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Ted Ohashi-Let's Toke Business
https://4495825a-d729-4d8f-ade8-e78f828e1c8d.usrfiles.com/ugd/449582_e6ca64a07fed4e79beff07483ab00436.pdf
Yea I just would think he would have many opportunities so for him to choose Lexaria he must see something. I don’t know just found it interesting. What’s your thoughts on price targets?
“As we look towards 2022 and 2023, Lexaria is also taking steps to ensure we have multiple choices in how we fund the Company. Some details must remain undisclosed for now and will be revealed at the appropriate times, but in other respects we clearly are trying to position the Company for non-dilutive injections of capital through strategic partners and other commercial relationships.”
"Lexaria is also in discussions with a number of larger companies in Europe and North America regarding licensed use of our DehydraTECH technology both for consumer sectors as well as – for the first time ever - within the pharmaceutical industry."
Lexaria is still waiting on at least 2 more reports on the secondary aims of the hypertension study HYPER-H21-4. Clinicians are writing peer reviewed papers, which would be published, so one can assume that the results were positive. Secondary aims were arterial stiffness, vascular health biomarkers, inflammation, heart rate variability, and the psychological well-being of patients. Take your pick. A deal with a pharmaceutical company could come after all the data is published.
Why would a former President At GWPH come to Lexaria. It’s crazy that this is .07 pre split. Seems like they are going to need a lot more capital to do these trials.
hope you are well. Another raise - no big surprise. If I get my money back that would be great. So I am hanging in there - in too deep to walk away at this point. gltu
How’s everyone doing here. It’s been awhile so just checking in.
Let's Toke Business-Ted Ohashi
https://4495825a-d729-4d8f-ade8-e78f828e1c8d.usrfiles.com/ugd/449582_f7179f6d8a184c848f53fc9011d21f5d.pdf
For years l have believed some entity wishes nothing but harm on this stock. No mater how much good news the company puts out the stock is always driven down, Bunka must have pissed off someone big time in the past.
Finally. And not just pemarket fuckboi mm bullshit volume either
We've already surpassed the daily highest share volume since august of 2022 and there's still 2.5 hours to go!
There's still more data to come from the Hypertension study, I'm particularly interested in seeing the data on Arterial Stiffness. I believe the delay is caused by the need to have the data 'peer reviewed' and published in an appropriate medical journal.
"Additional study endpoint analyses as described in the complete study protocol are still underway and any relevant material findings will be reported upon as these findings become available."
Is LEXX actually making a run? Sooner or Later... Bang!
pps today a pleasant surprise - maybe there is a good reason?
On a positive note, this morning's volume is strong with the share price rising above the 6 month high. Up 8.6% on volume of 66,000.
ty looks like nothing new - i will keep on waiting glta
Ted Ohashi-Let's Toke Business
/https://4495825a-d729-4d8f-ade8-e78f828e1c8d.usrfiles.com/ugd/449582_d6a00860938245228995fb017fae007d.pdf
Mansax-- they are putting small pieces of bait on a lot of hooks (DR Death spending lots of cash on rat studies). Bunka is preparing a library of studies to impress big fish/pharma -- instead of doing one or two things well -- they are doing many studies that no one gives a "rats a##" about in big fish/pharma land. Unfortunately, comp for bunko and dr death $600k plus -- they get paid for effort/failure and not results. If I get my money back -- it would be a miracle.
Something is not right harlem. Look at the news announcements and the price of the stock. things don't add up and that's a major red flag. Maybe LEXX is just a marketing platform of what if's and no revenue or results. So far, that is how it is
NEWS_Lexaria's DehydraTECH-CBD Diabetes Study Demonstrates Weight Loss, Improved Triglyceride and Cholesterol Levels
8:45 am ET March 2, 2023 (Accesswire) Print
KELOWNA, BC / ACCESSWIRE / March 2, 2023 / Lexaria Bioscience Corp. (Nasdaq:LEXX) (Nasdaq:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms announces that its diabetes animal model study DIAB-A22-1 has completed and produced at least three positive outcomes including weight loss in obese diabetic-conditioned animals, together with improved triglyceride and cholesterol levels.
REDUCED BODY WEIGHT
Beginning just four days after the start of dosing with DehydraTECH-CBD, the obese rats began to lose weight. The weight loss was maximized nine days after dosing and maintained throughout the 8-week study duration. This apparent trend demonstrated roughly a 7% loss of body weight throughout the course of treatment at both DehydraTECH-CBD doses studied (30 mg/Kg and 100 mg/Kg). Only the DehydraTECH-CBD-dosed animals weighed less at the end of the study than at the beginning, whereas the weight of the untreated obese animals trended upwards throughout the study. The lean untreated animals gained the most weight of all to actually become obese by the end of the study.
Lexaria Bioscience Corp., Thursday, March 2, 2023, Press release picture
Furthermore, in the DehydraTECH-CBD treated rats the weight loss trend observed did not appear to be a result of lower levels of food or water intake. Food and water intake was comparable in both the treated and untreated obese animal groups suggesting that the weight loss was more so related to enhanced metabolic function.
According to the National Institute for Health, obesity or being overweight is the leading cause of diabetes.
ACTIVITY LEVELS
Obesity is often accompanied by reduced activity levels, which were measured in this study via locomotor activity, the distance the animals travelled in open field observations. Interestingly, the lower dose of DehydraTECH-CBD resulted in a statistically significant improvement in locomotor activity compared to the untreated obese control rats (*p<0.05), whereas there was no significant difference accordingly evidenced at the higher dose. As expected, activity levels for all obese rats were significantly lower than the lean control rats (#p<0.05), although only the lower dose DehydraTECH-CBD treated rats approached the activity levels of the lean rats. Previous research has suggested that CBD may enhance motor activity through its action upon the serotonin 5-HT1A receptor.
Lexaria Bioscience Corp., Thursday, March 2, 2023, Press release picture
Additional investigation will be required to learn what an optimum DehydraTECH-CBD dose related to both weight loss and increased physical activity might be, given the fact that the higher dose studied may have elicited sedative-like effects of CBD triggering hypolocomotion which others have also observed upon high systemic exposure.
TRIGLYCERIDE AND CHOLESTEROL LEVELS
Higher triglyceride levels in the blood can be an indication of the onset of diabetes. One of the best ways to manage triglyceride levels is to lose weight. In study DIAB-A22-1, the animals dosed with DehydraTECH-CBD showed statistically significant reductions in triglyceride levels from day 35 onwards compared to the obese animals not dosed with DehydraTECH-CBD. Once again, the lower dose of 30 mg/Kg of DehydraTECH-CBD outperformed the higher dose of 100mg/kg. By the end of the study the triglyceride levels in the animals receiving 30 mg/Kg of DehydraTECH-CBD was over 25% lower than that of the untreated obese animals (*p=0.007).
Lexaria Bioscience Corp., Thursday, March 2, 2023, Press release picture
Lexaria Bioscience Corp., Thursday, March 2, 2023, Press release picture
Cholesterol levels in the animals receiving DehydraTECH-CBD were also higher. There are two types of cholesterol - HDL and LDL - where HDL cholesterol is generally considered "good" and is desired and LDL cholesterol is generally considered "bad", although some studies are beginning to question whether this is true. Again, the lower dose of 30 mg/Kg appeared to outperform the higher 100 mg/Kg dose of DehydraTECH-CBD, with a trend toward increased HDL good cholesterol but with no significant effect upon LDL bad cholesterol levels compared to the untreated obese animals. The 100 mg/Kg dosed animals demonstrated increases in both desired HDL and the undesired LDL levels, with significance relative to the untreated obese animals in the latter instance (*p<0.05). The findings with the lower dose therefore appeared to support improved physiological function relative to the diabetic state.
According to the American Diabetes Association, CBD is not thought to directly reduce blood glucose levels as previous clinical studies have discovered, nor was any significant effect from DehydraTECH-CBD dosing on blood glucose measured or expected in this study.
SUMMARY
Animal study DIAB-A22-1 evidenced, at times, dramatic changes in body weight, general activity, and triglyceride and cholesterol levels associated with administration of DehydraTECH-CBD. These findings are well aligned with other study work in animals that points to the known anti-inflammatory and antioxidant properties of CBD functioning to lessen some of the essential pathophysiological factors associated with diabetes. Lexaria is pleased that relatively low doses of DehydraTECH-CBD seem to be supportive of real improvements in day-to-day health of the lab animals and the Company is very encouraged by the positive findings from its first study of DehydraTECH-CBD in this diabetes animal model, indicating many prospective benefits worthy of further investigation together, perhaps, with other drugs that further help to control glucose levels directly.
ABOUT THE STUDY
Study DIAB-A22-1 administered select Lexaria "DehydraTECH-CBD 2.0" formulations at doses of either 30 mg/Kg or 100 mg/Kg of body weight in a total of 32 male Zucker "ZDF" rats - 24 obese and 8 lean. The study length was doubled from four weeks of dosing to eight weeks of dosing, after initial positive early responses were witnessed. Treatment was well tolerated throughout the course of dosing with no serious health concerns observed in the animals that received DehydraTECH-CBD. The health of some of the obese animals declined after the study had concluded as might be expected, likely as a result of the advanced pathology and possible ketoacidosis from the prolonged diabetic condition of these disease-model animals. Study DIAB-A22-1 was undertaken by a leading, third-party testing laboratory located in Canada.
ABOUT THE DIABETES MARKET OPPORTUNITY
Diabetes is a disease whereby the body does not produce sufficient insulin, leading to higher than normal levels of sugars in the blood. Risks of kidney disease, vision loss, heart and cardiovascular disease and more are greatly enhanced by individuals with diabetes. Because diabetes is often closely connected to obesity, it is a chronic and growing problem around much of the world.
People with type-2 diabetes can often control the disease through lifestyle changes and/or taking certain diabetes medications, whereas those with type-1 diabetes are required to add insulin to their body through syringes, insulin pumps, or other similar devices. Thus the treatment of diabetes includes devices, drugs, and lifestyle alteration. The global diabetes devices market is estimated at $26.7 billion in 2021. The global diabetes drug market is estimated at $63.1 billion in 2021. Due to the pain and unpleasantness of injections, many diabetes sufferers prefer to treat their condition with drugs rather than devices, if they have the choice. More than 1.9 billion people were overweight in 2016, and due to the growth in obesity, which has nearly tripled from 1975 to 2016, the number of people experiencing diabetes continues to grow.
About Lexaria Bioscience Corp.
Lexaria Bioscience Corp.'s patented drug delivery technology, DehydraTECH™, improves the way active pharmaceutical ingredients (APIs) enter the bloodstream through 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 28 patents granted and many 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. The Company provides links to third-party websites only as a courtesy to readers and disclaims any responsibility for the thoroughness, accuracy or timeliness of information at third-party websites. 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 or links to third-party websites 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.
Thanks for passing this along.
Ted Ohashi-Let's Toke Business
https://4495825a-d729-4d8f-ade8-e78f828e1c8d.usrfiles.com/ugd/449582_77e1f80791914f6fa995aeaffa86094e.pdf
ted o ...ty - shawking
Ted Ohashi Let's Toke Business Pg. 11
https://4495825a-d729-4d8f-ade8-e78f828e1c8d.usrfiles.com/ugd/449582_87f74e0b9c6c4d7492b0afaf509e4dbd.pdf
thank you eom
Thanks for this!
Wow!
Does this explain this morning's jump?
Ted Ohashi-Let's Toke Business.
https://4495825a-d729-4d8f-ade8-e78f828e1c8d.usrfiles.com/ugd/449582_3ec4ed316d5740b0ac4c38141587efb8.pdf
Thanks Shawking -- I am in too deep to walk away now. gltu
Yes, the silence is deafening. I just asked them if there will be more data from the HYPER-H21-4 study. They said there was more data but couldn't say when it would be released as the team was still analyzing the data. Are they late because they're still being peer reviewed? I don't know, it's been almost 4 months since the first results though, WTF.
Here's a quote from their news release dated Oct 27 2022
"Additional study endpoint analyses as described in the complete study protocol are still underway and any relevant material findings will be reported upon in due course as these findings become available, currently expected during the remainder of 2022. The current findings will be submitted to an appropriate peer-reviewed clinical hypertension journal for possible publication."
the silence is deafening -- glta eom
Don’t take much to move this bish
Agreed! I am looking forward to brighter days for LEXY
Who better to negotiate with Jazz Phama than someone who's been there already?
probably - but I believe he must see something of value as I think he would have various opportunities with a host of companies...but he is here! gltu
I wonder what he sees? Is it greater efficacy with lower side effects for DehydraTECH CBD than Epidiolex?
Former President of GW Pharmaceuticals USA Joins Lexaria Bioscience as Strategic Advisor
8:45 am ET January 23, 2023 (Accesswire) Print
KELOWNA, BC / ACCESSWIRE / January 23, 2023 / Lexaria Bioscience Corp. (NASDAQ:LEXX)(NASDAQ:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms is pleased to announce that the former President of GW Pharmaceuticals USA, Julian Gangolli, is joining Lexaria Bioscience Corp as a Strategic Advisor.
"I am excited to be advising Lexaria Bioscience as it has become an established force in the field of improved drug delivery. As with GW Pharmaceutical's innovations in the cannabinoid field, the potential of Lexaria's disruptive drug delivery technology is significant and I hope to assist Lexaria in its commercial development of DehydraTECH for multiple applications," said Julian Gangolli.
"As we intensify our focus during 2023 on commercial execution of our robust DehydraTECH technology portfolio, I am very pleased to welcome Julian with his extensive pharmaceutical experience, to the broadening Lexaria team," said Chris Bunka, CEO of Lexaria.
Julian Gangolli was appointed US President of GW Pharmaceuticals in 2015. He oversaw approval by the US Food and Drug Administration of the first and only pure cannabidiol ("CBD") drug ever approved by the FDA, Epidiolex®, and its subsequent successful commercialization in the USA. This commercial success led ultimately to the acquisition of GW Pharmaceuticals by Jazz Pharmaceuticals in 2021 in a $7.2 billion transaction.
Mr. Gangolli was previously North American President of Allergan and a member of their Executive Management team that oversaw the sale of Allergan to Actavis in 2015. Mr. Gangolli was a senior member of the Allergan management team from 1998 onwards that transformed Allergan into one of the leading specialty pharmaceutical companies in the US.
Stock options valid to purchase 5,000 shares of the Company are being issued to Mr. Gangolli with an exercise price of $2.73 per share, valid for 5 years from the date of issuance.
About Lexaria Bioscience Corp.
Lexaria Bioscience Corp.'s patented drug delivery technology, DehydraTECH™, improves the way active pharmaceutical ingredients (APIs) enter the bloodstream through 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 28 patents granted and many 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. The Company provides links to third-party websites only as a courtesy to readers and disclaims any responsibility for the thoroughness, accuracy or timeliness of information at third-party websites. 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 or links to third-party websites 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.
Here's why a lower effective dose is important.
'The most common side effects for Epidiolex include: sleepiness, decreased appetite, diarrhea, increase in liver enzymes, feeling very tired or weak, rash, sleep problems, fever, vomiting and infections.'
When I said 'Nice to see such big name players involved.' I clearly meant as a group, here are some of the Assets under management.
Geode Capital Management 799 billion USD
Susquehanna International Group $293M USD
Vanguard Group Inc $8.1 trillion USD
UBS Group AG $2.124 trillion USD
Invenomic Capital Management LP $477.7 MM USD
Citadel Advisors LLC $253.4 BB USD
Two Sigma Investments, LP $60B+ USD
LEXX has NOT announced that Premier has made a payment to maintain exclusivity. Those payments were set to start September 1st. Given how often LEXX throws out pressers, I figure this payment was not made.
1) They aren't a "big name player"
2) LEXX is 0.1% of their portfolio
3) They own more than 200 stocks and its a mutual fund strategy
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.
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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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