KELOWNA, BC / June 6, 2022 / Lexaria Bioscience Corp. (Nasdaq:LEXX)(Nasdaq:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms is pleased to announce it has successfully filed a pre-Investigational New Drug ("IND") meeting request letter with the U.S. Food and Drug Administration ("FDA"). The FDA has already responded to and confirmed Lexaria's filing. A target date of July 30, 2022, has been provided to Lexaria, subject to certain conditions being met.

The request for a pre-IND meeting formally initiates communications with the FDA regarding development of Lexaria's DehydraTECH-CBD for the treatment of hypertension. The purpose of the pre-IND meeting will be to confirm the details and acceptability of Lexaria's ongoing IND-enabling development program to be completed thereafter prior to proceeding with its full IND application filing expected in late 2022 / early 2023.

"We are excited to take this important first regulatory step with the FDA for the development of our DehydraTECH-CBD for the treatment of hypertension," said John Docherty, President of Lexaria. "Submission of this request letter initiates formal communication with the FDA regarding our IND clinical trial plans, in order to help define the critical path for clinical development and marketing approval of our potentially very significant new hypertension therapeutic."

In pre-clinical and exploratory clinical studies conducted to-date, Lexaria has repeatedly evidenced efficacy in utilizing DehydraTECH-CBD to reduce blood pressure while avoiding negative serious adverse effects. Efficacy and lack of negative side effects are two major objectives of FDA-registered clinical studies.

Lexaria will update progress on its FDA program for DehydraTECH-CBD when there are material developments.

About DehydraTECH-CBD

DehydraTECH-CBD is a unique CBD formulation Lexaria has developed and is optimizing based on its patented and proprietary DehydraTECH drug delivery technology. DehydraTECH is designed to improve the way active molecules enter the bloodstream upon oral ingestion. DehydraTECH has also demonstrated enhanced delivery of certain active molecules including CBD into brain tissue, which Lexaria believes to be of particular importance for the effectiveness of its DehydraTECH-CBD specifically against hypertension because of the significant influence of central mediation upon blood pressure. Lexaria has also developed DehydraTECH-CBD formulations for other applications demonstrating superior bio-absorption when administered intraorally and topically.

Hypertension Markets

The hypertension market is valued at $28 billion per year and is expected to continue growing as one of the world's top health problems and as a subset of the larger heart disease market. Geographically, some of the highest rates of growth are expected in more recently industrialized nations such as China and India. Over 1.1 billion people worldwide suffer from hypertension.

Fewer than 1 person in 4 with hypertension have successfully controlled their blood pressure through medications, meaning the potential market for hypertension drugs is much larger than $28 billion per year if an affordable drug was available with few or no side effects. Lexaria believes that its DehydraTECH-CBD may introduce a more tolerable anti-hypertensive treatment option that may be used alone or in combination with other medications, to reduce blood pressure with fewer discouraging and unwanted side effects. Lexaria would seek to satisfy this currently unmet demand and in doing so could expand the overall hypertension market.

Among persons 50 years of age or older, isolated systolic hypertension is the most common form of hypertension, and systolic blood pressure becomes more important than diastolic blood pressure as an independent risk predictor for coronary events, stroke, heart failure, and end-stage renal disease (ESRD). The Global Burden of Disease Study identified elevated blood pressure as the leading risk factor, among 67 studied, for death and disability-adjusted life-years lost during 2010.

Drugs focused on blood pressure and related conditions are some of the highest selling drugs in the world. Lipitor, used to treat high cholesterol and reduce the risk of heart disease, has generated $94.7 billion in revenue from 1992 until 2017. Plavix, used to prevent heart attack and stroke, has sold $46.5 billion from 1992 until 2017. There are several hypertension drugs that each generate $1 billion per year or more in revenue.

About Lexaria Bioscience Corp.

Lexaria Bioscience Corp.'s patented drug delivery technology, DehydraTECH™, improves the way active pharmaceutical ingredients (APIs) enter the bloodstream by promoting more effective oral delivery. Since 2016, DehydraTECH has repeatedly demonstrated the ability to increase bio-absorption with cannabinoids, antiviral drugs, PDE5 inhibitors and more. DehydraTECH has also evidenced an ability to deliver some drugs more effectively across the blood brain barrier. Lexaria operates a licensed in-house research laboratory and holds a robust intellectual property portfolio with 25 patents granted and over 50 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.

INVESTOR CONTACT:

George Jurcic - Head of Investor Relations
[email protected]
Phone: 250-765-6424, ext 202

SOURCE: Lexaria Bioscience Corp.



View source version on accesswire.com:
https://www.accesswire.com/703931/Lexaria-Files-Pre-IND-Meeting-Request-Letter-with-US-FDA

  • Minimum payments due to Lexaria of US$4,527,500 over the first five years to retain exclusivity
  • Lexaria to receive royalty revenue from DehydraTECH product sales

KELOWNA, BC / June 2, 2022 / Lexaria Bioscience Corp. (NASDAQ:LEXX) (NASDAQ:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms is pleased to announce a significant exclusive* commercial licensing agreement (the "Agreement") in Japan with Premier Wellness Science Co., Ltd., ("Premier").

Under the terms of the Agreement, Premier is purchasing the rights to DehydraTECH technology for the Japanese non-pharmaceutical market for use with CBD and hemp ingredients in oral liquid and non-liquid products, as well as for topical, hair-care, lip-care and cosmetics products. Premier is a wholly-owned subsidiary of Premier Anti-Aging Co., Ltd. ("Parent") which is listed on the Tokyo Stock Exchange Mothers division with securities code 4934.

"Premier conducted a global competition to evaluate the world's most advanced molecule delivery technologies, and selected Lexaria's DehydraTECH technology based on its superior performance and the extensive data available through Lexaria's years of testing," said Shinji Shosoyama, CEO of Premier.

"Lexaria is delighted to be working with Premier Wellness Science which we expect will dominate the newly opening Japanese market for CBD-based products," said Chris Bunka, CEO of Lexaria. "Premier and Lexaria share similar philosophies, such as the provision of world-leading products created through scientific advantages and placing the consumer's needs ahead of our own. We could not have found a better partner with which to introduce DehydraTECH-enabled products to the Japanese markets."

In order to retain ongoing exclusivity, the negotiated minimum quarterly payments ("Payments") to Lexaria begin September 1, 2022 and, during the first five years of the Agreement, amount to US$4,527,500. Assuming that Premier continues to submit all required payments, the license for the Japanese market is perpetual.

In addition to the Payments, Lexaria will also receive royalty revenue from DehydraTECH licensed product sales, the terms of which have been agreed to. Total revenue is expected to be significantly greater than the minimum Payments if Premier is capable of meeting its expected revenue targets. If Premier achieves even their worst-case projected penetration into the Japanese non-pharmaceutical CBD market, then based on their projections Lexaria could expect to receive annual payments of over $5 million by the fifth year of the contract.

Premier's Parent had revenues of approximately US$187,000,000 in the first three quarters of fiscal 2021 with year-over-year revenue growth of 63.1% and strong profit margins. Parent sells over 45 product SKU's across four brands, and these products are sold in more than 16,000 retail stores as well as directly through mail/web order to over 2.6 million proprietary members. The overall Japanese cosmetics and personal products markets are estimated to be more than US$35 billion in annual sales.

As well, Lexaria and Premier have agreed to examine on a case-by-case basis the possibility of entering research and development collaborations related to advanced formulation science. Premier and Parent have long-established scientific relationships with some of the leading scientists in relevant fields in Japan.

This Agreement with Premier follows the awarding of two issued patents by the Japan Patent Office for DehydraTECH technology in Japan, strengthening Lexaria's long-held beliefs that new patent protection is a vital component of entering commercial agreements.

*The exclusive rights are subject to two previously issued licenses for use of DehydraTECH in Japan, which remain valid. Lexaria will not be issuing any further licenses in Japan for non-pharmaceutical cannabinoid products.

About Premier Wellness Science Co., Ltd.

Premier Wellness Science Co., Ltd. is focused on the well-being of its customers that leads to good physical, mental and social health. The company seeks to achieve precision, individualized growth in health through a scientific approach to creating the highest performance products in the world.

About Premier Anti-Aging Co., Ltd.

Premier Anti-Aging Co., Ltd. engages in the planning, development, import/export, mail order, wholesale, and retail business of cosmetics and health foods. The company offers its cosmetic products under the DUO and CANADEL brands. It is also involved on the information provision and consulting services related to anti-aging, beauty, and health; research on management and beauty of beauty clinics, etc.; and marketing research and collection and analysis of various information. The company was founded in 2009 and is headquartered in Tokyo, Japan.

About Lexaria Bioscience Corp.

Lexaria Bioscience Corp.'s patented drug delivery technology, DehydraTECH™, improves the way active pharmaceutical ingredients (APIs) enter the bloodstream by promoting more effective oral delivery. Since 2016, DehydraTECH has repeatedly demonstrated the ability to increase bio-absorption with cannabinoids, antiviral drugs, PDE5 inhibitors and more. DehydraTECH has also evidenced an ability to deliver some drugs more effectively across the blood brain barrier. Lexaria operates a licensed in-house research laboratory and holds a robust intellectual property portfolio with 25 patents granted and over 50 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.

INVESTOR CONTACT:

George Jurcic - Head of Investor Relations
[email protected]
Phone: 250-765-6424, ext 202

SOURCE: Lexaria Bioscience Corp.



View source version on accesswire.com:
https://www.accesswire.com/703811/Lexaria-Grants-Exclusive-License-to-Premier-Wellness-Science-Co-Ltd-for-Strategic-and-Long-Term-Partnership-in-the-Japanese-Market

  • Contract Manufacturing Organization first in Europe to License DehydraTECH
  • Lexaria will receive milestone fees and royalty payments from product sales

KELOWNA, BC / June 2, 2022 / Lexaria Bioscience Corp. (Nasdaq:LEXX) (Nasdaq:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms is pleased to announce the awarding of a European and United Kingdom ("UK") DehydraTECH license for medical cannabis applications from Lexaria Pharmaceutical Corp. to Valcon Medical A/S ("Valcon").

Valcon Medical is a European contract manufacturing organization ("CMO"), specialized in the manufacturing of medical cannabis extracts for the European Union ("EU") and the UK. Valcon is GMP certified and licensed under the Danish medical cannabis program to manufacture cannabis products that require physician-patient consultation.

Valcon products will span non-registered medical products through magistral programs, country-level market-authorized medical cannabis products through pilot programs, and country and/or EU Commission registered medical cannabis products. These products include bulk powders or solid oral dosage forms including, but not limited to, powder-filled capsules, compressed tablets, pills, oral melts, and topical creams and lotions with or without patch integration.

The non-exclusive license includes a combination of defined milestone fees payable to Lexaria upon completion of batch validation and marketing authorization application approvals for the first DehydraTECH-enabled products completed by Valcon for each of several product categories it shall pursue, together with defined royalties payable to Lexaria on revenues generated from Valcon's product sales.

"We are very excited to have licensed Lexaria's DehydraTECH technology for what we expect will be rapid growth across the European markets," said Pete Patterson, CEO of Valcon Medical A/S. "As Valcon continues to build out its manufacturing capabilities we are developing new IP and partnering with industry leaders. Lexaria has developed and patented an incredible technology which will benefit medical cannabis patients with enhanced bioavailability with a quicker effect onset. Backed by substantial clinical efficacy studies, Valcon will bridge the extensive work that Lexaria has done in the US, over to Europe."

Lexaria notes the potential for growth in utilization of DehydraTECH across these European markets given the advanced technical capabilities of Valcon, and their business focus on providing CMO services to a wide spectrum of companies active in the EU.

About Valcon Medical A/S

Founded in 2018, Valcon Medical is the most advanced medical cannabis manufacturer in its field in Europe and leads the cannabis industry in manufacturing capacity and production of the highest quality full spectrum extracts and API cannabinoid isolates. Valcon Medical is supported by a shareholder group comprised of some of the leading cannabis investment funds in the world, including Altitude Capital, Artemis Growth Partners, Enexis AB, Greenfield Global Opportunities, and Nimb Capital.

About Lexaria Bioscience Corp.

Lexaria Bioscience Corp.'s patented drug delivery technology, DehydraTECH™, improves the way active pharmaceutical ingredients (APIs) enter the bloodstream by promoting more effective oral delivery. Since 2016, DehydraTECH has repeatedly demonstrated the ability to increase bio-absorption with cannabinoids and nicotine by 5-10x and, in some instances with cannabinoids by as much as 27x compared to standard industry formulations, reduce time of onset from 1 - 2 hours to minutes, and mask unwanted tastes; and is also being evaluated for orally administered antiviral drugs, non-steroidal anti-inflammatory drugs (NSAIDs), PDE5 inhibitors and more. DehydraTECH has also evidenced an ability to deliver some drugs more effectively across the blood brain barrier. Lexaria operates a licensed in-house research laboratory and holds a robust intellectual property portfolio with 25 patents granted and over 50 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.

INVESTOR CONTACT:
George Jurcic - Head of Investor Relations
[email protected]
Phone: 250-765-6424, ext 202

SOURCE: Lexaria Bioscience Corp.



View source version on accesswire.com:
https://www.accesswire.com/703612/Lexaria-Grants-License-to-Valcon-Medical-for-the-European-Market

KELOWNA, BC / June 1, 2022 / Lexaria Bioscience Corp. (NASDAQ:LEXX)(NASDAQ:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms announces the results of the 2022 Annual Meeting (the "Meeting").

On May 31, 2022 at 1:00 p.m. (Pacific Time), the Company held the Meeting whereby there were 2,927,321 shares of the Company represented in person or by proxy at the meeting, constituting 49.2% of the Company's issued share capital as at April 4, 2022, being the record date of the Meeting. The matters voted upon at the Meeting and the final voting results are set forth below:

Matter Being Voted On

For

Against/

Withheld

Abstain

Broker Non-Vote

Percent

Approved By1

To Elect Chris Bunka as a director

1,708,178

49,986

0

1,169,157

97.15%

To Elect John Docherty as a director

1,533,997

224,167

0

1,169,157

87.25%

To Elect Nicholas Baxter as a director

1,485,669

272,495

0

1,169,157

84.5%

To Elect Ted McKechnie as a director

1,689,378

68,786

0

1,169,157

96.1%

To Elect Albert Reese Jr. as a director

1,697,646

60,518

0

1,169,157

96.56%

To Appoint Davidson & Company LLP as Auditors

2,891,381

13,634

22,306

0

98.77%

To Approve, on an advisory non-binding basis, the compensation paid to the executive officers in the 2021 fiscal year

1,644,229

86,673

27,262

1,169,157

93.52%

To ratify the lawful actions of the directors for the past year

1,601,239

126,568

30,357

1,169,157

91.1%

1 Percentage is calculated based on abstained votes being counted as a vote against the resolution

All of the proposals are described in detail in the Company's proxy statement filed with the Securities Exchange Commission via Edgar and with the BC Securities Commission and Ontario Securities Commission via SEDAR on April 13, 2022.

About Lexaria Bioscience Corp.

Lexaria Bioscience Corp.'s patented drug delivery technology, DehydraTECH™, improves the way active pharmaceutical ingredients (APIs) enter the bloodstream by promoting more effective oral delivery. Since 2016, DehydraTECH has repeatedly demonstrated the ability to increase bio-absorption with cannabinoids, antiviral drugs, PDE5 inhibitors and more. DehydraTECH has also evidenced an ability to deliver some drugs more effectively across the blood brain barrier. Lexaria operates a licensed in-house research laboratory and holds a robust intellectual property portfolio with 25 patents granted and over 50 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.

INVESTOR CONTACT:

George Jurcic - Head of Investor Relations
[email protected]
Phone: 250-765-6424, ext 202

SOURCE: Lexaria Bioscience Corp.



View source version on accesswire.com:
https://www.accesswire.com/703491/Lexaria-Announces-2022-Annual-Meeting-Results

NEW YORK, May 26, 2022 -- NetworkNewsAudio - Lexaria Bioscience Corp. (NASDAQ: LEXX) announces the availability of a broadcast titled, "Nicotine Surges as Smoking Sags."

To hear the AudioPressRelease, please visit: The NetworkNewsAudio News Podcast

To view the full editorial, please visit: https://nnw.fm/WNblw

The fact remains that an estimated 1.1 billion people smoked cigarettes in 2019. According to stats from the World Health Organization, a stunning 780 million people said they want to quit. As a result, people look to a multitude of options, such as nicotine pouches, boosting the market from $2.33 billion in 2020 with an eye-popping 30.7% annual growth rate to $21.84 billion by the end of 2027, according to MarketResearch.com.

This is an opportunity that lands right in the wheelhouse of Lexaria Bioscience Corp. (NASDAQ: LEXX). The company has been developing its DehydraTECH technology since 2014, regularly strengthening and broadening the technology to an unprecedented degree. The company now stands as a global leader in enhancing the speed and efficiency of orally delivered lipophilic (fat-soluble) drugs and active pharmaceutical ingredients (APIs). The company has protected its intellectual property with a robust patent portfolio that currently consists of 25 patents granted in more than 40 countries, as well as another 50 patents pending worldwide

About Lexaria Bioscience Corp.

Lexaria's patented drug delivery technology, DehydraTECH(TM), improves the way active pharmaceutical ingredients ("APIs") enter the bloodstream by promoting more effective oral delivery. Since 2016, DehydraTECH has repeatedly demonstrated the ability to increase bioabsorption with cannabinoids and nicotine by up to five to ten times, reduce time of onset from one to two hours to minutes, and mask unwanted tastes; the innovative tech is also being evaluated for orally administered anti-viral drugs, nonsteroidal anti-inflammatory drugs ("NSAIDs"), PDE5 inhibitors and more. DehydraTECH has also evidenced an ability to deliver some drugs more effectively across the blood brain barrier. Lexaria operates a licensed in-house research laboratory and holds a robust intellectual property portfolio with 25 patents granted and more than 50 patents pending worldwide.

For more information about the company, please visit www.LexariaBioscience.com.

NOTE TO INVESTORS: The latest news and updates relating to LEXX are available in the company's newsroom at https://ibn.fm/LEXX

About NetworkNewsWire

NetworkNewsWire (NNW) is an information service that provides (1) access to our news aggregation and syndication servers, (2) NetworkNewsBreaks that summarize corporate news and information, (3) enhanced press release services, (4) social media distribution and optimization services, and (5) a full array of corporate communication solutions. As a multifaceted financial news and content distribution company with an extensive team of contributing journalists and writers, NNW is uniquely positioned to best serve private and public companies that desire to reach a wide audience of investors, consumers, journalists and the general public. NNW has an ever-growing distribution network of more than 5,000 key syndication outlets across the country. By cutting through the overload of information in today's market, NNW brings its clients unparalleled visibility, recognition and brand awareness. NNW is where news, content and information converge.

To receive SMS text alerts from NetworkNewsWire, text "STOCKS" to 77948 (U.S. Mobile Phones Only)
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NEW YORK, May 25, 2022 -- via InvestorWire - Lexaria Bioscience Corp. (NASDAQ: LEXX) today announces its placement in an editorial published by NetworkNewsWire ("NNW"), one of 50+ trusted brands within the InvestorBrandNetwork ("IBN"), a multifaceted financial news and publishing company for private and public entities.

To view the full publication, "Nicotine Surges as Smoking Sags," please visit: https://nnw.fm/WNblw

Seems like yesterday people were smoking cigarettes everywhere; many people still have memories of Grandpa puffing on his Camels. It wasn't until 1993 that smoking was banned in hospitals and on airplanes in 1998. Despite these and many other restrictions, the global market for nicotine-based products remains incredibly robust. Total global retail sales associated with the nicotine ecosystem during 2020 reached approximately $853 billion with around 5.2 trillion retail cigarette sticks sold. Nicotine isn't just big business, it's huge business, and companies are constantly looking for ways to keep and grow market share.

The majors are evermore turning to innovation and alternative delivery methods to achieve their objectives. An example of that is the breakthrough technology of Lexaria Bioscience Corp. (NASDAQ: LEXX) and its patented DehydraTECH(TM) delivery platform. Suitable for use across a wide range of product formats such as pharmaceuticals, nutraceuticals and over-the-counter products, Lexaria's DehydraTECH also increases the delivery characteristics of orally administered nicotine.

About Lexaria Bioscience Corp.

Lexaria's patented drug delivery technology, DehydraTECH(TM), improves the way active pharmaceutical ingredients ("APIs") enter the bloodstream by promoting more effective oral delivery. Since 2016, DehydraTECH has repeatedly demonstrated the ability to increase bioabsorption with cannabinoids and nicotine by up to five to ten times, reduce time of onset from one to two hours to minutes, and mask unwanted tastes; the innovative tech is also being evaluated for orally administered anti-viral drugs, nonsteroidal anti-inflammatory drugs ("NSAIDs"), PDE5 inhibitors and more. DehydraTECH has also evidenced an ability to deliver some drugs more effectively across the blood brain barrier. Lexaria operates a licensed in-house research laboratory and holds a robust intellectual property portfolio with 25 patents granted and more than 50 patents pending worldwide.

For more information about the company, visit at www.LexariaBioscience.com.

NOTE TO INVESTORS: The latest news and updates relating to LEXX are available in the company's newsroom at https://ibn.fm/LEXX

About NetworkNewsWire

NetworkNewsWire (NNW) is an information service that provides (1) access to our news aggregation and syndication servers, (2) NetworkNewsBreaks that summarize corporate news and information, (3) enhanced press release services, (4) social media distribution and optimization services, and (5) a full array of corporate communication solutions. As a multifaceted financial news and content distribution company with an extensive team of contributing journalists and writers, NNW is uniquely positioned to best serve private and public companies that desire to reach a wide audience of investors, consumers, journalists and the general public. NNW has an ever-growing distribution network of more than 5,000 key syndication outlets across the country. By cutting through the overload of information in today's market, NNW brings its clients unparalleled visibility, recognition and brand awareness.

NNW is where news, content and information converge.

To receive SMS text alerts from NetworkNewsWire, text "STOCKS" to 77948 (U.S. Mobile Phones Only)
For more information please visit https://www.NetworkNewsWire.com

Please see full terms of use and disclaimers on the NetworkNewsWire website applicable to all content provided by NNW, wherever published or re-published: http://NNW.fm/Disclaimer

NetworkNewsWire (NNW)
New York, New York
www.NetworkNewsWire.com
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[email protected]

NetworkNewsWire is part of the InvestorBrandNetwork


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  • 25th patent grant is Lexaria's first-ever patent for the enhanced delivery of antivirals

KELOWNA, BC / April 21, 2022 / Lexaria Bioscience Corp. (NASDAQ:LEXX) (NASDAQ:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms announces the Company is receiving its first-ever patent for the use of DehydraTECH technology in the enhanced delivery of antiviral drugs.

Lexaria has received notification from the United States Patent and Trademark Office that patent 11,311,559 for Compositions and Methods For Enhanced Delivery Of Antiviral Agents will be issued to the Company on April 26, 2022.

"This will be our 25th patent granted worldwide and another validation of the versatility of our DehydraTECH drug delivery technology," said Chris Bunka, CEO of Lexaria. "This new patent adds to our existing suite of granted patents in the EU, the U.S., India, Japan and Australia, and continues to build value for Lexaria shareholders and clients."

Lexaria previously announced that remdesivir and ebastine processed with DehydraTECH were effective at inhibiting the COVID-19/SARS-CoV-2 virus using an in vitro screening assay in infected cells in study VIRAL-C21-3. Lexaria separately demonstrated that antiviral drugs processed with DehydraTECH were able to reach peak blood concentration levels that were double those of non-DehydraTECH-processed; and overall volumes of drug delivered into bloodstream were up to triple the amount compared to non-DehydraTECH-processed drugs.

As evidenced with other drugs that Lexaria has investigated, the award of intellectual property protection is a key step towards ultimately monetizing Lexaria's revolutionary DehydraTECH drug delivery technology. This is Lexaria's 25th granted patent and the 10th granted in the U.S. Lexaria continues to file new patent applications as its research and development programs uncover new discoveries.

About Lexaria Bioscience Corp.

Lexaria Bioscience Corp.'s patented drug delivery technology, DehydraTECH™, improves the way active pharmaceutical ingredients (APIs) enter the bloodstream by promoting more effective oral delivery. Since 2016, DehydraTECH has repeatedly demonstrated the ability to increase bio-absorption with cannabinoids and nicotine by 5-10x and, in some instances with cannabinoids by as much as 27x compared to standard industry formulations, reduce time of onset from 1 - 2 hours to minutes, and mask unwanted tastes; and is also being evaluated for orally administered antiviral drugs, non-steroidal anti-inflammatory drugs (NSAIDs), PDE5 inhibitors and more. DehydraTECH has also evidenced an ability to deliver some drugs more effectively across the blood brain barrier. Lexaria operates a licensed in-house research laboratory and holds a robust intellectual property portfolio with 25 patents granted and over 50 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.

INVESTOR CONTACT:
George Jurcic - Head of Investor Relations
[email protected]
Phone: 250-765-6424, ext 202

SOURCE: Lexaria Bioscience Corp.



View source version on accesswire.com:
https://www.accesswire.com/698264/Lexaria-Granted-Patent-for-Use-of-DehydraTECH-to-Deliver-Antiviral-Drugs

  • HYPER-H21-4 will evaluate DehydraTECHTM-CBD for reducing blood pressure together with other potential clinical benefits
  • This study is designed to enhance Lexaria's probabilities of success with its expected subsequent Investigational New Drug application filing

KELOWNA, BC / April 19, 2022 / Lexaria Bioscience Corp. (NASDAQ:LEXX) (NASDAQ:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms, is pleased to announce that it has begun its multi-week human clinical hypertension study.

The study, HYPER-H21-4, is a randomized, double blinded, placebo-controlled, cross-over study in 60 people and the most comprehensive study ever undertaken by Lexaria. Dosing in more than half the volunteers has already commenced ahead of schedule, with all treatment visits expected to conclude in early July, 2022. Baseline brain magnetic resonance imaging ("MRI") scanning has also already begun. Of significant note, there have been no serious adverse events reported by these volunteers, demonstrating that DehydraTECH-CBD has been well tolerated in those that have received it thus far.

HYPER-H21-4 is designed to enhance Lexaria's probability of success with its expected subsequent Investigational New Drug ("IND") application filing to seek Food and Drug Administration ("FDA") approval to commence registered clinical testing at the Phase I level or higher, to be determined in consultation with the FDA. This human study is also expected to enhance Lexaria's understanding of DehydraTECH-CBD for the treatment of cardiovascular and other disease states beyond hypertension related to increased arterial stiffness, pursuant to earlier promising findings in this area. HYPER-H21-4 follows Lexaria's previously announced successes in significantly reducing blood pressure in similarly hypertensive human volunteers in its 2021 studies HYPER-H21-1 and HYPER-H21-2.

This study is entirely funded through the Company's existing cash resources and is not subject to any financing requirement. Independent Review Board approval was received in December 2021. The clinical test articles for this study have been manufactured, quality control tested and shipped to the European research hospital conducting the study.

HYPER-H21-4 consists of a minimum of 60 volunteers between the ages of 40-70 with documented or measured elevated blood pressure (120/80 to 139/80 mmHg), mild (stage 1) hypertension (140/90 to 159/99 mmHg) or moderate (stage 2) hypertension (160/100 to 179/109 mmHg) who will use DehydraTECH-CBD every day for a 5-week duration. DehydraTECH-CBD doses will escalate between a range of 225 mg/day to 450 mg/day over the study duration. Some volunteers will already be using leading standard of care hypertension drugs such as angiotensin-converting enzyme ("ACE") inhibitors with or without diuretics and/or calcium channel blockers, which will help evaluate the efficacy of DehydraTECH-CBD with and without other hypertension treatments. The extended duration of the study will allow Lexaria to gather critical data monitoring the safety and efficacy of DehydraTECH-CBD over time and will evaluate the potential for longer term health benefits.

HYPER-H21-4 is more comprehensive than any work previously undertaken by Lexaria and many types of analysis will be performed including 24-hour ambulatory blood pressure, which is the primary study outcome.

Secondary study outcomes include: vascular health including arterial stiffness and autonomic balance; electrocardiogram ("ECG") analysis; brain structure and function through MRI testing; blood biomarkers (including lipids such as cholesterol and more); renal and hepatic analysis, sleep quality / daytime sleepiness / sleep disorders; actigraphy, geriatric depression scale, perceived stress, and Beck anxiety inventory. Each of these sets of data may lead to additional applications for DehydraTECH-CBD. For example, the MRI data may assist one of the secondary outcome measurements in the study to evaluate possible positive effects upon brain structure and function; and the detailed psychometric testing may reveal new insights into the potential benefits for mental health. The wide range of data collection could provide additional insights into the long-term health benefits of DehydraTECH-CBD that might otherwise remain undetected.

Lexaria will provide further updates on the progress of study HYPER-H21-4 and its IND application enabling program as they become available. Details on the outcomes after the expected July conclusion of all treatment visits in study HYPER-H21-4 will follow in due course after performing the necessary data analyses.

Hypertension Markets

The hypertension market is valued at $28 billion per year and is expected to continue growing as one of the world's top health problems and as a subset of the larger heart disease market. Geographically, some of the highest rates of growth are expected in more recently industrialized nations such as China and India. Over 1.1 billion people worldwide suffer from hypertension.

Fewer than 1 person in 4 with hypertension have successfully controlled their blood pressure through medications, meaning the potential market for hypertension drugs is much larger than $28 billion per year if an affordable drug was available with few or no side effects. Lexaria believes that its DehydraTECH-CBD may introduce a more tolerable anti-hypertensive treatment option that may be used alone or in combination with other medications, to reduce BP with fewer discouraging and unwanted side effects. Lexaria would seek to satisfy this currently unmet demand and in doing so could expand the overall hypertension market.

"Among persons 50 years of age or older, isolated systolic hypertension is the most common form of hypertension, and systolic blood pressure becomes more important than diastolic blood pressure as an independent risk predictor for coronary events, stroke, heart failure, and end-stage renal disease (ESRD). The Global Burden of Disease Study identified elevated blood pressure as the leading risk factor, among 67 studied, for death and disability-adjusted life-years lost during 2010."

Drugs focused on blood pressure and related conditions are some of the highest selling drugs in the world. Lipitor, used to treat high cholesterol and reduce the risk of heart disease, has generated $94.7 billion in revenue from 1992 until 2017. Plavix, used to prevent heart attack and stroke, has sold $46.5 billion from 1992 until 2017. There are several hypertension drugs that each generate $1 billion per year or more in revenue.

About DehydraTECH-CBD

DehydraTECH-CBD is a unique CBD formulation Lexaria has developed and is optimizing based on its patented and proprietary DehydraTECH drug delivery technology. DehydraTECH is designed to improve the way active molecules enter the bloodstream upon oral ingestion. DehydraTECH has also demonstrated enhanced delivery of certain active molecules including CBD into brain tissue, which Lexaria believes to be of particular importance for the effectiveness of its DehydraTECH-CBD specifically against hypertension because of the significant influence of central mediation upon blood pressure. Lexaria has also developed DehydraTECH-CBD formulations for other applications demonstrating superior bioabsorption when administered intraorally and topically.

About Lexaria Bioscience Corp.

Lexaria Bioscience Corp.'s patented drug delivery technology, DehydraTECH™, improves the way active pharmaceutical ingredients (APIs) enter the bloodstream by promoting more effective oral delivery. Since 2016, DehydraTECH has repeatedly demonstrated the ability to increase bio-absorption with cannabinoids and nicotine by up to 5-10x, reduce time of onset from 1 - 2 hours to minutes, and mask unwanted tastes; and is also being evaluated for orally administered anti-viral drugs, non-steroidal anti-inflammatory drugs (NSAIDs), and more. DehydraTECH has also evidenced an ability to deliver some drugs more effectively across the blood brain barrier. Lexaria operates a licensed in-house research laboratory and holds a robust intellectual property portfolio with 24 patents granted and over 50 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.

INVESTOR CONTACT:

George Jurcic - Head of Investor Relations
[email protected]
Phone: 250-765-6424, ext 202

SOURCE: Lexaria Bioscience Corp.



View source version on accesswire.com:
https://www.accesswire.com/697834/Lexaria-Commences-Multi-Week-Human-Clinical-Hypertension-Study

Data From This Human Study, Together With the Findings From Lexaria's Other Previously Announced Successful Studies, Intended To Support the Company's Plans To Seek Approvals by the U.S. Food and Drug Administration

KELOWNA, BC / April 14, 2022 / Lexaria Bioscience Corp. (NASDAQ:LEXX)(NASDAQ:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms announces that all data analyses from its simulated pulmonary hypertension clinical study HYPER-H21-3 have been successfully completed with positive safety and efficacy findings.

The study findings indicated a tendency (p=0.1) during 15 minutes of simulated low levels of oxygen (hypoxia) for reduced pulmonary artery systolic pressure ("PASP") with DehydraTECH-CBD treatment versus placebo. Most notably, PASP was significantly attenuated by about 5 mmHg or 41% overall (p=0.045) in male participants specifically suggesting differences by sex in responsiveness to CBD treatment under hypoxic stress conditions.

These findings are complementary to Lexaria's growing body of evidence demonstrating the ability of DehydraTECH-CBD to reduce blood pressure, which it has shown across a wide variety of clinical presentations, ranging from individuals with differing degrees of "essential hypertension", the most common form of hypertension, to individuals with stress-induced simulated pulmonary hypertension as reported here. These new findings from HYPER-H21-3 will help direct prospective future research into the efficacy of DehydraTECH-CBD use for the management of elevations in pulmonary arterial pressure under hypoxic conditions (e.g., exposure to altitude), related hypoxemic pathologies (e.g., severe lung disease), and pulmonary hypertension.

Lexaria intends to use the data from study HYPER-H21-3, together with the findings from its other previously announced successful studies that evidenced DehydraTECH-CBD's ability to lower human blood pressure, to support Lexaria's plans to seek approvals by the U.S. Food and Drug Administration ("FDA") to commence formal, registered clinical testing in the treatment of hypertension under the Investigational New Drug ("IND") process.

As in past studies, all study participants tolerated DehydraTECH-CBD well and no serious adverse side effects were recorded. Lexaria will continue to provide updates on its work towards IND filing as they become available.

About Study HYPER-H21-3

Study HYPER-H21-3 used a placebo-controlled and double-blinded design, with administration of a single 300mg dose of a specific DehydraTECH-2.0 CBD formulation compared to placebo in a target group of sixteen enrolled volunteers (8 females and 8 males; aged 18-35 years). The study participants were subjected to a 30-minute period of rest following dosing, during which time they breathed normal room air (i.e., 21% oxygen), followed by a 40-minute period of simulated hypoxia (i.e., 12% oxygen) that was induced in order to safely simulate robust hypoxic pulmonary vasoconstriction ("HPV") and, as a result, an acute state of pulmonary hypertension. The hypoxia state was intended to mimic conditions experienced by those traveling or walking at high altitude or by those engaging in other activities of diminished oxygen availability conducive to development of HPV. Adverse elevations in HPV also commonly occur in related hypoxemic pathologies (e.g., severe lung disease) and pulmonary hypertension. Measurements of PASP were performed via echocardiography at intervals of 15 and 30 minutes during the 40-minute hypoxic period comparing the effects of DehydraTECH-CBD to placebo.

Hypertension Markets

The hypertension market is valued at $28 billion per year and is expected to continue growing as one of the world's top health problems and as a subset of the larger heart disease market. Geographically, some of the highest rates of growth are expected in more recently industrialized nations such as China and India. Over 1.1 billion people worldwide suffer from hypertension.

Fewer than 1 person in 4 with hypertension have successfully controlled their blood pressure ("BP") through medications, meaning the potential market for hypertension drugs is much larger than $28 billion per year if an affordable drug was available with few or no side effects. Lexaria believes that its DehydraTECH-CBD may introduce a more tolerable anti-hypertensive treatment option that may be used alone or in combination with other medications, to reduce BP with fewer discouraging and unwanted side effects. Lexaria would seek to satisfy this currently unmet demand and in doing so could expand the overall hypertension market.

"Among persons 50 years of age or older, isolated systolic hypertension is the most common form of hypertension, and systolic blood pressure becomes more important than diastolic blood pressure as an independent risk predictor for coronary events, stroke, heart failure, and end-stage renal disease (ESRD). The Global Burden of Disease Study identified elevated blood pressure as the leading risk factor, among 67 studied, for death and disability-adjusted life-years lost during 2010."

Drugs focused on blood pressure and related conditions are some of the highest selling drugs in the world. Lipitor, used to treat high cholesterol and reduce the risk of heart disease, has generated $94.7 billion in revenue from 1992 until 2017. Plavix, used to prevent heart attack and stroke, has sold $46.5 billion from 1992 until 2017. There are several hypertension drugs that each generate $1 billion per year or more in revenue.

About DehydraTECH-CBD

DehydraTECH-CBD is a unique CBD formulation Lexaria has developed and is optimizing based on its patented and proprietary DehydraTECH drug delivery technology. DehydraTECH is designed to improve the way active molecules enter the bloodstream upon oral ingestion. DehydraTECH has also demonstrated enhanced delivery of certain active molecules including CBD into brain tissue, which Lexaria believes to be of particular importance for the effectiveness of its DehydraTECH-CBD specifically against hypertension because of the significant influence of central mediation upon blood pressure. Lexaria has also developed DehydraTECH-CBD formulations for other applications demonstrating superior bio-absorption when administered intraorally and topically.

About Lexaria Bioscience Corp.

Lexaria Bioscience Corp.'s patented drug delivery technology, DehydraTECH™, improves the way active pharmaceutical ingredients (APIs) enter the bloodstream by promoting more effective oral delivery. Since 2016, DehydraTECH has repeatedly demonstrated the ability to increase bio-absorption with cannabinoids and nicotine by 5-10x and, in some instances with cannabinoids by as much as 27x compared to standard industry formulations, reduce time of onset from 1 - 2 hours to minutes, and mask unwanted tastes; and is also being evaluated for orally administered anti-viral drugs, non-steroidal anti-inflammatory drugs (NSAIDs), PDE5 inhibitors and more. DehydraTECH has also evidenced an ability to deliver some drugs more effectively across the blood brain barrier. Lexaria operates a licensed in-house research laboratory and holds a robust intellectual property portfolio with 24 patents granted and over 50 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.

INVESTOR CONTACT:
George Jurcic - Head of Investor Relations
[email protected]
Phone: 250-765-6424, ext 202

SOURCE: Lexaria Bioscience Corp.



View source version on accesswire.com:
https://www.accesswire.com/697377/Lexarias-Pulmonary-Hypertension-Clinical-Study-HYPER-H21-3-Delivers-Positive-Results

  • Lexaria's DehydraTECH-nicotine pouch performance will be compared to existing leading brands currently sold in the United States such as ON! and Zyn

KELOWNA, BC / April 12, 2022 / Lexaria Bioscience Corp. (NASDAQ:LEXX)(NASDAQ:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms, announces details of human nicotine study NIC-H22-1, which is expected to begin dosing this summer.

Study NIC-H22-1 is a minimum 36-person human pharmacokinetic ("pk") randomized, double blinded, cross-over study to compare Lexaria's DehydraTECH-nicotine pouch performance to that of existing leading brands currently sold in the US such as ON! and Zyn. Objective data collection from blood samples that will evidence Tmax, Cmax, and AUC is the primary objective of the study. Secondary objectives include extensive subjective evaluations related to throat burn, user experience, and more. Lexaria hopes to evidence that processing purified nicotine with DehydraTECH leads to better oral-tissue absorption and reduced negative experiences compared to currently sold brands.

The design phase of study NIC-H22-1 is complete and test articles are currently being manufactured. The Company will announce when dosing begins, which is expected this summer. This study is funded by Lexaria with existing capital. The Company is optimistic that this larger human study will produce positive findings pursuant to those evidenced in its previous 2021 subjective human testing that utilized DehydraTECH-nicotine formulations demonstrating onset of initial nicotine effectiveness in as little as 1.5 to 4 minutes after an oral dose.

As reported on October 5, 2021, Lexaria demonstrated in animal study NIC-A21-1 that nicotine oral pouches using DehydraTECH technology were 10x to 20x faster in reaching peak delivery of nicotine to bloodstream than controls. Findings using a DehydraTECH nicotine benzoate formulation relative to a concentration-matched control from that study are shown in the figure above.

The oral nicotine pouch category is of intense interest to Lexaria and is one of the fastest growing segments of the nicotine industry due in part to its reduced risk health outcomes as noted by the Food and Drug Administration ("FDA"). This delivery method, in the white pouch format specifically, which avoids harmful lung outcomes experienced by smokers or vapers, involves absorption primarily through the buccal tissues of the mouth, of purified nicotine that has been separated from most other harmful compounds in the tobacco leaf. The global market for the oral nicotine pouch category was US$2.33 billion in 2020 and is growing at a rapid CAGR of 30.7% and is expected to reach $21.84 billion in 2027.

As reported on March 8, 2022, Lexaria recently received its first ever patent granted to use DehydraTECH to more efficiently deliver nicotine through buccal tissue absorption. Similar patent filings have been made in the USA and in the EU and Lexaria believes those potential patent awards could support significant competitive advantages in the nicotine white pouch category, as well as other oral nicotine product formats.

About Lexaria Bioscience Corp.

Lexaria Bioscience Corp.'s patented drug delivery technology, DehydraTECH™, improves the way active pharmaceutical ingredients (APIs) enter the bloodstream by promoting more effective oral delivery. Since 2016, DehydraTECH has repeatedly demonstrated the ability to increase bio-absorption with cannabinoids and nicotine by up to 5-10x, reduce time of onset from 1 - 2 hours to minutes, and mask unwanted tastes; and is also being evaluated for orally administered anti-viral drugs, non-steroidal anti-inflammatory drugs (NSAIDs), and more. DehydraTECH has also evidenced an ability to deliver some drugs more effectively across the blood brain barrier. Lexaria operates a licensed in-house research laboratory and holds a robust intellectual property portfolio with 24 patents granted and over 50 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.

INVESTOR CONTACT:

George Jurcic - Head of Investor Relations
[email protected]
Phone: 250-765-6424, ext 202

SOURCE: Lexaria Bioscience Corp.



View source version on accesswire.com:
https://www.accesswire.com/697005/Lexaria-Provides-Update-on-Human-Nicotine-Study-NIC-H22-1