Life Science News

Dosing is expected to begin by April, 2022Lexaria Bioscience Corp. a global innovator in drug delivery platforms, is pleased to report that Independent Review Board approval has been received ahead of schedule for its upcoming DehydraTECH-CBD human hypertension study HYPER-H21-4This study should "de-risk" outcomes prior to Lexaria's planned entry into regulatory pathways for the use of DehydraTECH-CBD to treat ...

Dosing is expected to begin by April, 2022

Lexaria Bioscience Corp. (NASDAQ:LEXX)(NASDAQ:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms, is pleased to report that Independent Review Board ("IRB") approval has been received ahead of schedule for its upcoming DehydraTECH-CBD human hypertension study HYPER-H21-4

This study should "de-risk" outcomes prior to Lexaria's planned entry into regulatory pathways for the use of DehydraTECH-CBD to treat hypertension and perhaps other forms of cardiovascular disease. This study is entirely funded through the Company's existing cash resources and is not subject to any financing requirement. Dosing is tentatively scheduled to begin by April, 2022.

HYPER-H21-4 is expected to consist of 60 volunteers between the ages of 45-70 using three 150 mg doses of DehydraTECH-CBD, every day for the 6-week duration of the study. The study will use a double blinded, randomized cross-over design, and a placebo control. Some volunteers will already be using leading standard of care hypertension drugs such as ACE inhibitors with or without diuretics which will help evaluate the efficacy of DehydraTECH-CBD with and without other hypertension treatments. The extended duration of the study will allow Lexaria to gather critical data monitoring of DehydraTECH-CBD over time and will evaluate the potential for longer term health benefits.

HYPER-H21-4 is more comprehensive than any work previously undertaken by Lexaria and many types of analysis will be performed including 24-hour ambulatory blood pressure (the primary outcome); arterial stiffness and autonomic balance; brain structure and function through brain magnetic resonance imaging ("MRI"); blood biomarkers (including lipids such as cholesterol and more); renal, hepatic, sleep quality / daytime sleepiness / sleep disorders; actigraphy, geriatric depression scale, perceived stress, and Beck anxiety inventory. The wide range of data collection could provide additional insights into the long-term health benefits of DehydraTECH-CBD that might otherwise remain undetected.

Hypertension Markets

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

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

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

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

About Lexaria Bioscience Corp.

Lexaria Bioscience Corp.'s patented drug delivery technology, DehydraTECH™, improves the way active pharmaceutical ingredients (APIs) enter the bloodstream by promoting more effective oral delivery. Since 2016, DehydraTECH has repeatedly demonstrated the ability to increase bio-absorption with cannabinoids and nicotine by 5-10x and, in some instances with cannabinoids by as much as 27x compared to standard industry formulations, reduce time of onset from 1 - 2 hours to minutes, and mask unwanted tastes; and is also being evaluated for orally administered anti-viral drugs, non-steroidal anti-inflammatory drugs (NSAIDs), PDE5 inhibitors and more. DehydraTECH has also evidenced an ability to deliver some drugs more effectively across the blood brain barrier. Lexaria operates a licensed in-house research laboratory and holds a robust intellectual property portfolio with 23 patents granted and over 50 patents pending worldwide. For more information, please visit www.lexariabioscience.com.

CAUTION REGARDING FORWARD-LOOKING STATEMENTS

This press release includes forward-looking statements. Statements as such term is defined under applicable securities laws. These statements may be identified by words such as "anticipate," "if," "believe," "plan," "estimate," "expect," "intend," "may," "could," "should," "will," and other similar expressions. Such forward-looking statements in this press release include, but are not limited to, statements by the company relating the Company's ability to carry out research initiatives, receive regulatory approvals or grants or experience positive effects or results from any research or study. Such forward-looking statements are estimates reflecting the Company's best judgment based upon current information and involve a number of risks and uncertainties, and there can be no assurance that the Company will actually achieve the plans, intentions, or expectations disclosed in these forward-looking statements. As such, you should not place undue reliance on these forward-looking statements. Factors which could cause actual results to differ materially from those estimated by the Company include, but are not limited to, government regulation and regulatory approvals, managing and maintaining growth, the effect of adverse publicity, litigation, competition, scientific discovery, the patent application and approval process, potential adverse effects arising from the testing or use of products utilizing the DehydraTECH technology, the Company's ability to maintain existing collaborations and realize the benefits thereof, delays or cancellations of planned R&D that could occur related to pandemics or for other reasons, and other factors which may be identified from time to time in the Company's public announcements and periodic filings with the US Securities and Exchange Commission on EDGAR. There is no assurance that any of Lexaria's postulated uses, benefits, or advantages for the patented and patent-pending technology will in fact be realized in any manner or in any part. No statement herein has been evaluated by the Food and Drug Administration (FDA). Lexaria-associated products are not intended to diagnose, treat, cure or prevent any disease. Any forward-looking statements contained in this release speak only as of the date hereof, and the Company expressly disclaims any obligation to update any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise, except as otherwise required by law.

INVESTOR CONTACT:
George Jurcic - Head of Investor Relations
ir@lexariabioscience.com
Phone: 250-765-6424, ext 202

SOURCE: Lexaria Bioscience Corp.



View source version on accesswire.com:
https://www.accesswire.com/679972/Lexaria-Receives-Independent-Review-Board-Approval-For-DehydraTECH-CBD-Human-Clinical-Study-HYPER-H21-4

News Provided by ACCESSWIRE via QuoteMedia

LEXX:ARC
wellteq

BTV Highlights Promising Investment Opportunities

On Sat. Sept 25th at 5pm EST broadcast on FOX Business News - BTV-Business Television visits up-and-coming innovative investment opportunities.

Discover Companies to Invest In - Watch their TV feature!

Keep reading... Show less

U.S. FDA Approves RINVOQ® to Treat Adults and Children 12 Years and Older with Refractory, Moderate to Severe Atopic Dermatitis

ABBVie (NYSE: ABBV) today announced the U.S. Food and Drug Administration (FDA) has approved RINVOQ ® (upadacitinib) for the treatment of moderate to severe atopic dermatitis in adults and children 12 years of age and older whose disease did not respond to previous treatment and is not well controlled with other pills or injections, including biologic medicines, or when use of other pills or injections is not recommended. 1 RINVOQ 15 mg once daily can be initiated in adults and children 12 years of age and older weighing at least 40 kg. 1 In these children and adults less than 65 years of age who do not achieve an adequate response, the dose may be increased to 30 mg once daily. 1

"Early in my career as an allergist, I saw how relentless the itch and rash could be for my patients with moderate to severe atopic dermatitis yet had limited options to offer those whose disease could not be adequately controlled with systemic therapy," said Thomas Hudson , M.D., senior vice president, research and development, chief scientific officer, AbbVie. "This additional approval for RINVOQ provides a once-daily oral option that can significantly improve the debilitating itch and skin symptoms of atopic dermatitis. It's also a proud moment for AbbVie as we continue our efforts to improve care in this disease state and other chronic, immune-mediated conditions."

Keep reading... Show less
Naturally Splendid Closes Second Tranche of $1,120,456 for a Total Raise of $3,270,971

Naturally Splendid Closes Second Tranche of $1,120,456 for a Total Raise of $3,270,971

Naturally Splendid Enterprises Ltd. ("Naturally Splendid" or "NSE" or the "Company" ) (FRANKFURT:50N)(TSXV:NSP)(OTC PINK:NSPDF) announces that it has closed the second tranche of its previously announced non-brokered private placement financing (the "Financing") (see news release dated November 23, 2021 and December 23, 2021) by issuing 37,348,532 Units (each a "Unit") at a price of $0.03 per Unit for gross proceeds of $1,120,455.96 (the "Second Tranche"). In total, the Company has issued 109,032,378 Units for gross proceeds of $3,270,971.34 under the entire private placement financing. The Financing has been oversubscribed by $270,971.34

Each Unit in the Second Tranche consists of one common share of Naturally Splendid and one common share purchase warrant (each a "Warrant"), with each Warrant entitling the holder to purchase one additional common share for a period of two years from the date of the issue at an exercise price of $0.05 per share.

Keep reading... Show less

TEZSPIRE NOW AVAILABLE IN THE UNITED STATES FOR THE TREATMENT OF SEVERE ASTHMA

- Amgen (NASDAQ:AMGN) and AstraZeneca today announced TEZSPIRE™ (tezepelumab-ekko) is now available for shipment to wholesalers in the U.S. TEZSPIRE was approved by the U.S. Food and Drug Administration (FDA) on Dec. 17, 2021 for the add-on maintenance treatment of adult and pediatric patients aged 12 years and older with severe asthma. 1

"Severe asthma has historically been a complex disease for patients to manage and for physicians to treat," said Murdo Gordon , executive vice president of Global Commercial Operations at Amgen. "About 60 percent of people have multiple drivers of disease and may not respond well to existing treatments. TEZSPIRE was approved for a broad population of people living with severe asthma, and we look forward to getting this important medicine into the hands of millions of patients who have had an unmet medical need."

Keep reading... Show less
Komo Plant Based Foods to Launch in Whole Foods Market Retail Locations in Western Canada

Komo Plant Based Foods to Launch in Whole Foods Market Retail Locations in Western Canada

Komo Plant Based Foods Inc. (CSE:YUM)(OTCQB:KOMOF)(FRA:9HB) ("Komo"), a premium plant-based food company, is pleased to announce all 7 Whole Foods Market retail locations in Western Canada will begin carrying Komo Plant Based Comfort Foods. Komo products are planogrammed to be on the shelves in all 7 stores in early 2022. Whole Foods has expanded to 6 stores within key neighbourhoods in the greater Vancouver area and most recently opened a flagship store in the capital city of Victoria on southern Vancouver Island

Whole Foods Market, Inc. is an American multinational supermarketchain headquartered in Austin, Texas, which sells organic foods and products free from hydrogenated fats and artificial colors, flavors, and preservatives. Whole Foods seeks out the finest natural and organic foods available, maintains the strictest quality standards in the industry, and has an unshakeable commitment to sustainable agriculture. Whole Foods has more than 500 retail and non-retail locations in the US, Canada and the United Kingdom. It has 14 retail locations in Canada, of which 7 are in British Columbia, and 7 are in Ontario. In 2017, Amazon purchased Whole Foods Market for USD$13.7 Billion.

Keep reading... Show less

Top Canadian Biotech Stocks

Click here to read the previous top Canadian biotech stocks article.

Although it’s not as large as the US biotech industry, the Canadian biotech market is still making a name for itself on the global investment stage in terms of size and opportunities.

In recent years, the biotech sector worldwide has become a “real industry” that has brought “spectacular” returns for mid-cap companies, according to Jessica Chutter, managing director and chairman of biotechnology investment banking with Morgan Stanley (NYSE:MS).

Much of the growth in biotech is attributable to technology advancements in drug research and development, said Chutter, who was speaking at a virtual event hosted by the Globe and Mail.

Keep reading... Show less
Solarvest To Sell on China's E-Commerce Application Redbook

Solarvest To Sell on China's E-Commerce Application Redbook

(TheNewswire)

Solarvest BioEnergy Inc.

Solarvest ( TSXV:SVS ) is pleased to announce that the Eversea TM "branded" account has been launched on the Chinese e-commerce platform application Redbook

Keep reading... Show less

Latest Press Releases

Related News

×