Psychedelics for Cancer Patients Positive Update!
Mindbio begins dosing 20th patient in MB22001 trial
2024-10-24 14:02 ET - News Release
Mr. Justin Hanka reports
MINDBIO ANNOUNCES CLINICAL TRIAL MILESTONE IN PHASE 2B MICRODOSING TRIALS TARGETING EXISTENTIAL DISTRESS, DEPRESSION & ANXIETY IN ADVANCED STAGE CANCER
Mindbio Therapeutics Corp. has provided an update on progress of its trial of MB22001 in advanced-stage cancer patients.
In this phase 2B clinical trial in advanced-stage cancer patients experiencing symptoms of anxiety and or depression (N equal to 40), will be randomized under double-blind conditions to receive seven sessions of meaning-centred psychotherapy alongside 13 doses of either MB22001 (4ug-12ug) or inactive placebo. The company has started dosing the 20th participant and reached the halfway milestone in this important work.
The commercial objective is to target global special access schemes assuming phase 2B completion produces positive results -- for example: Health Canada's special access program (SAP) and Australia's special access scheme (SAS) and authorized prescriber (AP) schemes which allow certain registered health practitioners to access unapproved therapeutic goods for patients under their care.
Special access schemes for late-stage cancer patients are highly relevant to Mindbio's work and it is known that pharmacotherapeutic interventions are commonly used to treat anxiety and depression in cancer care; however, they have notable limitations with several meta-analyses of placebo-controlled trials of antidepressants failing to demonstrate a clear effect of treatment in cancer patients.
Meaning-centred psychotherapy (MCP) was developed in response to the despair, hopelessness, loss of meaning and desire for hastened death that commonly occurs in people with advanced cancer, and there is compelling evidence for the use of MCP to improve meaning and quality of life in this population.
The company's thesis is that MB22001 will be an effective pharmacological treatment alongside MCP and will improve symptoms of anxiety and depression, compared with when MCP is administered on its own.
The company's thesis is now backed by four years of data collection and analysis in prior clinical trial works. In addition to improvements in mood, a 60-per-cent reduction in depressive symptoms, improved sleep, and enhanced feelings of creativity and energy, there have been improvements in a range of secondary outcome measures in depressed patients following an eight-week treatment course with MB22001. This includes a 52-per-cent reduction in anxiety (HAM-A), and self-reported reductions in stress (35 per cent), anxiety (59 per cent) and depression (40 per cent) using the DASS (Depression, Anxiety and Stress Scale) questionnaire. The psychological quality of life of participants was improved by 37 per cent as measured by the WHOQOL (World Health Organization Quality-of-Life Scale).
Safety analysis has shown a favourable adverse event profile with a low frequency of adverse events. No clinically significant abnormalities were seen in follow-up blood tests, electrocardiograms or echocardiograms. Tolerability of treatment is important when dosing vulnerable patients in their last stages of life in cancer care.
These results give management a high level of confidence that MB22001 could be useful in treating cancer patients suffering from end-of-life distress and the company is looking forward to sharing top-line data in 2025.
Justin Hanka, chief executive officer of Mindbio, said, "We are delighted with the progress of our cancer trials as we continue to dose patients in multiple phase 2B programs."
The company invites you to join Mindbio in support of creating a brighter future for mental health.
About Mindbio Therapeutics Corp.
Mindbio is a leading biotech/biopharma company focused on creating novel and emerging treatments for mental health conditions and is conducting world-first take-home microdosing (MB22001) human clinical trials. MB22001 is Mindbio's lead candidate drug, a proprietary titratable form of lysergic acid diethylamide (LSD) designed for take-home microdosing. Mindbio is a leader in microdosing of psychedelic medicines and is advancing its drug and technology protocols through clinical trials. Mindbio has developed a multidisciplinary platform for developing treatments; is involved in psychedelic medicine development and digital therapeutics; has completed phase 1 clinical trials in 80 healthy participants; and has completed a phase 2a clinical trial in patients with major depressive disorder, both trials with positive top-line data reported. Currently under way are two phase 2B trials, one in cancer patients experiencing existential distress and another in patients with major depressive disorder. The company is also approved for multiple phase 1/phase 2B trials in women's health. 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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