Full Press Release Details
Lexaria Bioscience Announces Further Advancement of Edibles
Delivery Measured Within Minutes
| Nicotine, in an edible form, delivered to blood plasma within minutes after dosing. | |
| Statistically significant positive in vivo results (n=40; two groups of 20 animals). | |
| 90.2% greater delivery by the 10-minute mark of the study (95% CI; p=0.044) than the study control, and significantly greater absorption levels than the control at all subsequent time points. | |
| This study represents Lexaria s second in vivo nicotine study, building on the previous nicotine breakthrough study announced April 17, 2018. |
Kelowna, British Columbia August 7, 2018 Lexaria Bioscience
Corp. (OTCQX: LXRP) (CSE: LXX) (the Company or Lexaria ), a drug delivery
platform innovator, announces that it has successfully delivered nicotine in an
edible form into blood plasma just minutes after dosing in an animal in
vivo study. Lexaria s DehydraTECH technology delivered nicotine at each of
the 2, 4, 6, 8 and 10-minute intervals post-dosing, with 90.2% greater delivery
than the concentration-matched control formulation by the 10-minute mark (95%
CI; p=0.044), and significantly greater absorption levels than the control
formulation at all subsequent time points in the study.
Speed of onset is a key attribute for oral drug administration,
and it is of particular importance for the consideration of non-inhalation
nicotine delivery formats.
Lexaria contracted a third-party laboratory to perform the
study which focused on detailed analysis of absorption over a 60-minute period,
with particular emphasis on the first 15-minutes after dosing (n=40; two groups
of 20 rats per group; nicotine polacrilex dosage at 10mg/kg). This study is in
follow-up to in vivo study results previously announced on April 17, 2018
which utilized a smaller animal population over a 6-hour period.
Key highlights are as follows:
| Peak Level: 79% improvement in peak blood levels (maximum concentration or Cmax ) at 394 ng/mL using Lexaria s DehydraTECH TM technology vs. 220 ng/mL with the control (95% CI; p=0.0257); | ||
| Total Quantity: 94% improvement in total quantity of nicotine delivered (area under the curve or AUC ) to the blood during the 60-minute course of the study, at 266 hr ng/mL versus 137 hr ng/mL (95% CI; p=0.0086); | ||
| Rapidity: Lexaria s technology delivered nicotine into the blood stream by the first time interval of blood sampling at the 2-minute mark. On average, Lexaria s technology delivered 203 ng/mL to the blood in aggregate of the 2, 4, 6, 8, 10, 12 and 15-minute time points, compared to only 120 ng/mL in aggregate over the same period by the control, an improvement of 70% (95% CI; p=0.0004). |
A significant amount of data has yet to be received and
analyzed from this study, including brain absorption data. The blood plasma data
from this nicotine study is considered statistically significant and corroborates and confirms the validity of the
results previously announced on April 17, 2018.
| DehydraTECH Formulation (nicotine polacrilex 10 mg/Kg) | Control Formulation (nicotine polacrilex 10 mg/Kg) | % Improvement | pValue | |
| Average Nicotine Blood Level 0-15 min (ng/mL) | 203 | 120 | 70 | 0.0004 |
| Peak Nicotine Blood Level 0-60 min (ng/mL) | 394 | 220 | 79 | 0.0257 |
| Total Nicotine Absorption (i.e., AUC) 0-60 min (hr ng/mL) | 266 | 137 | 94 | 0.0086 |
According to the CDC, global deaths from smoking are currently
6 million per year and expected to reach 8 million yearly by 2030. For every
fatality from smoking 30 more people live with serious smoking-related illness.
Lexaria s DehydraTECH breakthrough technology is
demonstrating significant effectiveness in delivering nicotine into the
bloodstream much more rapidly than we thought possible, and at levels
approaching two times more effective than controls, said Chris Bunka, Chief
Executive Officer of Lexaria Bioscience Corp. If we can develop viable
ingestible alternatives to cigarette smoking we could help hundreds of millions
of people avoid many of the disease states associated with smoking and I cannot
imagine a more rewarding destiny bestowed upon Lexaria Bioscience Corp.
Lexaria s in vitro laboratory, in vivo animal and
human clinical absorption studies have consistently shown faster delivery and
more effective delivery of substances such as nicotine and cannabinoids. Lexaria
continues to focus on advancing both its R&D and commercialization
initiatives with its DehydraTECHTM technology platform.
Lexaria Bioscience Corp. has developed
and out-licenses its disruptive delivery technology that promotes healthier
ingestion methods, lower overall dosing and higher effectiveness of lipophilic
active molecules. Lexaria has multiple patents pending in over 40 countries
around the world and has patents granted in the USA and in Australia for
utilization of its DehydraTECHTM delivery technology. Lexaria s
technology provides increases in intestinal absorption rates; more rapid
delivery to the bloodstream; and important taste-masking benefits, for orally
administered bioactive molecules including cannabinoids, vitamins, non-steroidal
anti-inflammatory drugs (NSAIDs), nicotine and other molecules.
For regular updates, connect with Lexaria on Twitter https://twitter.com/lexariacorp
and on Facebook https://www.facebook.com/lexariabioscience/
FOR FURTHER INFORMATION PLEASE CONTACT:
Alex Blanchard, Communications Manager
NetworkNewsWire (NNW)
FORWARD-LOOKING STATEMENTS
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forward-looking statements. Statements which are not historical facts are
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include, but are not limited to, government regulation, managing and maintaining
growth, the effect of adverse publicity, litigation, competition, the patent
application and approval process and other factors which may be identified from
time to time in the Company's public announcements and filings. There is no
assurance that existing capital is sufficient for the Company's needs or that it
will be able to raise additional capital. There is no assurance that Lexaria
will successfully complete any other contemplated or existing technology license
agreements; or that results from any studies will be favorable or in any way
support future business activities of any kind. Scientific R&D is often
unpredictable and unanticipated results could emerge from any study and have a
material impact as can any results that cannot be reproduced in subsequent
testing. There is no assurance that any planned corporate activity, scientific
study, R&D, business venture, or initiative will be pursued, or if pursued,
will be successful. 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). TurboCBDTM,
DehydraTECHTM technology and ViPovaTM products are not
intended to diagnose, treat, cure or prevent any disease.
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