Rapid
Progress
in Hypertension
Studies
by
Lexaria
-
Five
studies
underway
to examine
DehydraTECHTM
CBD
for Hypertension.
Kelowna,
British Columbia, March
15,
2021 -- InvestorsHub NewsWire -- Lexaria Bioscience
Corp. (Nasdaq: LEXX) (Nasdaq: LEXXW) (CSE: LXX) (the "Company" or "Lexaria"), a global innovator in
drug delivery platforms, announces extensive progress
in five studies focused on the performance of
DehydraTECHTM
CBD as a
treatment
for hypertension. Three human clinical
trials and two
animal research trials are part of the
Company's 2021 applied research and
development (R&D) program. The Company
has
additional studies
under
design, to be announced when
available. Lexaria's DehydraTECH
CBD for
hypertension studies are being performed by
third-party laboratories to ensure study objectivity.
DehydraTECH
CBD For
Hypertension.
All five of the planned
2021 hypertension studies
are underway:
HYPER-A21-1:
Dosing is complete and
sample
analysis is underway in this animal study. No observed behavioural tolerability issues
were noted during or after
dosing. This study is
evaluating the rate of absorption
and speed
with which various new
enhanced
DehydraTECH
experimental
formulations
-
"DehydraTECH 2.0" - deliver CBD
to
the
bloodstream and brain. Enhanced
DehydraTECH 2.0
formulations represent next-generation drug
delivery enhancements not yet commercially
available
anywhere in the
world. Results should be
reported in or around the first half
of
May.
HYPER-A21-2:
Dosing
is scheduled to
begin next
week and is expected to be completed in this animal study
by March
30. This
study is also evaluating the rate of absorption and speed with
which additional enhanced
DehydraTECH 2.0
formulations
deliver CBD
to the
bloodstream and brain. Results should be reported
in or
around the first half of June.
Studies
HYPER-A21-1 and HYPER-A21-2
may
contribute to
superior performance in future generations of
commercial products, and also to formulation enhancement in human
studies contemplated
for late
2021 and
2022. Additional work
pursuant to these studies is also expected that will evaluate impacts upon real-time blood pressure
in
animals at the
doses
studied.
HYPER-H21-1:
Regulatory
importation
clearance
was received for
the
clinical test articles for this human study which have arrived at
the European research site. Following this, recruitment
of
the
24
volunteers
with otherwise
untreated pre- or mild-hypertension has begun. Human dosing - using a single 300mg dose of
CBD with
or without
DehydraTECH
formulation
enhancement - is tentatively expected to be complete by May. A particular
DehydraTECH 2.0
formulation will be evaluated
in this
study. 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.
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
or
thereabouts, though preliminary
outcomes may be reported before
then.
HYPER-H21-2:
Formal
hospital and ethics
board applications
for this
upcoming European human clinical study
have been approved and test articles
are
expected
to
arrive
at
the
research
site as early as next
week. Following this, recruitment of 16 volunteers
will
commence soon in this study. A particular DehydraTECH 2.0
formulation will again be utilized
in this
study. As in HYPER-H21-1,
volunteers
will be pre-
or
mildly-hypertensive males
and
females
aged 45-70 years. In this study, however, volunteers
will consume
three separate doses
of 150mg of
DehydraTECH CBD or placebo
that will be
split over a 24-hr
period,
and be
monitored continuously
via
ambulatory
(portable)
monitoring
technology
throughout this
time. The primary objectives of this
study are blood pressure and heart
rate evaluation,
while the
secondary objectives include central
arterial
stiffness, physical activity and sleep
quality (e.g., total sleep time, total
wake time, and sleep efficiency). Once again, a large array of data
points
will be generated and analyzed and final reporting on this
study is likely to be reported
in
late
September or thereabouts, though preliminary
outcomes
may be
reported before
then.
HYPER-H21-3:
Formal hospital
and ethics board approvals for this
upcoming European human clinical study
have also been received and
test articles are also expected to arrive at the research site
as early
as next week. Following this,
16
volunteers
will be
recruited once recruitment in
studies HYPER-H21-1 and HYPER-H21-2 is complete. In a placebo-controlled
and
blinded design, a single 300mg dose of
a
particular DehydraTECH 2.0 CBD
formulation
will be
administered in this "Stress Test" study to examine its effect on acute pulmonary
hypertension. Exposure to
acute
reductions
in oxygen tension (i.e., hypoxia) causes rapid hypoxic pulmonary
vasoconstriction (HPV) and, as a consequence
of this HPV
response, pulmonary arterial
pressure increases.
If this
increase in pressure
becomes
too high, as is
the case in many cardiac pathologies,
an excess of fluid in the
lungs can
occur that
causes difficulty
with
breathing. The extent to which CBD
may
act as a novel treatment for
HPV,
and potentially as
an
alternative
treatment
for
pulmonary
hypertension,
is
unknown.
Thus, the
primary objective of this
study is
to evaluate the effect of
DehydraTECH CBD on pulmonary vascular
function in normotensive
individuals exposed to hypoxia. The magnitude of HPV, blood
pressure,
heart
rate, blood samples
(as per
HYPER-H21-1 , see above), and pulmonary gas exchange data will be collected and
analyzed. Details will be furnished at a future
date on
the likely
timing of reporting from this study once recruitment has begun.
The five studies in Lexaria's 2021
DehydraTECH CBD hypertension program
are
expected
to generate data required to further support the validity
of using
DehydraTECH CBD as a potential
anti-hypertension treatment
across
various prospective applications
to
the US$28
billion
annual
hypertension drug
market. In
addition,
direct
healthcare
costs for patients with pulmonary
arterial hypertension has been estimated at
between
US$29,712
and $142,500
per year. Lexaria holds 18 granted
patents
internationally,
including
issuances
in
the
European Union and Australia
specifically
to use DehydraTECH-processed
CBD to treat heart
disease.
Summary
Lexaria relies on applied R&D
programs to generate confirmatory results and data
evidencing
improved drug delivery
characteristics that enable pursuit of commercial opportunities and/or
corporate
relationships. As such, Lexaria
considers advancing these applied R&D studies to be a
vital early step toward its goal of
establishing
commercial relationships with potential
industry
partners
to utilize DehydraTECH within their
existing product lines or in the development of new
product lines.
All studies
referenced
within
this press release are fully funded from existing Company
resources.
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