🎉 Health Canada Provides a No Objection Letter for ATMA’s N500 Phase II Clinical Trial Application

CALGARY, May 12, 2021 – ATMA Journey Centers Inc. (“ATMA”), an Alberta-based company focused on delivering innovative psychedelic-assisted therapies internationally, announced today that it has received notice of approval from Health Canada for two additional Alberta-based patients who had applied for a Section 56 Exemption to undergo legal psychedelic-assisted therapy.

Health Canada has been taking steps to increase access to psychedelic medicine to patients facing mental health challenges through its ongoing approvals of exemptions under Section 56 of the Controlled Drugs and Substances Act (“CDSA”), the legislation that governs controlled substances in Canada such as psychedelics.  ATMA was the first private company in Canada to conduct legal psychedelic-assisted therapy using psilocybin on behalf of a palliative client who had been granted a Section 56 exemption in January 2021.  The two new approvals bring the total number of patients to five for whom ATMA has been permitted to conduct legal psychedelic-assisted therapy.

Psilocybin is an active hallucinogenic substance found in “magic mushrooms” and a growing body of research and scientific data suggests that psilocybin can be effective in addressing the severe mental health challenges that arise with a terminal medical diagnosis.  Encouraging research continues to emerge that suggests psychedelic-assisted therapeutic approaches to mental and emotional health conditions demonstrate remarkable efficacy and outcomes for a variety of other conditions including Post Traumatic Stress Disorder (PTSD) and treatment-resistant depression and anxiety.

“We cannot overstate our appreciation and excitement that Health Canada, the Hon. Minister Hajdu and her team have continued to respond to the skyrocketing mental health challenges that are a reality for so many Canadians,” said ATMA’s Chief Medical Officer, Dr. Ravinder (Ravi) Bains.  “In the face of a growing crisis in mental healthcare, Health Canada is demonstrating bold leadership in responding to the need for what has been now proven to be a safe and effective means of helping those with end-of-life distress.”

In August 2020, Health Canada approved the ground-breaking exemption for a Section 56 application enabling access to legal psychedelic-assisted therapy for the first time in approximately 40 years.  Since then, approximately 30 exemptions have been granted by Health Canada to patients across the country.  Health Canada also recently completed a public consultation period regarding the Special Access Program (“SAP”) with a view to reversing certain regulatory changes made in 2013 that prohibited access to restricted drugs (such as psychedelics) through the SAP.

“We know from the previous legal psychedelic-assisted therapy we have delivered for palliative patients just how meaningful access to this therapy can be,” explained Dr. Bains. “For example, our experience with Mr. Tony White, the first palliative patient we worked with, generated outcomes that were nothing short of extraordinary.  He was able to live out his last weeks with a newfound sense of peace and joy, and it had a dramatic impact on his family for which they are truly grateful.  We know from first-hand experience just how important this work can be, and we’re pleased to be able to bring it to more Canadians as a result of today’s announcement.”

The two patients who received the Section 56 Exemptions this week will soon undertake their therapy at one of ATMA’s Journey Centers, part of the growing network of psychedelic therapy centers that ATMA is building throughout Canada and internationally.

“As Health Canada continues to authorize safe and effective access to novel therapeutic solutions such as psychedelic medicine, ATMA will continue in its unwavering goal of facilitating access to legal psychedelic-assisted therapy across the country”, added Dr. Bains.

One of the key advisors of ATMA’s medical team working with Section 56 Exemptions is Dr. Lyle Galloway, a Palliative Care Physician working at Tom Baker Cancer Centre and Foothills Hospital in Calgary.  He commented: “I’m excited about the potential for this therapy to help with suffering in a way that has been unavailable to us in palliative care previously. This feels like healing rather than suppression of symptoms and could represent a real breakthrough in how we manage distress related to life-threatening illness.  We’re very much still learning about how to best apply this approach to therapy but are looking forward to contributing to the evolution of research and practice in the area. “

In addition to the development of a national network of Journey Centers from which to service patients, ATMA is also at the forefront of developing a national training and support network for therapists who wish to provide clients access to the healing and transformative potential of psychedelics.

According to David Harder, Co-CEO of ATMA, “we believe that those in palliative care are only the first category of patients who can greatly benefit from this innovative approach.  We are optimistic that Health Canada will soon begin to provide other Canadians who are suffering from a range of mental health issues access to psychedelic-assisted therapy as well.”

Dr. Bains concluded: “Public awareness is rising, and Canadians are increasingly looking for novel and more effective ways to improve their mental health without submitting to chronic use of pharmaceutical agents.  We are humbled to be able to help facilitate this long-overdue mental health revolution, and we’re excited to be on the cutting edge of the future of mental health care in Canada.”

ATMA is hopeful that the trickle of exemption approvals from Health Canada seen to date will soon increase in volume so that more Canadians are presented the opportunity to benefit from the use of psychedelics in therapeutic treatment.  “Whether through Section 56 Exemptions, the Special Access Program or through a larger scale move to update the policies and legislation around the use of psychedelics, we continue to work tirelessly to make this work accessible to more Canadians,” added Harder.

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