Positive results using DehydraTECH-CBD support progressing to FDA IND application

KELOWNA, BC / September 8, 2021 / Lexaria Bioscience Corp. (NASDAQ:LEXX) (NASDAQ:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms today announced it is formally beginning the process towards an Investigational New Drug ("IND") application filing with the Food and Drug Administration ("FDA") with its DehydraTECH-processed cannabidiol ("DehydraTECH-CBD") as a prospective registered pharmaceutical treatment for hypertension.

Lexaria has retained the services of an expert regulatory affairs and quality assurance consultancy group that will help prepare Lexaria for a pre-IND meeting with the FDA, as well as with designing the necessary non-clinical, clinical and related product development IND-enabling work to be completed in advance of the IND filing.

Lexaria's new IND enabling program is made possible through successfully completed studies that have provided support for more ambitious commercial goals. Recently achieved successful results from two 2021 human clinical pharmacodynamic hypertension studies and a 2018 human clinical pharmacokinetic ("PK") study, along with a number of successful animal studies demonstrating PK performance and molecular characterization work completed through Canada's National Research Council, have together established a strong body of evidence for Lexaria's DehydraTECH-CBD. These studies have shown that DehydraTECH-CBD demonstrates superior bioabsorption upon oral administration and is effective at reducing blood pressure with no significant unwanted side effects.

Provided that ongoing and upcoming studies continue to deliver favorable results, and that IND and other approvals from regulators are obtained, Lexaria intends to progress to a New Drug Application ("NDA") at the appropriate time, possibly via the abbreviated 505(b)(2) pathway.

The IND application process is also expected to utilize data from the Company's third and fourth 2021 human clinical hypertension studies, whereby Lexaria hopes that these studies will contribute further valuable data to its growing information package.

Lexaria will provide details on the timing and specifics of its planned pre-IND meeting and of the non-clinical, clinical and related product development IND-enabling work program elements to be completed in advance of and to culminate in IND filing as these details become available.

In addition, Lexaria is evaluating whether additional therapeutic indications for DehydraTECH-CBD might be pursued with the FDA in due course.

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.

CBD in the Regulatory Environment.

CBD under the brand name Epidiolex® was approved by the FDA in June 2018 for treating certain types of pediatric seizure disorders. Recommended dosing of Epidiolex CBD is 2.5 mg per kilogram of bodyweight to begin treatment, taken twice per day, increasing to 5.0 mg per kilogram of bodyweight, taken twice per day. An average 9 year-old child weighs about 28 kg, so the FDA recommended dose of Epidiolex would initially be 140 mg, increasing to 280 mg daily for long term use. The average adult man in the US weighs 199.6 lbs (90.7kg), so if he was using CBD at that same rate, he would require 900 mg per day for a sustainable dose. The maximum FDA-approved dose of Epidiolex is 10.0 mg per kilogram of bodyweight, taken twice daily.

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. 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 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), 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 21 patents granted in nations with a combined population of 2.6 billion, and over 50 additional patents pending worldwide. For more information, please visit www.lexariabioscience.com.

CAUTION REGARDING FORWARD-LOOKING STATEMENTS

This press release includes forward-looking 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 or prohibitions, 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:

[email protected]

Phone: 250-765-6424, ext 202

SOURCE: Lexaria Bioscience Corp.



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https://www.accesswire.com/662960/Lexaria-Begins-Investigational-New-Drug-IND-Enabling-Program-for-DehydraTECH-CBD-for-Hypertension

Human Clinical Study HYPER-H21-2 evidences up to a remarkable 23% decrease in blood pressure with patented DehydraTECH-CBD relative to placebo

KELOWNA, BC / September 7, 2021 / Lexaria Bioscience Corp. (Nasdaq:LEXX)(Nasdaq:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms is extremely pleased to issue initial results from human clinical study HYPER-H21-2 evaluating DehydraTECHTM-processed cannabidiol ("CBD") for potential application against hypertension. Partial results related to blood pressure ("BP") are being released today, while additional BP subset analyses, sleep quality and all other data analyses are in progress and will be reported upon when complete.

At selected times during the 24-hour study, volunteers with mild to moderate hypertension averaged as much as a 20 mmHg (i.e., 23%) decrease in BP relative to placebo.

Over the 24-hour ambulatory monitoring period, volunteers averaged a significant reduction of 7.0% (p < 0.001) in systolic pressure with DehydraTECH-CBD relative to placebo as shown below in Figure 1.

Figures 1, 2, and 3 below: Changes in 24-hr ambulatory systolic pressure ( SBP), mean arterial pressure ( MAP) and diastolic pressure ( DBP) between placebo (blue) and DehydraTECH-CBD (purple). Data are grouped means (n=16) with linear regression denoted by the trend lines. Timing of the three administered doses of DehdyraTECH-CBD (150 mg CBD x 3 dosing intervals) is indicated by the vertical arrows.

Over the 24-hour ambulatory monitoring period, volunteers averaged a significant reduction of 5.3% (p < 0.001) in MAP with DehydraTECH-CBD relative to placebo, as shown below in Figure 2.

Over the 24-hour ambulatory monitoring period, volunteers averaged a significant reduction of 3.5% in diastolic pressure relative to an increase in diastolic pressure (-0.8 vs. +2.7; p<0.001) from baseline with DehydraTECH-CBD relative to placebo, as shown below in Figure 3.

Lead investigator Dr. Phil Ainslie, Professor, School of Health and Exercise Sciences and Co-Director, Centre for Heart, Lung & Vascular Health, University of British Columbia Okanagan, and Canada Research Chair in Cerebrovascular Physiology, commented, "These improvements in BP results are particularly remarkable given the fact that many existing drugs used to treat hypertension require several weeks of treatment and/or combination dosing before they produce comparable reductions in blood pressure.

"Over the initial 24 hours, Lexaria's 2021 hypertension program is now delivering blood pressure reduction results competitive with - and in some cases even superior to - established oral pharmaceutical hypertension drugs," said Chris Bunka, CEO of Lexaria. "DehydraTECH-CBD demonstrated a sustained and augmented effect upon blood pressure attenuation throughout the day, indicating effectiveness of the repeat dosing treatment schedule used in this study."

DehydraTECH-CBD triggered its most significant effects upon BP attenuation through the overnight period while subjects slept and in the early morning period. This observation could have tremendous value therapeutically as these periods of the day are most often associated with cardiac stress and infarct events in hypertensive patients when people rise suddenly from and/or become increasingly active relative to the supine/sleeping state.

Analysis of the physical activity levels of the volunteers with mild to moderate hypertension during the 24-hour monitored period showed no significant differences in activity between the placebo and the DehydraTECH-CBD treated volunteers, indicating that the observed differences in BP were not due to disparate physical movement or demands.

Other studies of coronary heart disease ("CHD") have concluded that "lowering systolic pressure by 10 mmHg or diastolic pressure by 5 mmHg using any of the main classes of drugs reduced CHD events (fatal and nonfatal) by about a quarter and stroke by about a third, regardless of the presence or absence of vascular disease and of pretreatment BP. Heart failure is also reduced by about 25%."

Lexaria was also pleased that, as in past studies, its DehydraTECH-CBD was well tolerated by all subjects, with no serious adverse events or side effects observed or reported or incidence differences between groups. Over 100 million adult Americans have high blood pressure, but only one in four of those have the condition under control. Many patients stop taking their medications because of troublesome side effects: some diuretics can cause excessive urination, beta blockers can cause erectile dysfunction, calcium-channel blockers can cause leg swelling, and ACE inhibitors can lead to persistent cough. 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.

Next Steps

Data analysis from this study is continuing and additional outcomes will be reported upon when complete. On July 29, 2021, Lexaria reported it was "optimistic that repeat dosing such as this over a sustained period may further enhance efficacy," and is delighted to have now shown this by way of the 3-dose and 24-hour monitoring used in study HYPER-H21-2. The results of these first two human clinical hypertension studies are being carefully evaluated and considered before Lexaria's third planned human clinical (pulmonary) hypertension study of 2021 begins, expected this Fall.

With the positive results generated from these first two 2021 human clinical studies, Lexaria reaffirms its intention to also pursue a fourth hypertension study. Study design considerations are already underway with expectations to include a larger hypertensive population, regular monitoring of BP over at least a 4-week duration designed to monitor longer term performance and tolerability, and measurements of inflammatory and oxidative markers as well as overall vascular health.

Given the remarkable reduction in BP of up to 20 mmHg, Lexaria will be investigating whether similar decreases might be achievable over longer periods of time which could lead to effective long term BP treatment strategies.

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.

About Human Study HYPER-H21-2

Human Study HYPER-H21-2 was conducted at a European medical research hospital. Sixteen human volunteers (8 male; 8 female) aged 45-65 with otherwise untreated pre- or mild-hypertension were given either a placebo, or three separate doses of 150 mg each of DehydraTECH-CBD over a 14-hour period and studied over a 24-hour duration. The average weight and height were 91 ± 13 kg and 173 ± 9 cm. Ambulatory blood pressure was recorded for 24 hours. Additional BP subset analyses, sleep quality and all other data analyses are in progress and will be reported upon when complete.

CBD in the Regulatory Environment.

CBD under the brand name Epidiolex® was approved by the FDA in June 2018 for treating certain types of pediatric seizure disorders. Recommended dosing of Epidiolex CBD is 2.5 mg per kilogram of bodyweight to begin treatment, taken twice per day, increasing to 5.0 mg per kilogram of bodyweight, taken twice per day. An average 9 year-old child weighs about 28 kg, so the FDA recommended dose of Epidiolex would initially be 140 mg, increasing to 280 mg daily for long term use. The average adult man in the US weighs 199.6 lbs (90.7kg), so if he was using CBD at that same rate, he would require 900 mg per day for a sustainable dose. The maximum FDA-approved dose of Epidiolex is 10.0 mg per kilogram of bodyweight, taken twice daily.

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. 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 - elevated blood pressure. Hypertension is a major risk factor for cardiovascular and cerebrovascular disease, and accounts for approximately 45% of cardiovascular disease mortality and morbidity worldwide.

"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 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), 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 21 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:

[email protected]
Phone: 250-765-6424, ext 202

SOURCE: Lexaria Bioscience Corp.



View source version on accesswire.com:
https://www.accesswire.com/662848/Lexarias-Human-Clinical-Study-Delivers-Effective-and-Safe-Blood-Pressure-Reduction-Results-over-24-hour-Ambulatory-Period

Human Clinical Study HYPER-H21-1 evidences a rapid and sustained drop in blood pressure with DehydraTECH-CBD and excellent tolerability

KELOWNA, BC / July 29, 2021 / Lexaria Bioscience Corp. (NASDAQ:LEXX)(NASDAQ:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms is extremely pleased to issue partial results from human clinical study HYPER-H21-1 evaluating DehydraTECHTM-processed cannabidiol ("CBD") for potential application against hypertension. Partial results related to blood pressure ("BP") are being released today, while additional BP subset analyses and all other data analyses including pharmacokinetic ("PK") evaluations and detailed blood chemistry work is in progress and will be released when complete.

"We are very encouraged by these early results in our 2021 hypertension program," said Chris Bunka, CEO of Lexaria. "Lexaria's technology enabled a rapid and sustained drop in blood pressure, especially systolic pressure and particularly in Stage 2 hypertensive volunteers."

Lead investigator Dr. Phil Ainslie, Professor, School of Health and Exercise Sciences and Co-Director, Centre for Heart, Lung & Vascular Health University of British Columbia Okanagan, and Canada Research Chair in Cerebrovascular Physiology, commented that, "these early results are extremely promising in this at-risk hypertensive population and provide a fundamental support for expansion into more prolonged repeat dosing and future longer term clinical trials."

BP was reduced across both male and female volunteers and was most pronounced with DehydraTECH-CBD in the first 10-50 minutes of the study, reinforcing our pre-existing findings demonstrating that DehydraTECH delivers superior performance over generic CBD controls.

Blood pressure reduction from baseline was greatest when measured via systolic pressure. In the subset of volunteers who were Stage 2 hypertensive, peak systolic BP reductions from baseline were observed of as much as approximately 13 mmHg by the 50-minute time point with DehydraTECH-CBD, and systolic BP remained depressed throughout almost the entire 3-hour duration of the study. For reference, other studies of coronary heart disease ("CHD") have concluded that "lowering systolic pressure by 10 mm Hg or diastolic pressure by 5 mm Hg using any of the main classes of drugs reduced CHD events (fatal and nonfatal) by about a quarter and stroke by about a third, regardless of the presence or absence of vascular disease and of pretreatment BP. Heart failure is also reduced by about 25%."

There was also a tendency for a greater reduction in relative diastolic pressure from baseline with DehydraTECH-CBD than the concentration matched, generic CBD control (Fig 1). This was most notable in the initial 10-20 minute period post-dosing evidencing statistical significance at the 20-minute timepoint (p=0.025).

Fig 1. Changes in diastolic blood pressure between generic CBD control (dose A) and DehydraTECH-CBD (dose B). Data are grouped means (n=24) with linear regression.

As well, there was a tendency for relative Mean Arterial Pressure ("MAP") to be reduced greater from baseline with the DehydraTECH-CBD than the concentration matched, generic CBD control; again, most notably in the initial 20 minutes post-dosing (Fig 2.). By comparison, in Lexaria's 2018 human clinical study, 120 minutes were required to achieve the same level of MAP reduction, demonstrating superior rapidity of onset of the "DehydraTECH 2.0" CBD formulation used in the present study relatively speaking.

Fig 2. Changes in mean arterial blood pressure between generic CBD control (dose A) and DehydraTECH-CBD (dose B). Data are grouped means (n=24) with linear regression.

Lexaria was also pleased that its DehydraTECH-CBD was well tolerated by all subjects, with no serious adverse events or side effects observed or reported. Ingestion of the concentration-matched, generic CBD control, on the other hand, resulted in unwanted side effects in some of the volunteers, namely gastrointestinal distress including diarrhea. These findings corroborate what Lexaria has previously evidenced in other unrelated studies whereby human volunteers have also experienced reduced side effects with DehydraTECH-processed test articles compared to concentration-matched, generic controls.

Lexaria looks forward to completing its ongoing additional sample and data analyses work for this study and reporting upon those outcomes when complete. Lexaria's second human clinical hypertension study of 2021, study HYPER-H21-2, has completed dosing as previously reported and, in that study, three separate doses of DehydraTECH-CBD (150mg per dose) were used, administered evenly over the course of a 24-hour monitoring period. Based on the BP reducing trends witnessed in the present study, Lexaria is optimistic that repeat dosing such as this over a sustained period may further enhance efficacy. The results of these two studies will be carefully evaluated and considered before Lexaria's third planned human clinical hypertension study of 2021 begins, expected this Fall. Lexaria is evaluating study considerations for a fourth, expanded, randomized, controlled human clinical hypertension trial, with a view to building upon the results of current investigations in a larger population for enhanced statistical and clinical significance.

About Human Study HYPER-H21-1
Human Study HYPER-H21-1 was conducted at a European medical research hospital. Twenty-four human volunteers aged 45-65 with otherwise untreated pre- or mild-hypertension were given either a single 300mg dose of generic CBD, or a single 300mg dose of DehydraTECH-CBD and studied over a 3-hour duration. The weight of the average woman in the study was 178 lbs, and the weight of the average man in the study was 223 pounds. Blood pressure and heart rate analyses were taken every 10 minutes and speed and rate of absorption of the CBD and its main metabolites (PK assessments) were also assessed during the study. Secondary analyses that will be reported when complete include evaluation of inflammatory and oxidative markers associated with cardiovascular disease and gold-standard biomarkers of nitric oxide. This latter measure provides mechanistic insight into the 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, where Lexaria has already successfully demonstrated DehydraTECH utility with one such anti-inflammatory drug, colchicine, used for COVID-19 treatment today as previously reported.

CBD in the Regulatory Environment.
CBD under the brand name Epidiolex was approved by the FDA in June 2018 for treating certain types of pediatric seizure disorders. Recommended dosing of Epidiolex CBD is 2.5mg per kilogram of bodyweight to begin treatment, taken twice per day, increasing to 5.0mg per kilogram of bodyweight, taken twice per day. An average 9 year-old child weighs about 28 kg, so the FDA recommended dose of Epidiolex would initially be 140mg, increasing to 280mg daily for long term use. The average adult man in the US weighs 199.6 lbs (90.7kg), so if he was using CBD at that same rate, he would require 900mg per day for a sustainable dose. The maximum FDA-approved dose of Epidiolex is 10.0mg per kilogram of bodyweight, taken twice daily.

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. 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 - elevated blood pressure.

"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 is 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 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. 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 planned to be further evaluated for orally administered bioactive molecules, including anti-viral drugs, vitamins, non-steroidal anti-inflammatory drugs (NSAIDs) and more. 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 21 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:
[email protected]
Phone: 250-765-6424, ext 202

SOURCE: Lexaria Bioscience Corp.



View source version on accesswire.com:
https://www.accesswire.com/657567/Lexarias-DehydraTECH-CBD-Lowers-Blood-Pressure

Lexaria's technology empowers brands nationwide in stores including Albertsons, Hudson News, and many more

KELOWNA, BC / July 28, 2021 / Lexaria Bioscience Corp. (NASDAQ:LEXX)(NASDAQ:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms is pleased to announce that its DehydraTECHTM technology has been embraced by consumer brands now available for sale in over 7,000 stores across the US.

"Lexaria's technology is enabling increased market share and sales growth for our continually growing list of corporate clients," said Chris Bunka, CEO of Lexaria. "We are delighted to help these innovators of today and leaders of tomorrow offer their clients superior performance and experiences that competitors simply cannot match, and we are highly anticipatory of additional growth to come."

Lexaria asked several of its corporate clients to share their experiences with DehydraTECH:

Case Mandal, President of Cannadips, said, "Cannadips is the original tobacco-free and nicotine-free CBD pouch and we pride our Humboldt County traditions of innovation and continual technological evolution to help consumers nationwide enjoy superior dip experiences. We scoured the market for the best technology to put into our products and DehydraTECH was, hands down, the most palatable and efficacious delivery system for our CBD products. Cannadips CBD pouches are available nationwide in 5,500 stores, and online at www.cannadipscbd.com."

Brent Mann, Founder and President of New World CBD, offered that "New World CBD is family owned and operated and is striving to become the best CBD company in America. Our diverse CBD products are sold now in over 1,500 Albertsons, Safeway, and Vons stores, and in more than 300 Hudson News locations, and we are in discussions to have our products sold in another 96,000 convenience and grocery stores nationwide. All of our next-generation topical products - five new SKUs expected in Q4 2021 - will be using Lexaria's DehydraTECH technology; we chose the best for our product lines. Our products are also available at www.newworldcbd.com."

Vassili Kotlova, President of Impact Naturals said that "Impact Naturals is a science- and health-focused group with decades of biotech and pharmaceutical experience where our R&D seeks to unlock the full potential of natural compounds to benefit human health and wellness. We chose to use DehydraTECH as the basis of our next-generation CHYLOSOMA™ formulations of CBD, CBG and CBN along with American Ginseng, Ginkgo Biloba and Melatonin. We will also be introducing 3 topical skin SKUs empowered with DehydraTECH during Q4, 2021. All our products can be purchased at www.impact-naturals.com."

Eric Gricus, CEO and Founder of Amari, commented, "Amari went through an extensive selection process for our CBD technology supplier. Lexaria exceeded our expectations for product quality, service and pricing. DehydraTECH's fast onset, high bioavailability and water solubility is the perfect complement to our proprietary blends of turmeric, ashwagandha and plant-based ingredients designed to help people Play Longer and Recover Faster. We are thrilled to have the Lexaria team working with Amari to provide products our customers love while winning industry accolades. Our products can be purchased at retailers across the country and at www.amaribotanicals.com."

Lexaria only partners with the most advanced thinking, forward looking brands in America and is delighted to be experiencing increases in market share and growth with these and our numerous other B2B clients this year that it believes will continue to flourish into the future. The companies above do not represent a complete list of Lexaria's B2B clients and we will introduce more of these industry leaders at a future date.

All of Lexaria's B2B clients share at least one vital attribute; that their customers are the most important part of their businesses and delivering "average" consumer experiences is simply not good enough. Lexaria and our B2B partners expect our consumers to demand the best, and this is what we deliver, each and every day.

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. 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 planned to be further evaluated for orally administered bioactive molecules, including anti-viral drugs, vitamins, non-steroidal anti-inflammatory drugs (NSAIDs) and more. 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 21 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:
[email protected]
Phone: 250-765-6424, ext 202

SOURCE: Lexaria Bioscience Corp.



View source version on accesswire.com:
https://www.accesswire.com/657339/DehydraTECH-Enabled-Consumer-Products-Now-Available-in-Over-7000-Stores

Additionally, second patent award received in Japan

KELOWNA, BC / July 27, 2021 / Lexaria Bioscience Corp. (NASDAQ:LEXX) (NASDAQ:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms is pleased to announce that dosing has been completed in its second human clinical study of 2021.

Human clinical study HYPER-H21-2 consisted of 16 human volunteers who were pre- or mildly hypertensive and received three separate doses of 150 mg each of DehydraTECHTM 2.0-enabled CBD versus a placebo (total dose of 450mg). HYPER-H21-2 included 24-hour continuous ambulatory (portable) monitoring of blood pressure and heart rate, together with evaluations of central arterial stiffness, physical activity and sleep quality (e.g., total sleep time, total wake time, and sleep efficiency).

Together, these evaluations were designed to provide a greater understanding of the human response to DehydraTECH 2.0-enabled CBD upon 24-hour monitoring of potential blood pressure reduction and other real-world effects. This study is proceeding on schedule and on budget and the Company expects to have at least preliminary results to report in September or earlier.

In contrast, the first human clinical study of 2021, study HYPER-H21-1, utilized a single 300 mg dose of DehydraTECH 2.0-enabled CBD, and took blood samples from 24 human volunteers every 10 minutes for a 3-hour duration, evaluating blood pressure, heart rate and inflammatory markers associated with cardiovascular disease and biomarkers of nitric oxide. This latter measure was intended to provide mechanistic insight into the anticipated reduction in blood pressure via vasodilation. Preliminary results related to blood pressure only from study HYPER-H21-1 are expected to be reported upon soon, while the blood chemistry analyses work is in progress for reporting at a later date once completed.

Both studies referenced herein were randomized and double-blinded and were performed at a European medical research hospital. Both studies were fully funded from existing Company resources. Following analysis of results from both studies, Lexaria's third DehydraTECH 2.0-enabled CBD human clinical hypertension study of 2021, HYPER-H21-3 will commence and additional information related to that third human clinical study of 2021 will be provided in due course.

Lexaria is also pleased to announce the additional expansion of its intellectual property portfolio with the allowance of its second patent in Japan. The patent is titled "Food and Beverage Compositions Infused with Lipophilic Active Agents and Methods of Use Thereof" and becomes the 21st patent granted to Lexaria and the 17th patent granted in Lexaria's first patent family. Lexaria has 13 patent families. Active ingredients that may be used under this new patent include non-psychoactive cannabinoids.

Lexaria continues to build on earlier successes in developing its intellectual property portfolio which it views as a critical part of long-term value creation for its shareholders. Lexaria enjoys active granted patent protection in the USA, the EU, Australia, India and Japan. Additional patents are pending in all of those regions and also in Canada, China, Mexico and other countries internationally.

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. 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 planned to be further evaluated for orally administered bioactive molecules, including anti-viral drugs, vitamins, non-steroidal anti-inflammatory drugs (NSAIDs) and more. 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 21 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:
[email protected]
Phone: 250-765-6424, ext 202

SOURCE: Lexaria Bioscience Corp.



View source version on accesswire.com:
https://www.accesswire.com/657096/Lexaria-Completes-Dosing-in-Human-Clinical-Study-HYPER-H21-2

KELOWNA, BC / July 26, 2021 / Lexaria Bioscience Corp. (NASDAQ:LEXX)(NASDAQ:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms is pleased to announce the receipt of US$3,817,643 from the exercise of share purchase warrants (the "Warrants").

The Warrants were issued by the Company pursuant to its January 2021 public underwritten offering (the "Offering") whereby the shares and Warrants issued thereunder were registered pursuant to a Form S-1 Registration Statement (No. 333-250326), as amended and a Form S-1MEF Registration Statement (No. 333-252031). The Warrants were exercised into 580,189 shares of voting common stock of the Company at an exercise price of US$6.58 per share.

As a further breakdown, of the Warrants exercised, 83,284 Warrants were exercised by the underwriters of the Offering, leaving 143,877 underwriter Warrants remaining; and 496,905 Warrants were exercised by investors of the Offering, leaving 1,605,951 listed Warrants remaining and trading on the Nasdaq Capital Markets under symbol LEXXW.

All proceeds received from the Warrant exercises will be used for the continued advancement of the Company's investigational research program and for general corporate purposes. With this additional capital, the Company believes its business plan objectives and all operations are now funded well into the year 2022.

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. 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 planned to be further evaluated for orally administered bioactive molecules, including anti-viral drugs, vitamins, non-steroidal anti-inflammatory drugs (NSAIDs) and more. 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 20 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:

[email protected]
Phone: 250-765-6424, ext 202

SOURCE: Lexaria Bioscience Corp.



View source version on accesswire.com:
https://www.accesswire.com/657075/Lexaria-Receives-US3817643-From-Warrant-Exercises

All objectives evaluating DehydraTECH drug delivery platform successfully achieved

KELOWNA, BC / July 22, 2021 / Lexaria Bioscience Corp. (NASDAQ:LEXX)(NASDAQ:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms is pleased to review its successful 2021 antiviral drug program to date and summarize expected next steps.

Lexaria's objectives in its 2021 antiviral drug examination program thus far have been to determine whether:

  • DehydraTECH processing of compounds from leading classes of antiviral drugs for SARS-CoV-2/COVID-19, HIV/AIDS and other infectious diseases could exhibit evidence of superior oral absorption relative to controls,
  • DehydraTECH processing of those compounds would preserve expected viral inhibitory performance upon efficacy testing in infected mammalian cells, and
  • DehydraTECH does not alter nor degrade the drug molecules chemically as to create new molecular entities that could be challenging to guide through the regulatory approval process.

All three of these objectives have been met.

Lexaria has successfully tested and published summary results on five compounds from three antiviral drug classes, and in each of these drug classes has evidenced significant gains with up to a three-fold increase in oral drug delivery into the bloodstream ("Area Under the Curve" or "AUC") upon animal testing when processed with DehydraTECH:

Drug

Drug Class

AUC DehydraTECH Delivery Improvement (hr ng/mL)

Efavirenz

RTI

42% (p=0.028)

Darunavir

PI

54% (p=0.036)

Remdesivir

(GS-441524)

RTI

82% (p=0.12)

Colchicine

TPMI

167% (p=0.0028)

Ebastine

PI

204% (p=0.027)

Protease Inhibitors ("PI"): Darunavir and Ebastine (AKA an antihistamine and 3CL or SARS-CoV-2 main protease "MPro" inhibitor)

Reverse Transcriptase Inhibitors ("RTI"): Efavirenz (AKA a non-nucleoside RTI or "NNRTI") and Remdesivir (AKA a nucleotide RTI or "NtRTI"; quantified in its nucleoside analogue metabolite form GS-441524)

Tubulin Polymerization and Microtubule Inhibitor ("TPMI"): Colchicine (AKA an anti-inflammatory)

Lexaria believes that the absorption gains it has demonstrated with the above compounds from their respective antiviral drug classes could have significant commercial potential given the fact that many antiviral drugs exhibit diminished oral bioavailability in their available forms today due to poor intestinal uptake and/or significant liver biotransformation. The DehydraTECH delivery system is designed to overcome this bioavailability issue.

For example, drugs like colchicine in its currently available oral form demonstrate bioavailability of about 45%, and are also known to have a narrow therapeutic index, meaning that the distinction between toxic and non-toxic doses is marginal. There could be significant benefits in allowing its dosing to be reduced while maintaining therapeutic delivery levels. DehydraTECH formulations of antiviral compounds such as colchicine have the potential to lead to significantly improved bioavailability while allowing for lower overall dosing requirements and improved safety and tolerability. The majority of drugs that are currently delivered via injection could also experience lower costs of administration and larger market potential if delivery characteristics were enhanced sufficiently to allow for oral dosing.

The next steps in Lexaria's DehydraTECH antiviral drug testing program are expected to include, but not be limited to, larger in vivo efficacy evaluations in animals infected with SARS-CoV-2, HIV or other infectious disease-causing viruses, which Lexaria is planning, subject to further investigation to select lead compounds based on our work to-date for this effort. The Company will release further plans and results related to these upcoming studies as they become available.

Lexaria is working diligently on a comprehensive, multi-pronged program that is intended to demonstrate pivotal proof-of-concept safety, efficacy and formulation/scalability feasibility data to prospective pharmaceutical industry partners with a view to creating opportunities for expanded, collaborative product development. The Company is interested in pursuing strategic collaboration opportunities with established pharmaceutical industry partners who may be interested in incorporating DehydraTECH technology with antiviral drugs including and/or similar to those that are currently being investigated. Lexaria would like to evidence that DehydraTECH works to enhance the oral delivery characteristics of the drugs mentioned above and potentially others which are used to fight many virus triggered diseases, including but not limited to shingles, influenza and viral forms of gastroenteritis, hepatitis, meningitis, and pneumonia.

Antiviral Drug Background and DehydraTECH Formulation Strategy
The first antiviral drug was approved for use in the USA in 1963, and over 90 additional antiviral drugs have been approved since, with thousands of other antiviral inhibitors having been proposed. Eleven of the approved drugs are used to treat more than one infectious disease, illustrating that some of these drugs are effectively used for multiple applications.

Antiviral drugs treat those who have been infected and try to preserve life; whereas antiviral vaccines are administered to those who are not infected in an effort to prevent or lessen the severity of subsequent infection.

Of note, "antiviral drugs from the same drug group share similar mechanisms of drug action to inhibit viral reproduction during the viral life cycle." This phenomenon is a crucial component to Lexaria's strategy of evidencing that DehydraTECH improves the delivery characteristics of many drugs from the classes Lexaria has investigated, potentially assisting in their efficacy for both their original approved use, as well as for use treating additional health indications if/when that delivery performance has been enhanced.

For example, there are six main classes of antiviral drugs used to treat HIV, including drugs from the PI and RTI classes, above. There are 37.7 million people currently known to be infected with HIV and 36.3 million people have died from HIV/AIDS since the beginning of the epidemic, roughly equal to the entire population of Canada. There are over 200 drugs approved by the FDA to treat HIV/AIDS. Because of the massive regulatory and scientific response to the onset of HIV, this disease is thankfully killing fewer people now than in the past, although significant demand remains for safe and effective HIV/AIDS therapies that can be used on a chronic treatment basis to preserve life.

Influenza is caused by viruses even though vaccines have been widely available for years and remain the #1 recommended method to prevent infection. Despite that, between 290,000 and 650,000 people die every year from seasonal influenza. The 1918-19 influenza epidemic is thought to have killed up to 50 million people, and the 1958 and 1968 influenza epidemics are thought to have killed between 1 and 4 million people each. There are only 4 drugs approved by the FDA to treat influenza; three of them belong to the Neuraminidase Inhibitors class and must be administered by injection, and one belongs to the PA endonucleases inhibitor class and is taken as an oral tablet.

Over 189 million people have been infected by SARS-CoV-2 in the current global epidemic, and over 4 million have died to date. It is not known today if or when infections and deaths will stop. Many drugs are being investigated for use in treatment of SARS-CoV-2, including but not limited to compounds from each of the PI, RTI, and TPMI drug classes. Only remdesivir has received emergency use authorization from the FDA for treatment of SARS-CoV-2.

Regardless of the efficacy and availability of vaccines to prevent many viral infections including influenza vaccines that have been widely available since 1945, thousands of people die every year because they are infected with viruses while unvaccinated, or live in large areas of the world where vaccines are not available. It is currently estimated that over 99% of the over 200,000 deaths in the US since January 1, 2021 from SARS-CoV-2 have occurred in unvaccinated victims, demonstrating the vital current need for successful treatment options for those who are unvaccinated.

Based on all these facts, the need and demand for effective antiviral drugs via oral delivery that are available to all, has never been more profound than today. Lexaria has progressed significantly in evidencing that its DehydraTECH delivery technology can sufficiently enhance the usable fraction of known antiviral drugs that reach the bloodstream so that they can safely and more effectively do what they are designed to accomplish. Lexaria continues to evaluate the data generated from its 2021 antiviral drug program and will make an announcement regarding next steps as soon as possible.

The Company is not making any express or implied claims that its products have the ability to eliminate, cure or contain the COVID-19 pandemic (or SARS-CoV-2 or novel Coronavirus) or any other virally induced diseases at this time.

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 20 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.

INVESTOR CONTACT:
[email protected]
Phone: 250-765-6424, ext 202

SOURCE: Lexaria Bioscience Corp.



View source version on accesswire.com:
https://www.accesswire.com/656564/Lexaria-Summarizes-Successful-Antiviral-Drug-Studies-and-Ongoing-Strategy

Possible Benefits for Treating SARS-CoV-2/COVID-19 and mRNA Vaccine Side Effects

KELOWNA, BC / July 21, 2021 / Lexaria Bioscience Corp. (NASDAQ:LEXX)(NASDAQ:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms is pleased to announce that its tolerability and pharmacokinetic study VIRAL-A20-3 has been completed with positive results.

This study demonstrated that DehydraTECHTM enabled colchicine, the latest of several drugs Lexaria has successfully tested with known SARS-CoV-2 antiviral properties, benefited from our proprietary formulation and processing, resulting in increased delivery:

Drug

Cmax* % Improvement
(ng/mL)

Control
(ng/mL)

AUClast** % Improvement
(hr ng/mL)

Control
(hr ng/mL)

Colchicine

31.97
91%
(p=0.0005)

16.73

104.43
167%
(p=0.0028)

38.97


Colchicine is an approved therapeutic with anti-inflammatory effects that is principally used to treat gout and conditions such as cardiac inflammation (i.e., pericarditis), and also has potent effects in mitigating the cytokine storm associated with SARS-CoV-2/COVID-19. Colchicine is occasionally recommended and used to treat emergent pericarditis in children in cases where this form of cardiac inflammation develops following administration of mRNA COVID-19 vaccines.

Similar to other antiviral agents that Lexaria has processed with DehydraTECH (e.g., darunavir, efavirenz, remdesivir's nucleoside analogue GS-441524 and ebastine), oral colchicine in its available forms today exhibits diminished bioavailability in humans, which Lexaria believes it can improve upon for better safety and efficacy outcomes. Currently available oral colchicine demonstrates bioavailability of about 45%.

Colchicine is also known to have a narrow therapeutic index, meaning the distinction between toxic and non-toxic doses is marginal and there could be significant benefits in allowing its dosing to be reduced while maintaining therapeutic delivery levels. Lexaria hopes to improve the bioavailability of colchicine to a sufficient level which could potentially allow for lower overall dosing requirements.

Study VIRAL-A20-3 was performed using Sprague-Dawley rats, with twenty rats dosed via oral gavage using either DehydraTECH or control colchicine formulations (i.e,. 10 rats per test article). The study evaluated peak concentration ("Maximum Concentration" or "Cmax"*) and total drug delivery into the rodent bloodstream ("Area Under the Curve" or "AUClast**"). The study was conducted by an independent, premier animal testing laboratory located in the United States.

The study also examined absorption with two other antiviral drugs previously untested by Lexaria. The bloodstream delivery findings were unremarkable with these two drugs, which Lexaria believes was correlated to analytical methodology limitations related to discerning blood levels for the two drugs in question. Further work would be required should Lexaria decide to pursue additional testing with these two drugs, however, Lexaria will likely focus on DehydraTECH-processed colchicine and other antiviral drugs it has tested given the superior results already demonstrated.

Lexaria will summarize and provide guidance on the 2021 antiviral program to date and next steps it is planning in an imminent press release. Chris Bunka, CEO, is responsible for the accuracy of this press release. The Company is not making any express or implied claims that its products have the ability to eliminate, cure or contain the COVID-19 pandemic (or SARS-CoV-2 or novel Coronavirus) or any other virally induced diseases at this time.

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 20 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.

INVESTOR CONTACT:

[email protected]
Phone: 250-765-6424, ext 202

SOURCE: Lexaria Bioscience Corp.



View source version on accesswire.com:
https://www.accesswire.com/656368/Lexarias-DehydraTECH-Significantly-Enhances-Delivery-of-Colchicine-in-Study-VIRAL-A20-3

VIRAL-MC21-1 Demonstrates Stability of DehydraTECH™-Enabled Antiviral Drugs

KELOWNA, BC / July 15, 2021 / Lexaria Bioscience Corp. (NASDAQ:LEXX)(NASDAQ:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms is pleased to announce results from its antiviral drug molecular characterization study VIRAL-MC21-1 recently completed by Canada's premier federally funded research organization, the National Research Council ("NRC").

The NRC has successfully confirmed Lexaria's study objectives, demonstrating DehydraTECH™ processing and formulation technology does not create a covalently bonded new molecular entity ("NME") and that each drug tested remained stable and did not undergo change in chemical structure. The five drugs studied were remdesivir, ebastine, bepridil, rupintrivir and colchicine, which have antiviral effects through a variety of different modes of action.

These findings are strongly supportive of accelerated regulatory filings such as the 505(b)(2) pathway permitted by the Food and Drug Administration ("FDA") and other international regulators, for more rapid market authorizations of prospective DehydraTECH-enabled, repurposed antiviral drugs. By comparison, NMEs are generally subjected to more involved regulatory examination and approval processes than non-NMEs.

The work carried out by NRC consisted primarily of nuclear magnetic resonance ("NMR") and Liquid Chromatography-High Resolution Mass Spectrometry ("LC-HRMS") evaluations. NMR spectroscopy is an analytical chemistry method that can determine purity and molecular structures. LC-HRMS uses mass spectrometers and can be used to determine elemental compositions and distinguish between different molecules.

As Lexaria's validating datasets continue to grow, the Company will pursue strategic collaboration opportunities with established pharmaceutical industry partners to incorporate DehydraTECH technology with antiviral drugs including and/or similar to those that are currently being investigated.

DRUG USES:

REMDESIVIR is a well-known nucleotide reverse transcriptase inhibitor, available under the trade name Veklury® from Gilead Sciences Inc., that interferes with the SARS-CoV-2 viral replication life cycle and has received emergency use authorization in many regions of the world for treatment of COVID-19. It is also used to treat hepatitis, Ebola disease and Marburg virus infections.

EBASTINE is an antihistamine drug that has potent effects in inhibiting the SARS-CoV-2 main protease (Mpro, also called the 3CL protease) blocking viral entry into human cells, together with effects to reduce COVID-19 inflammatory reactions. It is also used to treat allergic rhinitis, hives, idiopathic urticaria, and relief from mosquito bites and atopic dermatitis.

BEPRIDIL is used primarily to treat angina pectoris due to coronary heart disease and is indicated to treat chronic stable angina; is being investigated to treat atrial fibrillation; and, in at least one cellular study utilizing Vero E6 cells, was shown to inhibit cytopathogenic effect induces by SARS-CoV-2.

RUPINTRIVIR was originally developed for treatment of rhinoviruses (common colds) and is also being investigated for treatment of picornaviruses, norovirus, and coronaviruses such as SARS-CoV-2.

COLCHICINE is an approved therapeutic with anti-inflammatory effects that is principally used to treat gout and conditions like cardiac inflammation (i.e., pericarditis), but also has potent effects in mitigating the cytokine storm associated with SARS-CoV-2/COVID-19. Colchicine is also sometimes recommended and used to treat emergent pericarditis in children in cases where this form of cardiac inflammation develops following administration of mRNA COVID-19 vaccines. It is also used to treat atrial fibrillation and Periodic Fever Syndromes.

Chris Bunka, CEO, is responsible for the accuracy of this press release. The Company is not making any express or implied claims that its products have the ability to eliminate, cure or contain the COVID-19 pandemic (or SARS-CoV-2 or novel Coronavirus) or any other virally induced diseases at this time.

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. 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 planned to be further evaluated for orally administered bioactive molecules, including anti-viral drugs, vitamins, non-steroidal anti-inflammatory drugs (NSAIDs) and more. 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 20 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:
[email protected]
Phone: 250-765-6424, ext 202

SOURCE: Lexaria Bioscience Corp.



View source version on accesswire.com:
https://www.accesswire.com/655576/Lexaria-Completes-Successful-Antiviral-Drug-Molecular-Characterization-Study-With-Canadas-National-Research-Council

New patent granted in Japan adds to existing patents in the EU, the U.S., India and Australia

KELOWNA, BC / July 13, 2021 / Lexaria Bioscience Corp. (NASDAQ:LEXX)(NASDAQ:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms, announces an additional expansion of its intellectual property portfolio with its first-ever patent granted in Japan.

The patent is titled "Stable ready-to-drink beverage compositions comprising lipophilic active agents" and becomes the 20th patent granted to Lexaria, continuing to add to the Company's considerable intellectual property portfolio.

"With our 20th patent granted worldwide, Lexaria continues to demonstrate the versatility of our DehydraTECH drug delivery platform, encouraging innovation in the consumable liquid category around the world," said Chris Bunka, CEO of Lexaria. "This new patent adds to our existing suite of granted patents spanning the EU, the U.S., India and Australia, and continues to build value for Lexaria shareholders and clients."

This is the third patent granted from Lexaria's third patent family. Lexaria's patent application suite comprises a total of 13 patent families. Active ingredients that may be used under this new patent include non-psychoactive cannabinoids and NSAIDS (e.g., acetylsalicylic acid, ibuprofen, diclofenac, indomethacin, piroxicam).

Lexaria has patent applications progressing in countries around the world with aggregate populations of nearly 4 billion people and will report on further progress as information becomes available.

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. DehydraTECH 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 19 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 U.S. 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:
[email protected]
Phone: 250-765-6424, ext 202

SOURCE: Lexaria Bioscience Corp.



View source version on accesswire.com:
https://www.accesswire.com/655223/Lexaria-Receives-Patent-Protection-in-Japan