• Ethics approval granted
• The clinical trial protocol has been submitted for publication and the trial registered
• A Phase 2 clinical trial assessing the effectiveness of psychedelic (LSD) Microdosing and Meaning Centred Psychotherapy in advanced stage cancer patients
• One of two Phase 2 LSD-Microdosing Clinical Trials running in 2023

VANCOUVER, BC / ACCESSWIRE / May 11, 2023 / MindBio Therapeutics Corp. (CSE:MBIO); (the "Company" or "MindBio") is pleased to announce the successful ethics approval received for a Phase 2 randomized double-blind and placebo controlled clinical trial in advanced stage cancer patients using microdoses of Lysergic Acid Diethylamide (LSD) and Meaning Centred Psychotherapy in a world's first LSD take-home 6-week trial involving a total of 40 participants.

Patients with a stage IV solid tumour cancer and experiencing emotional distress will be randomized into the trial. Meaning Centred Psychotherapy is a well-established psychotherapeutic intervention in advanced cancer patients with symptoms of anxiety and or depression.

Patients with cancer often develop ongoing, clinically significant, symptoms of psychological distress. People with advanced-stage cancer have a high prevalence of depression, anxiety and reduced quality of life with 40% meeting the criteria for a mood disorder. MindBio is focused on developing targeted treatments to meet this need in cancer patients.

Such disorders can significantly impact a patient's end of life experience and can contribute to feelings of loss of meaning, hope, or a desire for hastened death (otherwise known as ‘existential distress'); which is regarded as one of the most challenging problems in palliative medicine. Additionally, depression and anxiety have been associated with decreased treatment adherence, prolonged hospitalisation, decreased quality of life and increased suicidality in this population. Depression is itself an independent risk factor of early death in cancer patients.

The efficacy of standard treatment approaches to anxiety and depression in cancer patients is mixed. The onset of clinical improvement with anti-depressants in cancer is delayed, relapse rates are high, and significant side effects compromise treatment adherence. LSD-Microdosing data from a Phase 1 clinical trial in healthy individuals showed increases in energy, social connectivity, creativity, wellness and happiness and microdoses of LSD are well tolerated.

Chief Executive Officer of MindBio Therapeutics, Justin Hanka said "The data we have collected in our clinical trials has exceeded our expectations and shows much promise for treating patients with mental health conditions such as depression and anxiety where diminished mood, compromised wellbeing and low energy is experienced. We are excited by this Phase 2 clinical trial in Cancer patients and look forward to sharing the results with the market"

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For further information, please contact:

Justin Hanka, Chief Executive Officer
61 433140886
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About MindBio Therapeutics

MindBio is a biotech/biopharma company focused on creating novel and emerging treatments for mental health conditions and is conducting world first take-home LSD-Microdosing human clinical trials. MindBio is a leader in microdosing of psychedelic medicines and is advancing its drug and technology protocols through clinical trials. MindBio has developed a multi-disciplinary platform for developing treatments and is involved in psychedelic medicine development and digital therapeutics, has completed Phase 1 clinical trials microdosing Lysergic Acid Diethylamide (LSD) in 80 patients, has a Phase 2 clinical trial in development microdosing LSD in patients with Major Depressive Disorder and a Phase 2 clinical trial in development microdosing LSD in late stage cancer patients experiencing existential distress. MindBio invests in research that forms the basis for developing novel and clinically proven treatments including digital technologies and interventions to treat debilitating health conditions such as depression, anxiety and other related mental health conditions.

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