LEXXW - Lexaria's Clinical Hypertension Study HYPER-H21-3 Nears Completion
(TheNewswire)
Kelowna, British Columbia – TheNewswire - December 14, 2021 – Lexaria Bioscience Corp. (Nasdaq:LEXX) (Nasdaq:LEXXW) (the“Company” or “Lexaria”), a global innovator in drug deliveryplatforms announces that its human clinical study HYPER-H21-3 isexpected to complete all dosing and sample collection this week.
Formal hospital and ethics board approvals for humanclinical study HYPER-H21-3 had been received in March. StudyHYPER-H21-3 used a placebo-controlled and blinded design, withadministration of a single 300mg dose of a specific DehydraTECH 2.0CBD formulation compared to placebo in a target group of sixteenenrolled volunteers. This “Stress Test” study was undertaken toexamine the effects of DehydraTECH-CBD upon acute pulmonaryhypertension. Blood samples collected from this study will besubjected to analysis and the blood pressure results are expected tobe reported soon.
Exposure to acute reductions in oxygen tension (i.e.,hypoxia) causes rapid hypoxic pulmonary vasoconstriction (HPV) and, asa consequence of this HPV response, pulmonary arterial pressureincreases. If this increase in pressure becomes too high, as is thecase in many cardiac pathologies, an excess of fluid in the lungs canoccur that causes difficulty with breathing.
The extent to which CBD may actas a novel treatment for HPV, and potentially as an alternativetreatment for pulmonary hypertension, is unknown. Thus, the primary objective of this study is to evaluate theeffect of DehydraTECH-CBD on pulmonary vascular function innormotensive individuals exposed to hypoxia. The magnitude of HPV,blood pressure, heart rate, blood samples and pulmonary gas exchangedata is being collected and analysis is ongoing.
Results from study HYPER-H21-3 are expected to add toLexaria’s growing body of evidence for the effectiveness ofDehydraTECH-CBD against hypertension, and will be submitted toregulators such as the FDA, as the Company pursues its planned investigational new drugresearch program . Lexaria offers itsgratitude to the teams of experts conducting its series of three humanclinical studies through 2021 overwhelmingly on schedule and on budgetparticularly during the past year when challenges from the COVID-19epidemic were pronounced.
About Lexaria Bioscience Corp.
Lexaria Bioscience Corp.’s patented drug deliverytechnology, DehydraTECH™, improves the way active pharmaceuticalingredients (APIs) enter the bloodstream by promoting more effectiveoral delivery. Since 2016, DehydraTECH has repeatedly demonstrated theability to increase bio-absorption withcannabinoids and nicotine by 5-10x and, in someinstances with cannabinoids by as much as 27x compared to standardindustry formulations, reduce time of onset from 1 – 2 hours tominutes, and mask unwanted tastes; and is also being evaluated fororally administered anti-viral drugs, non-steroidal anti-inflammatorydrugs (NSAIDs), PDE5 inhibitors and more. DehydraTECH has alsoevidenced an ability to deliver some drugs more effectively across theblood brain barrier. Lexaria operates a licensed in-house researchlaboratory and holds a robust intellectual property portfolio with 23patents granted and over 50 patents pending worldwide. For moreinformation, please visit www.lexariabioscience.com .
CAUTION REGARDING FORWARD-LOOKING STATEMENTS
This press releaseincludes forward-looking statements. Statements as such term isdefined under applicable securities laws. These statements may beidentified 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 arenot limited to, statements by the company relating the Company’sability to carry out research initiatives, receive regulatoryapprovals or grants or experience positive effects or results from anyresearch or study. Such forward-looking statements are estimatesreflecting the Company’s best judgment based upon currentinformation and involve a number of risks and uncertainties, and therecan be no assurance that the Company will actually achieve the plans,intentions, or expectations disclosed in these forward-lookingstatements. As such, you should not place undue reliance on theseforward-looking statements. Factors which could cause actualresults to differ materially from those estimated by the Companyinclude, but are not limited to, government regulation and regulatoryapprovals, managing and maintaining growth, the effect of adversepublicity, litigation, competition, scientific discovery, the patentapplication and approval process, potential adverse effects arisingfrom the testing or use of products utilizing the DehydraTECHtechnology, the Company’s ability to maintain existingcollaborations and realize the benefits thereof, delays orcancellations of planned R&D that could occur related to pandemicsor for other reasons, and other factors which may be identified fromtime to time in the Company’s public announcements and periodicfilings with the US Securities and Exchange Commission on EDGAR. Thereis no assurance that any of Lexaria’s postulated uses, benefits, oradvantages for the patented and patent-pending technology will in factbe realized in any manner or in any part. No statement herein has beenevaluated 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 containedin this release speak only as of the date hereof, and the Companyexpressly disclaims any obligation to update any forward-lookingstatements contained herein, whether as a result of any newinformation, future events, changed circumstances or otherwise, exceptas otherwise required by law.
George Jurcic - Headof Investor Relations
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