Enveric
Biosciences and University of Calgary Collaborate on a
Groundbreaking Clinical Trial for EVM-101 in Cancer Related
Distress
Clinical
trial aim is to include the identification and characterization of
the Cancer Related Distress symptoms most responsive to
psychedelic-associated therapy
NAPLES, FL,
February 175,
2022 - InvestorsHub NewsWire
-- Enveric
Biosciences (NASDAQ: ENVB)("Enveric" or the "Company),
a cutting-edge
neuroscience company developing next-generation,
psychedelic-inspired
mental health
medicines, is working with
the University of Calgary's Hotchkiss
Brain Institute ("HBI"), a leading neurosciences center of
excellence, at the Cumming School of Medicine in Calgary, Canada
that is dedicated to advancing brain and mental health research and
education, to establish a groundbreaking clinical trial of EVM-101
for the treatment of Cancer Related Distress ("CRD").
Approximately 50% of cancer
patients report clinical levels of psychological distress having
depressed mood, anxiety, demoralization, stress-induced clinical
manifestations, and reduced quality of life1.
Up to 40% of cancer patients meet the criteria for a mood disorder
requiring treatment2.
CRD is a significant unmet medical need with no current regulatory
approval of pharmacotherapies and an urgent need to optimize the
current standard of care for patients with
cancer.3
A clinical trial, expected to
launch later this year, of EVM-101, a first-generation psychedelic
treatment, for CRD will be led by HBI researcher, Dr. Valerie
Taylor, Head of the Department of Psychiatry, in Calgary,
Canada.
"We are excited to collaborate with Enveric
to study next-generation medicines that we hope will help people
cope with the mental health challenges of a cancer
diagnosis.
This
work will allow us to mobilize our combined resources to research
options for cancer patients living with CRD," says Dr. Valerie
Taylor.
The EVM-101 study will directly
assess the core features of CRD that are most affected and amenable
to improvement following a psilocybin-based treatment.
"With the rising rates of cancer
and its associated psychological ailments that have been
underestimated and underdiagnosed until recently, we are working
hard to develop new treatments that help cancer patients suffering
from CRD" said Dr. Bob Dagher, Enveric's Chief Medical Officer.
"Our collaboration with the research team at the University of
Calgary's Hotchkiss Brain Institute and IMPACT Clinical Trial
Accelerator will help us to demonstrate the potential benefits of
these novel treatments and get them to market as quickly as
possible."
A regulatory submission to Health
Canada is expected to soon be finalized. Patient enrollment in the
clinical trial is expected to begin late in 2022 or early in 2023.
The study design will employ proprietary psychiatry and
psychotherapy-focused treatments for cancer patients with CRD.
Patients will receive a single oral dose of EVM-101 in a supportive
environment with psychotherapy to improve outcomes.
Enveric is committed to
discovering and developing more effective treatments for cancer
patients living with psychological distress and is currently
working on three classes of new medicines: EVM-101, a
first-generation oral psilocybin; EVM-201, a second-generation
pro-drug; and EVM-301, a third-generation psychedelic-inspired and
optimized new molecule.
References:
-
Mehnert, A., Hartung, T. J., Friedrich, M., Vehling, S.,
Brahler, E., Harter, M., et al. (2018). One in two cancer patients
is significantly distressed: prevalence and indicators of distress.
Psychooncology 27, 75-82. Doi: 10.1002/pon.4464
-
Holland et al. (2013). Distress Management. J Natl Compr
Cancer Network 2013 Feb 1;11(2):190-209. doi:
10.6004/jnccn.2013.0027
-
Peters, L., Brederecke, J., Franzke, A., Zwaan, M.,
Zimmermann, T. (2020). Psychological Distress in a Sample of
Inpatients With Mixed Cancer—A Cross-Sectional Study of Routine
Clinical Data. Front Psychol. 2020 Nov 30; 11:591771. doi:
10.3389/fpsyg.2020.591771
About
Enveric Biosciences
Enveric Biosciences (NASDAQ: ENVB)
is a
cutting-edge neuroscience company developing next-generation
psychedelic-inspired mental health medicines. Enveric's robust
pipeline supports drug development from the clinic to
commercialization for millions of patients in need around the world
suffering from conditions that include cancer-related distress,
PTSD, and more. For more information, please visit
www.enveric.com.
About
Hotchkiss Brain Institute
The
Hotchkiss Brain Institute is an internationally recognized center
of excellence in brain and mental health research and education,
based at the University of Calgary's Cumming School of
Medicine. The Hotchkiss Brain
Institute was launched in October 2004 by a foundational gift from
Calgary's own Hotchkiss family, the late Harley Hotchkiss,
well-known entrepreneur, supporter of neuroscience research, and
key founder of the Calgary Flames. The Institute is devoted to
understanding the mechanisms and impact of brain injury, disease,
disorders and mental health. Today the HBI is
composed of nearly 1400 people, including over 220 members spanning
12 academic departments and nine faculties at the University of
Calgary, all working towards a shared vision: Healthy Brains for
Better Lives.
www.hbi.ucalgary.ca
About
IMPACT Clinical Trials Accelerator
IMPACT is a program for new
ventures in the life sciences or biomedical industries who are
seeking guidance in conducting clinical trials to secure regulatory
approval for their new health-related inventions. IMPACT disrupts
traditional healthcare innovation by accelerating marketing
approval via a tailored evidence collection and regulatory
framework. www.research.ucalgary.ca/impact
Forward-Looking
Statements
This
press release contains forward-looking statements and
forward-looking information within the meaning of applicable
securities laws. These statements relate to future events or future
performance. All statements other than statements of historical
fact may be forward-looking statements or information. Generally,
forward-looking statements and information may be identified by the
use of forward-looking terminology such as "plans", " expects" or
"does not expect", "proposed", "is expected", "budgets",
"scheduled", "estimates", "forecasts", "intends", "anticipates" or
"does not anticipate", or "believes", or variations of such words
and phrases, or by the use of words or phrases which state that
certain actions, events or results may, could, would, or might
occur or be achieved. Forward-looking statements consist of
statements that are not purely historical, including any statements
regarding beliefs, plans, expectations, or intentions regarding the
future. Such forward-looking statements are based on the beliefs of
management as well as assumptions made by and information currently
available to management. Actual results could differ materially
from those contemplated by the forward-looking statements as a
result of certain factors, including, but not limited to, the
ability to achieve the value creation contemplated by technical
developments; the impact of the novel coronavirus (COVID-19) on
Enveric's ongoing and planned clinical trials; the geographic,
social and economic impact of COVID-19 on Enveric's ability to
conduct its business and raise capital in the future when needed;
delays in planned clinical trials; the ability to establish that
potential products are efficacious or safe in preclinical or
clinical trials; the ability to establish or maintain
collaborations on the development of therapeutic candidates; the
ability to obtain appropriate or necessary governmental approvals
to market potential products; the ability to obtain future funding
for developmental products and working capital and to obtain such
funding on commercially reasonable terms; Enveric's ability to
manufacture product candidates on a commercial scale or in
collaborations with third parties; changes in the size and nature
of competitors; the ability to retain key executives and
scientists; and the ability to secure and enforce legal rights
related to Enveric's products, including patent protection. A
discussion of these and other factors, including risks and
uncertainties with respect to Enveric, is set forth in Enveric's
filings with the Securities and Exchange Commission (SEC),
including the Company's Annual Report on Form 10-K and its
Quarterly Reports on Form 10-Q. Enveric disclaims any intention or
obligation to revise any forward-looking statements, whether as a
result of new information, future events or otherwise, except as
required by law.
Investor
Contacts
Valter
Pinto / Allison Soss
KCSA
Strategic Communications
212.896.1254 /
212.896.1267
valter@kcsa.com /
asoss@kcsa.com
Media
Contacts
Natalie
Dolphin
Enveric
Biosciences Inc.
416.706.6364
ndolphin@enveric.com
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