Category Archives: Psychedelics

The federal government has announced it will pour millions of dollars into clinical trials using psychedelics like magic mushrooms and MDMA to see if they can help treat debilitating mental illnesses.

But why is the government forking out taxpayer dollars for magic mushrooms? And are there any risks in taking these, even in a trialled environment?

Here's what we know about the plan and whether psychedelics are a realistic option.

Psychedelics or hallucinogens are a class of psychoactive substances that can change your mood, senses and even cause hallucinations.

There are many different types and some occur naturally, like in mushrooms or leaves, while others are made in labs.

Some of the ones the government is talking about trialling in this instance include psilocybin (better known as magic mushrooms), ketamine (which is primarily used for starting and maintaining anaesthesia) and 3,4-methylenedioxymethamphetamine, which is also known as MDMA, molly or ecstasy.

Supplied: St Vincents Hospital

The government is investing $15 million in grants to support Australian-led research into the use of magic mushrooms, ecstasy and ketamine to combat illnesses like post-traumatic stress disorder (PTSD), major depressive disorder, addiction disorders and eating disorders.

Health Minister Greg Hunt said it was vital the government continued to search for new and better treatments for mental illness.

"The early results of trials in Australia and internationally are extremely encouraging," he said.

"But more research is desperately needed before these approaches can be used by psychiatrists outside of controlled clinical trials.

"This grant opportunity will boost local research into potentially life-saving therapies and offers hope to all those suffering from mental illness, including our veterans and emergency service personnel dealing with the devastating effects of PTSD."

It's estimated 4 million Australians experience a mental health disorder every year, and almost half of all Australians will be affected at some point in their lifetime.

Many of the standard treatments for these illnesses vary greatly in how effective they are, and there haven't been many major pharmaceutical discoveries in this area in recent years.

At the same time, once dismissed as dangerous party drugs, psychedelics are gaining mainstream acceptance in the medical world as ways to treat mental illnesses such as depression and PTSD.

The idea of treating mental illness with psychedelics has been around for a while (even centuries in some cultures), but there's been a gap in the research into their potential use as a treatment for mental illnesses because they were declared prohibited substances in the 1960s.

Australia's national medical regulator, the Therapeutic Goods Administration, currently doesn't recognise MDMA and psilocybin as legitimate medicines to treat psychiatric conditions.

But that could change, depending on these trial results.

A memorandum published by The Royal Australian and New Zealand College of Psychiatrists (RANZCP) last year noted there was an ongoing need to collect more data.

But it said so far, in controlled trials and when administered at therapeutic doses, psychedelic therapies demonstrated an initial high-safety and low-risk profile, with limited physiological concerns.

It did note though that MDMA could increase your heart rate and blood pressure.

It also said that when misused, psychedelics could cause psychosis a medical condition in which the mind is affected and there's some loss of contact with reality.

For this reason, current trials for psychedelic therapy generally exclude people with a personal or family history of psychosis or mania.

Reuters: DEA

But there's also a risk in not exploring this in clinical trials.

A recent Global Drug Survey found 6,500 of 110,000 respondents said they were self-treating their mental illness, particularly with ecstasy, magic mushrooms and LSD.

The head of the Australian arm of the survey, RMIT University's Monica Barratt, said the findings were a reminder people were already using psychedelics as a DIY mental health treatment.

"As Australia awaits the progress of clinical trials of these substances for mental health conditions, we need to recognise the demand for them is increasing and this demand may end up being filled outside of the medical setting," Dr Barratt said.

Worldwide, there are currently about 100 psychedelic trials for the treatment of depression, anxiety, alcohol and drug-use disorders, dementia, anorexia and chronic pain.

Psilocybin-assisted therapy for depression and MDMA-assisted therapy for PTSD have been given "breakthrough therapy" designation from the Food and Drug Administration (FDA) in the United States.

That means the FDA believes the therapies may offer substantial advantages over current therapies, and have therefore been expedited in their transition to prescribed medicines (although it hinges on the results from clinical trials).

RANZCP president John Allan said while further research was required to assess the safety and effectiveness of psychedelics, preliminary studies showed positive results.

"We are seeing limited but emerging evidence that psychedelic therapies may have therapeutic benefits in the treatment of a range of mental illnesses, such as PTSD substance abuse and depression," he said.

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The federal government is funding research into using psychedelics to treat mental illness. So, do they work? - ABC News

Lattice Biologics Ltd. (TSX-V: LBL) (OTCBB: LBLTF) ("Lattice Biologics" or the "Company") announced today that the Company will change its business strategy to focus on the fast growing psychedelics and cannabis markets through the creation of a new life sciences subsidiary. The Company will focus on the research and commercialization of psychedelic products in combination with its stem cell based regenerative compounds while leveraging the Companys distribution expertise.

The Company believes there is a sizeable legal market for psychedelic products and that there is a promising prospect for a strong, legal psychedelic industry to emerge globally. In November 2020, voters passed Oregon Ballot Measure 109, making Oregon the first state to both decriminalize psilocybin and also legalize it for therapeutic use. In August of 2020, the Canadian federal Minister of Health approved the use of psilocybin therapy in the treatment of end-of-life distress for certain patients. Lattice believes that the recent wave of deregulation and legalization of recreational cannabis across the globe will result in a new wave to psychedelics legalization. The Company believes that the new focus on psilocybin and psilocybin medicine may open up the approximately $15 billion-dollar global anti-depressant market to psilocybin.

The ability for neurons to regenerate with the use of psychedelics is a newly emerging area of research. We will utilize our knowledge of stem cells, and their potentiating effects, to create new and patentable technologies and medicines that improve health and alleviate suffering.

"Following a comprehensive strategic review of the Company, we have made the exciting decision to enter and focus on the fast growing psychedelic and Cannabis life sciences and to divest the Biologics business. With Lattices extensive knowledge of processing, purifying, and manipulating stem cells, we intend to be a leader in the emerging psychedelic market. The Company intends to announce key additions to its management and advisory board in the near future. Exiting Biologics allows the management team to reorganize the Biologics subsidiary and related debts while not affecting the holding and listed Company and to allow the Company and shareholders to focus on and benefit from future generated medicines and treatments. We believe the Biologics business is an attractive asset for someone who is better positioned to leverage the Biologics platform to build scale. During this transition period, we remain committed to our Biologics customers, and will continue to support our technologies and services," said Guy Cook, CEO.

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Beginning with the fiscal third quarter 2021, the Biologics Business will be presented as discontinued operations. As part of the reorganization, the wholly-owned subsidiary Lattice Biologics Inc. has filed a voluntary petition under Chapter 7 of the U.S. Bankruptcy Code. The Chapter 7 petition was filed March 12, 2021 with the U.S. Bankruptcy Court for the State of Montana. Chapter 7 will be administered under the oversight of a Court-appointed trustee. Additional information on the process can be obtained through the Court.

About Lattice Biologics Ltd.:

Lattice Biologics is traded on the TSX-V under the symbol: LBL.

Lattice Biologics develops and manufactures biologic products to domestic and international markets. The Companys products are used in a variety of surgical applications.

Lattice Biologics maintains its headquarters, laboratory and manufacturing facilities in Belgrade, Montana. The facility includes ISO Class 1000 and ISO Class 100 clean rooms, and specialized equipment capable of crafting traditional allografts and precision specialty allografts for various clinical applications. The Lattice Biologics team includes highly trained tissue bank specialists, surgical technicians, certified sterile processing and distribution technicians, and CNC operators who maintain the highest standards of aseptic technique throughout each step of the manufacturing process. From donor acceptance to the final packaging and distribution of finished allografts, Lattice is committed to maintaining the highest standards of allograft quality, innovation, and customer satisfaction.

Lattice Biologics maintains all necessary licensures to process and sell its tissue engineered products within the U.S. and internationally.

Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

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Certain information contained in this news release constitutes "forward-looking statements" within the meaning of the safe harbour provisions of Canadian securities laws. All statements herein, other than statements of historical fact, are to be considered forward looking. Generally, forward-looking information can be identified by the use of forward-looking terminology such as "planned", "potential", "future", "expected", "could", "possible", "goal", "intends", "will" or similar expressions. Forward-looking statements in this news release include, without limitation: information pertaining to the Companys strategy, plans, or future financial performance, such as statements with respect to the Transaction, and other statements that express managements expectations or estimates of future performance. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the actual results, level of activity, performance or achievements of Lattice to be materially different from those expressed or implied by such forward-looking statements.

Forward-looking statements are necessarily based upon a number of factors and assumptions that, while considered reasonable by management as of the date such statements are made, are inherently subject to significant business, economic and competitive uncertainties and contingencies. The factors and assumptions that could prove to be incorrect, include, but are not limited to: that market prices will be consistent with expectations, the continued availability of capital and financing, and that general economic, market and business conditions will be consistent with expectations. The forward-looking statements are not guarantees of future performance. We disclaim any obligation to update or revise any forward-looking statements, except as required by law. Readers are cautioned not to put undue reliance on these forward-looking statements.

United States Advisory: The securities referred to herein have not been and will not be registered under the United States Securities Act of 1933, as amended (the "U.S. Securities Act"), and may not be offered, sold, or resold in the United States or to, or for the account of or benefit of, a U.S. Person (as such term is defined in Regulation S under the U.S. Securities Act) unless an exemption from the registration requirements of the U.S. Securities Act is available. This press release shall not constitute an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any sale of securities in the state in the United States in which such offer, solicitation or sale would be unlawful.

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Media Contact: Guy Cook, CEOLattice Biologics Ltd.(TSX-V: LBL) (OTCBB: LBLTF)512 E. Madison Ave. Suite#A1Belgrade, MT 59714480-563-0800 OfficeNews@LatticeBiologics.com http://www.LatticeBiologics.com

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Lattice Biologics Reorganizes to Focus on Psychedelics and Cannabis Therapies - Yahoo Finance

Meaghan Buisson agreed to take part in a clinical trial on the use of MDMA for treating post-traumatic stress disorder after what she calls a "year of darkness."

She was homeless in Vancouver and out of treatment options as she confronted the aftermath of sexual abuse and assault.

"It was a Hail Mary. It was like, well, what do I have to lose, really?" Buisson, now an instructor with Outward Bound Canada, recalled in an interview with CBC News.

In early 2015, Buisson embarked on a Phase II clinical trial sponsored by the Multidisciplinary Association for Psychedelic Studies (MAPS). Court documents show that her co-therapists were a married couple living on Cortes Island near Campbell River Richard Yensen, an unregulated psychotherapist, and psychiatrist Dr. Donna Dryer.

"What I had been told was that psychedelics open you up and there's deep healing," Buisson said.

"There was no mention ever of the risks of sexual abuse."

But there's a documented history of sexual violation within psychedelic therapy, and Buisson has alleged that Yensen took advantage of her vulnerability to do the same.

She believes there is potential for psychedelics to be healing and says they may have a place in the health-care system, but the risk of serious harm means safeguards are essential. That includes stronger oversight of clinical trials, better measures to prevent abuse and strict regulations for who can provide psychedelic therapy or, for that matter, any type of psychotherapy.

MDMA, also known as ecstasy, is a recreational drug that produces feelings of euphoria and enhances sensation and sexuality. It's one of several illicit substances, including ketamine, LSD and psilocybin mushrooms, that's currently being studied for potential uses in psychotherapy.

These substances are slowly making their way into mainstream patient care. Health Canada has begun granting exemptions for the legal use of magic mushrooms in therapy, and the College of Physicians and Surgeons of B.C. has opened the door for psychiatrists to prescribe ketamine for treatment of depression.

But Lily Kay Ross, an editor at the drug-focused publication Psymposia, who completed a PhD on social responses to sexual violence, cautions that there is a real danger of coercion in this type of treatment because of the power imbalance and the nature of the substances.

"In therapy, people take drugs to alter their consciousness and enter into a boundary dissolving state," she wrote in an email.

"They may report feeling and even appear quite lucid, but they are not able to make sound decisions about sexual engagement. And it is a violation of therapeutic trust to engage sexually."

In a civil claim filed in B.C. Supreme Court in 2018, Buisson alleges she was repeatedly sexually assaulted by Yensen, with Dryer's knowledge, while in treatment with the couple.

Yensen does not deny having sex with Buisson, but in his response to her lawsuit, he accuses her of initiating it, describing her as "a skilled manipulator." He also denies owing her the duty of care inherent in a doctor-patient relationship, suggesting they were merely fellow participants in a research study, albeit with different roles.

The civil claim has since been settled out of court on undisclosed terms, but MAPS has acknowledged that Yensen carried on an "unethical" sexual relationship with Buisson and said Dryer knew but failed to report it to any authorities. The organization has cut ties with both Yensen and Dryer.

Neither Yensen nor Dryer responded to requests for comment.

Buisson has also sought accountability in other ways.

She filed a sexual assault complaint with the Quadra Island detachment of the RCMP, who confirmed for CBC that an investigation is ongoing.

She also turned to the professional regulators, filing a complaint against Dryer with the College of Physicians and Surgeons of B.C., which has yet to be resolved after three years.

Finally, because Yensen was described as a psychologist on the website for MAPS Canada, Buisson filed a complaint with the College of Psychologists of B.C.

But it turns out Yensen is not a registered psychologist in this province, so the college had no power to investigate or discipline him. Officials did, however, ask him to stop calling himself a psychologist online, according to a letter provided to CBC.

There is no regulatory body governing people like Yensen in B.C. As it stands, literally anyone can call themselves a therapist or counsellor and start advertising their services to British Columbians.

In December, the Federation of Associations for Counselling Therapists in B.C. (FACTBC) submitted a formal application to Health Minister Adrian Dix, calling for urgent regulation of the profession.

But Dix has now rejected that effort, writing in a Feb. 9 letter that the government won't consider regulation of any new health professions until a new oversight body for health professional colleges is in place.

Glen Grigg, chair of FACTBC, described that decision as "tragically out of step with the gravity of Ms. Buisson's experience." In an email, he said lack of regulation was a major factor in what happened to Buisson.

Buisson is disappointed as well.

"Regulation alone is not going to fix the problem. Therapists can be regulated and still be deeply unethical. But the difference is when therapists are regulated and there's oversight and there's a college, patients have some kind of recourse," Buisson said.

The allegations against Yensen and Dryer are not outliers in the field of psychedelic therapy, where sexual abuse has long been acknowledged as a potential risk.

In fact, MAPS founder and executive director Rick Doblin wrote in his PhD dissertation that: "The loving and trusting feelings that can be induced by MDMA can make patients more vulnerable to sexual pressure."

One of the early American proponents for the use of MDMA in therapy, Richard Ingrasci, was permanently barred from practising psychiatry in 1989 after patients came forward to allege he'd sexually abused them while they were under the influence. Psychiatrist Francesco DiLeo of Maryland had been disciplined for similar violations just two years earlier.

In response to Buisson's experience, MAPS issued a statement in 2019 saying that its policies forbid sexual relationships between therapists and their patients, and "there was no prior indication that Richard Yensen or Donna Dryer would violate this policy."

The organization says its lawyers have determined MAPS was not legally responsible for what happened to Buisson, though it agreed to pay her $15,000 for therapy "on a compassionate basis."

Since Buisson's experience, MAPS has formalized a Code of Ethics that makes it clear practitioners must "avoid entering into dual relationships that are likely to lead to impaired professional judgment or exploitation."

The organization has not, however, tightened its policies on who can act as a therapist in clinical trials.

Protective measures including a requirement for two therapy providers to work together on each case were already in place when Buisson began treatment with Yensen and Dryer. MAPS still only requires one member of the team to be licensed, and there are still married couplesworking together, according to a spokesperson.

Buisson is deeply unsatisfied with the response.

"They didn't put the protocols in place to keep the patient safe. After a harm occurred, MAPS has taken no corrective measures to mitigate the harms," she said.

She urges anyone who is considering taking part in psychedelic therapy not to buy into the hype about psychedelics as miracle cures for psychological issues and to understand that there are risks as well. She also recommends bringing along a buddy who will stay sober and make sure the situation is safe.

"This is not a safe situation.What that does for patients is it puts us in a position of responsibility for our own care," Buisson said.

"Go into it with your eyes open and get informed, get educated."

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As psychedelic therapy goes mainstream, former patient warns of danger of sexual abuse - CBC.ca

Psychedelics are seeing a resurgence with a growing body of research exploring the potential of psychedelic-assisted therapy for a variety of clinical applications. But while progress around psychedelics has accelerated in a relatively brief period in recent years, their exploration has been a long-evolving process dating back to the late 1800s, and their earliest origins trace back to indigenous groups in North America as far back as 5,000 years ago.

The minds behind the Sana Symposium, a virtual conference scheduled for Sept. 17-19, have published a new infographic guiding readers through the history of the human relationship with psychedelics. The document chronicles the first psychedelic experience involving a purified compound in 1897, groundbreaking moments throughout the 20th century, and landmark breakthroughs of the past five years.

The infographic can be downloaded here.

For more information on the Sana Symposium, visit sanasymposium.com.

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From Sacred Rituals to Breakthrough Therapies, History of Psychedelics a Long, Winding Road - Psych Congress Network

With recent landmark progress in legalization efforts around the world, its clear we are in a psychedelic renaissance. In its wake has come a wave of innovation and the emergence of new-age pioneers in the space. Mydecine Innovations Group (CSE:MYCO) (OTC:MYCOF) (FSE:0NFA) is an example of a company that is far ahead of the curve. Based out of Denver, Mydecine has established itself as a leader in the emerging field of psychedelic-assisted treatments for mental health.

Earlier this week, Director and CEO Josh Bartch sat down with the Dales Report to discuss how the past 12 months have been monumental to both the psychedelics industry and Mydecine.

There are a few key differentiators that place Mydecine in a league of its own. Whether its their R&D or the actual production of drugs, the company has a rare combination of capabilities. Josh explains these in more detail, One thing about Mydecine thats incredibly unique is that were fully vertically integrated, So as it pertains to psychedelic assisted psychotherapy, we really have an A-Z capability. This comprehensive pipeline gives Mydecine a unique advantage when it comes to clinical trials. With a full set of operations in-house Mydecine can rapidly innovate.

Evidently, Mydecine has taken full advantage of its integrated supply chain with a global clinical trial infrastructure with sites approved throughout Canada, Europe and the United States.

Despite Mydecines vast array of capabilities, the companys mission can be broken down into a few defining elements. As Josh lays it out, Mydecine Innovations Group really now has become a global company with really three main focuses: One is IP and R&D and our drug development pipeline is in that branch. Two is our clinical trial development and three is going to be our technology platform MindLeap.

During the last few months, the clinical pipeline has been in full swing with Mydecine announcing an upcoming phase 2A trial which will center around exploring psilocybin-assisted therapy for the treatment of PTSD in veterans and emergency personnel. In a global display of research capability, the clinical trials will take place across 3 continents with the goal of establishing the safety and efficacy of psychedelic administered psychotherapy in a supervised setting.

On the technological side, Mydecine has been continuing development of the Mindleap platform which will allow them to administer psychotherapy protocols remotely. With a growing number of people avoiding in person health services at the moment, the mindleap platform is proving to be especially relevant. The company believes this key differentiator will strengthen the connection between patients and healthcare providers.

Josh explains in more detail, So I think something thats really important to remember is that this is psychedelic-assisted psychotherapy. Seven-tenths or eight-tenths of the equation are one-on-one psychotherapy meetings between psychotherapists and patients with no substances taken at all So if we can aggregate with what weve been able to do with MindLeap, professionals that have been trained in the psychotherapy protocol under one roof and give patients access to be able to take the seven or eight-tenths of the equation, remotely, obvious vastly increases the scalability of the treatment.

Mydecine encompasses the new era of medicine, making it a one stop shop for psychedelic treatment and innovation. To watch for in 2021: Mindleap recently announced a 2.0 coming to the platform to deliver ancillary services that are complementary to the psychotherapy. In the coming months, Mydecine has its sights set on uplisting to the NEO and Nasdaq exchanges.

Published March 18th, 2021

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Mydecine CEO Josh Bartch on the Future of Psychedelics - Influencive

OXNARD, Calif.--(BUSINESS WIRE)--CURE Pharmaceutical Holding Corp. (CURE or the Company) (OTC: CURR), a vertically integrated drug delivery and product development company, announced today that it has launched a new initiative for the clinical development of psychedelic compounds such as psilocybin, LSD, and MDMA for the treatment of various mental health disorders.

Utilizing CUREs patented oral film platform CUREfilm for precision dosing, the company intends to optimize the absorption and metabolism of psychedelic actives targeting clinical efficacy of both macrodosing and microdosing treatment regimens. CURE will use its DEA Schedule 1 license and cGMP-certified and FDA-registered facility providing a United States footprint for anticipated commercialization.

Our specialty pharmaceutical pipeline is robust, protected by our IP and differentiated relative to others developing psychedelics, said Rob Davidson, CEO of CURE. Through innovation and selective diversification, we are confident that these new psychedelic programs and our corresponding product development efforts will open many doors to research advancement and new patient solutions. These programs not only broaden our internal pipeline but are also reflective of CUREs focus on treatments for critical disease states including central nervous system disorders, viral infections, and now the serious burden of mental health disorders as well.

Ongoing research, which has been active for decades, continues to showcase a growing body of evidence in support of psychedelics as effective treatments for mental health disorders such as depression, PTSD, addiction disorders, obsessive compulsive disorder, and anxiety. For example, in 2017, the US Food and Drug Administration (FDA) recognized the potential benefits of MDMA by assigning a Breakthrough Therapy Designation to an MDMA-assisted therapy to treat PTSD. In 2019, The Johns Hopkins University launched the Center for Psychedelic and Consciousness Research.

We are dedicated to applying our film technology to leading compounds in high-impact, unmet need areas. Advancing these psychedelic product development programs helps ensure our end-goal of targeting those patients who would have otherwise been left without an important treatment option. We plan to advance our programs in a strategic, thoughtful, and fiscally-responsible way, said Jonathan Berlent, CURE Chief Business Officer.

A recent study published by Data Bridge Market Research states that the legal U.S. psychedelic drug market is projected to grow at 16.3% CAGR from 2020 to 2027 and is expected to reach approximately $6.8 billion by 2027, up from $2 billion in 2019.

About CURE Pharmaceutical Holding Corp.CURE Pharmaceutical is the pioneering developer of CUREform, a patented drug delivery platform that offers a number of unique immediate- and controlled-release drug delivery vehicles designed to improve drug efficacy, safety, and patient experience for a wide range of active ingredients.

As a vertically integrated company, CUREs 25,000 square foot, FDA-registered, NSF and cGMP-certified manufacturing facility enables it to partner with pharmaceutical and wellness companies worldwide for private and white-labeled production. CURE has partnerships in the U.S., China, Mexico, Canada, Israel, and other markets in Europe.

Forward Looking StatementStatements CURE makes in this press release may include statements which are not historical facts and are considered forward-looking within the meaning of Section 27A of the Securities Act of 1933, as amended (Securities Act), and Section 21E of the Securities Exchange Act of 1934, as amended (Exchange Act), which are usually identified by the use of words such as anticipates, believes, estimates, expects, intends, may, plans, projects, seeks, should, will, and variations of such words or similar expressions. CURE intends these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Exchange Act and is making this statement for purposes of complying with those safe harbor provisions. These forward-looking statements include, without limitation, the ability to successfully market the partnered products, the difficulty in predicting the timing or outcome of related research and development efforts, partnered product characteristics and indications, marketing approvals and launches of other products, the impact of pharmaceutical industry regulation, the impact of competitive products and pricing, the acceptance and demand of new pharmaceutical products, the impact of patents and other proprietary rights held by competitors and other third parties and the ability to obtain financing on favorable terms. The forward-looking statements in this press release reflect CUREs judgment as of the date of this press release. CURE disclaims any intent or obligation to update these forward-looking statements. This press release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of our securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

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CURE Pharmaceutical Launches Psychedelic Oral Film Program Targeting the Treatment of Mental Health Disorders - Business Wire

La Jolla, California--(Newsfile Corp. - March 18, 2021) - Tryp Therapeutics (CSE: TRYP), a pharmaceutical company focused on developing clinical-stage compounds for diseases with unmet medical needs, announced today that it has submitted a provisional patent (US 63/161,070) to improve how psychedelics are administered across a broad range of indications.

The provisional patent describes novel methods for the formulation, delivery, and dosing of psychedelics resulting in a potential reduction in the time spent by patients in the dissociative state. These proprietary methods represent the foundational elements of the comprehensive medical treatment program Tryp is developing for a wide variety of conditions. This filing is expected to be the first of a series of patent filings to enhance the effectiveness of psychedelics and to further differentiate Tryp's intellectual property position.

The filing includes a method for measuring the response to psychedelic therapeutics, further supporting a more controlled psychedelic experience. The patent application also covers unique methods to manufacture the active pharmaceutical ingredient, novel formulations, methods to enhance the safety profile of treatments, and methods to reduce risk of abuse and addiction.

"We are seizing the opportunity to further differentiate our intellectual property position in psychedelics through core improvements to the formulating, delivery, and dosing of active ingredients," said Jim Gilligan, Ph.D., President and Chief Science Officer of Tryp Therapeutics. "I am continually impressed with the ingenuity and determination of our world-class team of scientists and advisors. Their innovations are empowering Tryp's work to significantly expand the availability of treatment options for those patients with unmet medical needs by demonstrating the safety and efficacy of our psychedelic drug programs."

About Tryp Therapeutics:

Tryp Therapeutics is a pharmaceutical company focused on developing compounds with known activity and safety profiles for the treatment of rare and other diseases with unmet medical needs. Tryp's psilocybin-for-neuropsychiatric disorders, or PFN, program is focused on the development of synthetic psilocybin as a new class of drug for the treatment of certain neuropsychiatric-based disorders. Tryp's lead PFN drug candidate is TRP-8802 for the treatment of fibromyalgia, a chronic pain syndrome estimated to affect more than 5 million people in the United States. The Company is also preparing to initiate a Phase 2a clinical study for eating disorders in partnership with the Dr. Jennifer Miller at the University of Florida.

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In addition to its PFN Program, Tryp is developing TRP-1001, an oral formulation of razoxane for the treatment of soft tissue sarcoma. Soft tissue sarcomas are a rare and diverse group of tumors that account for about 1% of all cancers in adults and 7% in children. Based on the prevalence of soft tissue sarcomas in the United States, Tryp believes it is a rare disease and that TRP-1001 should qualify for Orphan Drug status.

For inquiries, please contact us at:T: 1-833-811-TRYP (8797)E: investors@tryptherapeutics.comW: http://www.tryptherapeutics.com

Forward-Looking Information

Certain information in this news release, including statements relating to the anticipated closing date of the Placement, constitutes forward-looking information. In some cases, but not necessarily in all cases, forward-looking information can be identified by the use of forward-looking terminology such as "plans", "targets", "expects" or "does not expect", "is expected", "an opportunity exists", "is positioned", "estimates", "intends", "assumes", "anticipates" or "does not anticipate" or "believes", or variations of such words and phrases or state that certain actions, events or results "may", "could", "would", "might", "will" or "will be taken", "occur" or "be achieved". In addition, any statements that refer to expectations, projections or other characterizations of future events or circumstances contain forward-looking information. Statements containing forward-looking information are not historical facts but instead represent management's expectations, estimates and projections regarding future events.

Forward-looking information is necessarily based on a number of opinions, assumptions and estimates that, while considered reasonable by Tryp as of the date of this news release, are subject to known and unknown risks, uncertainties, assumptions and other factors that may cause the actual results, level of activity, performance or achievements to be materially different from those expressed or implied by such forward-looking information, including but not limited to the factors described in greater detail in the "Risk Factors" section of Tryp's final prospectus available at http://www.sedar.com. These factors are not intended to represent a complete list of the factors that could affect Tryp; however, these factors should be considered carefully. There can be no assurance that such estimates and assumptions will prove to be correct. The forward-looking statements contained in this news release are made as of the date of this news release, and Tryp expressly disclaims any obligation to update or alter statements containing any forward-looking information, or the factors or assumptions underlying them, whether as a result of new information, future events or otherwise, except as required by law.

NEITHER THE CANADIAN SECURITIES EXCHANGE NOR ITS REGULATION SERVICES PROVIDER HAS REVIEWED OR ACCEPTED RESPONSIBILITY FOR THE ADEQUACY OR ACCURACY OF THIS RELEASE.

To view the source version of this press release, please visit https://www.newsfilecorp.com/release/77712

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Tryp Therapeutics Announces Provisional Patent Filing For Improved Administration of Psychedelics - Yahoo Finance

A California lawmaker has introduced legislation that would decriminalize psychedelics in the state, the latest bold step in a movement to end Americas war on drugs.

Scott Wiener, the state senator who authored the bill, hopes that in following the lead of places such as Oakland, Santa Cruz and the District of Columbia all cities which have decriminalized psychedelics California will move one step closer to decriminalizing the use and possession of all drugs, something that Oregon passed by voter initiative in November.

People should not be going to jail for possessing or using drugs, Wiener told the Guardian. Its a health issue, not a criminal issue, and I hope that we get all the way there.

This bill, unveiled on Thursday, would decriminalize possession and personal use of psilocybin, psilocyn, MDMA, LSD, ketamine, DMT, mescaline and ibogaine all drugs that can be used for medical treatment. While the decriminalization would apply for any kind of possession or use, not just medical, the bill makes a point to tout the medical benefits of psychedelics, a strategy familiar to drug policy reform advocates.

Thats how it worked with cannabis, said Anthony Johnson, a longtime advocate and chief petitioner for Oregons Measure 110, the initiative that decriminalized personal possession of small amounts of all illicit drugs. Its definitely a way to help people that need it first and foremost, but also then to educate the public about these substances of how the drug war has been a failed policy and how there is a better approach.

The bill would also expunge criminal records for people convicted of possession or personal use of these substances. It would create a taskforce to recommend which regulatory body would oversee personal and therapeutic use of these substances for mental health treatment.

Wiener did not include peyote as one of the substances because of a shortage of the drug among indigenous practitioners, he said. Peyote is a sacred plant for many indigenous tribes, and at the behest of the native community, the bill will not decriminalize peyote, or mescaline when it is sourced from peyote.

In his advocacy, Johnson found that the biggest opponent of decriminalization have been law enforcement, who cite public safety concerns, and those in the private rehabilitation industry. Wiener hopes that testimony from veterans the bill is sponsored by two groups who help them with PTSD and therapists who support the therapeutic use of psychedelics will break down prejudices about psychedelics users.

Theres a stereotype of whos using psychedelics, but its much broader than that and when you have veterans coming into the Capitol talking about how psychedelics help them with PTSD and help them get their lives back, thats incredibly powerful for legislators, he said.

Juliana Mercer, 38, is one of those veterans. She graduated boot camp one week before September 11. In her 16 years as a Marine, 10 of which she was active duty, she served two tours: one in Iraq and one in Afghanistan.

Most of her time involved civil affairs, working with local communities and learning of the devastation of war first-hand. For four years, she was in the wounded warriors unit, providing support and services to injured Marines and their families.

I lost quite a few friends and just saw a lot of a lot of damage and destruction along the way, said Mercer, who described the experience as leaving her with lingering, unaddressed trauma. I put all of that stuff away and kind of forgot about it for a while, and once I slowed down it was all just sitting there and I didnt know what to do with it.

Mercers first foray into psychedelics was recreational. But her experience gave her a feeling of connectedness that she had not felt for a long time, spurring her to reach out to the Heroic Hearts Project, a group that specializes in ayahuasca therapy with military veterans, about a year and a half ago.

Her first session exceeded anything she had expected, releasing years of grief.

I kept hearing that when you do some of these plant medicines, youll be able to do 10 years worth of work in one session, Mercer said. Just one of my sessions really brought out all of that pain and the grief that I didnt even know was in there and allowed me to just completely release it and expel it, things that I had no idea were there.

With the help of her coach and therapist, Mercer was able to unpack why I was so stuck.

It had nothing to do with not knowing who I was or what direction to go, it had to do with just being bogged down with all of these things, she said.

Lauren Taus, a licensed clinical social worker who facilitates ketamine therapy, is adamant that plant medicine therapy is only a potent tool, not a solution, in mental health work but one that should be decriminalized as soon as possible.

We are in a mental health crisis and Covid-19 has exacerbated what was already a crisis, Taus said. And the causes of trauma are multiplying way faster than the solutions. Current treatment is generally not very effective. Psychedelic medicine has been engaged with globally for eons. This stuff works and we deserve to have access to solutions that will be sustainable.

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California bill would decriminalize psychedelics, paving the way for medical treatment - The Guardian

This column is a collaboration with DoubleBlind, a print magazine and media company at the forefront of the psychedelic movement.

Psychedelic reform isnt exactly President Joe Bidens top priority. But as his administration and the new congress gets underway, advocates are hopeful that the next four years will continue to bring policy changes that chip away at the federal prohibition of psilocybin, MDMA, and other psychedelics.

For several years, psychedelics advocates have been focused on local initiatives. This past election, Oregon legalized psilocybin therapy and decriminalized all drugs, while Washington D.C. decriminalized all plant- and fungi-based psychedelics. Since then, California State Senator Scott Wiener has begun drafting a bill to decriminalize psychedelics on the state level, four Hawaii state senators introduced a psilocybin therapy bill, and Florida State Representative Michael Greico has been working on legislation to legalize psilocybin therapy for people with a diagnosed mental health condition. Meanwhile, grassroots activists in dozens of cities and counties (including Chicago, Philadelphia, Berkeley, and Nashville) are seeking to decriminalize psychedelics either at the ballot box or through city council. These initiatives are mostly modeled after the Decriminalize Nature resolution, which decriminalized all natural psychedelics through city council in Oakland in June 2019.

We can look to the cannabis movement to map the trajectory of psychedelics, says Noah Potter, the author of the New Amsterdam Psychedelic Law blog and co-founder of the advocacy organization New Yorkers for Mental Health Alternatives: You saw a wave of state level legislative changes and decriminalization in the 70s and early 80s, and then California voters passed Prop 215 and it went from there, he says. The psychedelic activists are following the same model. Why are you going to bang your head against the wall federally when you can start by dealing with your own local government?

That said, psychedelic insiders are optimistic that alongside local reform there will be federal movement towards ending prohibition, too. Potter says one thing he could see being done immediately by the new attorney general which is likely to be Merrick Garland would be something akin to the Cole Memo. Issued under the Obama Administration, and then rescinded by Attorney General Jeff Sessions following the election of President Trump, the memo directed state attorneys to not enforce federal cannabis prohibition in states where cannabis was legal in some form. Potter says now that Oregon has become the first state to legalize not just decriminalize medical psilocybin, he could see Bidens attorney general doing something similar for psilocybin.

Potter also makes the case that, now that a state is claiming that psilocybin has medical use, the DEA is obligated to schedule hearings to reconsider whether it should be on the Controlled Substances Act. Granted, he says, the DEA also should have held hearings when the first state claimed cannabis had medical use they never did. But, he says, if a member of the public petitioned the DEA to hold hearings based on Oregons new law, they might be forced to. Biden could also just direct the DEA to hold these hearings, although that doesnt seem likely.

By virtue of the DEAs interpretation of the [Controlled Substances Act], once a state finds theres a medical use for a Schedule I substance, they have to hold a hearing before an administrative law judge and hear witnesses and review evidence, says Potter. As soon as a state found there was a medical use for cannabis, the DEA was obligated to hold an evidentiary hearing. I would make the same argument with psychedelics now that Oregon has legalized psilocybin therapy.

The question for many activists now is really: Will the Biden Administration interfere with state, city, and county-level psychedelic reform? Kevin Matthews, founder of SPORE, the Society for Psychedelic Outreach, Reform, and Education, doesnt think so. Since Denver became the first jurisdiction to decriminalize a psychedelic at the ballot box in 2019, the DEA has stayed out of the county, except for when they arrested one magic mushroom dealer who activists believe was just being reckless by publicizing his grow. The DEA has more important things to address than safe psychedelic use, says Matthews, such as the opioid crisis.

Melissa Lavasani, who proposed Initiative 81, which decriminalized all natural psychedelics in Washington, D.C., agrees. I dont think the feds are going to get in the way of cities and states decriminalizing, she says. Theyre going to want to see what happens in Oregon. Theyre going to let the states do their thing and see how everything pans out. Lavasani, who lives in D.C. and worked for the District of Columbia as a senior budget analyst and budget officer for nearly a decade, says shes been connecting with congressmen on both sides of the aisle to gauge their interest in psychedelic reform since first drafting Initiative 81. At this point, shes spoken to about 10 congressmen in total about what they accomplished in D.C., and theyve all responded with openness and curiosity.

However, Lavasani says its important to remember that the cannabis industry still doesnt even have legitimate banking opportunities, so she thinks federal psychedelic reform will be a very long game. She recently founded the Plant Medicine Coalition, a women-led nonprofit, with the intention of increasing access to psychedelic medicine through local and national advocacy. One of their primary goals is to get the federal government to allocate $100 million to psychedelic research. Theyre first going to see if theres a possibility Biden will put it into his budget, although they think thats unlikely. If that doesnt work, theyll start aggressively speaking to congressmen about passing a bill with the funding.

We think that once there is a body of data that is sponsored by the federal government that proves without a shadow of a doubt that there is a therapeutic application, that these are real medicines, thats when things are really going to change in congress, Lavasani says.

Theres hopes of many other changes, too, in the next four years. President Biden sponsored the Reducing Americans Vulnerability to Ecstasy Act, or RAVE Act, in 2003. That law made it a liability for venues to offer harm reduction services, like onsite drug testing, which drug policy activists widely agree has only made festivals, clubs, and other environments where people use drugs more dangerous. Harm reduction activists hope that Biden may support renewed efforts to revise the law.

Theres also been a wave of ayahuasca churches in recent years applying to the DEA for permission to use ayahuasca religiously. Natalie Ginsberg, Director of Policy & Advocacy at MAPS, says shes eager to see an amendment to the Religious Freedom Restoration Act, which considers how spirituality and religion play a role in psychedelics use and traditional practice, while making sure peyote is protected. Something like this, Lavasani says, could be attached to the bill approving the $100 million allocated for federal psychedelics research.

Ginsberg says, generally speaking, she also has high hopes for the Biden administration, especially because he ran on a platform of criminal justice reform and has already ended Justice Department contracts with privately-owned prisons. She says the vision, ultimately, is really to end the war on drugs altogether.

[Its not] unreasonable to hold as a goal that were moving towards, especially because so many states are starting to revisit their approach to drug criminalization, she adds.

Its impossible to put a timeline on all these efforts, but the movement certainly isnt slowing down. And its important to remember, too, says Lavasani, Potter, Matthews, and others, that when the pandemic ends, well be left with its psychological aftermath. This, they hope, will make therapeutic access to psychedelics feel more prescient for legislators everywhere.

My hope with the Biden administration and other lawmakers is that theyre going to be receptive to having a conversation about psilocybin and other psychedelics, says Matthews. Were facing a global mental health and addiction crisis, and thats only been accentuated by COVID-19 with the lockdowns and business closures and further isolation. We need radical, safe effective solutions to address this emergency before it gets any worse.

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Will the Federal Government Finally Embrace the Psychedelic Revolution? - Rolling Stone

For many years, drugs such as LSD, psilocybin and Dimethyltryptamine (DMT) were viewed only as highly dangerous drugs. However, in recent years they have had a bit of rebrand. Now theyre believed by some to have the power to heal, to reconnect us with nature even resolve political tensions.

Use of these drugs is on the rise. At the start of the pandemic in 2020, the UK Home Office released data showing a 230% rise in confiscations of LSD compared to the previous year. The pandemic itself might be changing drug preferences. Almost half of those using magic mushrooms reported using more during the pandemic according to a recent survey.

The changing view of psychedelics can in part be attributed to the renewed interest in their potential to treat mental health problems such as depression. Between the early 1950s and 1970s, there was a great deal of interest in the use of LSD in the treatment for a wide range of conditions, including alcohol use disorders, schizophrenia, childhood autism and sexual dysfunction.

Despite some promising findings, a lack of scientific rigour and wider political and cultural pressures meant that almost all research ended in America in the late 1960s, although it has continued in Europe.

This work has now started up again to a limited extent. As demonstrated with medicinal cannabis, emphasising the therapeutic potential of a drug can help shift attitudes towards it. In recent years, as research activity has increased, media attention has moved from the risks associated with psychedelics to their potential benefits. This has helped reshape attitudes towards this group of drugs.

The gradual rebrand of psychedelics, from dangerous to therapeutic, has been bolstered by a booming wellbeing industry. An increasing number of people are looking for ways they can extend the mind, body and soul. This has led to a rise in companies selling herbal remedies (as seen with the popularity of turmeric touted as natures-wonder drug) and now even psychedelics.

Before the pandemic, psychedelic tourism was a growing niche of wellbeing. One popular strand was ayahuasca retreats in South America, which attracted thousands of wealthy customers keen to explore their psyche.

Ayahuasca has been used in traditional healing and spiritual practices for generations by South American indigenous populations. The potent brew contains DMT, the active ingredient that produces a powerful psychedelic experience. For a few thousand pounds travellers can engage in this practice and claim these celebrity-endorsed rituals as their own to address their physical, psychological and spiritual maladies.

While some are seeking spiritual awakening, others are using psychedelics to boost brain function.

Microdosing psychedelics, which involves taking small doses of the drug, has also grown in popularity. The aim is to enhance cognitive performance, without the disruption of a full-blown experience. People who engage in the practice claim it makes them more productive, creative and focused. The practice has been enthusiastically reported and promoted in media, despite little evidence of its effectiveness.

This has also helped reshape the image of psychedelics, with a focus on benefits including savings to healthcare services rather than the risk of harm. Access to psychedelics has never been easier via the internet and dark web markets.

Likewise, the recent decision by legislators in the US to reduce penalties for possession of small quantities of magic mushrooms reflects the view that these substances are potentially therapeutic, distinct from many other controlled drugs that are discussed in relation to the harms that they can potentially cause.

Private industry, sensing a shift in attitudes and seeing there are profits to be made from legal cannabis in the US, are now setting their sights on psychedelics.

New companies have started up, supported by experienced investors and tech billionaires and advised by leading psychedelic researchers. The initial focus has been on patenting new techniques for synthesising psychedelic drugs and establishing private medical clinics and therapies to distinguish medical uses from recreational.

But as with cannabis, over the long term, as attitudes continue to shift, big money is also likely to be made in non-medical and wellness markets.

While were unlikely to see psilocybin hummus on our shelves, wellness is a trillion-dollar global industry. Whether thats home microdosing kits, spiritual retreats, or therapies for people feeling lost and without direction, where theres a disposable income, theres a psychedelics company with an answer.

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From trippy drugs to therapeutic aids how psychedelics got their groove back - The Conversation UK