Further Research into Psilocybin Opens New Doors for Treatment

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Jan 07, 2021, 09:00 ET

NEW YORK, Jan. 7, 2021 /PRNewswire/ -- Among the popular fields of study for biotech companies in recent years are gene editing, tissue engineering and regeneration, nanobiotechnology and others. In addition, new segments under the biotech umbrella are constantly being developed. For example, the medical cannabis segment has rapidly emerged in recent years, and the continuously growing acceptance of psychedelic drugs is further evidence. The perceptions about psychedelics and their possible uses have also started to shift from a potentially dangerous party drug to an approachable medicinal product. For example, earlier in 2019, the U.S. Food and Drug Administration (FDA) approved Spravato (esketamine) a nasal spray, in conjunction with an oral antidepressant, for the treatment of depression in adults who have tried other antidepressant medicines but have not benefited from them (treatment-resistant depression). Also, in 2019, the FDA awarded the second Breakthrough Therapy designation to non-profit Usona Institute, which is studying the effects of psilocybin as an anti-depressant. Psilocybin is a naturally occurring psychedelic compound produced by more than 200 species of mushrooms, collectively known as psilocybin mushrooms. Mydecine Innovations Group Inc. (OTC: MYCOF) (CSE: MYCO), Eli Lilly and Company (NYSE: LLY), Revive Therapeutics Ltd. (OTC: RVVTF), Hollister Biosciences Inc. (OTC: HSTRF), Tonix Pharmaceuticals Holding Corp. (NASDAQ: TNXP)

James Kuo, the CEO and co-founder of California-based Tryp Therapeutics, explained, according to a report by Forbes, that while psilocybin remains among the most restricted drugs in North America, recent changes in regulations are enabling more clinical research and trials of the substance to be carried out. "These substances [including psilocybin] will become more available with their safety being demonstrated over time … Over-the-counter happened with some of the older medications — they were initially available at drugstores for prescriptions only… but I think people with very specific medical problems, such as pain or eating disorders, will be the most likely to adopt the type of functional food with psychiatric care components."

Mydecine Innovations Group Inc. (OTC: MYCOF) (CSE: MYCO) announced earlier this week that, "it is sponsoring a study titled: "The neurocognitive effects of low dose psychoactive substances," at Australia's Macquarie University

The research, led by Principal Investigator Dr. Vince Polito, Senior Research Fellow at the Department of Cognitive Science at Macquarie University, is the first study of naturalistic microdosing in a lab setting. Previous studies have either relied on surveys of microdosers or have given people who have not microdosed before a single controlled dose. In this study people who already have an established practice of microdosing will come to the lab to complete a cutting-edge battery of measures.

'Our focus of the study is exploring whether microdosing leads to changes in novelty perception or pattern recognition,' said Dr. Polito. 'In exploring the experiences of genuine microdosers from multiple angles, looking at behavioural, neuroimaging and biomarker data, we want to discover what actually happens when people microdose 'in the wild' and whether we can find objective indicators of some of the benefits that microdosers claim.'

The study will also be the first to use Magnetoencephalography, or MEG scans, to identify brain activity, along with planned cognitive and biometric measures, while microdosing.

'This study will further shed light on currently ambiguous effects of microdosing,' said Josh Bartch, CEO and Co-Founder of Mydecine. 'Microdosing has a strong following of self-administering users, but actual medical data is currently thin. By applying scientific rigor like this, along with the ongoing work at the Imperial College London, we are helping to build a library of solid data sets that begin to tell us how microdosing works, and how it can be used in future clinical trials for various mental health issues.'

Dr. Polito is a Research Fellow in the Department of Cognitive Science at Macquarie University. His focus is on self representation and developing measures of how our sense of self changes in different contexts, clinical conditions, and altered states of consciousness."

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Eli Lilly and Company (NYSE: LLY) is currently one of the largest manufacturers of psychiatric medications and produces Prozac (fluoxetine), Dolophine (methadone), Cymbalta (duloxetine), and Zyprexa (olanzapine). A recent study in mice led by UCLA biologists strongly suggests that serotonin and drugs that target serotonin, such as anti-depressants, can have a major effect on the gut's microbiota — the 100 trillion or so bacteria and other microbes that live in the human body's intestines. Serotonin — a neurotransmitter, or chemical messenger that sends messages among cells — serves many functions in the human body, including playing a role in emotions and happiness. An estimated 90% of the body's serotonin is produced in the gut, where it influences gut immunity. When mice were given the antidepressant fluoxetine, or Prozac, the biologists found this reduced the transport of serotonin into their cells. This bacterium, about which little is known, is called Turicibacter sanguinis.

Revive Therapeutics Ltd. (OTC: RVVTF) announced on November 18th, that it had entered into an exclusive research collaboration agreement with PharmaTher Inc., a wholly-owned subsidiary of Newscope Capital Corporation and a specialty psychedelics pharmaceutical company, to accelerate the development of psilocybin in the treatment of cancer and the discovery of novel uses of undisclosed psychedelic compounds. "Revive continues to be focused on developing novel uses for psilocybin that leverages our proprietary oral thin film delivery technology as a differentiated therapeutic approach," said Michael Frank, CEO of Revive. "We are excited to advance the development of PharmaTher's recent discovery in the potential of psilocybin to treat certain cancers such as Liver Carcinoma, Melanoma, Breast Neoplasms, Kidney Neoplasms and Acute Myeloid Leukemia. We are also leveraging PharmaTher's panaceAI™ discovery AI platform to discover new uses of undisclosed psychedelic compounds to be potentially used with our oral thin film delivery technology and expand our psychedelics drug pipeline."

Hollister Biosciences Inc. (OTC: HSTRF) announced on June 4th, that the Company's 100% owned subsidiary, AlphaMind Brands Inc. plans to launch medicinal mushroom based capsule and powder product lines. The initial product line will consist of a blended and bottled powder and capsule consisting of powdered cordyceps, lion's mane, oyster, reishi and shiitake medicinal mushroom varietals. The formulations for both products are unique and developed through research driven initiatives. The health benefits that the capsules and powder intend to provide include but are not limited to anti-inflammatory, antioxidant, anti-aging, anti-microbial and immune system support. Dr. Nikos Apostolopoulos, CSO of AlphaMind shared, "Our AlphaMind five mushroom blend will be a game changer for both athletes and non-athletes alike. This ethically sourced and organically grown blend provides potent antioxidants, and anti-inflammatory responses, helping to improve and maximize performance as well as daily activities."

Tonix Pharmaceuticals Holding Corp. (NASDAQ: TNXP) is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring, and developing small molecules and biologics to treat and prevent human disease and alleviate suffering. Tonix's portfolio is primarily composed of central nervous system (CNS) and immunology product candidates. The immunology portfolio includes vaccines to prevent infectious diseases and biologics to address immunosuppression, cancer, and autoimmune diseases. The CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric, and addiction conditions. Last yeah, Seth Lederman, M.D., President and Chief Executive Officer of Tonix Pharmaceuticals, outlined a new statistical method to analyze future Posttraumatic Stress Disorder (PTSD) drug studies and presented a retrospective analysis using the new method of the Phase 3 HONOR study (P301) of TNX-102 SL (cyclobenzaprine HCl sublingual tablets), for the treatment of military-related PTSD. "The paradox that confounds modern PTSD studies is that the placebo response has increased over time, even as we and others have striven to improve study methods and data quality," said Dr. Lederman.

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