Lexaria
Commences Human
Clinical Hypertension
Study
-
Study to
examine
DehydraTECHTM
CBD's
ability to
control blood pressure
-
First of
three human clinical studies hoped to validate
Lexaria's
patented technology for hypertension relief
Kelowna,
British Columbia,
April
22,
2021 -- InvestorsHub
NewsWire -- Lexaria Bioscience Corp. (Nasdaq: LEXX) (Nasdaq: LEXXW) (CSE: LXX) (the "Company"
or
"Lexaria"), a global innovator in
drug delivery platforms, announces that its human clinical hypertension
study
HYPER-H21-1 is officially underway. Lexaria's patented DehydraTECH CBD
formulation will be
examined
to assess its ability to control blood
pressure and assess impact on
inflammation.
"We are very pleased
that
dosing of human
volunteers as part of Lexaria's hypertension study
has
begun," said Lexaria CEO Mr. Chris
Bunka. "Dosing is expected to be
completed, on schedule,
within several weeks, and we may be in a position
to report preliminary data in July or
thereabouts. Despite challenges in
launching a human clinical study during
a global pandemic,
Lexaria's Europe-based research
partners have done an excellent job
of
balancing the need for scientific validation for a
potential new hypertension
treatment, with the required safety
protocols currently in place."
HYPER-H21-1
is a
randomized,
double-blinded,
controlled
human
clinical
study expected to involve
24 human
volunteers with symptoms of
either
pre-hypertension,
or mild hypertension. A single 300mg dose of
an
advanced DehydraTECHTM
2.0
CBD
formulation
will be
evaluated relative to a
concentration-matched control
without
Lexaria's DehydraTECH
enhancements.
Time
series blood pressure and heart rate
analyses are the primary
objectives of this study. Secondary
objectives include speed and rate of absorption
of
the
CBD
and
its main
metabolites
(pharmacokinetics
or
"PK" assessments), as well as evaluation of
inflammatory
markers associated with
cardiovascular disease and gold-standard biomarkers of
nitric
oxide.
This latter measure provides mechanistic
insight into the anticipated reduction in
blood pressure
via
vasodilation.
These
inflammatory marker
assessments may also be applicable
to
Lexaria's research initiatives in the antiviral therapeutics
space
whereby
effective anti-inflammatory therapies are also
useful in treating diseases like
COVID-19 or other common
pro-inflammatory conditions.
Since
a large
array of data points will be
generated and analyzed, final reporting on this
study is
likely to
be reported in early
September.
There are five studies in Lexaria's 2021
hypertension program
which are expected to
generate
data
required to further support
the
validity of using
DehydraTECH-processed CBD as
a potential
hypertension treatment across various
applications. Lexaria has received 18 granted patents
internationally,
including
issuances in the European Union and
Australia specifically
to
use DehydraTECH-processed CBD to treat heart
disease.
About
Lexaria Bioscience
Corp.
Lexaria Bioscience
Corp.'s
proprietary drug delivery technology,
DehydraTECH™,
improves the way active pharmaceutical
ingredients (APIs)
enter the bloodstream by promoting healthier
oral
ingestion methods and increasing the effectiveness of
fat-soluble active
molecules,
thereby
lowering overall dosing. The Company's technology
can
be applied to many different ingestible
product
formats, including foods, beverages, oral suspensions,
tablets,
and capsules. DehydraTECH has repeatedly demonstrated
since 2016
with cannabinoids and
nicotine
the ability to increase bio-absorption by up
to 5-10x, reduce time of onset from 1 - 2
hours
to minutes,
and mask unwanted tastes; and is planned to be
further
evaluated for orally administered bioactive molecules,
including
anti-virals,
cannabinoids, vitamins,
non-steroidal anti-inflammatory drugs
(NSAIDs),
and
nicotine. Lexaria has licensed
DehydraTECH to
multiple companies including a world-leading tobacco
producer for the
development of smokeless, oral-based
nicotine
products and for use in
industries
that produce cannabinoid beverages, edibles,
and
oral
products. Lexaria operates a
licensed
in-house
research laboratory and holds a robust intellectual
property
portfolio with 18 patents granted and approximately
60 patents
pending
worldwide. For
more
information, please visit
www.lexariabioscience.com.
CAUTION
REGARDING
FORWARD-LOOKING
STATEMENTS
This press
release includes
forward-looking statements. Statements as
such term
is defined under
applicable
securities laws. These statements may be identified by words such as "anticipate," "if," "believe," "plan,"
"estimate," "expect," "intend," "may," "could,"
"should,"
"will," and other similar expressions. Such
forward-looking
statements in this press
release include,
but are
not limited to, statements by the company relating the Company's ability to carry out
research initiatives, receive regulatory approvals or
grants or
experience positive effects or results from any
research or
study. Such
forward-looking statements are
estimates reflecting the Company's best judgment based upon current information and involve a
number of risks and uncertainties, and there can
be no assurance
that the
Company will actually achieve
the plans,
intentions, or
expectations disclosed in these
forward-looking statements.
As
such, you should not place undue reliance on these
forward-looking statements. Factors which could cause
actual
results to differ materially from those estimated by
the Company
include, but are not
limited to,
government regulation and regulatory approvals, managing and maintaining growth, the effect of adverse
publicity, litigation, competition, scientific
discovery,
the patent application and approval process,
potential adverse
effects arising from
the testing
or use of products utilizing the DehydraTECH technology, the Company's ability to maintain existing
collaborations and realize the benefits thereof,
delays or cancellations of
planned
R&D
that could occur
related to
pandemics or for other
reasons, and other factors
which may
be identified from
time to time in the Company's public announcements and periodic
filings
with the US Securities and Exchange Commission on EDGAR. There is no
assurance that any of Lexaria's postulated uses,
benefits, or advantages for the
patented
and patent-pending
technology will in fact be realized in any manner or in any part. No
statement
herein has been evaluated by the Food and Drug Administration
(FDA). Lexaria-associated products are not intended to
diagnose, treat,
cure
or
prevent any
disease. Any forward-looking
statements contained in
this
release speak only as of the date
hereof, and
the Company expressly disclaims any obligation to update any
forward-looking statements contained herein, whether
as a
result of
any new
information,
future
events, changed
circumstances or otherwise, except as otherwise required by law.
The CSE
has not
reviewed
and
does
not
accept
responsibility
for the adequacy or accuracy
of
this release.
INVESTOR
CONTACT:
ir@lexariabioscience.com
Phone:
866-221-3341