Enveric Biosciences (NASDAQ:ENVB) has said it is working with the University of Calgary's Hotchkiss Brain Institute (HBI), a leading neurosciences center of excellence at the Cumming School of Medicine in Calgary, to establish a groundbreaking clinical trial of EVM-101 for the treatment of cancer-related distress (CRD).
A clinical trial of EVM-101, a first-generation psychedelic treatment, expected to launch later this year, will be led by HBI researcher, Dr Valerie Taylor in Calgary, Canada.
"We are excited to collaborate with Enveric to study next-generation medicines that we hope will help people cope with the mental health challenges of a cancer diagnosis. This work will allow us to mobilize our combined resources to research options for cancer patients living with CRD," Taylor said in a statement.
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The EVM-101 study will directly assess the core features of CRD that are most affected and amenable to improvement following a psilocybin-based treatment.
"With the rising rates of cancer and its associated psychological ailments that have been underestimated and underdiagnosed until recently, we are working hard to develop new treatments that help cancer patients suffering from CRD" said Dr. Bob Dagher, Enveric's chief medical officer. "Our collaboration with the research team at the University of Calgary's Hotchkiss Brain Institute and IMPACT Clinical Trial Accelerator will help us to demonstrate the potential benefits of these novel treatments and get them to market as quickly as possible."
Approximately 50% of cancer patients report clinical levels of psychological distress having depressed mood, anxiety, demoralization, stress-induced clinical manifestations, and reduced quality of life.
Up to 40% of cancer patients meet the criteria for a mood disorder requiring treatment. CRD is a significant unmet medical need with no current regulatory approval of pharmacotherapies and an urgent need to optimize the current standard of care for patients with cancer.
A regulatory submission to Health Canada is expected to soon be finalized. Patient enrolment in the clinical trial is expected to begin late in 2022 or early in 2023.
The study design will employ proprietary psychiatry and psychotherapy-focused treatments for cancer patients with CRD. Patients will receive a single oral dose of EVM-101 in a supportive environment with psychotherapy to improve outcomes.
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