Mydecine Innovations Group Offers Management and Clinical Trials Update
November 17th, 2020
Psychedelics, Top News
Dr. Rakesh Jetly Appointed Chief Medical Officer
Company Announces International Expansion of Clinical Trial Sites for Phase 2A Study into Psychedelic Treatments for PTSD in Veterans
VANCOUVER, British Columbia, Nov. 17, 2020 (GLOBE NEWSWIRE) — 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 therapeutic medicine for mainstream use, announced the appointment of Dr. Rakesh Jetly as Chief Medical Officer. The Company is also announcing a significant international expansion of its Phase 2A clinical research into the efficacy of psilocybin and psychedelic-assisted psychotherapy to treat Veterans, EMS, and First Responders with a PTSD indication.
Dr. Rakesh Jetly Appointed as Chief Medical Officer
In an effort to build a team of diverse experts who understand the potential of psychedelic-based treatments and the mental health struggles of veterans and frontline service members, Mydecine has appointed Dr. Rakesh Jetly, OMM, CD, MD, FRCPC to serve as Chief Medical Officer. Dr. Jetly brings to Mydecine a wealth of experience not only as a medical advocate for the use of psychedelic-assisted psychotherapy, but also as a prominent voice in the fight against post-traumatic stress disorder (PTSD) and other mental health issues facing vulnerable populations like veterans and first responders. Dr. Jetly currently serves as Academic Chair of Military Mental Health at The Royal’s Institute of Mental Health Research, and as an associate professor of psychiatry at Dalhousie University (Halifax), and the University of Ottawa. In 2015, he was appointed, “The Canadian Forces Brigadier Jonathan C. Meakins, CBE, RCAMC Chair in Military Mental Health.” He has published numerous articles in professional journals and presents nationally and internationally on such topics as PTSD and operational psychiatry.
“Over the years as a general duty medical officer and then a uniformed psychiatrist I have become acutely aware of the importance and challenge of transition from active duty to veteran,” said Dr. Jetly. “I am now facing the same process and am thankful that my transition will allow me to continue to work in the space that confronts the challenge of PTSD. Having deployed in missions in Rwanda and the Middle East, and witnessing first hand intense trauma of combat during deployments in Afghanistan, I am keenly aware of the suffering of the incredible men and women that sacrifice so much in our Armed Forces and suffer from operational stress injuries.”
As Chief Medical Officer, Dr. Jetly will lead Mydecine’s scientific research and clinical trials related to psychedelic-assisted psychotherapy using psilocybin to treat PTSD. Dr. Jetly will also keep Mydecine abreast of new scientific research related to psychedelics, and offer strategic guidance as it relates to all aspects of patient care, medical safety, medical compliance and the administration of psychedelics. Additionally, Dr. Jetly will also engage medical professionals and veterans’ organizations through outreach and educational offerings regarding the use of psychedelics as medicine.
Dr. Jetly added, “upon following the favorable clinical data and developments in the psychedelic space, I was struck by the commitment and enthusiasm of the Mydecine team to bring forth mental health solutions, specifically among the veteran population. I am extremely excited to join Mydecine’s leadership team and look forward to the opportunity to continue to educate and advance the global conversation on the promise of psychedelics in dealing with things like treatment-resistant PTSD. I am particularly excited to leverage the relationships that I have within NATO and beyond to bring some of the best clinicians and scientists to help tackle the deployment related mental health injuries.”
“We welcome Dr. Jetly to our senior leadership team as he makes his transition back into civilian life. We expect his impeccable reputation, medical knowledge and relationships with key veterans’ organizations will be valuable assets for Mydecine,” said Joshua Bartch, CEO of Mydecine. “In our research, we are targeting some of the most debilitating conditions and treatment-resistant syndromes facing the veteran’s population like chronic PTSD, depression and extreme anxiety. With Dr. Jetly’s leadership and guidance we believe we will be able to prove the long-term importance and efficacy of these compounds and treatments.”
New International Sites for Phase 2A Clinical Trials into Psychedelic Therapy for PTSD in Veterans
Mydecine announced the international expansion of its Phase 2A clinical trials of 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.
The purpose of these trials will be to explore how the brain responds to psychedelics and develop a better understanding of the biological underpinnings created by the psychedelic experience. 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.
“The choice of working with veterans as our first subjects in our clinical trials was made for a variety of reasons. Along with my experience, and that of our Scientific Advisory Board, we have devoted our professional lives to the treatment of soldiers and veterans suffering from a variety of mental health conditions including PTSD,” said Dr. Jetly. “Those who have treated veterans and connected research in the same group have come to the realization that, although many evidence-based treatments exist for PTSD, they are built largely on the ‘fear-based model,’ and sadly a significant proportion of those suffering do not respond positively. In fact, veterans tend to respond less often to the evidence-based therapies compared to other types of trauma.”
Psychedelic-assisted psychotherapy also allows for exploration of an important growing concept that appears to be particularly relevant in military populations known as Moral Injury. Moral Injury describes persistent psychological difficulties that include guilt, shame and anger that may become amplified when one perceives moral transgression of highly held values. It is hoped that after the psychedelic experience the internal reflection may allow therapists to influence these difficult-to-treat emotions.
Dr. Jetly added, “when we review the literature, we see psychedelics and psychotherapy being used effectively to treat a variety of conditions from depression and PTSD to chronic pain and addictions. When a treatment works in such varied conditions, we must wonder about a common underlying mechanism. We hope to study the brain and body via neuroimaging, electrophysiology and blood-based biomarkers in order to identify the key characteristics that lead to patients fundamentally changing to accept psychotherapy that they would not otherwise be receptive to.”
In addition to the sites in the Netherlands, Ontario and Alberta, Mydecine is exploring additional trial sites across North America including Ottawa, Los Angeles, New York and Boston.
About Mydecine Innovations Group
Mydecine Innovations Group™ is a life sciences company dedicated to developing and commercializing innovative solutions for treating mental health problems and enhancing wellbeing. The company’s world-renowned medical and scientific advisory board is progressing 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.
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.
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