on developing psychedelic medicines to treat addiction, announced it has entered into a Clinical Study Agreement with the Contract Research Organization (CRO) Centre for Human Drug Research (CHDR) to conduct an early phase human clinical trial with DMT.
CHDR is a Leiden, Netherlands-based contract research organization (CRO) that specializes in early-stage clinical drug research. Based on an agreement signed October 7th, 2020, Entheon has contracted CHDR to carry out a study to evaluate the pharmacodynamics, pharmacokinetics and safety of a target-controlled intravenous infusion of N,N-dimethyltryptamine (DMT) (the "Product") in humans.
CHDR research director of psychiatry, Gabiel Jacobs stated, "The CHDR psychiatry team is looking forward to the exciting collaboration with Entheon in conducting this data-intensive study with DMT in humans. Characterization of both its functional central nervous system effects and its impact on subjective experience, and to relate these to its pharmacokinetics, is crucial to properly understand DMT's potential as pharmacotherapeutic."
"This is a significant milestone in our mission to develop therapeutic protocols to treat substance use disorders. We believe that the CHDR's renowned expertise in conducting early-stage clinicals trials and their use of innovative technology makes them an excellent CRO to partner with," said Timothy Ko, Chief Executive Officer of Entheon. "With the CHDR's partner pharmacy having successfully received an amendment to its opiate license to include DMT and having applied for its import permit for DMT, we are advancing on steps for our clinical trial, which is expected to start in the late summer of 2021."
About the Centre for Human Drug Research (CHDR)
The Centre for Human Drug Research (CHDR) is an independent institute that specializes in cutting-edge early-stage clinical drug research. Combining innovative methods and technologies, state-of-the-art facilities, and talented, motivated researchers helps CHDR maximize their clients' success. In addition, CHDR places the highest priority on their subjects' comfort and safety, and they play an active role in helping educate the medical and clinical research communities. In addition, 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, and offers tailor-made solutions to help answer our sponsors' questions.
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.
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Cautionary Note on Forward Looking Information
This news release contains forward‐looking statements and forward‐looking information within the meaning of applicable securities laws. These statements relate to future events or future performance. All statements other than statements of historical fact may be forward‐looking statements or information. More particularly and without limitation, this news release contains forward‐looking statements and information relating to the approval of the proposed study protocol by the Dutch Medical Ethics Review Committee, the commencement of the study, the ability to obtain study participants, the results and outcomes of the study, and other matters. The forward‐looking statements and information are based on certain key expectations and assumptions made by management of the Company. Although management of the Company believes that the expectations and assumptions on which such forward-looking statements and information are based are reasonable, undue reliance should not be placed on the forward‐looking statements and information since no assurance can be given that they will prove to be correct.
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