Associated tags: Biomedicine, Mental health, Palliative care, Psychological trauma, Science, PBM, Research, Adjustment disorder, Psychotherapy, Patient, Anxiety, Adjustment, World Health Organization, Quality of life, Diagnosis, Therapy, Caregiver, Nursing, FDA, WHO, Clinical trial, Contract research organization, Standard of care
Retrieved on:
Wednesday, April 17, 2024
NEW YORK, April 17, 2024 (GLOBE NEWSWIRE) -- Psyence Biomedical Ltd (Nasdaq:PBM) (“Psyence Biomed” or the “Company”) today announced that details of its upcoming Phase IIb clinical trial of nature-derived psilocybin in patients diagnosed with Adjustment Disorder following an advanced cancer diagnosis in the Palliative Care context has been listed on the Australian New Zealand Clinical Trials Registry (“ANZCTR”), under registration number 12624000449538p.
Key Points:
- NEW YORK, April 17, 2024 (GLOBE NEWSWIRE) -- Psyence Biomedical Ltd (Nasdaq:PBM) (“Psyence Biomed” or the “Company”) today announced that details of its upcoming Phase IIb clinical trial of nature-derived psilocybin in patients diagnosed with Adjustment Disorder following an advanced cancer diagnosis in the Palliative Care context has been listed on the Australian New Zealand Clinical Trials Registry (“ANZCTR”), under registration number 12624000449538p.
- The randomized, double-blind, placebo-controlled Phase IIb study will test three doses (25mg, 10mg and 1mg) of nature-derived psilocybin in 84 patients in conjunction with psychotherapy.
- Psyence Biomed anticipates enrolling the first subject in the second quarter of 2024 and expects the primary endpoint results to be available in 2025.
- “The listing for our Phase IIb clinical trial on ANZCTR reflects the meaningful progress that we are making in the development of a safe and effective psilocybin-based treatment for the roughly 19% of patients who suffer from Adjustment Disorder following an advanced cancer diagnosis1, with a focus on Palliative Care,” said Neil Maresky, MD, Chief Executive Officer of Psyence Biomed.
Diagnosis,
The Lancet,
Depression,
NASW,
Partnership,
PAP,
Psychotherapy,
Palliative care,
Patient,
Research,
Gold,
American Psychological Association,
Standard of care,
Anxiety,
Cancer,
Doctor of Philosophy,
Quality of life,
Adjustment disorder,
Social work,
World Health Organization,
Clinical trial,
Safety,
Adjustment,
WHO,
National Association,
DSM-IV codes,
APA,
FDA,
Physician,
Health,
PBM,
Practitioner,
Nursing NEW YORK, April 08, 2024 (GLOBE NEWSWIRE) -- Psyence Biomedical Ltd (Nasdaq:PBM) (“Psyence Biomed” or the “Company”) today announced that its Australian subsidiary, Psyence Australia Pty Ltd. (“Psyence Australia”), has entered into a partnership with Fluence , a global leader in professional education and training for psychedelic therapy research, and iNGENū CRO Pty Ltd (“iNGENū”), an Australian clinical research organization (CRO), to support an upcoming Phase llb clinical trial.
Key Points:
- NEW YORK, April 08, 2024 (GLOBE NEWSWIRE) -- Psyence Biomedical Ltd (Nasdaq:PBM) (“Psyence Biomed” or the “Company”) today announced that its Australian subsidiary, Psyence Australia Pty Ltd. (“Psyence Australia”), has entered into a partnership with Fluence , a global leader in professional education and training for psychedelic therapy research, and iNGENū CRO Pty Ltd (“iNGENū”), an Australian clinical research organization (CRO), to support an upcoming Phase llb clinical trial.
- According to Lancet Oncology, Adjustment Disorder affects as many as 19% of patients following a life-limiting cancer diagnosis.
- “The success of the clinical trial relies on rigorous, standardized therapist training designed to achieve the highest standard of patient care,” said Elizabeth Nielson, PhD, Fluence co-founder.
- Psyence Biomed anticipates enrolling the first subject in the second quarter of 2024 and expects the primary endpoint results to be available in 2025.
Survival,
JCO,
Caregiver,
Therapy,
Palliative care,
Patient,
Ethics,
Journal,
Mouse,
Research,
Hebrew University of Jerusalem,
Anxiety,
MD,
Nature,
Quality of life,
Adjustment disorder,
World Health Organization,
Adjustment,
ASCO,
Molecular Psychiatry,
WHO,
Paper,
FDA,
PBM NEW YORK, March 18, 2024 (GLOBE NEWSWIRE) -- Psyence Biomedical Ltd. (Nasdaq:PBM) ("Psyence Biomed" or the "Company") today issued a statement welcoming the results of a recent study finding evidence that nature-derived psilocybin may be demonstrably more therapeutic than synthetic psilocybin.
Key Points:
- The study presents evidence that nature (mushroom)-derived psilocybin delivers a “more potent and prolonged effect” on “neuroplasticity” than its synthetic analog.
- “Neuroplasticity” is increasingly recognized as the gold standard by which the therapeutic efficacy of psychedelic pharmaceutical medicines can be measured.
- The Psyence Biomed study will examine the use of nature-derived psilocybin as a treatment for Adjustment Disorder due to a recent cancer diagnosis in the Palliative Care context.
- Neither Psyence Biomedical nor any of its investors or affiliates funded or in any way sponsored the Hebrew University study.
The MVLS Notice and the MVPHS Notice are only notifications of deficiencies and have no immediate effect on the listing of the Company’s securities.
Key Points:
- The MVLS Notice and the MVPHS Notice are only notifications of deficiencies and have no immediate effect on the listing of the Company’s securities.
- The Company’s securities continue to trade on Nasdaq.
- In accordance with Nasdaq Listing Rule 5810(c)(3)(C), the Company has 180 calendar days, or until September 9, 2024, to regain compliance with the Market Value Standard and the MVPHS Standard.
- The Company intends to actively monitor its MVLS and MVPHS and will evaluate available options to regain compliance with the Nasdaq continued listing standards.
Psilocybin,
Hospice,
Letter,
Growth,
Newcourt,
Psychotherapy,
Mental health,
Research,
Fungus,
Contract research organization,
Adjustment disorder,
NCE,
Phase,
Optimism,
Intellectual property,
Patent,
Therapy,
Medicine,
PBM,
Pharmaceutical industry Our merger with Newcourt and subsequent listing on Nasdaq confers numerous benefits to our company.
Key Points:
- Our merger with Newcourt and subsequent listing on Nasdaq confers numerous benefits to our company.
- While other companies are exploring synthetic psilocybin, Psyence is the world’s first Nasdaq traded biopharmaceutical company researching a nature-derived (non-synthetic) psilocybin candidate.
- Furthermore, Psyence is the only publicly traded company to research a non-synthetic psilocybin candidate to treat Adjustment Disorder in the context of Palliative Care.
- To reflect this exciting new chapter in our company’s evolution, we have created a new investor presentation, which can be found here .
Anxiety,
Palliative care,
Caregiver,
Research,
Quality of life,
Terminal,
Standard of care,
Adjustment disorder,
Contract research organization,
World Health Organization,
Patient,
Clinical trial,
Diagnosis,
PBM,
Psychotherapy,
Adjustment,
Nursing NEW YORK, March 06, 2024 (GLOBE NEWSWIRE) -- Psyence Biomedical Ltd (NASDAQ:PBM) ("Psyence Biomed" or the "Company") is pleased to announce that its wholly-owned subsidiary, Psyence Australia (Pty) Ltd ("Psyence Australia"), has received full approval from the Australian Health Research Ethics Committee (HREC) to initiate its planned Phase IIb study in Melbourne, Australia.
Key Points:
- NEW YORK, March 06, 2024 (GLOBE NEWSWIRE) -- Psyence Biomedical Ltd (NASDAQ:PBM) ("Psyence Biomed" or the "Company") is pleased to announce that its wholly-owned subsidiary, Psyence Australia (Pty) Ltd ("Psyence Australia"), has received full approval from the Australian Health Research Ethics Committee (HREC) to initiate its planned Phase IIb study in Melbourne, Australia.
- The study will examine the use of nature-derived psilocybin as a treatment for Adjustment Disorder due to a recent cancer diagnosis in the palliative care context.
- Psyence Australia has partnered with a noted psychedelic Contract Research Organization (CRO), iNGENū Pty Ltd ("iNGENū"), to design and execute the clinical trial.
- Psyence anticipates enrolling the first patient in Q2 2024 and expects the primary endpoint results to be available in 2025.
