IRW-PRESS: MindBio Therapeutics Corp. : MindBio Therapeutics Phase 2 Clinical Trial, World’s First Study of LSD Microdosing for Home Use in Cancer Patients with Emotional Distress, Approved by Ethics Committee
– Positive evaluation by the ethics committee
– The clinical study protocol was submitted for publication and the study was registered
– A phase 2 clinical trial to evaluate the efficacy of psychedelics (LSD) microdosing and meaning-centered psychotherapy in end-stage cancer patients
– One of two phase 2 clinical trials on LSD microdosing to be conducted in 2023
Vancouver, British Columbia, May 11, 2023 / IRW-Press / – MindBio Therapeutics Corp (CSE: MBIO / ISIN: CA60256C1086); (the Company or MindBio) is pleased to announce receipt of positive ethics committee review for a randomized, double-blind, placebo-controlled Phase 2 clinical trial in end-stage cancer patients using microdosed lysergic acid diethylamide (LSD) and Purpose-Centered Psychotherapy in a world-first 6th -week study on home use of LSD with a total of 40 participants.
Patients with stage IV solid tumors and emotional distress are enrolled in the study. Purpose-centered psychotherapy is a well-established psychotherapeutic intervention for end-stage cancer patients with symptoms of anxiety and/or depression.
Cancer patients often develop persistent, clinically significant symptoms of psychological distress. In end-stage cancer patients, the prevalence of depression, anxiety and reduced quality of life is high, with 40 percent meeting criteria for a mood disorder. MindBio is focused on developing targeted therapies to address this need in cancer patients.
Such disorders can significantly affect a patient’s experience of end-of-life, contributing to a sense of meaninglessness and loss of hope, or a desire for an accelerated death (also known as existential distress), which is considered one of the most difficult problems in palliative care. In addition, depression and anxiety in this population have been associated with reduced treatment adherence, longer hospital stays, reduced quality of life, and increased suicidality. Depression itself is an independent risk factor for premature death in cancer patients.
The effectiveness of standard treatments for anxiety and depression in cancer patients has been mixed. Clinical improvement with antidepressants in cancer is delayed, relapse rates are high, and significant side effects impair adherence to therapy. LSD microdosing data from a Phase 1 clinical trial in healthy subjects showed increases in energy, social connections, creativity, well-being, and happiness, and that LSD microdosing was well tolerated.
Justin Hanka, Chief Executive Officer of MindBio Therapeutics, said: The data we have collected from our clinical trials has exceeded our expectations and shows much success in treating patients with mental illnesses such as depression and anxiety associated with low mood, impaired mood well-being and low energy. We are excited about this phase 2 clinical trial in cancer patients and look forward to reporting the results to the market.
About MindBio Therapeutics
MindBio is a biotech/biopharmaceutical company focused on the development of novel and emerging treatments for mental illness and is conducting the world’s first clinical human microdosing of LSD. MindBio is a leader in microdosing psychedelic drugs, advancing its drug and technology protocols through clinical trials.
MindBio has developed a multidisciplinary platform for therapy development and is involved in the development of psychedelics and digital therapeutics. It has completed phase 1 clinical trials of lysergic acid diethylamide (LSD) microdosing in 80 patients and is developing a phase 2 clinical trial of LSD microdosing in patients with depression and a phase 2 clinical trial of LSD microdosing in cancer patients in the final stages who suffer from existential problems.
MindBio invests in research that forms the basis for the development of novel and clinically proven therapies. This includes digital technologies and interventions to treat distressing conditions such as depression, anxiety and other related mental illnesses.
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For more information please contact:
Justin Hanka, Chief Executive Officer
+61 433140886
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