PHASE 2
CLINICAL TRIAL HAS RECEIVED ETHICS APPROVAL FOR WORLD FIRST
TAKE-HOME LSD-MICRODOSING TRIALS IN CANCER PATIENTS EXPERIENCING
EMOTIONAL DISTRESS
-
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,
British Columbia – May 11, 2023 – InvestorsHub NewsWire --
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"
Receive our latest updates
here:
https://www.mindbiotherapeutics.com/get-updates
Follow MindBio
on LinkedIn: https://www.linkedin.com/company/mindbio-therapeutics/?viewAsMember=true
Follow CEO
Justin Hanka on LinkedIn:
https://www.linkedin.com/in/justinhanka/
For
further information, please contact:
Justin
Hanka, Chief Executive Officer
61
433140886
justin@mindbiotherapeutics.com
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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