DENVER, Dec. 21, 2020 — Mydecine Innovations Group (CSE: MYCO) (OTC: MYCOF) (“Mydecine” or the “Company”), an emerging biopharma and life sciences company committed to the research, development, and acceptance of alternative nature-sourced medicine for mainstream use, announced that it has engaged ethica CRO (“ethica CRO”), a full-service Contract Research Organization (“CRO”) that conducts and manages ethical clinical research on drugs, biologics, medical devices and more, as the contract research organization (“CRO”) for its upcoming Phase 2A PTSD clinical trials.
ethica CRO is a full-service, global CRO that provides drug development services to biopharmaceutical companies in clinical trials. ethica CRO provides a complete range of clinical study management and biometrics services for clinical research phases I through IV. Since its inception in 2002, ethica CRO has dedicated its efforts to bring a new dimension to the clinical research industry, the ethical dimension, focused on integrating research participants as partners in research rather than simply subjects of research. ethica CRO was the first CRO in the world to be accredited for its human research protection program in 2006 and is the only CRO in the world to have achieved accreditation from three different accrediting bodies
“We are excited to bring on a high-caliber partner in ethica CRO, which has extensive expertise in managing clinical studies to the highest standards of ethical and clinical practice, as the CRO for Mydecine’s upcoming Phase 2A PTSD clinical trials,” commented Josh Bartch, CEO of Mydecine Innovations Group. “Engaging ethica CRO is one of the key pieces of our preparations as we explore how the brain responds to psychedelics and develop a better understanding of the biological underpinnings created by the psychedelic experience. We maintain that their insight and unparalleled experience in trials of this nature provide the best opportunity to further drive Mydecine’s clinical development. We believe that with ethica CRO’s deep clinical experience, and through our achievements in trial preparation, we are optimally positioned for our upcoming Phase 2A PTSD clinical trials in Veterans in Canada and the United States.”
ethica CRO’s dedication to research participant protection made it a partner of choice for the Canadian Department of National Defence. ethica CRO has participated in a series of clinical development programs with the Canadian DND and various NATO allies, most notably synthetic cannabinoids in the treatment of PTSD, injectable antidotes to chemical weapons, and skin decontamination kits for neutralizing chemical warfare agents.
“Psychedelics and psychedelic-assisted therapies are rapidly proving to be some of the most exciting developments in mental health treatment in decades,” said Murray Jensen, Managing Director of ethica CRO. “Mydecine’s ambitious approach to researching and tackling the mental health challenges facing veterans and other frontline workers aligns with our values and mission at ethica and we are excited to hit the ground running with the Mydecine team as they push forward in their pursuit to transform mental health.”
Mydecine’s international Phase 2A clinical trials will focus on psilocybin-assisted psychotherapy to treat chronic PTSD in veterans and EMS personnel. The research will take place at Leiden University Medical Centre in the Netherlands; the University of Western Ontario; and the University of Alberta, with other clinical sites on the horizon in the USA, Europe, and Australia. Through these trials, Mydecine hopes to establish the safety and efficacy of psychedelic administered psychotherapy in a safe and supervised setting, utilizing strict protocols approved by research ethics boards and build upon the body of work that has led to psilocybin-assisted psychotherapy to receive “breakthrough” status by the FDA.
About Mydecine Innovations Group
Mydecine Innovations Group™ is an emerging biopharma and life sciences company dedicated to developing and commercializing innovative solutions for treating mental health challenges and enhancing wellbeing. The company’s world-renowned medical and scientific advisory board is advancing a robust R&D pipeline of psychedelic derived therapeutics, novel compounds, therapies, and controlled drug delivery systems. Mydecine has exclusive access to a full cGMP certified pharmaceutical manufacturing facility with the ability to import/export, extract, and analyze natural and synthetic psychedelic compounds with full government approval through Health Canada. Mydecine’s portfolio companies Mydecine Health Sciences™, Mindleap Health™, and NeuroPharm™ position the company at the forefront of disruptive modern medicine.
About ethica CRO Inc.
Founded in 2002, ethica CRO is a full-service contract research organization (CRO) that conducts all clinical phases of ethical research for new and innovative treatments on behalf of the pharmaceutical, biotechnology, medical device and natural health product industries. ethica CRO was the first Contract Research Organization (CRO) in the world to be accredited for its human research protection program in 2006 and is the only CRO in the world to have achieved accreditation from three different accrediting bodies. Human research protection program (HRPP) accreditation by an independent, industry-recognized organization confirms that an organization’s processes ensure the respect and protection of research participants, and that its services meet or exceed industry standards.
On behalf of the Board of Directors:
Joshua Bartch, Chief Executive Officer
Charles Lee, Investor Relations
The Canadian Securities Exchange has neither approved nor disapproved the contents of this news release and accepts no responsibility for the adequacy or accuracy hereof. This news release contains forward-looking statements, which relate to future events or future performance and reflect management’s current expectations and assumptions. Such forward-looking statements reflect management’s current beliefs and are based on assumptions made by and information currently available to the Company. Readers are cautioned that these forward-looking statements are neither promises nor guarantees, and are subject to risks and uncertainties that may cause future results to differ materially from those expected including, without limitation, the availability and continuity of financing, the ability of the Company to adequately protect and enforce its intellectual property, the Company’s ability to bring its products to commercial production, continued growth of the global adaptive pathway medicine, natural health products and digital health industries, and the risks presented by the highly regulated and competitive market concerning the development, production, sale and use of the Company’s products. Although the Company has attempted to identify important factors that could cause actual results to differ materially from those contained in forward-looking information, there may be other factors that cause results not to be as anticipated, estimated or intended. There can be no assurance that such information will prove to be accurate, as actual results and future events could differ materially from those anticipated in such information. These forward-looking statements are made as of the date hereof and the Company does not assume any obligation to update or revise them to reflect new events or circumstances save as required under applicable securities legislation. This news release does not constitute an offer to sell securities and the Company is not soliciting an offer to buy securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such jurisdiction. This news release does not constitute an offer of securities for sale in the United States. These securities have not and will not be registered under United States Securities Act of 1933, as amended, or any state securities laws and may not be offered or sold in the United States or to a U.S. Person unless so registered, or an exemption from registration is relied upon.