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Markets are tanking everywhere only way to make a profit is to invest in gun manufacturers or bullet manufacturers. No one will be buying pharmaceuticals
In the near future. Who knows maybe A.I can save the world because people are doing a lousy job.
Ted Ohashi
https://4495825a-d729-4d8f-ade8-e78f828e1c8d.usrfiles.com/ugd/449582_053e7eb435cb4b13a3bec8289cef44bd.pdf
Lexaria Bioscience (NASDAQ: LEXX) (NASDAQ: LEXXW) has a well developed, drug delivery platform technology, DehydraTECH™, that helps the body absorb fat soluble Active Pharmaceutical Ingredients (APIs) such as cannabinoids, oral nicotine, antiviral drugs, PDE5 Inhibitors, vitamins and other molecules. Although water soluble molecules are well absorbed, fat soluble drugs aren’t and LEXX’s technology facilitates the oral delivery of fat soluble drugs more rapidly and efficiently which has profound implications for a number of drugs. For example, LEXX is working to implement commercial strategies around this technology including a recently started FDA registration using LEXX’s proprietary DehydraTECH™- CBD for the treatment of hypertension. Because of the preparatory work done,
LEXX’s application to the FDA was well received and as a result, it is expected to start at an advanced position somewhere in the range of Step 3, Phase 1(a) and Step 3, Phase 11(a). Management expects to be ready to begin the process by March/April 2023 after receiving FDA approval of their formal application. In addition, in September/October 2022, LEXX will likely publish the results from the most recent human clinical studies.
There are two other points to consider:
(1) DehydraTECH™- CBD tests have given indications it also improves the arterial elasticity. One of the causes of heart disease is a stiffening or hardening of the arteries that results in higher blood pressure. It requires more work but it could mean that DehydraTECH™- CBD is restoring some of the bodies natural function of healthy arteries. This would be a spectacular outcome.
(2) At around this point in time, management’s plan was to partner with a major pharmaceutical company that would carry the project forward. The plan may have changed and that approach would be interesting as well. But I guess over the next 12 – 18 months, LEXX might announce a partner in their hypertension approval process.
In addition, the technology has demonstrated apparent advantages in delivering APIs across the blood brain barrier. This is another high potential avenue to explore but in LEXX’s case it has been associated with the oral delivery of nicotine which may be of interest to every major tobacco company in the world.
Working along these lines means LEXX deals with Fortune 500 companies. It is known, they have made various agreements with companies such as announced on April 11, 2022 new agreements with Altria Client Services, associated with Altria Group (NYSE: MO) with a market cap of approximately $75 billion. On August 31, 2020, Lexaria announced a research and development project with British American Tobacco (LON: BATS) with a market cap of approximately $76 billion. On January 15, 2019, Lexaria Nicotine announced agreements with Altria Ventures, a subsidiary of Altria Group.
LEXX management has experience with dealing with multi-billion dollar market cap companies.
I have had experience in the past working with small and microcap resource exploration companies that have made agreements with large cap mining operators. I know how difficult it is for a small or microcap company to work with a Fortune 500 operator. The small cap company needs news to sustain interest in their shares. The large cap company believes the less information they share with others, the better. As a result, I am not surprised that these associations have not produced outstanding10 results. But that doesn’t mean there isn’t any. In fact, the better the results to the Fortune 500 company, the more tight lipped they will tend to be. Although this means we are left waiting for news of some
development, we shouldn’t forget these agreements have been made and are being worked on.
Not to be overlooked is the Intellectual Property (IP) portfolio LEXX has built up. The company owns 27 patents worldwide covering DehydraTECH™ with 50 patents pending. This portfolio is an asset with value that should increase as LEXX’s commercial interests expand internationally. The most recent patent was issued by Mexico and covered heart disease. This could be important because Mexico, along with the U.S. and Canada, are part of the North American Free Trade Agreement (NAFTA) that was the first international trade agreement to protect intellectual property rights recognizing the rights of intellectual property holders.
Conclusion: with Lexaria Bioscience (NASDAQ: LEXX) (NASDAQ: LEXXW) we have a small cap company with large cap aspirations. When I look back at my original report on LEXX, there is very little taking place that wasn’t anticipated
seven years ago. A combination of business acumen, hard work and a touch of
luck has brought the company to the verge of breakthrough success. For investors, a little courage with a pinch of patience will produce massive return potential from current levels.
Hypertension, nicotine, Vitamins, etc. and it appears that no one gives a crap about the GREAT RESULTS? It does not make sense. Bunka needs to pull a rabbit out of his hat soon! I am in the same boat with Nosibar... glta
Sequire Spotlight Presents Lexaria Bioscience (LEXX): Bringing Vitamin Delivery to the Next Level
Great interview with Bunka
I think we are being taken for a ride by Lexaria. CEO Bunka paying himself a huge salary with still no significant revenue-generating deals. Been invested close to 3 years now and as such I no longer have faith in them. Bag holding at a hefty loss on paper which is why I am still invested.
I think it was just a recap of what we already know??
I don't get it! Are they saying they've gotten remarkable results from HYPER-H21-4, but they're not saying exactly what those results were?
Lexaria Bioscience: Taking Aim at the $28 Billion Hypertension Market; Human Clinical Study Yields 'Remarkable' Results
Lexaria Bioscience: Taking Aim at the $28 Billion Hypertension Market; Human Clinical Study Yields 'Remarkable' Results
@Tony: I know researchers have been doing studies for years on whether nicotine can help with Parkinsons Disease. This one paper, from 2015, said it's known that there's an inverse relationship between tobacco use and development of PD. They think it's about the nicotine. There also seems to be help with symptoms for those who already have it. I'm not sure what that would mean for DehydraTech. Anyhow, here's a copy of the paper if you or anyone else are interested: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4430096/
Cash and Burn:
They are raising cash since August 12 it seems, planning to sell shares worth about 1/3 of current mkt cap, which is insane (announcing 2 days after releasing a bullsh*t article where the FDA basically just said "okay we agree you should test this on 100 people."
They will continue to burn cash, then whenever they release something like this, they will raise again and dilute shortly after.
This is a nonsense study. They talk about how big the dimentia market is...All they are doing is running a test that nicotine and CBD helps symptoms of dimentia such as agitaiton and anxiety, not actually the causes and primary symptoms of dimentia.
Thanks for the link,
All the best,
Knife
Let's Toke Business-Ted Ohashi
https://4495825a-d729-4d8f-ade8-e78f828e1c8d.usrfiles.com/ugd/449582_03c92dcde04a4361ae4538084bed2dc9.pdf
Lexaria Bioscience (NASDAQ: LEXX) (NASDAQ: LEXXW) made a couple of announcements recently that many investors may have missed on overlooked. I will tell you what they were and why I think they are very important.
• LEXX announced that Catherine Turkel, PharmD, PhD has joined its board of directors.
The release reports that Dr. Turkel has more than 20 years' experience as an executive in start-up and mid-size pharma/biotech companies. She was Founder and CEO of Nezee Therapeutics and served as President and R&D head at Novus Therapeutics (renamed Eledon Pharmaceuticals - Nasdaq: ELDN). She currently acts as an independent Board Director at Object Pharma (private) and Prostate Cancer Research (non-profit; member of the Translational Scientific Advisory Committee) and is a Dean Advisor at Chapman University School of Pharmacy. Dr. Turkel has formulated Food and Drug Administration registration & commercial strategic plans and has led global development programs for pharmaceutical and biologic treatments from phase 1 through phase 4 related to Neurosciences, Pain, Cardiovascular, Psychiatry, Rare Diseases, Ophthalmology, Aesthetics, Urology and Otology therapeutic areas. Dr. Turkel designed and led Allergan's (now AbbVie - NYSE: ABBV) pioneering BOTOX® Chronic Migraine registration program, generating revenue of more than a billion dollars.
• LEXX has received its 27th worldwide patent granted in Mexico. The patent is from their third patent family, "Stable Ready-to-Drink Beverage Compositions Comprising Lipophilic Active Agents" that includes patents have already been issued in Australia, India and Japan. Certain claims allowed in this Mexican patent to use DehydraTECH-processed nonpsychoactive cannabinoids to treat cardiac and cardiometabolic disorders are of particular value to the Company. It also includes the treatment of Alzheimer's, Parkinson's, schizophrenia, and Human Immunodeficiency Virus (HIV) dementia; obesity; metabolic disorders
such as insulin related deficiencies and lipid profiles, hepatic diseases, diabetes, and appetite disorders; cancer chemotherapy; benign prostatic hypertrophy; irritable bowel syndrome; biliary diseases; ovarian disorders; marijuana abuse; and alcohol, opioid, nicotine, or cocaine addiction.
Conclusion: In broad brush strokes, here is what I expect from Lexaria Bioscience (NASDAQ: LEXX)
(NASDAQ: LEXXW). In the next six to nine months, I expect LEXX to receive approval from the FDA to initiate testing DehydraTECH-CBD as a treatment for hypertension. In the six to twelve months after that, I expect LEXX will conclude an agreement with a larger pharmaceutical company to complete the FDA approval process. If these objectives are met, I have shown in previous reports that LEXX’s market cap could be a ten-bagger or better in the next 12 – 24 months.
However, this is not the end of the story. If this were to happen, it would be a rare and tremendous accomplishment for LEXX but there would still be many opportunities ahead, some of which were covered in the Mexican patent above. Therefore, it is important to keep building the intellectual property values in the form of patents and to attract new and highly qualified people to join in the effort.
If LEXX gets to this point with hypertension in the next six to twelve months, CEO Chris Bunka and President John Docherty might step back and assume less active roles. But as investors, we may continue to benefit from today’s investment for decades to come. If you look at the charts above for the shares and warrants, you will see a pattern of accumulation since
mid-June. This is in stark contrast to what happened in the year or two previous when news would spark a sharp rally followed shortly by an equal or greater quick correction. This suggests to me that with what LEXX has underway at present, we may never see these prices again. This may be your last chance to accumulate LEXX at these extremely attractive price levels.
Don't worry, Be Happy! LOL
Ted Ohashi Pg. 5
https://4495825a-d729-4d8f-ade8-e78f828e1c8d.usrfiles.com/ugd/449582_f533eef7477f48caaed066fe2b00caaa.pdf
Delayed? We were promised up to 12 applied R&D programs planned for 2022, so far only one has started, HYPER-H21-4.
KELOWNA, BC / ACCESSWIRE / July 13, 2022 / Lexaria Bioscience Corp. (NASDAQ:LEXX) (NASDAQ:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms announces the pending start of its upcoming human nicotine study NIC-H22-1. Lexaria expects to evidence that processing purified nicotine with its patented drug delivery technology, DehydraTECHTM, leads to enhanced oral-tissue absorption and reduced negative experiences.
Delayed, cancelled?
-HOR-A22-1: April 2022. This PK study will evaluate the ability of DehydraTECH to enhance the delivery characteristics of estrogen. Estrogen helps to control the menstrual cycle but also controls cholesterol and protects bone health. The hormone replacement market is estimated at $46.5 billion in 2027.
-DEM-A22-1: July 2022. This efficacy study will evaluate DehydraTECH-CBD with and without nicotine for the potential treatment of dementia. Alzheimer's disease is the most common form of dementia and accounts for at least 60% of all cases, and nicotine is already showing promising results related to Alzheimer's treatment. An estimated 55 million people worldwide are currently affected by dementia, with 78 million expected to be living with some form of dementia by 2030. The dementia drug treatment market is estimated at $19.6 billion in 2026.
thoughts RE: cash on hand/burn rate anyone? TY
Yeah, what the heck, all of a sudden we've traded almost a half million.
Interesting volume!
Show us any revenue of substance and $10 is easy
There is hope. This puppy could get squeezed to $30/$40/$50 if someone had the kahunas.
Bro, It's either the best thing since white bread and so many are missing the boat....or it's a complete fraud. No other way to explain the inaction on news they have put out. Dig in and wait. It's either gonna be $40 or .00001. Amazed they have been able to drag this on for so many years with the same promise. In all honestly, the reverse, patents and financing do give this some credibility, just the appreciation or lack thereof, is the only hard fact on the table
@Mansax: For what it's worth, I feel like they could use a better copywriter. I read the press release, and it's a bit murky just what the benefit is. I realize some things are just complicated; but maybe they could have some dramatic sounding examples of how this tech. could benefit people. I know people have mentioned this before, but sometimes the tech. sounds a little like it's a solution in search of a problem. For example, if DehydraTech makes a drug take effect in 30 minutes instead of an hour, so what? They really need to drive home in dramatic fashion how this is going to help. I realize they can't lie or exaggerate, but they need to do something to make this sound -- more interesting, I guess.
Just PR, looks like we are done for the day
New Drugs in Pipeline for Hypertension, the Silent Global Pandemic
8:30 am ET August 10, 2022 (PR Newswire) Print
NetworkNewsWire Editorial Coverage
In medicine, there is a term called "clinical inertia," or the case of what someone doesn't know -- or what they ignore -- could kill them. Simply put, it means failing to start or intensify a therapy when appropriate, which leads to advanced or chronic disease. It is particularly appropriate with a silent killer such as hypertension, a condition that all too often goes untreated, becoming a culprit in morbidity and mortality from cardiovascular, kidney and other serious diseases. Hypertension, or high blood pressure, stats continue to trend the wrong way, showing hundreds of thousands of people dying each year while costs of the disease are a major burden on already strained healthcare systems globally. Truth be told, hypertension is generally treatable with lifestyle changes and any number of prescription drugs, but most of the 1.28 billion people worldwide with high blood pressure go untreated. Because high blood pressure symptoms can be benign, patients would often rather go untreated than deal with unpleasant side effects of today's drugs. A new, safer option made available through Lexaria Bioscience Corp. (NASDAQ: LEXX) (Profile) may offer blockbuster potential. Lexaria, a global innovator in drug-delivery platforms, is working its way through the FDA pathway. Lexaria completed the pre-investigational new drug (IND) application meeting process for its newest DehydraTECH(TM) delivery system with the U.S. Food and Drug Administration (FDA) and is proceeding with plans to file an IND as soon as possible and begin clinical studies shortly thereafter. Quietly going about its business, Lexaria maintains a low market capitalization compared to bigger peers, such as Jazz Pharmaceuticals plc (NASDAQ: JAZZ), Johnson & Johnson (NYSE: JNJ), United Therapeutics Corporation (NASDAQ: UTHR) and Bristol-Myers Squibb (NASDAQ: BMY), a fact the company hopes to change by moving through the FDA process, where met milestones often equate to higher valuations.
-- The global market for drugs treating hypertension is forecast to climb from $24.17 billion in 2020 to $27.81 billion in 2025.
-- The economic burden of hypertension was $131 billion in 2020, while the disease was culpable in the death of more than 670,000 Americans.
-- Lexaria's patented DehydraTECH has been shown in laboratory, human studies to improve bioavailability of APIs to improve anti-hypertension therapy.
-- The most recent hypertension study hit a major milestone, while the company completed a highly constructive pre-IND application meeting with the FDA to plan the development of the company's DehydraTECH treatment of hypertension.
Click here to view the custom infographic of the Lexaria Bioscience Corp. editorial.
Nothing Slowing This Persistent Killer . . . Yet
Blood pressure (BP) is the measure of the force of blood pushing against artery walls as it courses throughout the body. While levels change throughout the day based on activity, normal BP is 120 over 80, meaning the pressure measurement is 120 mmHG when the heart beats and 80 mmHG in between heartbeats. Persistent high readings are considered hypertension and can result in increased chances of life-threatening complications such as heart disease, stroke, kidney and brain disease, among other things. A comprehensive study published in The Lancet shows hypertension cases in people aged 30 to 79 doubled worldwide from 1990 to 2019.
Today's approved drugs for hypertension are diverse, including alpha-blockers, beta-blockers, diuretics, ACE inhibitors, ARB inhibitors and other options for drug-resistant hypertension. Given the prevalence, it's no small market. ReportLinker last year estimated the global anti-hypertensive drugs market at $24.17 billion in 2020 with steady growth to $27.81 billion in 2025. The economic burden is staggering, averaging $131 billion annually according to the Centers for Disease Control and Prevention. Each year, more than 670,000 deaths in the United States are attributed to hypertension as a primary or contributing cause.
A recognized global innovator in drug-delivery platforms, Lexaria Bioscience Corp. (NASDAQ: LEXX) has its sights set on delivering a new, safe, effective and tolerable hypertension therapeutic that can slow the pervasive trend for the good of patients and healthcare systems alike. Lexaria's 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. The technology has been evaluated extensively across in vivo, in vitro and clinical research demonstrating that it promotes rapid absorption and improved effectiveness via oral delivery at a less-expensive cost point.
Moreover, implementation of DehydraTECH technology into production lines is relatively easy, achievable with the addition of only a few steps into the formulation and manufacturing of oral or topical products, albeit new or existing. During these new steps, the API is combined with suitable fatty acids with the mixture then infused into a substrate. From there, a controlled dehydration synthesis process associates the payload and fatty acids at a molecular level for integration into the final product at the specified form factor.
Lexaria has an extensive patent franchise covering the DehydraTECH intellectual property. There are 26 granted patents in the United States, the European Union, Australia, Japan, Mexico and India, with about four dozen more patents pending.
Strong Clinical Evidence
Lexaria is emerging as a pioneer of innovation with the DehydraTECH platform technology and its spate of potential applications with potential to improve pharmacokinetics in patient-friendly delivery methods. In doing so, the company is amassing a collection of evidence showcasing the prowess of DehydraTECH. For instance, a 12-patient study in 2018 resulted in a 317% improvement in substance delivery to the human bloodstream at 30 minutes after ingestion, followed by more studies this year specific to improved bioavailability specific to hypertension.
The most recent studies -- HYPER-H21-1, HYPER-H21-2 and HYPER-H21-3 -- speak volumes about the opportunity for DehydraTECH in hypertension. HYPER-H21-1 was a 24-person trial that evidenced rapid and sustained drop in blood pressure. The changes were especially notable in systolic pressure (the first number in BP readings, when the heart is beating) in stage 2 hypertensive patients. HYPER-H21-2 built on that data, adding info from a 16-patient study that exhibited a 23% average reduction in overnight blood pressure and reduced arterial stiffness, indicating a durable response. HYPER-H21-3, also a 16-person study, witnessed attenuated pulmonary artery systolic pressure by approximately 5 mmHG or 41% overall in male participants.
Importantly, all of the clinical work continued to build upon a robust safety and tolerability profile for DehydraTECH therapy.
Marching Towards an IND with FDA
Lexaria has just announced it has successfully completed its pre-IND meeting with the FDA -- a vital milestone. Now Lexaria is working to complete its planned IND-enabling program, and has early approval to pursue a coveted 505(b)(2) drug pathway for its DehydraTECH drug-delivery platform. In doing so, Lexaria is progressing smoothly through its most comprehensive hypertension study yet: HYPER-H21-4. On July 27, 2022, Lexaria reported that dosing in the study had been completed, adding that no serious drug-related adverse events had been reported.
The study was structured as a randomized, double-blinded, placebo-controlled, crossover study slated to enroll at least 60 patients. A total of 64 patients were enrolled and treated either with the experimental therapy or placebo. The highest dose of the Lexaria drug was ~5 mg/kg/day, a level substantially lower than maximum dose levels for similar drugs on the market today. The lower dosing level can have big implications for Lexaria, as lower doses are theorized to mitigate negative side effects of hypertension drugs, such as elevated levels of liver enzymes.
"Demonstrating a noteworthy safety and tolerability profile relative to conventional anti-hypertensive medications is one of Lexaria's major goals with this program, and avoiding serious adverse events at clinically efficacious doses will be a primary requirement to achieve eventual regulatory marketing authorizations," said Lexaria CEO Chris Bunka.
The primary outcome of the study is the impact of the drug related to 24-hour ambulatory blood pressure, where blood pressures are recorded automatically multiple times during the day and night. Secondary outcomes abound, including a measure of effect on vascular health, electrocardiogram analysis, MRI examinations of brain structure and function, renal and hepatic analysis, readings of blood biomarkers, sleep quality, daytime sleepiness and sleep disorders, actigraphy, geriatric depression scale, perceived stress and Beck anxiety inventory.
While safety and efficacy as related to ambulatory blood pressure are top priorities, the abundance of secondary data should not be underappreciated. Lexaria wants to cull all this information as part of its broader strategy to develop DehydraTECH as a true platform technology. Understanding a full spectrum of effects could underpin other drug-development initiatives.
Each Step Adds Value (And It's Not Linear)
According to the FDA, there are five steps to developing a new drug. These include 1) discovery and development; 2) preclinical research; 3) clinical research; 4) FDA drug review; and 5) FDA post-market drug safety monitoring. In the eyes of the investment community, the third step, or clinical research, which is broken into Phase 1, 2 and 3 human trials, is crucial.
During this step, valuations can surge on the market being addressed. Take note that only a small percentage of drugs (fewer than 250 out of 5,000 to 10,000) exit the discovery stage to make it to preclinical research, and fewer yet make it to human trials. Thus, it is not uncommon for nonrevenue biotechs and pharmas to have market capitalizations in the hundreds of millions by phase 2 and billions of dollars in phase 3 trials.
Lexaria is on the cusp of the FDA's steps 2 and 3 with its mix of lab and clinical work in the DehydraTECH program generating a solid understanding of safety, tolerability and efficacy. The company's current market cap is about $17 million.
To provide a little backdrop as to what can happen with valuations for novel drugs, understand that Jazz Pharma paid $7.2 billion for GW Pharma after GW Pharma obtained marketing approval for its patented Epidiolex to treat two rare types of pediatric seizure disorders. In March, Pfizer shelled out $6.7 billion for Arena Pharmaceuticals to gain control of Arena's diverse portfolio of drugs. Big pharma is looking to reload pipelines with promising drugs and new revenue streams.
Follow the Trend to Value
At this moment, there is no real reason to think that the hypertension trend is going to change direction solely upon today's marketed drugs. The silent killer typically begins with unhealthy lifestyles and is frequently accompanied by obesity, a fellow killer in its own right with diagnoses running rampant as evidenced by 42% of American adults clinically obese. With that in mind, anti-hypertension drugs should continue to command high value for the foreseeable future.
Jazz Pharmaceuticals plc (NASDAQ: JAZZ) is best known for its deep pipeline and approved drugs in the areas of neuroscience and oncology and an optimal example of building value by moving through the FDA process. For instance, shares were trading around $125 in December when Jazz and partner PharmaMar initiated a phase 3 trial of Zepzelca(R) (lurbinectedin) for the treatment of patients with relapsed small cell lung cancer. Two days later, Jazz said the first patient was enrolled in a global phase 2b trial evaluating the safety and efficacy of suvecaltamide for the potential treatment of moderate to severe essential tremor (ET). The stock has remained in an uptrend since.
The Janssen Pharmaceutical Companies of Johnson & Johnson (NYSE: JNJ) are committed to developing a portfolio of pulmonary arterial hypertension (PAH) drug candidates; that development includes sponsoring the largest randomized, controlled trial ever conducted in PAH patients. PAH is a rare type of high blood pressure in the lungs that occurs when the organ's tiny arteries narrow, stiffen and block blood flow, ultimately leading to right-side heart failure.
United Therapeutics Corporation (NASDAQ: UTHR) is also in the PAH space. In May, United won FDA approval for Tyvaso DPI(TM) (treprostinil) inhalation powder for the treatment of pulmonary arterial hypertension (PAH; WHO Group 1) and pulmonary hypertension associated with interstitial lung disease (PH-ILD; WHO Group 3) to improve exercise ability. Tyvaso DPI represents a new formulation and inhalation device for inhaled treprostinil and is the only dry powder inhaler approved by the FDA for use in PAH and PH-ILD.
Bristol-Myers Squibb (NASDAQ: BMY) is in the heart space in many areas, as exemplified by the company's April announcement of winning FDA approval for Camzyos(TM) (mavacamten, 2.5 mg, 5 mg, 10 mg, 15 mg capsules) for the treatment of adults with symptomatic New York Heart Association (NYHA) class II-III obstructive hypertrophic cardiomyopathy (obstructive HCM) to improve functional capacity and symptoms. Camzyos is the first and only FDA-approved allosteric and reversible inhibitor selective for cardiac myosin that targets the underlying pathophysiology of obstructive HCM.
The World Health Organization estimates that about 700 million people in the world between the ages 30 and 79 have untreated high blood pressure. A new drug that assumes the role as a standard of care aside, treating a portion of these people not already on medications is a massive market opportunity, especially if a drug can be differentiated from others. Safe to say that with that type of potential, companies of all sizes are on the lookout to be the company that brings a new, better drug to market.
For more information about Lexaria Bioscience Corp., please visit Lexaria Bioscience Corp.
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More news today.
Big question.....why do investors not care and are not taking positions down here?
Shawking--once again-Thank You!! eom
Abundance, your post beat mine by 57 seconds (not that its a contest) - just wanted to say good job and TY for posting it...GLTA
And still barely a sniff in the market
Hypertension PR JULY 27-Lexaria's DehydraTECH-CBD Hypertension Study HYPER-H21-4 Dosing Complete with No Serious Adverse Events
9:12 am ET July 27, 2022 (Accesswire) Print
KELOWNA, BC / ACCESSWIRE / July 27, 2022 / Lexaria Bioscience Corp. (NASDAQ:LEXX)(NASDAQ:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms is pleased to announce that dosing with Lexaria's DehydraTECHT-processed cannabidiol ("DehydraTECH-CBD") has been completed in its multi-week human clinical hypertension study HYPER-H21-4, and that no serious adverse events have been reported as a result of the dosing.
HYPER-H21-4, is a randomized, double blinded, placebo-controlled, cross-over study that was designed to enrol a minimum of 60 patients. Dosing has now completed, meaning all patients at different times during the study have now received both the full DehydraTECH-CBD dose regimen as well as the placebo. A total of 64 patients were dosed in this study. Maximum dose levels were roughly 5 mg/kg/day which is significantly lower than maximum dose levels practiced for other regulator-approved pharmaceutical CBD applications, which Lexaria postulates may be beneficial in avoiding unwanted side effects such as clinically significant elevated liver enzymes sometimes reported in the published scientific literature at higher dose levels.
"We are extremely pleased that dosing has been completed on time in this multi-week clinical study without any serious adverse events having occurred," said Chris Bunka, CEO of Lexaria Bioscience Corp. "Demonstrating a noteworthy safety and tolerability profile relative to conventional anti-hypertensive medications is one of Lexaria's major goals with this program, and avoiding serious adverse events at clinically efficacious doses will be a primary requirement to achieve eventual regulatory marketing authorizations."
HYPER-H21-4 is designed to enhance Lexaria's probability of success toward an Investigational New Drug ("IND") application filing to seek U.S. Food and Drug Administration ("FDA") approval to commence registered clinical testing at the Phase I level or higher, to be determined in consultation with the FDA. This human study is also expected to enhance Lexaria's understanding of DehydraTECH-CBD for the treatment of cardiovascular and other disease states beyond hypertension related to increased arterial stiffness and blood biochemistry, pursuant to earlier promising findings in this area. HYPER-H21-4 follows Lexaria's previously announced successes in significantly reducing blood pressure in similarly hypertensive human volunteers in its 2021 studies HYPER-H21-1 and HYPER-H21-2.
HYPER-H21-4 consisted of male and female volunteers between the ages of 40-70 with documented or measured elevated blood pressure (120/80 to 139/80 mmHg), mild (stage 1) hypertension (140/90 to 159/99 mmHg) or moderate (stage 2) hypertension (160/100 to 179/109 mmHg) who received DehydraTECH-CBD every day for a 5-week duration. DehydraTECH-CBD doses escalated between 225 mg/day to 450 mg/day over the study duration adjusted relative to body weight. Some volunteers were already using leading standard of care hypertension drugs such as angiotensin-converting enzyme ("ACE") inhibitors with or without diuretics and/or calcium channel blockers, which will help evaluate the safety and efficacy of DehydraTECH-CBD with and without other hypertension treatments. The extended duration of the study allowed Lexaria to gather critical data monitoring the safety and efficacy of DehydraTECH-CBD over time and will evaluate the potential for longer term health benefits.
HYPER-H21-4 is more comprehensive than any clinical study previously undertaken by Lexaria and many types of analysis will be performed including 24-hour ambulatory blood pressure, which is the primary study outcome.
Secondary study outcomes include: vascular health including arterial stiffness and autonomic balance; electrocardiogram ("ECG") analysis; brain structure and function through MRI testing; blood biomarkers (including renal, hepatic inflammation, lipids such as cholesterol and more); sleep quality / daytime sleepiness / sleep disorders; actigraphy, geriatric depression scale, perceived stress, and Beck anxiety inventory. Large quantities of data have been gathered since the initiation of the study, and most data analyses will begin in September once results are available from ongoing bioanalyses work upon biological samples collected during the study.
Each of these sets of data may lead to additional applications for DehydraTECH-CBD. For example, the MRI data may assist one of the secondary outcome measurements in the study to evaluate possible positive effects upon brain structure and function; and the detailed psychometric testing may reveal new insights into the potential benefits for mental health. The wide range of data collection could provide additional insights into the long-term health benefits of DehydraTECH-CBD that might otherwise remain undetected.
About Lexaria Bioscience Corp.
Lexaria Bioscience Corp.'s patented drug delivery technology, DehydraTECHT, improves the way active pharmaceutical ingredients (APIs) enter the bloodstream by promoting more effective oral delivery. Since 2016, DehydraTECH has repeatedly demonstrated the ability to increase bio-absorption with cannabinoids, antiviral drugs, PDE5 inhibitors and more. DehydraTECH has also evidenced an ability to deliver some drugs more effectively across the blood brain barrier. Lexaria operates a licensed in-house research laboratory and holds a robust intellectual property portfolio with 25 patents granted, 1 patent allowed, and roughly 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.
Hypertension study H21-4 dosing complete w/ no serious adverse affects https://ir.lexariabioscience.com/news-events/press-releases/detail/186/lexarias-dehydratech-cbd-hypertension-study-hyper-h21-4
Ted Ohashi-Pg.32
https://4495825a-d729-4d8f-ade8-e78f828e1c8d.usrfiles.com/ugd/449582_022fd8eeb4b84c2883fb2fec968ad232.pdf
No mention of Lexaria's HYPER-H21-4 and other studies for some unknown reason.
Oral Cannabidiol Effect on Blood Pressure in Hypertensive Patients (HYPER-H21-4) https://clinicaltrials.gov/ct2/show/NCT05346562
Lexaria licensee Premier's new product launch https://www.marketscreener.com/quote/stock/PREMIER-ANTI-AGING-CO-L-119074088/news/Premier-Anti-Aging-Co-Ltd-146-s-Consolidated-Subsidiary-Premier-Wellness-Sciences-Co-Ltd-Anno-40920983/?utm_campaign=promo+202102+share_article++en_us&utm_source=twitter&utm_medium=display
Shawking. Thank you--eom
Ted Ohashi Pg. 14
https://4495825a-d729-4d8f-ade8-e78f828e1c8d.usrfiles.com...
1. Lexaria has been notified of the allowance of its 26th worldwide patent to be granted in Japan. Entitled Lipophilic Active Agent Infused Compositions With Reduced Food Effect, the patent recognizes DehydraTECH's ability to deliver active pharmaceutical ingredients (APIs) more efficiently regardless of the presence of foods within the gastrointestinal system. This can deliver drugs more consistently into the bloodstream regardless of the presence of food in the GI and is an important achievement in the quest for more reliable drug dosing. Lexaria has patents granted or patent applications progressing in countries around the world with aggregate populations of nearly 4 billion people.
2. Premier Anti-Aging Co. consolidated subsidiary Premier Wellness Sciences announced the launch of its new brand "Ko" with CBD (cannabidiol) as a core ingredient, effective July 21st, 2022. Ko will incorporate the DehydraTECH™ technology that increases the bioavailability of CBD and shorten the onset time of efficacy. DehydraTECH™ can increase CBD absorption by 5 to 10 times, even up to 27 times, compared to industry-standard formulated products. Furthermore, many studies have confirmed that DehydraTECH™ reduces the onset of efficacy from 1 to 2 hours to a few minutes
Good point. The samples would have to have no contaminants whatsoever.
It would have to be some entity with an accredited lab because it's a human randomized, double blinded, cross-over study. I doubt that the pouch manufacturer would be Altria either as they're testing it against Altria's pouch.
Nine major academic papers should get some attention :)
maybe Cannadips lol
Who is the third-party pouch manufacturing company? Is that Altria?
Glad to see that it's a human study and not an animal or lab study!
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Lexaria Bioscience Corp. (CSE:LXX; OTCQX:LXRP) has developed and out-licenses its disruptive and cost-effective DehydraTECH™ technology that promotes healthier administration methods, lower overall dosing and higher effectiveness of ingestible drugs and other beneficial molecules.
Lexaria’s DehydraTECHTM delivery technology is protected by a robust suite of patents granted or pending worldwide and is proven effective in multiple international studies in greatly assisting rapidity and quantity of absorption of a range of lipophilic (i.e., fat-soluble), bioactive molecules. By significantly enhancing the performance and experience with oral ingestion, Lexaria’s DehydraTECH delivery technology offers a viable and often healthier alternative to other delivery methods for bioactive substances in widespread use today such as inhalational delivery through smoking.
Lexaria’s patented technology, DehydraTECH™ delivers these important benefits:
Eliminates the strong tastes/odors of lipophilic compounds, without the need for unwanted sugar or sweeteners
Effects are felt within 15-20 min vs. 60-120 min.
Initial testing indirectly evidences DehydraTECH may deliver ingested molecules through the lymphatic system instead of being subject to immediate “first pass” liver exposure, potentially mitigating unwanted side effects and reducing liver biotransformation.
Bio-absorption increases up to 3 – 10X, to equate or exceed that of other routes of administration like inhalational delivery.
Lexaria’s DehydraTECH™ is designed specifically for formulating and delivering lipophilic (i.e. fat-soluble) drug payloads. It is patented or patent-pending for use with a broad range of bioactive molecules, including but not limited to:
Lexaria Bioscience Corp. (“Lexaria”) has formed the Lexaria Nicotine Corp. as its exclusive worldwide nicotine business unit. More than 89% of all nicotine that is consumed worldwide is delivered through smoking cigarettes. Approximately 6,000,000 deaths per year around the world are attributed primarily to the delivery of nicotine through the act of smoking according to the Centers for Disease Control and Prevention. Of note: “…it is primarily the toxins and carcinogens in tobacco smoke – not the nicotine – that cause illness and death.” (U.K. National Institute for Health and Care Excellence [NICE]). As many as 69% of U.S. adult smokers want to quit smoking and 43% of US adult smokers have attempted to quit in any twelve-month period. Lexaria postulates that delivery of nicotine to satisfy current demand, utilizing our patented DehydraTECH technology in common food and consumer product formats, could shift demand away from smoking cigarettes. However, ingestion of nicotine is challenging because it is poorly tolerated by the human gastrointestinal system and then significantly metabolized by the liver, thereby diminishing its overall effectiveness through edibles. Lexaria’s DehydraTECH technology offers a means to formulate ingestible product formats of nicotine and/or its analogs with higher bioavailability performance possibilities due to the benefits of our technology.
Lexaria is developing a patent suite with supporting intellectual property in the pharmaceutical sector that will supply significant long-term strategic growth potential. Lexaria Pharmaceutical Corp. is the 100%-owned subsidiary that has obtained exclusive worldwide rights to Lexaria’s patent portfolio related to pharmaceutical applications. Currently within this business unit resides the IP for Non-Steroidal Anti-Inflammatories (NSAIDs), Vitamins, hormone treatments utilizing estrogen or testosterone, phosphodiesterase inhibitors (PDE5). Additional molecules of interest could be added to this unit over time.
According to Statista.com, the global pharma industry was worth $1,105 billion in 2016, and the US pharma industry alone spent over $71 billion in 2017 on R&D: a larger R&D expenditure than the entire gross revenues of many other business sectors.. Lexaria Pharmaceutical Corp. is implementing a strategy of reinforcing its IP-suite to sufficient degree to begin partnering within this dynamic industry.
The Lexaria Hemp Co. holds exclusive global rights to the Lexaria patent portfolio related to hemp-based applications. Lexaria’s DehydraTECH technology is designed to deliver functional ingredients within hemp in oral product formats with significantly enhanced palatability, speed of effectiveness and potency as a viable and healthier alternative to conventional inhalational (i.e. smoking or vaping) administration practices. Extensively evaluated through invivo, invitro, and human clinical studies, one of the most extensive databases in the world has been collected by Lexaria related to hemp-based ingredients empowered with our DehydraTECH technology. In 2018, the World Anti Doping Agency (WADA) for the first time ever exempted cannabidiol from hemp from its list of restricted substances on its International Standards Prohibited List of substances.
Lexaria CanPharm Corp, a Canadian corporation, owns exclusive global rights to Lexaria’s intellectual property as it is applied to psychotropic bioactive molecules that act upon human CB1 and CB2 receptors in those areas of the world where it is permissible to do so. Substances that act upon these receptors and systems in the human body that affect pain, inflammation, anxiety and depression, and have also been shown to have utility against cancer and neurodegenerative conditions. Lexaria’s ground-breaking 2018 research that proved many-fold improvements in delivering an active ingredient across the blood-brain-barrier could have disruptive potential within this business sector as well as all others where Lexaria is active.
The safety and effectiveness of Lexaria’s DehydraTECH™ technology has been studied in a series of controlled and well designed in vitro and in vivo human focus studies, examining factors such as total bioabsorption directly and indirectly through surrogate biomarkers, time to onset of effectiveness, flavor appeal and quality of effectiveness. Studies to-date have focused on cannabinoid applications where Lexaria is most advanced commercially, although research is underway for the other bioactive compounds named in Lexaria’s patent portfolio and described under Commercial Applications.
Pre-Clinical Research into Lexaria’s DehydraTECH™
An in vitro absorption study was performed to assess unidirectional CBD permeability using a human epi-intestinal tissue model with various formulations in the presence of simulated intestinal fluid. The study was designed to, as closely as possible, mimic intestinal absorption as it would occur in a live subject. Samples of Lexaria’s commercially available CBD-fortified ViPova™ black tea were administered in the model compared with concentration-matched CBD control preparations that lacked Lexaria’s patented formulation and process enhancements. The study showed as much as a 499% improvement, on average, in intestinal tissue permeability with the ViPova™ black tea formulation relative to a concentration-matched CBD control preparation without any Lexaria technology enhancements. The study also showed a 325% improvement, on average, in intestinal tissue permeability comparing the ViPova™ black tea preparation to a concentration-matched CBD control preparation that utilized Lexaria`s dehydration synthesis processing methodology but lacked its fatty acid ingredient incorporation, demonstrating the power of the Lexaria technology as a whole (see Figure 1).
Following this study, a series of independent, well designed, well controlled human focus studies were undertaken corroborating Lexaria’s in vitro performance findings. A study in healthy volunteers (n=6) suggested as much as a 5-10X increase in CBD absorption, which was assessed indirectly through measurement of the increase in salivary nitric oxide as a directly proportional surrogate biomarker, with onset of action in as little as 15-30 minutes. In all cases, the maximum increased level of salivary nitric oxide remained evident at the 60-minute end period of this particular test. Further testing is required to determine the full duration of elevated nitric oxide levels.
Thereafter, a blinded human focus study was conducted to evaluate the performance of THC-infused chocolates formulated using Lexaria’s DehydraTECH™ technology. This study compared the performance of the THC-infused chocolates powered by Lexaria’s technology to concentration matched THC-infused chocolates formulated using a commercial dextrin absorption enhancer. The subjects (n=12) that participated in this study indicated a clear preference on taste and overall effectiveness with the chocolates formulated using Lexaria’s technology, and onset of effectiveness was again observed very quickly, in as little as 15-20 minutes.
Lexaria Bioscience Corp’s disruptive new patented technology DehydraTECH™ is available to be licensed.
DehydraTECH can be used to improve existing products or to create new products. It is suitable for use with a wide range of consumer product formats including:
DehydraTECH is designed to be effective in delivering most fat-soluble molecules through the human gastrointestinal system and has also demonstrated affinity for transdermal applications and even effectiveness in crossing the blood-brain-barrier once within blood plasma. Lexaria has, or is conducting, in vitro, in vivo and human clinical testing, including pharmacokinetic data gathering, for the delivery of API’s through ingestible means. Test data has consistently pointed to reduced time required to enter the bloodstream, increased absorption rate, and reported improvements in taste and smell of edible products.
Contact us today to speak about your licensing needs at ablanchard@lexariabioscience.com
Terms and rights associated with our licensing opportunities are discussed on an individual basis.
Lexaria’s typical approach to working with a new prospective licensee is to effect confidentiality terms and then collaborate with the license prospect under a non-binding letter of intent to evaluate the feasibility and applicability of the Lexaria DehydraTECH technology for the license prospect`s needs. Following this, if the license prospect is satisfied with the performance enhancements delivered by the DehydraTECH technology, Lexaria then seeks to transition to a definitive fee bearing agreement structure between it and the new licensee.
We will license our technology in any of the more than 40 countries around the world where the DehydraTECH is patented or patent-pending. Licensees can feel confident that Lexaria’s extensive IP portfolio – constantly expanding – will help to provide a competitive edge and protection against inferior methodologies or older, outdated technology.
If your company works in a different but related field, please contact us if you’d like to conduct research on applicability for your specific application.
Licensees should also always remember that DehydraTECH costs less than a penny per serving to implement – sometimes a bare fraction of a penny. Licensees may experience an increase in market share or an increase in pricing power as a result of offering their customers superior delivery characteristics. Customers are loyal to the improved performance of DehydraTECH based products.
DehydraTECH is one of the world’s ONLY delivery technologies that does not require the addition of chemicals or intimidating, complex ingredients requiring disclosure on a food label. DehydraTECH works with commons GRAS ingredients that can be organic, gluten-free, and dairy free.
If your company works in a different but related field, please contact us if you’d like to conduct research on applicability for your specific application.
Masks taste/odor
Eliminates the strong tastes/odors of lipophilic compounds, without the need for unwanted sugar or sweeteners.
Reduces time of onset
Effects are felt within 15-20 min vs. 60-120 min.
Increases bio-absorption
Increases bio-absorption by 2 – 10x, to equate or exceed that of other routes of administration like inhalational delivery.
Avoids first-pass liver metabolism
Testing has evidenced that DehydraTECH may deliver molecules through the lymphatic system instead of being subject to immediate “first pass” liver exposure, potentially mitigating unwanted side effects. More recent testing in animals even demonstrated an ability to cross the blood-brain-barrier to a degree previously thought not possible.
Interview with CEO Chris Bunka
https://youtu.be/9bRSWYKIEL8
New Enhanced DehydraTECHTM formulation delivers 8X more CBD into blood and over 19X more CBD into brain tissue than standard industry formulations.
Kelowna, British Columbia – June 4, 2019 – Lexaria Bioscience Corp. (OTCQX: LXRP) (CSE: LXX) (the “Company” or “Lexaria”), a drug delivery platform innovator, has discovered improved performance characteristics of a new version of the DehydraTECHTM delivery platform initially suitable for use in solid oral dosage forms like capsules, tablets and pills for the pharmaceutical, medical, and supplement markets. Lexaria’s innovative use of a naturally sourced formulation enhancement more than doubles DehydraTECH’s absorption performance compared to previous DehydraTECH results demonstrated to-date. The Company has filed new patent applications related to the recent innovations.
BACKGROUND
On March 20, 2019 Lexaria announced it was beginning a series of animal studies with multiple objectives, including evaluating enhanced DehydraTECH formulations that might offer improved performance. Copious data streams have been generated from these tests and continue to be analyzed.
In this arm of animal study, Lexaria tested its DehydraTECH delivery technology with compounds postulated to behave in a synergistic fashion for enhancement of gastro-intestinal absorption, which resulted in significantly enhanced DehydraTECH performance (“Enhanced DehydraTECH”).
Of note, the new Enhanced DehydraTECH and its improved performance is separate and distinct from the nanotech improvement techniques recently announced by the Company.
TEST RESULTS
In each arm of the Lexaria animal studies, 10 male Sprague-Dawley rats were administered an identically sourced CBD at a rate of 25mg per kg of bodyweight. Delivery of CBD into the bloodstream was measured at 2; 4; 6; 8; 12; 15; 30; 45; and 60 minutes after dosing. DehydraTECH-enabled CBD was measurable in animal blood within 2 to 4 minutes after dosing.
On May 15, 2019 the Company reported that DehydraTECH achieved a CBD blood concentration level that was 475% more than a generic industry medium chain triglyceride (“MCT”) coconut-oil formulation 15 minutes after dosing. Today, the Company reports that Enhanced DehydraTECH led to 811% more CBD delivery into blood than generic industry MCT coconut-oil formulations (p=0.00008); and 110% more CBD into blood than DehydraTECH in its traditional format (p=0.02).
Also of note is that both traditional DehydraTECH and Enhanced DehyraTECH delivered maximum blood concentration levels prior to the 60-minute end-of-test, with levels tapering off thereafter. The DehydraTECH technology therefore demonstrates both fast onset and fast offset as tested which is of interest for dose titration purposes when repeated dosing is desired.
CONCLUSION
DehydraTECH’s in its traditional format has been used commercially by the Company since 2014; and by the Company’s technology licensees since 2016. Lexaria has consistently introduced leading innovation for oral cannabis formats such as capsules, beverages and edibles, with a focus on the consumer experience as measured by qualities such as taste, rapidity of onset and offset, and reliability of effect. Unique among the cannabis industry, DehydraTECH has proven itself equally transformative in other sectors such as the nicotine industry where Lexaria has licensed its technology to one of the largest nicotine products companies in the world.
Enhanced DehydraTECH seems particularly adept at delivering previously unreachable quantities of CBD across the blood brain barrier and into brain tissue; more so than even the most advanced nanotech as previously reported utilized in these studies. Since most human receptor cells of the CB1 variety and otherwise that are associated with the psychotropic effects of cannabinoids are located within the brain these findings significantly expand upon the power of Lexaria’s technology to reach the target site of action for these purposes.
With this new innovation, Lexaria is establishing new performance thresholds for drug delivery technology, with tested performance of 8x (blood plasma) and more than 19x (brain tissue) of generic industry formulations. The Company intends to perform further studies to fully characterize Enhanced DehydraTECH and will work throughout 2019 to optimize implementation into the best product applications for use by its licensees.
The animal test results announced to date have led to additional new patent applications based on the positive performance results achieved. The specific nature of enhanced DehydraTECH shall remain undisclosed for proprietary reasons until the new patent filings are published. Although the current tests were limited to CBD absorption, Lexaria expects knowledge from the current innovation to apply equally to tetrahydrocannabinol (THC) as well to enhance formulation innovation for nicotine and various pharmaceutical compounds already named within the Lexaria patent suite.
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