Cybin Inc. ( NEO:CYBN ) (NYSE American:CYBN) (“ Cybin ” or the “ Company ”), a biopharmaceutical company focused on progressing “Psychedelics to Therapeutics™”, today announced that the U.S. Food and Drug Administration (“FDA”) has authorized an investigator-initiated randomized, placebo-controlled Phase 2 clinical trial evaluating psychedelic-assisted psychotherapy with psilocybin for frontline clinicians experiencing COVID-related distress. The trial will be conducted at the University of Washington and will aim to treat symptoms of depression, anxiety, burnout and post-traumatic stress among frontline doctors, nurses and healthcare professionals. The trial’s Primary Investigator, Dr. Anthony Back, received an investigational new drug ("IND") approval letter from the FDA, which provides authority to proceed with the Phase 2 trial.
Further to the authorization from the FDA, the study has also received Institutional Review Board (“IRB”) approval at the University of Washington. This investigator-initiated trial will be hosted in Seattle, a city significantly impacted by the COVID-19 pandemic and will be funded by multiple organizations.
“This study offers an important opportunity to assess psychedelics-assisted therapy as a new modality for clinicians who have suffered as a result of their frontline work in the pandemic,” said Dr. Anthony Back.
To support the initiative, Cybin’s Chief Clinical Officer, Alex Belser, PhD and Bill Brennan, PhD (candidate) developed EMBARK, a six-domain model of psychedelic-assisted psychotherapy. EMBARK was designed as a transdiagnostic psychotherapy model that can be adapted to address a range of clinical indications and populations. In collaboration with Dr. Anthony Back and Ladybird Morgan, RN, MSW, an adapted version of EMBARK has been co-authored to treat COVID-related burnout and symptoms of depression among frontline healthcare workers, and this version includes material that specifically addresses cultural in
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Ehave, Inc. a provider of digital therapeutics for the psychedelic and mental health sectors, announced today the Company Ehave has hired an Institutional Review Board (IRB) as it prepares to launch ketamine clinical Trials in Miami with Tristar Wellness.
The IRB will review all research involving human subjects and implement policies and procedures regarding such research. The primary function of the IRB is to protect the rights of human subjects.
Tristar Wellness is an upscale Miami Beach Florida based medical facility with an experienced team of doctors focused on implementing the latest in medical technology and research. Ehave previously announced it is ahead of schedule and plans launch its KetaDASH www.ketadash.com ketamine IV therapy by the end of the second quarter.
Ehave Chief Executive Officer, Ben Kaplan, said, "Hiring an IRB is a very important step in our ketamine clinical Trials in Miami with Tristar Wellness. The safety of the individuals participating in our trials is of utmost importance to both Ehave and Tristar Wellness."
Find the release here at: https://finance.yahoo.com/news/ehave-hires-institutional-review-board-133000265.html
This is not financial advice!!
Introduced: Sponsor: Rep. Elaine Luria [D-VA2]
This bill was referred to the House Committee on Veterans' Affairs which will consider it before sending it to the House floor for consideration.
Rep. Elaine Luria [D-VA2] is a member of the committee.
OTC Pink: EHVVF
Ehave, Inc. a provider of digital therapeutics for the psychedelic and mental health sectors, announced today the Company Ehave has hired an Institutional Review Board (IRB) as it prepares to launch ketamine clinical Trials in Miami with Tristar Wellness.
The IRB will review all research involving human subjects and implement policies and procedures regarding such research. The primary function of the IRB is to protect the rights of human subjects.
Tristar Wellness is an upscale Miami Beach Florida based medical facility with an experienced team of doctors focused on implementing the latest in medical technology and research. Ehave previously announced it is ahead of schedule and plans launch its KetaDASH www.ketadash.com ketamine IV therapy by the end of the second quarter.
Ehave Chief Executive Officer, Ben Kaplan, said, "Hiring an IRB is a very important step in our ketamine clinical Trials in Miami with Tristar Wellness. The safety of the individuals participating in our trials is of utmost importance to both Ehave and Tristar Wellness."
Find the release here at: https://finance.yahoo.com/news/ehave-hires-institutional-review-board-133000265.html
This is not financial advice!!
