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Psilocybin Life Science Company Encourages Broadening Palliative Care of Canadian Patients with the Inclusion of Psychedelic Therapies

Four Canadian patients battling incurable cancer were approved by the federal Minister of Health, the Honourable Patty Hajdu, to  incorporate psilocybin therapy in their end-of-life treatment. According to advocacy group TheraPsil, this group of four patients represent the first publicly-known individuals to receive a legal exemption from the Canadian Drugs and Substances Act, under Section 56, to access psychedelic therapy. They are also the first known patients to legally use psilocybin since the compound became illegal in Canada in 1974.

Companies in the nascent psychedelic healthcare sector lauded the move, including Cybin,  a Toronto-based life sciences company with R&D advancing mushroom-based psychedelic and nutraceutical products for various psychiatric and neurological conditions. As a mushroom life science company with a biotech arm, Cybin is developing technology that seeks to improve the bioavailability of psychedelics at lower dosages to achieve the desired therapeutic effects. The company is also developing novel products that utilize new delivery systems, including orally-dissolving film.

While Cybin is not directly involved in the palliative care of the four terminal Canadian patients, the broader mission of the company aligns with the advocacy goals of TheraPsil.

“This is a watershed moment for the patients involved who deserve the right to manage their health challenges with dignity,” said Paul Glavine, Co-founder of Cybin. “Everyone at Cybin applauds the efforts of TheraPsil and these brave individuals, and we thank the Minister of Health for her foresight.”

The four patients who were granted access to psilocybin are not using it to treat their late stage cancers per se; but rather to manage the anxiety associated with inevitable end-of-life distress.

According to a study published in frontiers in Pharmacology, “A growing body of evidence shows that existential and spiritual well-being in cancer patients is associated with better medical outcomes, improved quality of life, and serves as a buffer against depression, hopelessness, and desire for hastened death. Historical and recent research suggests a role for psilocybin-assisted psychotherapy in treating cancer-related anxiety and depression. A double-blind controlled trial was performed, where 29 patients with cancer-related anxiety and depression were randomly assigned to treatment with single-dose psilocybin (0.3 mg/kg) or niacin in conjunction with psychotherapy. Previously published results of this trial demonstrated that, in conjunction with psychotherapy, moderate-dose psilocybin produced rapid, robust, and enduring anxiolytic, and anti-depressant effects.”

Another study conducted by the New York University Langone Medical Center discovered that 60 to 80 per cent of tested patients saw long-term improvements in anxiety and depression after a single dose of psilocybin, combined with psychotherapy. Last year, the United States Food and Drug Administration designated psilocybin as a “Breakthrough Therapy,” a label that fast tracks clinical trials. The move only occurs when there is significant evidence that a new treatment might prove far more effective than current treatments.

In the case of psilocybin, it’s drug-assisted therapy for Major Depressive Disorder (MDD). So far, in clinical trials, the results of psilocybin-assisted therapy have outstripped those of early trials of antidepressants.

In some cases, swallowing a small amount of psilocybin, known as “microdosing” produces an uplifting, rather than hallucinogenic effect.

Thomas Hartle is one of the four Canadians with terminal health conditions who was recently given the green light by Health Canada to use psilocybin. Hartle never thought he would consume “magic mushrooms,” let alone grow them.

“Honestly, it isn’t exactly where I pictured my life taking me,” the 52-year-old father said. “But having stage four cancer isn’t exactly where I pictured life taking me, either.”

Hartle is growing his own psilocybin because pharmaceutical-grade drugs containing the fungi’s beneficial compound are not yet commercially or legally available in Canada. Cybin aims to rectify that, starting with R&D in countries where the substance is not prohibited.

Former Ontario Health Minister and Cybin advisor, Dr. Eric Hoskins, praised Minister Hajdu’s progressiveness, allowing an exemption for these terminally ill patients.

“I am pleased to see this important step towards considering psilocybin as a natural compound with a growing body of experience of therapeutic uses for patients in need, rather than strictly a prohibited substance,” Hoskins said. “I joined Cybin because of their dedication to patients who need and benefit from psilocybin-assisted therapy.”

Dr. Jukka Karjalainen, Cybin’s Chief Medical Officer, is in agreement: “This landmark recognition of the benefits of psilocybin is tremendous validation for our sector. Cybin is proud to applaud TheraPsil’s efforts, while continuing to focus on the development of a psilocybin oral film delivery system, which will potentially alleviate the burden of pill consumption for seniors and patients in palliative care, who often have difficulty swallowing.”

TheraPsil expects more applications for legal exemptions to follow this watershed decision. Meanwhile, Cybin intends to support clinical trials to evaluate the efficacy of psilocybin therapy to combat major depressive disorder, anxiety, addiction, and to improve cognitive flexibility.