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Category Archives: Psychedelics

Seelos Therapeutics: Year-End Results and Business Highlights Microdose – Microdose Psychedelic Insights

Posted: March 8, 2022 at 11:07 pm

Even if not on most peoples sexiest shroom stock list, Seelos Therapeuticshas been a solid presence in the psychedelic medicine space for some time.

For those who might not know, Seelos is a biopharmaceutical company focused on the development of novel therapeutics to treat central nervous system (CNS) disorders and other rare conditions.

The company has a portfolio of non-psychedelic compounds but its their SLS-002, an intranasal ketamine, thats made them an often overlooked but serious psychedelic player.

In 2019, the FDA granted Fast Track designation for Seelos SLS-002 molecule (ketamine) and Seelos has begun dosing patients as part of a study for Major Depressive Disorder giving the company a leg-up in the approval process of psychedelics.

With $20 million in capital raised in November, Seelos now has $78.7mm in cash on hand, a very healthy number that can help them withstand the current market pullback.

Theyre also in advanced clinical trials for other compounds like SLS-005, which is moving forward to Phase IIb/III after approval of its IND application by the FDA.

A pretty solid pipeline. See below for the companys 2021 year-end results and business highlights.

NEWS PROVIDED BY

Seelos Therapeutics, Inc.

Mar 07, 2022, 08:00 ET

NEW YORK, March 7, 2022 /PRNewswire/ Seelos Therapeutics, Inc. (Nasdaq: SEEL), a clinical-stage biopharmaceutical company focused on the development of therapies for central nervous system disorders and rare diseases, today announced its year-end 2021 business and clinical update.

In the second half of 2021, we continued to accomplish several significant milestones and continued to execute in the face of one of the most difficult environments for publicly-traded biotech companies that Ive seen in my career, said Raj Mehra Ph.D., Chairman and CEO of Seelos. We began the placebo-controlled Part 2 of the registration directed study of SLS-002 and plan to enroll in over 30 sites. The SLS-005 IV trehalose programs registrational study in ALS, which was accepted into the HEALEY ALS Platform Trial at Harvard, commenced dosing participants in February 2022 and our IND was accepted to study SLS-005 in spinocerebellar ataxia and its Phase IIb/III pivotal study should begin dosing in Q2 2022. We have begun additional in vivo studies with our Parkinsons disease focused gene therapy program SLS-004 after demonstrating its capability of reducing alpha-synuclein expression. We look forward to continuing to provide meaningful updates on the current state of progress on all of our programs as well as additional initiatives.

Seelos Clinical Update

SLS-002 (intranasal racemic ketamine)

SLS-005 (IV Trehalose)

SLS-004 and SLS-007 (Parkinsons disease gene therapy programs)

Seelos Business Update

Contact Information:

Anthony Marciano

Head of Corporate Communications

Seelos Therapeutics, Inc. (Nasdaq: SEEL)

300 Park Avenue, 2ndFloor

New York, NY 10022

(646) 293-2136

anthony.marciano@seelostx.com

https://seelostherapeutics.com/

https://www.linkedin.com/company/seelos

Mike Moyer

Managing Director

LifeSci Advisors, LLC

250 West 55th St., Suite 3401

New York, NY 10019

(617) 308-4306

mmoyer@lifesciadvisors.com

SOURCE Seelos Therapeutics, Inc.

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No worries: Severe anxiety disorders to get the Incannex, Monash Uni treatment via psychedelics within vir … – Stockhead

Posted: at 11:07 pm

Incannex and Monash University will collaborate on ground-breaking research to advance treatment for severe forms of anxiety disorders using virtual reality combined with psychedelics.

Medicinal cannabis and psychedelic clinical development companyIncannex Healthcare (ASX:IHL)has joined with Monash University to develop a novel treatment that combines Virtual Reality (VR) and psychedelics.

Incannex has executed an exclusive, global license in perpetuity over an immersive therapeutic VR environment developed by BrainPark, a state-of-the-art clinical research platform at Monash Universitys Turner Institute for Brain and Mental Health.

The license allows Incannex to investigate use of Monashs VR therapy tool in combination with a psychedelic drug to develop a new treatment for severe forms of one or more anxiety disorders.

The established VR treatment uses an exposure-based approach, providing triggering stimuli in a graded and controlled manner, known as Exposure and Response Prevention or ERP.

By adding specialised clinical support and the administration of a psychedelic drug, the combined approach may allow for the development of a totally new therapy for severe forms of anxiety mental illness.

The research will be led by Monashs The Clinical Psychedelic Research Lab, Turner Institute and Department of Psychiatry Head Dr Paul Liknaitzky and BrainPark, Turner Institute Director Professor Murat Ycel.

Monashs Department of Psychiatry Head Professor Suresh Sundram and BrainPark Deputy Director Dr Rebecca Segrave will collaborate on the project.

The parties are working towards a research agreement for the first of these trials, which will assess optimal dose, safety, and tolerability of the combination treatment method.

Incannex CEO and Managing Director Joel Latham said the company was delighted to start the project with Monash and further use of combined psychedelics and VR therapy.

The combination of psychedelic compounds with an evidence-based VR therapy is a leading edge in the field of mental health treatments, Latham said.

We look forward to providing more detail about the project in due course when clinical trial planning has been finalised.

This is Incannexs second psychedelic therapy clinical program. Incannexs initial psychedelic clinical trial is using psilocybin to treat severe generalised anxiety disorder and has already achieved FDA comments and HREC approval to commence patient recruitment.

The research deal follows Incannexs much anticipated Nasdaq listing with the company hoping to attract keen medical cannabis investors as it pursues North American growth.

Incannex commenced trading on the Nasdaq under ticker Code IXHL on February 25.

American Depositary Shares (ADS) representing Incannex ordinary shares started trading following a declaration of effectiveness by the US Securities and Exchange Commission (SEC) of its registration statement on Form 20-F and formal approval from Nasdaq upon meeting listing requirements.

Each IXHL ADS represents 25 ordinary shares of Incannex with the company simultaneously retaining its listing of ordinary shares on the Australian bourse.

The Nasdaq listing is part of the companys goal to be more accessible to a wider audience of investors with sophisticated understandings of medicinal cannabinoids, psychedelic therapies, and pharmaceutical development.

This article was developed in collaboration with Incannex, a Stockhead advertiser at the time of publishing.

This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.

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Meet the 16 Most Influential Women Shaping the Future of Psychedelics – Business Insider

Posted: February 15, 2022 at 5:47 am

Women working in psychedelics are shattering the status quo and shaping an industry that's set to become worth more than$100 billionat its peak, according to analysts.

From business executives to scientists, Insider has identified 16 of the most influential women in psychedelics. The list, comprising a mix of academia, investment firms, businesses, and advocates, is a microcosm of the wider industry, which has various forces collaborating to form its future.

Insider published a callout asking for nominations for the most influential women in psychedelics and received 158 names. We asked that nominees identify as women, be deeply involved in the psychedelics space, and stand out from their peers.

After careful review, Insider chose a list of 23 people and interviewed each to come up with the 16 names below. We considered past achievements and current work to determine how they might shape the space to come. Insider editors and reporters made the final decisions.

Perhaps unsurprisingly, many of the women on our list were affiliated with or have worked with the Multidisciplinary Association for Psychedelic Studies (MAPS) which is the closest of any organization to bringing a psychedelic compound to market.

Many of the nominees personally knew of or had collaborated with one another in their research, business ventures, and funding efforts, and many others were making active efforts in their work to highlight more women in the space.

Below, meet the most influential women in psychedelics in 2022, listed in alphabetical order by first name.

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Psychedelics startups are taking on mental health – Fast Company

Posted: at 5:47 am

Psychedelics, long stigmatized as risky recreational drugs, are finally finding a place in polite society. More and more research from prominent institutions like Johns Hopkins suggests that such drugs, in the right formulations and with supervision, can bring about therapeutic breakthroughs in patients, notably in those who have proven to be resistant to other types of treatment.

Venture capital firms have taken noticepouring money into startups developing psychedelic treatments for everything from PTSD to smoking cessation. A January analysis by Business Insideridentified 11 venture capital firms (most of them founded in the past three years) that have collectively invested roughly $140 million in the psychedelics category. Funding accelerated after psychedelic startup Compass Pathways raised $146 million in its September 2020 initial public offeringand an additional $144 million in a secondary offering in April 2021.

And on Thursday a group of mid-tier VCs (and a group of angels) announced an investment of $11.5 million in a small biotech company called Mindstate Design Labs, which is creating therapy drugs based on psychedelics. The funding round in Mindstate, which exited stealth mode Thursday after a stint in the Y Combinator startup accelerator, was led by Initialized Capital and included money from Metaplanet Holdings, Day One Ventures, Negev Capital, K50 Ventures, Page One Ventures, and a group of angels.

Mindstate founder and CEO Dillan DiNardo tells Fast Company that his first product is based on the design of MDMA, or ecstasy, and is meant for people suffering from treatment-resistant post-traumatic stress disorder (PTSD). MDMA-based drugs aim to remove the mental barriers that prevent patients from talking openly about the root causes of their PTSD.

Its creating this state of mindthe technical name is the entactogenic statethats characterized by a reduction in fear, this feeling that all is well with the world, says DiNardo, who cofounded the company with evolutionary biologist Tom Rayin 2021 after working as an investor in biotech companies at UPMC Enterprises in Pittsburgh. It creates an overwhelming feeling of empathy and the ability to safely contemplate mental pain.

In May the journal Nature published the startling results of aPhase-III clinical trials study of MDMA-assisted therapy. After three MDMA-assisted sessions, more than two-thirds of patients with severe PTSD saw their symptoms reduced to the point where their condition no longer met PTSD diagnostic criteria.

Unfortunately, psychedelic drugs can come with some considerable side effects, including fatigue, irritability, depression, and anxiety, which can become more pronounced with repeated use. DiNardo believes Mindstates MDMA-based drug will minimize the negative side effects, making more treatment sessionsand faster relief for the patientpossible. It could also open the door toward the use of MDMA-based drugs for treating other types of mental disorders. The drug will enter clinical trials next year.

Mindstate is starting with its MDMA-based drug, but intends to create designs based on other drugs in the psychedelics family. Psilocybin (the hallucinogenic agent in magic mushrooms) is currently the focus of much of the research on psychedelics because of its ability to induce an ego loss state.

Dillan DiNardo [Photo: courtesy of Mindstate]Its an oceanic boundlessness state where the patient loses this I am a separate entity from the rest of the world,' DiNardo says. Its a profound state that can have enduring consequences that are very positive across the board when you look at treatment outcomes in addiction, depression, and anxiety.

What were doing is designing . . . psychedelic states, other forms of consciousness that are very different from normal waking consciousness that can be applied in specific therapeutic settings, DiNardo adds, stressing that his company uses many types of data, including biochemical and anecdotal experience information, to carefully design the desired mental state. It then uses AI to find the combinations of molecules that interact with brain receptors in a way that safely induces the desired state.

The federal Controlled Substances Act of 1970 outlawed psychedelic drugs such as LSD and magic mushrooms, and put barriers in place to prevent research into the potential clinical uses of the compounds. Despite that, psychiatrists have been using small doses of psychedelic drugs to enhance cognitive therapy since the 1970s, and perhaps before. With the development of new safe drugs that are more carefully tailored for in-office use, the practice could become more common.

The World Health Organization says almost a billion people worldwide suffer from mental health problems.

State legislatures have begun altering the law to allow psychedelics for clinical use. Oregon passed a law that legalizes the production, sale, and use of psilocybin (magic mushrooms) at licensed facilities starting next year. Washington is considering a similar bill that would legalize the administration of psilocybin within clinical settings.

Theres rising demand for new approaches for treating depression and anxiety. Rates of depression and anxiety around the world have soared during the pandemic. The World Health Organization says almost a billion people worldwide suffer from mental health problems.

Mental health is by far the biggest market in the life sciences, far bigger than cancer or cardiovascular disease, DiNardo says. Currently theres a 3-to-1 ratio between disease burden (how much it costs societies) and the level of healthcare spending on the problem, he says, a ration that should be 1-to-1.What that tells us, he says, is if we actually do develop medicines that are curative, that market could very quickly expand.

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Psychedelics Are Trending: If You Are Seeing Psilocybin In The Headlines Everywhere, You Are Right! – Ben – Benzinga

Posted: at 5:47 am

This article was originally published on Cannabis.net and appears here with permission.

Yes, Psilocybin Is In Every Headline Now And Thats Exciting!

Psilocybin, better known asmagic mushrooms, are clearlyall the rageright now.

From consuming the raw real deal to accurately-dosed capsules, people are reaping the benefits of magic mushrooms left and right. They arent wrong: this compound in mushrooms is nothing short of miraculous when it comes to treating a variety of ailments affecting us, both mentally and physically. But since its still fairly new and less studied compared to conventional medications, theres always going to be some kind of backlash.

Having said that, here are some of the biggest recent news on psilocybin:

On January 11, the International Therapeutic Psilocybin Rescheduling Initiative (ITPRI) began their campaign for medical mushroom reform globally. They state that the notoriously old1971 UN Convention on Psychotropic Substances Actneeds some serious updating as it was originally established to keep people away from harmful drugs. They are working in collaboration with theBeckley Foundation,Mind Medicine Australia,MAPS,Osmond Foundation,Open Foundation, andNierika AC.

However, we now have more data that psilocybin is therapeutic, and thus requires a change in its category.

In most countries, legal control of psilocybin results from its Schedule I status under the 1971 Convention on Psychotropic Substances, they said in a press release. Meant for dangerous drugs which create an especially serious risk to public health and whose therapeutic value is little to none, Schedule I drugs are subject to strict limits on their scientific and medical use. Schedule I licensing, safe-custody, security, manufacturing, quantity, and import/export restrictions result in a level of regulatory control and oversight that is drastically more onerous than for the Conventions other three schedules. As a result, researchers wishing to study psilocybin face numerous regulatory hurdles which add significantly to the cost, complexity, and duration of research and can negatively impact ethical approvals, funding and collaboration.

Given todays scientific understanding of psilocybins high potential therapeutic value and low risk of dependence, a change of its status as a Schedule I drug is long overdue.

Researchers from theDell Medical School at the University of Texas at Austinhave just launched the Center for Psychedelic Research and Therapy. Its the first of its kind in the state, with a focus on clinical research aimed at determining the potential for psilocybin as well as other psychedelics including ibogaine, ayahuasca, and MDMA for the treatment of PTSD, anxiety, and severe depression when used in conjunction with treatment from a trained professional.This research will bring further scientific rigor and expertise to study psychedelic therapy, explains Charles B. Nemeroff, the center co-lead, as well as chair and professor of the Dell Meds Department of Psychiatry and Behavioral Sciences. Recent studies have demonstrated considerable promise for these drugs when incorporated with clinical support, and this work has the potential to transform how we treat conditions like depression and PTSD, and to identify synergies between these and other well-established therapies to achieve long-term benefits for those seeking treatment.

They will begin with a focus on military veterans suffering from PTSD, adults living with depression or prolonged grief, and those who struggle with childhood trauma.

In early January 2022, researchers releasedresults of a studyrevealing that there was no detrimental long or short term effects when 10 or 25mg doses of psilocybin were given to groups of healthy individuals. The researchers, from the Institute of Psychiatry, Psychology, and Neuroscience at Kings College London, was the first step they were taking to prove the safety of the compound in treating a range of conditions including treatment-resistant PTSD. They add that psilocybin should be taken in controlled settings together with talk therapy.

This rigorous study is an important first demonstration that the simultaneous administration of psilocybin can be explore further, explains lead author James Rucker, PhD. If we think about how psilocybin therapy (if approved) may be delivered in the future, its important to demonstrate the feasibility and safety of giving it to more than 1 person at the same time, so we can think about how we scale up the treatment.

Throughout it all, they found that the participants displayed no results of any long or short term effects as a result of psilocybin intake.

Israeli pharmaceutical startupPsyRxbelieves that psychedelics obtained from natural sources may be key in treating mental health conditions, and they are now working on it.

The world urgently needs a new way to treat mental health issues, and at PsyRx we believe psychedelics are a big part of the solution, explains co-founder and CEO Itay Hecht. The company uses an agro-medical bioreactor that they developed at the Hebrew University Faculty of Agriculture to come up with psychedelic botanic extracts psilocybin, from mushrooms, and ibogaine, from the iboga shrub root bark.

These natural ingredients have been promising in treating addiction, depression, PTSD, and anxiety among more, especially when compared to dangerous and addictive SSRI medications which have been the norm for decades now. SSRIs have some very bad side effects on libido and appetite, and patients often stop using them. We believe adding a microdose of ibogaine will counter those effects and make a better drug, Hecht explains, adding that microdosing psychedelic drugs wont cause hallucinations.

We are starting small animal trials soon to check safety and efficacy. Hopefully in a years time we can start human trials, he toldISRAEEL21C.

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Why theres a push to legalize psychedelic drug therapy in Missouri – KTVI Fox 2 St. Louis

Posted: at 5:47 am

JEFFERSON CITY, Mo. A new bill before the Missouri legislature would allow hallucinogenic drugs that are now illegal to be used to treat people struggling from depression, PTSD, and all sorts of addictions.

Many people think of psychedelic drugs like ecstasy and magic mushrooms as a recreational high to be taken at a music concert, but used in a therapeutic setting, veterans and their families say it saved their lives.

Veteran Jared Rinehart from Anderson, Missouri suffered from failed relationships, depression, and anger issues after retiring from the Marine Corps and trying to return to civilian life. When conventional treatment failed, he turned to psychedelic therapy.

Rinehart traveled to Peru and a treatment center that is widely known by the military community. After taking controlled amounts of hallucinogenic drugs under the watchful eye of trained therapists, Rinehart said his depression was cured. He said it felt like one of these sessions was like 10 years of therapy.

Elaine Brewer is a spouse of a Navy SEAL combat expert. War was very difficult on her entire household. She was having massive panic attacks and severe suicidal ideation. Brewer and other special ops spouses went to a psychedelic-assisted therapy retreat center in Mexico. She said the spiritual experience allowed her to understand forgiveness and closure.

The bill before the Missouri legislature would legalize psychedelic medications that are now outlawed under the right to try law for investigational drugs. Missouri State Rep. Michael Davis of Kansas City is behind the bill. Drugs like psilocybin found in magic mushrooms could be manufactured in Missouri and physicians and pharmacies could distribute them.

St Louis clinical psychologist Larry Shapiro said this therapy is a game-changer in mental health. What may have taken six years to get to in therapy is now taking six hours. Psychedelics work on a different receptor in the brain compared to antidepressants.

Meanwhile, Brewer and her husband have established the Humble Warrior Wellness Center for veterans and their families to continue to overall mental and body healing for military families. Rinehart is the lead psychedelic integration coach at the Heroic Hearts Project.

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Cybin Announces Grant of U.S. Patent Covering its Proprietary Compound CYB004 (Deuterated DMT) for the Treatment of Anxiety Disorders – Business Wire

Posted: at 5:47 am

TORONTO--(BUSINESS WIRE)--Cybin Inc. (NEO:CYBN) (NYSE American:CYBN) (Cybin or the Company), a biopharmaceutical company focused on progressing Psychedelics to TherapeuticsTM, today announced that the U.S. Patent and Trademark Office (USPTO) has granted U.S. patent 11,242,318 to the Companys investigational deuterated dimethyltryptamine (DMT) compound CYB004. The allowed claims include a range of deuterated forms of DMT and 5-MeO-DMT. The patent, which is expected to expire in 2041 before consideration of any patent term extensions, covers composition of matter and protects the CYB004 drug substance as a putative new chemical entity.

CYB004 is Cybins lead investigational proprietary DMT compound. In preclinical studies, CYB004 has demonstrated potential efficacy at lower doses while also increasing the duration of drug effect providing a therapeutic profile that may alleviate the common negative experiences associated with classical DMT.

From the outset, Cybin has focused on creating differentiated compounds that harness the potential efficacy of classical psychedelics, while addressing the known limitations necessary for these molecules to become approvable therapeutics. We are extremely pleased to receive a composition of matter patent for CYB004, adding strong protection for our growing intellectual property portfolio of psychedelic-based compounds, supporting and protecting the investments that we are making in our CYB004 program said Doug Drysdale, Chief Executive Officer of Cybin. This patent is both rewarding and timely as we prepare to initiate a pilot study for CYB004 in the third quarter of 2022 and work tirelessly to develop an important and alternative treatment option for the millions of people suffering from anxiety disorders.

Cybin plans to submit a clinical trial application for a pilot study of CYB004 in the second quarter of calendar year 2022 and expects to initiate the pilot study in the third quarter of calendar year 2022.

The Company continues to pursue multiple opportunities to secure and support its patent position for research and development evaluating deuterated tryptamines for future psychedelic-based treatments for mental illnesses

About Cybin

Cybin is a leading ethical biopharmaceutical company, working with a network of world-class partners and internationally recognized scientists, on a mission to create safe and effective therapeutics for patients to address a multitude of mental health issues. Headquartered in Canada and founded in 2019, Cybin is operational in Canada, the United States, United Kingdom and Ireland. The Company is focused on progressing Psychedelics to Therapeutics by engineering proprietary drug discovery platforms, innovative drug delivery systems, novel formulation approaches and treatment regimens for mental health disorders. Patent filings described herein are held by Cybin IRL Limited, a wholly owned subsidiary of Cybin.

Cautionary Notes and Forward-Looking Statements

Certain statements in this press release constitute forward-looking information. All statements other than statements of historical fact contained in this press release, including, without limitation, statements regarding Cybins future, strategy, plans, objectives, goals and targets, and any statements preceded by, followed by or that include the words believe, expect, aim, intend, plan, continue, will, may, would, anticipate, estimate, forecast, predict, project, seek, should or similar expressions or the negative thereof, are forward-looking statements. Forward-looking statements in this news release include statements regarding the Companys proprietary drug discovery platforms, innovative drug delivery systems, novel formulation approaches and treatment regimens to potentially treat psychiatric disorders.

These forward-looking statements are based on reasonable assumptions and estimates of management of the Company at the time such statements were made. Actual future results may differ materially as forward-looking statements involve known and unknown risks, uncertainties, and other factors which may cause the actual results, performance, or achievements of the Company to materially differ from any future results, performance, or achievements expressed or implied by such forward-looking statements. Such factors, among other things, include: implications of the COVID-19 pandemic on the Companys operations; fluctuations in general macroeconomic conditions; fluctuations in securities markets; expectations regarding the size of the psychedelics market; the ability of the Company to successfully achieve its business objectives; plans for growth; political, social and environmental uncertainties; employee relations; the presence of laws and regulations that may impose restrictions in the markets where the Company operates; and the risk factors set out in the Company's management's discussion and analysis for the period ended September 30, 2021 and the Company's listing statement dated November 9, 2020, which are available under the Company's profile on http://www.sedar.com and with the U.S. Securities and Exchange Commission on EDGAR at http://www.sec.gov. Although the forward-looking statements contained in this news release are based upon what management of the Company believes, or believed at the time, to be reasonable assumptions, the Company cannot assure shareholders that actual results will be consistent with such forward-looking statements, as there may be other factors that cause results not to be as anticipated, estimated or intended. Readers should not place undue reliance on the forward-looking statements and information contained in this news release. The Company assumes no obligation to update the forward-looking statements of beliefs, opinions, projections, or other factors, should they change, except as required by law.

Cybin makes no medical, treatment or health benefit claims about Cybins proposed products. The U.S. Food and Drug Administration, Health Canada or other similar regulatory authorities have not evaluated claims regarding psilocybin, psychedelic tryptamine, tryptamine derivatives or other psychedelic compounds. The efficacy of such products has not been confirmed by approved research. There is no assurance that the use of psilocybin, psychedelic tryptamine, tryptamine derivatives or other psychedelic compounds can diagnose, treat, cure or prevent any disease or condition. Rigorous scientific research and clinical trials are needed. Cybin has not conducted clinical trials for the use of its proposed products. Any references to quality, consistency, efficacy and safety of potential products do not imply that Cybin verified such in clinical trials or that Cybin will complete such trials. If Cybin cannot obtain the approvals or research necessary to commercialize its business, it may have a material adverse effect on Cybins performance and operations.

Neither the Neo Exchange Inc. nor the NYSE American LLC stock exchange have approved or disapproved the contents of this news release and are not responsible for the adequacy and accuracy of the contents herein.

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Cybin Announces Grant of U.S. Patent Covering its Proprietary Compound CYB004 (Deuterated DMT) for the Treatment of Anxiety Disorders - Business Wire

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Psychedelic-assisted therapy program coming to Vancouver Island University | CTV News – CTV News VI

Posted: at 5:47 am

Vancouver Island University is set to become the first accredited university in Canada to launch a psychedelic-assisted therapy course.

The graduate program launches in September through the Faculty of Health and Human Services for health-care professionals.

Its a really big deal because it sets the bar for psychedelic-assisted therapies, recognizing that its an advanced practice that takes a unique skill set, says VIU nursing professor Shannon Dames.

One of the programs registrants is Dr. Laura McLean. She signed up after having tried the therapy herself last summer through Roots to Thrive, which is the eventual practicum site for the course.

This is the start of a movement, she says.

The 12-week program through Roots to Thrive has virtual sessions featuring guided conversations and on three instances the option of using ketamine. McLean says it helped her let go of fears she didnt know she had.

And that cleared up a lot of noise, she says. I came out personally with more confidence.

The curriculum is also delivered in collaboration with VIUs elder-in-residence Geraldine Manson, Indigenous professionals and cultural safety experts.

The courses co-developer says the therapy takes a very different approach to mental health.

Its essentially a way to access some of those stuck energies or stuck emotions so that we can sit with them, process them, speak to them, soothe them, and then when theyre ready, they depart, says Dames.

Health-care professionals in the field believe psychedelic-assisted therapy could be especially helpful for people who are struggling with end-of-life distress, PTSD and treatment-resistant mental health issues.

Theres all this excitement and promise around the field of psychedelic therapies, although theres lots of research to be done, says psychiatrist Dr. Susan Abbey.

Shes with Torontos University Health Network, which is currently using a $5 million donation from the Nikean Foundation for a first-of-its-kind research centre in Canada.

Our first project is going to be looking at end-of-life distress and combining psychedelics. There are several studies that show they may be helpful for people with end-of-life distress, says Abbey.

There are also plans to look at whether therapists need experience using the drug compounds themselves in order to be effective.

I think the ultimate goal is to really see, Is this actually an effective treatment? says Abbey. Does this really help people? Because theres so many factors around it.

VIUs part-time program runs from September through August. Registration is open for the fall session until March 31 and is designed for health-care providers.

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Sponsor ‘confident’ cannabis banking will pass this year (Newsletter: February 14, 2022) – Marijuana Moment

Posted: at 5:47 am

UT House approves psychedelics bill; OH Senate leader will block legalization; Twitchs marijuana-friendly policy; Willie Nelson Super Bowl ad

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https://www.patreon.com/marijuanamoment/ TOP THINGS TO KNOWRep. Ed Perlmutter (D-CO) said hes confident his marijuana banking legislation is finally going to make it through the Senate and onto the presidents desk before he leaves office at the end of this year.The Utah House of Representatives voted 68-1 to create a task force to study and make recommendations on the therapeutic uses of psychedelics such as psilocybin for treating mental health disorders.Ohios Senate president says he wont bring a marijuana legalization measure to the floor for a vote, meaning that activists who collected enough signatures to force the legislature to consider the measure will need more petitions to place it on the November ballot.The Missouri House of Representatives approved a bill to make it harder to qualify and pass ballot initiativesbut included a delayed implementation date that a lawmaker says was requested by a current marijuana legalization campaign.Video game streaming service Twitchs username policy update says references to marijuana are totally finetreating it the same as alcohol and tobacco. But the Amazon-owned company bans mentions of psychedelics and hard drugs.Marijuana icon Willie Nelson called for the legalization ofcomfortable shoes in an ad for Sketchers that aired during the Super Bowl.

/ FEDERALThe Drug Enforcement Administration Museum proudly displayed a pair of platform shoes worn by an undercover agent in the 1970s.Senate Majority Leader Chuck Schumer (D-NY) tweeted, Hundreds of millions of Americans live in states where cannabis has been legalized in some way. Its long past time for the federal government to catch up. The Senate will move forward on cannabis legalization with justice for the communities most impacted by the War on Drugs.Several U.S. senators discussed their positions on the issue of marijuana legalization.Sens. Joe Manchin (D-WV) and Marco Rubio (R-FL) filed a bill to restrict the use of certain federal funds for syringes for the injection of illegal drugs or devices to smoke, inhale, or ingest narcotics.Rep. Mondaire Jones (D-NY) toured a cannabis testing facility.Rep. Nancy Mace (R-SC) said Republicans should lean in on marijuana reform.Rep. Dave Joyce (R-OH) tweeted, If anyone knows the unjust consequences of #cannabis criminalization, its @weldon_angelos. Humbled to have his endorsement of my bipartisan #HOPEAct, which will help remedy the War on Drugs where its been most pervasive at the state and local level.Rep. Mike Garcia (R-CA) tweeted, In my district, cartels are profiting off the illegal marijuana market through indentured servant labor, stealing land and water, and threatening Californians!Louisiana Democratic Senate candidate Gary Chambers said his cannabis consumption is not something that should be controversial./ STATESMichigan Gov. Gretchen Whitmer (D) issued an executive order consolidating the regulation of marijuana and hemp under the newly renamed Cannabis Regulatory Agency.Louisiana Gov. John Bel Edwardss (D) Drug Policy Board adopted a resolution opposing the legalization of marijuana.Texas Democratic gubernatorial candidate Beto ORourke, a former congressman, spoke about his support for legalizing marijuana at a campaign rally.South Carolina Democratic gubernatorial candidate Joe Cunningham, a former congressman, tweeted, By opposing medical marijuana, @henrymcmaster is keeping life-saving medical care from countless veterans and patients across SC. Governor, your conspiracy theories about cannabis are rooted in lies, fear and 1950s propaganda. Time to end your opposition and help get this done.Mississippis lieutenant governor spoke about the economic impact of legalizing medical cannabis.The Washington State Senate approved a bill to increase penalties for robbing marijuana dispensaries, on par with those for robbing pharmacies.The Oklahoma Legislative Office of Financial Transparency issued a report recommending a moratorium on medical cannabis business licenses.A Maryland delegate tweeted, The drug war has led to the mass incarceration of Black & Latinx Marylanders. Its way past time we legalize cannabis, release non-violent drug offenders, as well as ensure equity & reparations for the harm done. Today, I filed the Cannabis Legalization & Equity Act. He also hosting a series of Weed Weekend events.A Michigan senator tweeted, I passed the bill in Michigan that funded automatically expunging the records for those convicted of non-violent marijuana use. Now its time to legalize marijuana federally & ensure our sons, grandsons, brothers, and uncles are no longer incarcerated & have a clean slate. He also tweeted, Even though we legalized marijuana in Michigan, its still illegal for banks to provide services to cannabis businesses. This means they operate on a cash-only basis which is dangerous for them and our community. Its time for Congress to legalize and pass the #SAFEBankingAct.Arkansas regulators are being sued over a policy that doesnt allow doctors to issue medical cannabis recommendations without in-person patient examinations.Iowa regulators said they havent yet gotten any response from the Drug Enforcement Administration about a letter requesting a federal exemption for the states limited medical cannabis program.Montana regulators proposed rules for failed marijuana laboratory test samples.Alaska regulators are proposing changes to rules on reinstatement of marijuana business licenses after failure to renew.Maine regulators issued guidance on separation of co-located medical cannabis and recreational marijuana cultivation operations.Colorado regulators sent an update on medical cannabis rulemaking.Vermont regulators will review marijuana policies on Monday and accept public comments at a hearing on Friday.Marijuana Moment is already tracking more than 1,000 cannabis, psychedelics and drug policy bills in state legislatures and Congress this year. Patreon supporters pledging at least $25/month get access to our interactive maps, charts and hearing calendar so they dont miss any developments.Learn more about our marijuana bill tracker and become a supporter on Patreon to get access.

/ LOCALSt. Louis, Missouris mayor toured a black-owned medical cannabis dispensary, tweeting, Black entrepreneurs in St. Louis are leading the way towards what I hope is an inclusive, diverse medical marijuana industry. Delavana, Illinoiss mayor spoke about how the city is using marijuana revenue to improve infrastructure.Ann Arbor, Michigan is using marijuana tax revenue to help people expunge past convictions./ INTERNATIONALThe president of Italys Constitutional Court said his colleagues should not nitpick referendums on cannabis and other issues, as rumors circulated that the body may block voters from being able to decide on the proposals this week.The Spanish Parliaments medical cannabis subcommittee will hold its first meeting this week./ SCIENCE & HEALTHA review concluded that cannabis and cannabinoids may be effective in treating patients with chronic conditions such as back pain and spinal cord injuries but that longitudinal effects and implications on surgical outcomes and complications are poorly understood.A review concluded that clinical trials on psilocybin produced promising results concerning the treatment of addiction, depression, and end-of-life mood disorders and it has been shown to produce durable effects with minimal toxicity./ ADVOCACY, OPINION & ANALYSISA poll found that 65 percent of Malaysian adults support decriminalizing medical cannabis./ BUSINESSHarborside Inc. closed a $45.4 million tranche of debt financing.Innovative Industrial Properties, Inc closed on the acquisition of a New Jersey property and entered into a long-term lease with a subsidiary of Ascend Wellness Holdings, Inc.MedMen Enterprises Inc.s chief revenue officer resigned.The Harry Reid International Airport tweeted, Were not blowing smoke! Save your super bowls for the couch, not our departure and arrival curbs. As a reminder, the possession and use of marijuana is prohibited on all airport property. Cannabis products can be discarded in the green amnesty boxes located at various entrances./ CULTURE2 Chainz is the second-largest shareholder of a new marijuana dispensary in Los Angeles, California. He also said Snoop Dogg should smoke cannabis during the Super Bowl halftime show.Arnold Schwarzenegger talked about the marijuana pranks and Danny DeVito played on each other.

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Sponsor 'confident' cannabis banking will pass this year (Newsletter: February 14, 2022) - Marijuana Moment

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Core One Labs’ Successful Patent Application Filing for Protection of its Biosynthetic Production System for Psilocybin Marks a Significant Milestone…

Posted: at 5:47 am

VANCOUVER, British Columbia, Feb. 09, 2022 (GLOBE NEWSWIRE) -- Core One Labs Inc. (CSE: COOL), (OTC: CLABF), (Frankfurt: LD6, WKN: A3CSSU) (the Company or Core One) is pleased to announce that following its milestone announcement that its wholly-owned subsidiary, Vocan Biotechnologies Inc. (Vocan), has successfully engineered a novel recombinant production system for biologically synthesized (biosynthesized) psilocybin, and has filed for patent protection of its groundbreaking intellectual property (see Core Ones press release dated January 21, 2022), its team of scientist continue to make progress and are in the process of optimizing at scale production capacity.

Scaled up production of the Companys groundbreaking biosynthetic psilocybin, and an approval of the Companys patent application will further Core One and Vocans journey to becoming a significant player in the provision of cost effective psilocybin and has the potential to significantly change the face of psychedelic-based mental health care and patient access to alternative treatments around the globe.

Psilocybin is a psychedelic compound that is showing enormous promise in treating addiction and many mental health disorders; and the success of this game-changing patent propels Core One to the forefront of the rapidly expanding psychedelics industry, eliminating barriers for psychedelic treatments and research such as exorbitant costs and lack of availability and supply.

Currently, most companies use chemically synthesized psilocybin as the only available cGMP compliant product that is available in large volumes. The chemical process carries significant costs and is less efficient when compared to a biologically derived psilocybin.

Under the leadership of Dr. Jan Burian, Vocans Chief Scientist, and Dr. Robert EW Hancock, Vocans CEO, the teams ground-breaking psilocybin production method utilizes the well-established industrial process of fermentation and therefore can be scaled up while consistently producing a high-quality cGMP product. The process turns bacteria into a biological factory to produce synthesized psilocybin, cutting cost and time immensely.

With Vocans optimized recombinant production system, the subsidiary successfully tested its proof-of-concept for the manufacturing of biosynthetic psilocybin suitable for use in future scale-up and is awaiting patent approval. The application includes claims that Vocans technology will enable the production of cGMP API grade psilocybin, which can be used by pharmaceutical companies, API manufacturers and organizations conducting clinical trials and, where permitted by law, consumers, and patients. Vocans crucial breakthrough anticipates a rippling effect that could rearrange the industrys landscape hereafter.

This breakthrough in psilocybin production, can shift the entire industry. By making psychedelic treatments cost effective, this could make treatment more widely available to patients globally. Additionally, our patent on this process, gives us first mover advantage in this significant and emerging space, Stated Joel Shacker CEO of the Company.

About Core One Labs Inc.Core One is a biotechnology research and technology life sciences enterprise focused on bringing psychedelic medicines to market through novel delivery systems and psychedelic assisted psychotherapy.Core One has developed a patent pending thin film oral strip (the technology) which dissolves instantly when placed in the mouth and delivers organic molecules in precise quantities to the bloodstream, maintaining excellent bioavailability. The Company intends to further develop and apply the technology to psychedelic compounds, such as psilocybin. Core One also holds an interest in medical clinics which maintain a combined database of over 275,000 patients. Through these clinics, the integration of its intellectual property, R&D related to psychedelic treatments and novel drug therapies, the Company intends to obtain regulatory research approval for the advancement of psychedelic-derived treatments for mental health disorders.

Core One Labs Inc.

Joel ShackerChief Executive Officer

FOR MORE INFORMATION, PLEASE CONTACT: info@core1labs.com1-866-347-5058

Cautionary Disclaimer Statement: The Canadian Securities Exchange has not reviewed and does not accept responsibility for the adequacy or accuracy of the content of this news release.

Information set forth in this news release contains forward-looking statements that are based on assumptions as of the date of this news release. These statements reflect managements current estimates, beliefs, intentions, and expectations. They are not guarantees of future performance. The Company cautions that all forward-looking statements are inherently uncertain, and that actual performance may be affected by a number of material factors, many of which are beyond the Companys control. Such factors include, among other things: risks and uncertainties relating to the Companys limited operating history and the need to comply with strict regulatory regulations. Accordingly, actual and future events, conditions and results may differ materially from the estimates, beliefs, intentions and expectations expressed or implied in the forward-looking information. Except as required under applicable securities legislation, the Company undertakes no obligation to publicly update or revise forward-looking information.

In addition, psilocybin is currently a Schedule III drug under the Controlled Drugs and Substances Act (Canada) and it is a criminal offence to possess substances under the Controlled Drugs and Substances Act (Canada) without a prescription or authorization. Health Canada has not approved psilocybin as a drug for any indication. Core One does not have any direct or indirect involvement with illegal selling, production, or distribution of psychedelic substances in jurisdictions in which it operates. While Core One believes psychedelic substances can be used to treat certain medical conditions, it does not advocate for the legalization of psychedelics substances for recreational use. Core One does not deal with psychedelic substances, except within laboratory and clinical trial settings conducted within approved regulatory frameworks.

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Core One Labs' Successful Patent Application Filing for Protection of its Biosynthetic Production System for Psilocybin Marks a Significant Milestone...

Posted in Psychedelics | Comments Off on Core One Labs’ Successful Patent Application Filing for Protection of its Biosynthetic Production System for Psilocybin Marks a Significant Milestone…

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