07:15:56 EDT Fri 26 Apr 2024
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Psybio Therapeutics Corp
Symbol PSYB
Shares Issued 61,235,432
Close 2022-04-13 C$ 0.09
Market Cap C$ 5,511,189
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Psybio begins picking investigators for clinical trials

2022-04-13 11:46 ET - News Release

Mr. Evan Levine reports

PSYBIO THERAPEUTICS INITIATES CLINICAL TRIAL SITE SELECTION PROCESS

Psybio Therapeutics Corp. is initiating the process of recruiting, evaluating and selecting highly qualified investigators for coming clinical trials.

"The process of site selection is critically important to the success of clinical investigations," stated Michael Spigarelli, MD, PhD, MBA, Psybio's chief medical officer. "My experience running thousands of studies as a former clinical trial investigator and trial site operator will allow Psybio to develop partnerships with the clinical trial site investigators and work in collaboration with qualified sites to ensure the highest-quality data collection and the shortest timelines for clinical studies. While we have started to discuss potential participation in upcoming trials, there is still opportunity for other investigators to participate should a qualified investigator or site seek further information."

Psybio is currently in the process of drafting its second pre-IND (investigational new drug) application in anticipation of seeking investigational new drug approval from the United States Food and Drug Administration (FDA) for coming clinical trials. Once submitted and approved by the appropriate regulatory authorities, including the FDA, clinical investigators will be selected and trained to conduct clinical investigations, which will help facilitate rapid trial initiation and completion.

"The ability to launch clinical trials with our readily manufacturable and scalable psycho-targeted therapeutic candidates, once regulatorily approved, furthers Psybio's role as one of the only biotechnology companies in the psychoactive therapeutic industry developing their own compounds from bench to bedside," stated Evan Levine, Psybio's chief executive officer. "Collaborating with committed and talented local investigators and using their extensive content knowledge will be invaluable to Psybio as clinical trials are begun, the data analyzed and results reported."

About Psybio Therapeutics Corp.

Psybio Therapeutics is an integrated and intellectual-property-driven biotechnology company developing novel, bespoke psychoactive medicinal candidates targeting the potential treatment of mental health challenges, neurological disorders and other human health conditions. The team has extensive experience in drug discovery based on synthetic biology and metabolic engineering, as well as clinical and regulatory expertise progressing drugs through human studies and regulatory protocols. Research and development are currently continuing for naturally occurring psychoactive tryptamines originally discovered in different varieties of hallucinogenic mushrooms, other tryptamines and phenethylamines, and combinations thereof. The company utilizes a bio-medicinal chemistry approach to therapeutic development in which psychoactive compounds can be utilized as a template upon which to develop precursors and analogues, both naturally and non-naturally occurring, specifically because they are already known to have an effect within the brain.

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