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Press Release: Psyence Biomed Announces Export of Nature-Derived Psilocybin to Australia and Provides Update on Upcoming Phase IIb Trial

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NEW YORK, July 24, 2024 (GLOBE NEWSWIRE) — Psyence Biomedical Ltd. (Nasdaq: PBM) (“Psyence Biomed” or the “Company”) today announced the export of nature-derived psilocybin to Australia and provided an update on its upcoming Phase IIb clinical trial evaluating nature-derived psilocybin as a potential treatment for Adjustment Disorder following an advanced cancer diagnosis in the Palliative Care context.

The Company previously announced that it had entered into partnerships with Fluence, a global leader in professional education and training for psychedelic therapy research, and iNGENū CRO Pty Ltd (“iNGENū”), an Australian clinical research organization (CRO), to support the study. Following a recent site visit by Psyence Biomed leadership to partners and trial sites in Australia, the Company is preparing to initiate the study shortly following the recent successful export of drug candidate, PEX010, from its current supplier, Filament Health.

“Over the past several months, we have made substantial progress preparing for our Phase IIb study, and following my recent site visit to Australia, I am pleased to report that all parties, including Psyence and our partners, Fluence and iNGENū, are poised to initiate the study imminently,” said Dr. Clive Ward-Able, Medical Director of Psyence Biomed. “With the successful export of PEX010, we now plan to focus on the efficient enrollment of patients into this important study.”

The randomized, double-blind, placebo-controlled Phase IIb study will evaluate two therapeutic doses of nature-derived psilocybin (10mg, 25mg) against an active low-dose comparator (1mg) in 84 patients in conjunction with psychotherapy. Psyence aims to execute an efficient yet rigorously designed study that, if successful, would best support advancement into future late-stage studies.

More information on the study can be found at: 12624000449538p.

Filament Health Commercial Licensing Agreement Update

Psyence Biomed’s commercial licensing agreement with Filament Health, which covered supply of PEX010 for pivotal Phase III studies in Adjustment Disorder and also granted Psyence Biomed the worldwide right to commercialize PEX010 (25 mg) within the context of Palliative Care, remained subject to further negotiations between the parties and the completion of a subsequent definitive agreement within a predefined time period.

Following further discussions, both parties have mutually agreed to terminate the commercial licensing agreement. Filament Health will continue to support the supply PEX010 for the upcoming Phase IIb trial, as previously announced. Psyence Biomed is evaluating two exclusive supply and license agreements with duly licensed suppliers operating in the United Kingdom and North America. The Company intends to provide further updates on such agreements as they are executed. However, there can be no guarantees that such agreements will be finalized.

“We have made significant progress identifying alternative suppliers of nature-derived, non-synthetic psilocybin for use in subsequent clinical studies, and we look forward to securing a partner that can support our needs over the long-term,” stated Dr. Neil Maresky, CEO of Psyence Biomed. “Importantly, this change should have minimal impact on our internal development timelines for our Phase IIb program, and we remain committed to introducing a novel therapy for Adjustment Disorder following an advanced cancer diagnosis in the Palliative Care context as efficiently as possible.”



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Linked In Post – Jon Dennis, Psychedelic Lawyer: Washington SB 5201, the regulated psilocybin access bill, was considered today by the Senate Committee on Labor & Commerce ( 18 Feb 2025)

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Washington SB 5201, the regulated psilocybin access bill, was considered today by the Senate Committee on Labor & Commerce. The bill would require low-income and other taxpayers to subsidize regulated access that is cost-prohibitive for many, while continuing to criminalize the same activities outside of the regulated marketplace.

For context, Oregon’s regulated system was promised to be self-funded by licensing fees and sales taxes, but the program needed a $3.1MM bailout in 2023, and the program is now seeking an additional $3.5MM bailout from the legislature. This is despite already-exorbitant licensing fees, including a $2,000 annual fee for facilitators. (By contrast, the annual fee for an Oregon law license is $683; the annual fee for medical doctors is $702.)

Taxing residents for the administration of a costly access program, while criminalizing affordable access outside the program, is problematic–particularly in Washington where local governments representing 14% of the entire population have already called on state lawmakers to decriminalize psilocybin and other plant-based psychedelic substances. Washington lawmakers must do better and not ignore the socio-economic and criminal justice impacts of a regulated-only access program.



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Alert: We are just over a week away from the Natural Medicine Division opening our application process to individuals who are interested in becoming business Owners or Natural Medicine Handlers, and to business applications for Healing Centers, Cultivations, Testing Facilities and Product Manufacturers.

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Dear Interested Parties:

 

We are just over a week away from the Natural Medicine Division opening our application process to individuals who are interested in becoming business Owners or Natural Medicine Handlers, and to business applications for Healing Centers, Cultivations, Testing Facilities and Product Manufacturers.

 

This week, we wanted to share some logistical information about the application process.

 

We encourage you to submit your application online, and there will be instructions on how to submit applications on the Natural Medicine Division website.

However, based on stakeholder feedback, we will be opening up limited appointment slots for in-person assistance at our Lakewood office starting on Friday, Jan. 10, 2025. At this time, Fridays will be the only day that we will be offering in-person natural medicine licensing application assistance. We will be open from 9 a.m. to noon and 1 p.m. to 4 p.m. for in-person Friday appointments.

We are finalizing the applications and will be sharing those prior to our application process coming online. You can always check out our Public Resources folder to find information and compliance tools.

As always, please reach out to us at [email protected].us if you have any questions.

 

Stay tuned!

The Natural Medicine Division



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Mexican “Shamen” on The Run After Actress Dies In Frog Ceremony

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An actress in Mexico tragically lost her life after she ingested Amazonian frog venom as a part of a cleansing ritual while at a spiritual retreat. She experienced severe diarrhoea after taking part in the ceremony and was rushed to a hospital, but the doctors failed to save her life.

A shaman at the spiritual retreat where the actress took the Amazonian frog venom that caused her death has fled.
A shaman at the spiritual retreat where the actress took the Amazonian frog venom that caused her death has fled.

The 33-year-old actress Marcela Alcázar Rodríguez took part in the traditional South American Kambo ritual, which involves drinking water, getting burns on the body, and ingesting frog venom to cleanse the body of toxins, reported the Mirror. However, this ritual is known to have deadly consequences.

How is the Kambo ritual performed?

The participants in the ritual are made to drink more than a litre of water. Small burns are then created on their skin, following which frog mucus is applied on the wounds.

The mucus, which contains venom, increases blood pressure and induces vomiting, reported the outlet. It also causes diarrhoea in some cases. Other symptoms involve fainting, dizziness, swollen lips and face. Usually, the symptoms last for nearly half an hour. However, extended exposure of the venom to the blood stream can cause seizures and also death.

What happened to Marcela Alcázar Rodríguez?

Soon after beginning the ritual, Rodríguez reportedly started throwing up and eventually suffered from severe diarrhoea – these symptoms are often considered the body’s “healing” reactions during the cleansing process. Initially, she refused help but gave in when her friend visited her.

According to the Metro, a shaman at the retreat in Mayocoyani, Durango, told her she couldn’t leave. However, after her condition worsened, the person fled. Reportedly, police are now searching for the shaman.

Tribute to the actress

In a social media post, Durango Film Guild paid tribute to the actress after her untimely demise. They remembered her as “a young woman who worked in various short films, series and movies filmed in Durango.”

The guild added, “She leaves a void in the hearts of the people who knew her working in what she loved: cinema.”

 

https://www.hindustantimes.com/trending/actress-dies-after-taking-amazonian-frog-venom-during-cleansing-ritual-at-spiritual-retreat-101733371832107.html?ck_subscriber_id=1050193520



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