LXRP - Lexaria Receives Conditional Ethics Board Approval for Pilot Human Study Using its DehydraTECH technology in Delivering Antiviral Drugs
(TheNewswire)
Company Raises Commitment to Antiviral Research with Launch ofRodent Antiviral Drug Delivery Study with Potential COVID-19Applications
Kelowna, British Columbia - TheNewswire - September 29, 2020 -Lexaria Bioscience Corp. (OTC:LXRP) (CSE:LXX) (the "Company"or "Lexaria"), a global innovator in drug deliveryplatforms, today provides an update on apreviously announced antiviral research initiative and introduces anew research project with potential COVID-19 applications.
On March 19 2020, Lexaria announced that it planned toconduct a pilot human pharmacokinetic exploratory study in healthyvolunteers of antiviral drugs that have previously been studiedagainst other coronavirus strains, comparing Lexaria's DehydraTECH TM formulations to controls without Lexaria's technology.
The ethics board approval required as a first step inthis pilot study has now been received, conditional on furthergovernment regulatory approval also being granted. Lexaria will nowbegin the process of pursuing the necessary steps to file for approvalfrom federal regulators.
In parallel with this, Lexaria is also announcing thelaunch of a separate rodent antiviral study to evaluatepharmacokinetic benefits from the use of DehydraTECH in the deliveryof representative drugs from two classes of antiviral drugs heavilyunder investigation against COVID-19 today. The drugs to be used havealready been processed with DehydraTECH and sent to the testingfacility. Dosing of the rodents has already begun and study resultsare expected in December 2020.
"We are excited at this progress towards our pilothuman study using our patented DehydraTECH platform in the delivery ofantiviral drugs, and are continuing the process towards regulatoryapproval so we can advance this important study," said ChrisBunka, CEO of Lexaria. "Additionally, we are pleased to havestarted an animal study using DehydraTECH on certain potentialCOVID-19 drugs under investigation. Not only will this study help todetermine whether DehydraTECH is capable of delivering higherproportionate doses of the antiviral drugs than generic versions ofthe drugs, but the outcomes should also be beneficial in gainingregulatory approval for the planned human study."
As background, many antiviral drugs are fat soluble and known to present significant bioavailabilitychallenges in successfully reaching the human bloodstream intherapeutic quantities when administered in oral form. Lexaria'sexpertise in the enhanced oral delivery of fat-soluble drugs couldoffer significant benefits to antiviral drug administration thatpotentially could remove the need for costly and uncomfortableinjected treatments frequently used today.
Additional research may include expandedpharmacokinetic and pharmacodynamic screening, including studies inappropriate coronavirus animal models with the antiviral drugs Lexariais currently investigating and/or others from their classes forefficacy evaluation. If Lexaria's technology is proven to increasedelivery effectiveness of antiviral drugs, the Company will make its technology available to researchersthroughout the world looking to maximize the effectiveness of theirown drug investigations.
Enhancement of delivery properties of antiviral drugsis consistent with Lexaria's strategy as a drug delivery platforminnovator for multiple applications. The Company believes DehydraTECHmay prove useful in the fight against COVID-19 and other viruses thatare expected to be investigated in the future. Chris Bunka, CEO, isresponsible for the accuracy of this news. The Company is not making any express or implied claims thatits product has the ability to eliminate, cure or contain the Covid-19(or SARS-2 Coronavirus) at this time.
About Lexaria
Lexaria Bioscience Corp.'s (OTCQX: LXRP, CSE: LXX)proprietary drug delivery technology, DehydraTECH(TM), improves theway active pharmaceutical ingredients (APIs) enter the bloodstream bypromoting healthier ingestion methods and increasing the effectivenessof fat-soluble active molecules, thereby lowering overall dosing. TheCompany's technology can be applied to many different ingestibleproduct formats, including foods, beverages, oral suspensions,tablets, and capsules. DehydraTECH increases bio-absorption by up to5-10x, reduces time of onset from 1 - 2 hours to 10 - 20 minutes, andmasks unwanted tastes for orally administered bioactive molecules,including anti-virals, cannabinoids, vitamins, non-steroidalanti-inflammatory drugs (NSAIDs), nicotine, and other molecules.Lexaria has licensed DehydraTECH to multiple companies including aworld-leading tobacco producer for the development of smokeless,oral-based nicotine products and for use in industries that producecannabinoid beverages, edibles, and oral products. Lexaria operates alicensed in-house research laboratory and holds a robust intellectualproperty portfolio with 16 patents granted and over 60 patents pendingworldwide. For more information, please visit www.lexariabioscience.com.
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FORWARD-LOOKINGSTATEMENTS
This release includes forward-looking statements. Statements as suchterm is defined under applicable securities laws. These statements maybe identified by words such as "anticipate," "if,""believe," "plan," "estimate,""expect," "intend," "may,""could," "should," "will," and othersimilar expressions. Such forward-looking statements in this pressrelease include, but are not limited to, statements by the companyrelating the Company's ability to carry out the antiviral researchinitiatives, receive regulatory approvals or experience positiveeffects from any antiviral research or study.. Such forward-lookingstatements are estimates reflecting the Company's best judgment basedupon current information and involve a number of risks anduncertainties, and there can be no assurance that the Company willactually achieve the plans, intentions, or expectations disclosed inthese forward-looking statements. As such, you should not place unduereliance on these forward-looking statements. Factors which couldcause actual results to differ materially from those estimated by theCompany include, but are not limited to, government regulation andregulatory approvals, managing and maintaining growth, the effect ofadverse publicity, litigation, competition, scientific discovery, thepatent application and approval process, potential adverse effectsarising from the testing or use of products utilizing the DehydraTECHtechnology, the Company's ability to maintain existing collaborationsand realize the benefits thereof, and other factors which may beidentified from time to time in the Company's public announcements andperiodic filings with the US Securities and Exchange Commission onEDGAR. There is no assurance that existing capital is sufficient forthe Company's needs or that it will be able to raise additionalcapital. There is no assurance the Company will be capable ofdeveloping, marketing, licensing, or selling edible productscontaining any active ingredient. There is no assurance that anyplanned corporate activity, scientific research or study, businessventure, letter of intent, technology licensing pursuit, patentapplication or allowance, consumer study, or any initiative will bepursued, or if pursued, will be successful. There is no assurance thatany of Lexaria's postulated uses, benefits, or advantages for thepatented and patent-pending technology will in fact be realized in anymanner or in any part. No statement herein has been evaluated by theFood and Drug Administration (FDA). Lexaria-associated products arenot intended to diagnose, treat, cure or prevent any disease.
Any forward-looking statements contained in this release speak only asof the date hereof, and the Company expressly disclaims any obligationto update any forward-looking statements contained herein, whether asa result of any new information, future events, changed circumstancesor otherwise, except as otherwise required by law.
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