PsyBio Therapeutics is developing a network of
highly qualified, local principal investigators to recruit and
conduct upcoming clinical trials
OXFORD,
Ohio and COCONUT CREEK,
Fla., April 13, 2022 /CNW/ - PsyBio Therapeutics
Corp. (TSXV: PSYB) (OTCQB: PSYBF) ("PsyBio" or the
"Company"), 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, today is announcing that it is initiating the process
of recruiting, evaluating and selecting highly qualified
investigators for upcoming 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 application in anticipation of seeking investigational new
drug ("IND") approval from the United States Food and Drug
Administration ("FDA") for upcoming 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 is
currently ongoing 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
analogs, both naturally and non-naturally occurring, specifically
because they are already known to have an effect within the
brain.
Cautionary Note Regarding
Forward-Looking Statements
This press release contains statements that constitute
"forward-looking information" ("forward-looking
information") within the meaning of applicable Canadian
securities legislation. All statements, other than statements of
historical fact, are forward-looking information and are based on
expectations, estimates and projections as at the date of this news
release. Any statement that discusses predictions, expectations,
beliefs, plans, projections, objectives, assumptions, future events
or performance (often but not always using phrases such as
"expects", or "does not expect", "is expected", "anticipates" or
"does not anticipate", "plans", "budget", "scheduled", "forecasts",
"estimates", "believes" or "intends" or variations of such words
and phrases or stating that certain actions, events or results
"may" or "could", "would", "might" or "will" be taken to occur or
be achieved) are not statements of historical fact and may be
forward-looking information. Forward looking-statements in this
press release include statements regarding: PsyBio's plans and
ability to recruit clinical investigators for upcoming clinical
trials; PsyBio's ability to launch clinical trials; PsyBio's plans
and ability to complete its clinical site selection process;
PsyBio's plans to submit a second pre-IND application to the
FDA; PsyBio's ability to develop novel formulations to potentially
treat neurologic and psychologic conditions and other disorders;
PsyBio's ability to build its intellectual property portfolio of
novel drug candidates; the ability to achieve cost competitive
synthesis with reduced environmental impact over current production
methods; and the ability of PsyBio to move target candidates into
scaled commercial manufacturing and regulatory application.
In disclosing the forward-looking information contained in this
press release, the Company has made certain assumptions, including
that: PsyBio will be successful in recruiting highly qualified
investigators for clinical evaluations; PsyBio will submit a second
pre-IND application to the FDA; PsyBio will receive approval from
the FDA to launch clinical trials; clinical investigators will be
trained to conduct clinical investigations; clinical investigations
will help facilitate rapid trial initiation and completion; PsyBio
will be successful in protecting its intellectual property; PsyBio
will be successful in discovering new valuable target molecules;
PsyBio will be successful in obtaining Investigational New Drug
Applications and will be able to obtain all necessary approvals for
clinical trials; PsyBio will be successful in launching clinical
trials; the results of preclinical safety and efficacy testing will
be favourable; PsyBio's technology will be safe and effective; a
confirmed signal will be identified in PsyBio's selected
indications; and that drug development involves long lead times, is
very expensive and involves many variables of uncertainty. Although
the Company believes that the expectations reflected in such
forward-looking information are reasonable, it can give no
assurance that the expectations of any forward-looking information
will prove to be correct. Known and unknown risks, uncertainties,
and other factors which may cause the actual results and future
events to differ materially from those expressed or implied by such
forward-looking information. Such factors include, but are not
limited to: compliance with extensive government regulations;
domestic and foreign laws and regulations adversely affecting
PsyBio's business and results of operations; decreases in the
prevailing process for psilocybin and nutraceutical products in the
markets in which PsyBio operates; the impact of COVID-19; general
business, economic, competitive, political and social
uncertainties; and the risk factors set out in the Company's
management discussion and analysis for the period ended
December 31, 2021 and the Company's
annual information form dated March 2,
2022, which are available under the Company's profile on
www.sedar.com. Accordingly, readers should not place undue reliance
on the forward-looking information contained in this press release.
Except as required by law, the Company disclaims any intention and
assumes no obligation to update or revise any forward-looking
information to reflect actual results, whether as a result of new
information, future events, changes in assumptions, changes in
factors affecting such forward-looking information or
otherwise.
PsyBio makes no medical, treatment or health benefit claims
about PsyBio's proposed products. The FDA or other similar
regulatory authorities have not evaluated claims regarding
psilocybin and other next generation psychoactive compounds. The
efficacy of such products has not been confirmed by FDA-approved
research. There is no assurance that the use of psilocybin and
other psychoactive compounds can diagnose, treat, cure, or prevent
any disease or condition. Vigorous scientific research and clinical
trials are needed. PsyBio has not conducted clinical trials for the
use of its intellectual property. Any references to quality,
consistency, efficacy and safety of potential products do not imply
that PsyBio verified such in clinical trials or that PsyBio will
complete such trials. If PsyBio cannot obtain the approvals or
research necessary to commercialize its business, it may have a
material adverse effect on the PsyBio's performance and
operations.
The TSX Venture Exchange (the "TSXV") has neither
approved nor disapproved the contents of this news release. Neither
the TSXV nor its Regulation Services Provider (as that term is
defined in the policies of the TSXV) accepts responsibility for the
adequacy or accuracy of this release.
SOURCE PsyBio Therapeutics Corp.