Researchers Delve Into Psychedelics in the Search for New Therapies

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Apr 13, 2020, 09:00 ET

NEW YORK, April 13, 2020 /PRNewswire/ -- Psychedelics are a class of psychoactive substances that produce changes in perception, mood and cognitive processes. Recently, there have been various announcements related to psychedelics used in a medical context. For example, on March 2019, the FDA approved the first ketamine based psychedelic medicine from Johnston & Johnston to treat depression, called Spravato. Additionally, in May 2019, Colorado became the first state to decriminalize Magic Mushrooms (Psilocybin), taking a similar path to the legalization of marijuana. Then, in November 2019, the FDA awarded the second Breakthrough Therapy designation to non-profit Usona Institute, which is also studying the effects of psilocybin as an anti-depressant. In the United States alone, the psychedelic drugs market is projected to reach a value of USD 6,859.95 Million by 2027 from USD 2,077.90 Million in 2019 while growing at a CAGR of 16.3% during the forecast period of 2020 to 2027, according to Data Bridge Market Research. Global Trac Solutions Inc. (OTC: PSYC), Mind Medicine (MindMed) Inc. (OTC: MMEDF) (NEO: MMED), Champignon Brands Inc. (OTC: SHRMF) (CSE: SHRM), iBio, Inc. (NYSE: IBIO), Aytu BioScience, Inc. (NASDAQ: AYTU).

Another indicator that psychedelic's medicinal properties are getting attention is the existence of psychedelic therapy centers. For example, this March, New York City witnessed the debut of its first legal, upscale guided psychedelic therapy center. According to a report by Forbes, the new Mindbloom center offers science-backed, clinician-prescribed, guided ketamine therapy in a spa-like setting, for USD 150 to USD 250 per session. The program consists of four one-hour sessions where FDA-approved ketamine is administered via sublingual tablets or an intramuscular injection. "After conducting a few hundred private sessions over the past couple of months, Mindbloom is now making its clinical protocols (designed by well-known psychedelics researcher and psychiatric practitioner Dr. Casey Paleos) available to the public. The company will seek to address common conditions like anxiety and depression at first," the report indicates.

Global Trac Solutions Inc. (OTC: PSYC) announced today breaking news that it has, "successfully changed their ticker symbol to PSYC, aligning with their new business ventures in the emerging psychedelic market.

'Global Trac has always been at the forefront of innovative technologies, new and emerging industries and market perspective. Most recently, we took an underserved industry in dire need of a cashless payment processing solution and successfully delivered it through MTrac which quickly evolved into the first significant revenue source in our company's history,' Said Vanessa Luna, CEO of Global Trac Solutions. 'Within this process we have also assembled a truly unique and powerful network of innovators, partners and leaders from a variety of different new and emerging industries. And while the presence we have established for Global Trac has afforded us the benefit of being presented with several different opportunities for new ventures, we have maintained a steadfast and diligent approach in our decisions related to the direction we move this company in with our immediate and long-term success remaining a top priority for our valued shareholders.'

'At the core of Global Trac's identity is a genuine passion for ingenuity and bold innovations that refuse to be tamed by the status quo. And with this in mind, I am both proud and excited to share that over the coming months it is my intent to begin laying the strategic groundwork for PSYC to emerge as a recognized trailblazer within the sector of Psychedelic Medicine which I believe currently on a path of completely transforming the world of mental health as we know it,' Vanessa Luna, continues.

'While the subject of medicinal psychedelics remains a hot topic that, in my opinion, is reminiscent of how medicinal marijuana was hotly debated leading up to its wave of legalization across the U.S., there is a growing number of cities across the country including Denver, Santa Cruz, Portland and Chicago that are pushing for its decriminalization based on its demonstrated benefits with treating mental disorders ranging from depression to anxiety. And as this industry begins to lay a foundation for itself, we are intent on taking our knowledge of the business aspect of content, resource availability, financial and banking networks, and knowledge, and through the use of our team engaging in a new multi-level engagement platform for subscribership and utilization as a resource marketplace that will be centered around the emergence of medicinal psychedelics.'

'Some of the initiatives supporting our decision to open up our business expertise in this emerging market surround recent global events taking place such as the Covid-19 pandemic and the potentially beneficial effects some of these alternative medicines can have,' Vanessa Luna, states.

"For Example: Forbes recently reported: 'The Federal administration has green-lit expanded telehealth services, relaxing regulations to reduce exposure to the coronavirus – SARS-CoV-2. This has opened the door to innovation in the medical community, with one company going for a fully remote ketamine treatment option for anxiety and depression.'

The Sacramento Bee reported: A recent clinical trial of veterans, firefighters, and police officers with PTSD found that after two doses of MDMA, symptoms were significantly reduced, and this effect lasted until the study ended at one year. According to a 2020 study from the Journal of Psychopharmacology, a single dose of psilocybin can make symptoms of depression significantly improve, and this benefit lasts multiple years. Recognizing this, the Food and Drug Administration (FDA) has recently given "breakthrough" status to MDMA and psilocybin. This means the FDA is expediting development and review of MDMA and psilocybin because they "may demonstrate substantial improvement over other therapy on a clinically significant endpoint." Still, it could be years before final approval. Last month, the FDA relaxed regulations in the approval process for COVID-19 therapies, because addressing the problem faster can "flatten the curve." This means keeping the health infrastructure from being overwhelmed by new cases. Speedily addressing psychiatric issues with the best therapies available can similarly protect our healthcare system.

Renowned places such as John Hopkins Center for Psychedelic & Consciousness Research are at the helm of research and state: 'Johns Hopkins is deeply committed to exploring innovative treatments for our patients. Our scientists have shown that psychedelics have real potential as medicine, and this new center will help us explore that potential.' - Paul B. Rothman, M.D., Dean of the Johns Hopkins University School of Medicine and CEO of Johns Hopkins Medicine."

'Over the next several months, we intend to strategically leverage the more than 30 psychedelic-based domains we have secured to launch some of the new and exciting business ventures we believe will be at the forefront of establishing Global Trac as a valuable resource within this emerging industry. And as you continue to follow our progress, we will continue to successfully penetrate both the cannabis and psychedelic markets through use of our software, marketing, technology, and business expertise. We will continue to evolve and work diligently to engage the supporters and shareholders who understand our mission objectives, support the vision of the company, and we are thankful for your continued support,' Said Vanessa Luna, CEO."

Mind Medicine (MindMed) Inc. (OTC: MMEDF) (NEO: MMED) announced earlier this month the signing of a multi-year, branch exclusive collaboration with the laboratory of Professor Dr. Matthias Liechti, the world-leading psychedelics pharmacology and clinical research group at University Hospital Basel in Switzerland. Under the agreement, MindMed gains exclusive worldwide rights to data, compounds, and patent rights associated with the Liechti laboratory's research with LSD and other psychedelic compounds, including data from preclinical studies and eight completed or ongoing LSD clinical trials. MindMed has already begun working with Professor Dr. Liechti's laboratory to file patents for the data and clinical trials it has generated over a 10-year period.

Champignon Brands Inc. (OTC: SHRMF) (CSE: SHRM) continues to accelerate its advancements within the psychedelic medicine arena via the acquisition of a leading Canadian ketamine clinic operator, psychedelic medicine IP aggregator and novel drug discoverer (the "Transaction"). To this extent, the Company announce last week that it has entered into a definitive agreement (the "Agreement") to acquire 100% of AltMed Capital Corp. ("AltMed"). AltMed owns 75% of the CRTCE, a fully operational ketamine clinic located in Mississauga, Ontario, with over 18 months of operating history. The CRTCE is licensed (2018) by the College of Physicians and Surgeons Ontario (CPSO) under OHPP (Out of Hospital Premise Program) to administer ketamine treatments for indications including but not limited to depression, bipolar disorder, post-traumatic stress disorder (PTSD) and obsessive-compulsive disorder (OCD). The clinic has been licensed by Health Canada to dose eligible patients with psilocybin and is the only clinic in Canada to perform psilocybin doses under Health Canada approval.

iBio, Inc. (NYSE: IBIO) announced last week the signing of two Master Services Agreements (the MSAs") and a Memorandum of Understanding (the "MoU") with the Infectious Disease Research Institute ("IDRI") in support of iBio's SARS-CoV-2 Virus-Like Particle ("VLP") vaccine development. Under the MSAs, IDRI will support pre-clinical development and provide clinical trial oversight, while iBio will provide process development and manufacturing services to IDRI, as needed. Additionally, the MoU calls for iBio and IDRI to establish a separate, additional agreement within the next 60 days if the Company opts to include one of IDRI's novel adjuvants in the COVID-19 vaccine development program ("IBIO-200"). The MSAs and the MoU integrate IDRI into iBio's collaboration with the Texas A&M University System to create a strong partnership that brings deep experience and advanced technologies and capabilities to the task of moving IBIO-200 into the clinic.

Aytu BioScience, Inc. (NASDAQ: AYTU), a specialty pharmaceutical company focused on commercializing novel products that address significant patient needs announced on April 3rd, that it began shipping its Coronavirus Disease 2019 ("COVID-2019") IgG/IgM Rapid Test to U.S. customers. Upon receipt of the initial 100,000 tests, the company completed product relabeling to ensure compliance with FDA guidance on COVID-19 serology test kits. The Company's first 2,750 COVID-19 Rapid Tests have been purchased by the Denver Police Department for use in screening Denver's first responders. The test kits were delivered to Denver Chief of Police Paul Pazen and members of his leadership team at Aytu BioScience's corporate headquarters on April 2, 2020. Josh Disbrow, Chief Executive Officer of Aytu BioScience, commented, "Upon receipt of our initial product shipment on March 31st, we immediately went to work to prepare the test kits for commercial distribution. The Aytu team has worked very hard over the last two days to relabel all 100,000 tests, and we're now shipping product to our customers across the country. Importantly, we are proud to be assisting our first responders here at home as we delivered over 2,000 tests to Denver Police Chief Pazen and his team."

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