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Numinus receives Health Canada SAP approval for psilocybin therapy

Numinus says it hopes the approval is the beginning for Canadian patients to obtain access to mental health care through psychedelic medicine.

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Numinus receives Health Canada SAP approval for psilocybin therapy

Health Canada has granted approval to Numinus’ application to complete psychedelic-assisted therapy using psilocybin to treat an applicant with treatment-resistant depression.

In January this year, Health Canada amended its Special Access Program (SAP) to include access to psychedelic compounds on a case-by-case basis.

To be considered for the SAP program, an applicant must have a serious or life-threatening condition where conventional treatments have failed, are unsuitable or are not available in Canada.

Recent research has shown that psilocybin-assisted therapy holds promise as a treatment for a number of different mental health disorders such as depression. Numinus, which is focused on advancing innovative treatments and safe, evidence-based psychedelic-assisted therapies, put forward an application for its psilocybin therapy to be included on the (SAP).

See also  Extension of MDMA PTSD study to be hosted by Numinus

Founder and CEO of Numinus, Payton Nyquvest, commented: “I am proud that Numinus is working with Health Canada to help Canadians with mental health challenges in ways that were not previously available, including using psilocybin-assisted therapy through Health Canada’s SAP.

”The SAP recognises a growing body of research that has consistently shown the efficacy of psychedelic-assisted psychotherapy to treat a broad range of mental health conditions that are extremely difficult to treat with conventional therapies. 

“We hope that our first psilocybin-assisted therapy treatment is the beginning for more opportunities for Canadian patients to obtain safe access to treatment and care in the mental health sector through psychedelic medicine.”

See also  Health Canada approves low-dose psilocybin mental health clinical trial  

Numinus has confirmed that the treatment will take place at one of its Montreal clinics, consisting of psilocybin-assisted therapy including several preparatory and integration therapy sessions, medical consults and one psilocybin-dosing session. 

All practitioners involved in the treatment have been trained through Numinus’ proprietary psilocybin-assisted therapy protocol and Numinus will partner with Psygen Labs, an approved Health Canada supplier, to provide the synthetic psilocybin to be taken orally during the dosing session.

Dr. Andrew Bui-Nguyen, Numinus’ Québec regional medical director, who completed the application, said: “Numinus has been working with this applicant through other available services over an extended period and we are proud that we can now provide this deeply important treatment. 

“To our knowledge, this is the first Health Canada SAP approval for psilocybin-assisted therapy for someone suffering from treatment-resistant depression in Québec, and the first time our Numinus team will provide this treatment outside of the clinical trial setting.”

As they are approached by treatment-resistant patients who meet this criteria, Numinus-affiliate physicians plan to make additional applications for clients suffering from a range of mental health conditions in BC and Québec.

Medicinal

Silo Pharma to utilise psilocybin for autoimmune diseases

The company has announced it is expanding its license agreement and patent portfolio.

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Silo Pharma to utilise psilocybin for autoimmune diseases

Silo Pharma has entered into a commercial evaluation license agreement (CELA) for next-gen liposomes therapeutics to target multiple diseases, including autoimmune disorders.

Silo Pharma has expanded its CELA with the University of Maryland Baltimore (UMB) for its next-generation liposomal peptide targeting autoimmune diseases.

CEO of Silo Pharma, Eric Weisblum, commented: “We are delighted to expand our partnership with UMB. Pre-clinical testing of these peptides has shown positive results in animal studies. 

“The three-phage peptides we identified specifically target inflamed vascular endothelium of arthritic joints in an adjuvant-induced arthritis rat model.”  

See also  Brain activity in depressed people increases following psilocybin use

Weisblum stated that to test the therapeutic effect of the peptides, arthritic Lewis rats (n=4/group) were injected intravenously with one of the peptides or PBS either at the onset or just following the onset of arthritis. 

“The rats were monitored regularly for disease severity and were assigned an “arthritic score.” The results show treatment of arthritic Lewis rats with two of the three phage-encoded peptides (NQR and RGD) suppresses adjuvant arthritis, with RGD producing the most robust effect,” he said.

“Therefore, phage peptides ADK homes to the synovial vasculature of the inflamed joint, while phage peptides NQR and RGD both home to this area of the inflamed joint and have a therapeutic effect in a rat model of arthritis.”

Silo Pharma’s drug – SPU-21, arthritogenic joint homing peptides utilising psilocybin – has demonstrated it significantly inhibited arthritic progression in the animal model, and the company is carrying out further studies at UMB.

It highlights on its website that the ability of the peptides to target inflamed epithelium suggest they could be used to target drug delivery. 

It notes that: “This approach could enhance the therapeutic effect of current and future therapies and decrease potential systemic toxicity despite systemic administration of the drug. These peptides have potential for the development of fusion imaging molecules and/or nanoparticles to study arthritic pathogenesis. 

“They could also be customizable and used to deliver nanoparticles for precise imaging. In addition, these novel joint-homing peptides can be used to treat autoimmune diseases, including but not limited to RA [rheumatoid arthritis].”

With the global market for autoimmune disease therapeutics projected to be over $150bn by 2025, Weisblum stated that the company believes the issued patent portfolio that comes with these assets allows Silo to further advance its value to investors and future partners.

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Medicinal

Application submitted for trial exploring LSD analogue for migraines

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Application submitted for trial exploring LSD analogue for migraines

Ceruvia Lifesciences has submitted an FDA Investigational New Drug (IND) Application for its NYPRG-101 Migraine Prevention Program.

The company is aiming to begin a Phase 1 clinical trial of NYPRG-101, which is being developed for the prevention of migraines.

The trial would be a Phase 1, single center, randomised, double blind, placebo controlled, single ascending dose study assessing the safety, tolerability, pharmacokinetics and pharmacodynamics of NYPRG-101 (in healthy adult participants.

See also  Analysis finds clinical administration of LSD safe in healthy subjects 

NYPRG-101, also referred to in the literature as BOL-148, is a non-hallucinogenic analogue of LSD, differing by only one atom. 

First synthesised at Sandoz by Albert Hofmann in 1957, BOL-148 was used as a placebo in early LSD trials. BOL-148 has been administered to more than 150 humans (126 healthy volunteers and 28 patients) in clinical and experimental settings since the 1950s, with most of the research occurring prior to 1970. In these early studies, BOL-148 was observed to be non-hallucinogenic.

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Founder and CEO of Ceruvia Lifesciences, Carey Turnbull, commented: “This is another exciting milestone in the roll-out of our clinical drug development program and builds on our longstanding relationship with Harvard Medical School to investigate the use of BOL-148 to treat headache disorders.

“Migraine, which affects approximately 15 per cent of the population and disproportionately impacts women, is associated with significant psychosocial burden and disability. Results from our IND-enabling pre-clinical toxicology work as well as research conducted with human subjects prior to the 1970s, indicate a positive safety profile for NYPRG-101. 

“We believe that this molecule has great potential to provide meaningful relief to those suffering from migraine.”

This Phase 1 single ascending dose trial, to be held at a single clinical research site in the United States, will evaluate the safety, tolerability, pharmacokinetics and effects on neurocognitive functioning of healthy adult participants.

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Medicinal

New plant medicine retreat series launched in Jamaica

Dimensions has launched ‘ASCEND’ – a series of psychedelic-assisted experiences.

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New plant medicine retreat series launched in Jamaica

Dimensions has launched its new international plant medicine retreat series in Jamaica.

The new ASCEND programme will combine legal plant medicine experiences with immersive luxury hospitality on the Good Hope Estate in Trelawny, Jamaica

Led by Dimensions’ chief clinical officer, Jesse Hanson, PhD, the ASCEND programme will span 11 weeks, including four weeks of preparation, one week of onsite practices and six weeks of post-retreat integration. 

This will ensure that participants maximise their transformational experiences, as well as have a clear plan and path to sustain their life improvements. 

Christopher Dawson, co-founder and CEO of Dimensions, commented: “We are relentless in the pursuit of our mission, which is Retreat, Reset, Transform. 

“The ASCEND program has been carefully designed by our expert teams to offer the very highest standards in self-betterment in pristine, natural environments to maximise our guests’ journeys to wellbeing, and ensure that participants receive personalised experiences that initiate lasting personal growth.”

Dimensions’ Chief Clinical Officer, Jesse Hanson, PhD, commented: “The launch of the Jamaica ASCEND retreats is an ideal complement to the retreat experience that we will be offering at our flagship Dimensions Algonquin Highlands location in Ontario, Canada, and future retreats that we are developing in Costa Rica and Mexico. 

“This a significant milestone as we continue to expand our diverse programming with a focus on the intersection of luxury hospitality, modern science, and plant medicine.”

The ASCEND program combines ancient practices with modern neuroscience while utilising the practices of poly-vagal theory with psychedelic medicine to deliver a uniquely integrated guest experience in an intimate and safe environment.

The Good Hope Estate is set on a 2000-acre historical property with hills, vales and a river running through its tropical landscape, underscoring Dimensions’ belief in the importance and role of nature in the healing experience. 

The first two retreat experiences will take place from Friday, 30 September to Friday, 7 October, 2022 and Saturday, 10 December to Saturday, 17 December, 2022.

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Psychedelic Health is a journalist-led news site. Any views expressed by interviewees or commentators do not reflect our own. We do not provide medical advice or promote the personal use of psychedelic compounds. Please seek professional medical advice if you are concerned about any of the issues raised.

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