Entheon Biomedical Corp. (CSE: ENBI) (OTC Pink: ENTBF) (FSE: 1XU1) ("Entheon" or the "Company"), a biotechnology company focused on developing psychedelic medicines to treat addiction, provides an update on license amendments issued to its clinical research organization, The Centre for Human Drug Research (CHDR).
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.
On Behalf of the Board of Directors,
"Timothy Ko"
Timothy Ko, CEO
For more information, please contact the Company at:
Entheon Biomedical Corp.
Joseph Cullen, Investor Relations
Telephone: +1 (778) 919-8615
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https://entheonbiomedical.com/
For media inquiries, please contact Crystal Quast at:
Bullseye Corporate
Crystal Quast
Telephone: +1 (647) 529-6364
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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.
Forward-looking statements and information are provided for the purpose of providing information about the current expectations and plans of management of the Company relating to the future. Readers are cautioned that reliance on such statements and information may not be appropriate for other purposes, such as making investment decisions. Since forward‐looking statements and information address future events and conditions, by their very nature they involve inherent risks and uncertainties. Actual results could differ materially from those currently anticipated due to a number of factors and risks. These include, but are not limited to, the Company's ability to raise further capital and the Company's ability to obtain regulatory and exchange approvals. Accordingly, readers should not place undue reliance on the forward‐looking statements and information contained in this news release. Readers are cautioned that the foregoing list of factors is not exhaustive. The forward‐looking statements and information contained in this news release are made as of the date hereof and no undertaking is given to update publicly or revise any forward‐looking statements or information, whether as a result of new information, future events or otherwise, unless so required by applicable securities laws. The forward-looking statements or information contained in this news release are expressly qualified by this cautionary statement.
Neither the CSE nor the Investment Industry Regulatory Organization of Canada accepts responsibility for the adequacy or accuracy of this release.
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March 29, 2022 February 24, 2022 |
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