Lobe Sciences Ltd. (CSE: LOBE) (OTC Pink: GTSIF) ("Lobe" or the "Company") is pleased to announce the launch of preclinical research studies using psilocybin and N-Acetylcysteine ("NAC") for the treatment of mild traumatic brain injury/concussion ("mTBI") with post-traumatic stress disorder ("PTSD"). The study is in collaboration with a multidisciplinary team of scientists and physicians at the University of Miami Miller School of Medicine under the lead of Michael E. Hoffer, M.D., professor of otolaryngology and neurological surgery.
NAC has been shown to be safe and efficacious in a phase I human clinical study in treating military personnel who had suffered mTBI. The initial research focus is to demonstrate the safety and efficacy of the combination of psilocybin and NAC using broadly accepted rodent models. Final results are expected in 2021. Once this is established, more specific work can examine dose response, medicine uptake, and medicine levels. The research team at the Miller School of Medicine has conducted prior studies involving NAC with mTBI and has a license from the United States Drug Enforcement Administration to conduct research using Schedule I controlled substances, which includes psilocybin.
The Miller School of Medicine is an internationally recognized leader in medical research, ranked No. 39 among the top medical schools in the nation by Blue Ridge Institute for Medical Research. In 2019, the medical school submitted 1,968 research proposals and was awarded $149 million in research funding from the National Institutes of Health (NIH).
Advances in neuro-diagnostic assessment have revealed mild traumatic brain injury (concussion) is more common than previously thought and potentially associated with a host of negative health outcomes. The Centers for Disease Control ("CDC") estimates that there are 3 million emergency room visits and over 230,000 hospitalizations due to TBI in any given year in the United States alone. Also, at the same time there are 5.3 million Americans living with the effects of mTBI (a 53% increase over ten years ago). The World Health Organization calls traumatic brain injury a "silent epidemic" that affects over 70 million individuals across the world. The United States Department of Defense estimates that over 345,000 individuals are affected by mTBI and that 20% of all service members who deploy suffer mTBI. mTBI and PTSD are significant health care issues that often co-occur and impact each other.
Dr. Hoffer, the principal investigator on the study, said, "This a very important extension of our work with NAC and other medicines to identify new treatments for mTBI and PTSD. We are hopeful that this new combination of psilocybin with NAC will lead us to better solutions for those suffering from mTBI and/or PTSD."
Maghsoud Dariani, Chief Science Officer of Lobe said, "We are very excited to begin the preclinical studies in collaboration with Dr. Hoffer and his team at the University of Miami. They have made significant in-roads studying psychedelic medicine specifically as it relates to mTBI and PTSD. NAC has been shown as the only compound that has adequate pre-clinical studies to validate use and, to date, remains the only compound that has successfully completed a phase 1 equivalent trial in a population of individuals who had acute mTBI. Given there are currently no proven effective medical treatments for the treatment of mTBI and PTSD, we feel this is an important study that can lead to human clinical trials and eventually therapeutics to make a positive impact in the physical and mental wellbeing of millions of people."
About Lobe Sciences Ltd.
Lobe Sciences is a life sciences company focused on psychedelic medicines. Lobe conducts drug research and development using psychedelic compounds as well as development of innovative delivery mechanisms to improve mental health and wellness.
For further information please contact:
Lobe Sciences Ltd.
Thomas Baird, CEO
Tel: (949) 505-5623
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Disclaimer for Forward Looking Statements
This news release contains forward-looking statements relating to the future operations of the Company and other statements that are not historical facts. Forward-looking statements are often identified by terms such as "will", "may", "should", "anticipate", "expects" and similar expressions. All statements other than statements of historical fact included in this release, including statements regarding the future plans and objectives of the Company, the Company's expectations surrounding its development of treatments and/or therapeutics for mTBI and PTSD, goals and results of the preclinical research studies with the Miller School of Medicine and future expectations surrounding additional studies, research and development using NAC and psilocybin, are forward looking statements that involve risks and uncertainties. There can be no assurance that such statements will prove to be accurate, and actual results and future events could differ materially from those anticipated in such statements. Important factors that could cause actual results to differ materially from the Company's expectations are risks detailed from time to time in the filings made by the Company with securities regulations. Readers are cautioned that assumptions used in the preparation of the forward-looking statements may prove to be incorrect. Events or circumstances may cause actual results to differ materially from those predicted, as a result of numerous known and unknown risks, uncertainties, and other factors, many of which are beyond the control of the Company, including changes to the regulatory environment; and that the current Board and management may not be able to attain the Company's corporate goals and objectives. As a result, the Company cannot guarantee that any forward-looking statement will materialize and the reader is cautioned not to place undue reliance on any forward-looking information. Forward-looking statements contained in this news release are expressly qualified by this cautionary statement. The forward-looking statements contained in this news release are made only as of the date of this news release and the Company does not intend to update any of the included forward-looking statements except as expressly required by applicable Canadian securities laws.