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Lexaria Submits Investigational New Drug Application
Kelowna, British Columbia – TheNewswire -- January 30, 2024 – Lexaria Bioscience Corp. (Nasdaq:LEXX) (Nasdaq:LEXXW) (the “Company” or “Lexaria”), a global innovator in drug delivery platforms, announces that, on January 29, it submitted its much-anticipated Investigational New Drug (“IND”) application with the U.S. Food and Drug Administration (“FDA”) for its planned U.S. phase 1b hypertension clinical trial HYPER-H23-1 of DehydraTECH-CBD.
This IND submission follows a successful pre-IND meeting with the FDA which provided Lexaria with guidance related to the development and filing of the IND. From 2018 through 2023, Lexaria sponsored five investigator-initiated human clinical studies of its DehydraTECH-CBD in an aggregate total of 134 people, without recording a single serious adverse event (the “Studies”). These Studies evidenced significant reductions in resting blood pressure over both acute and multi-week dosing regimens alone and, in some cases, complementary to standard of care medications; suggesting that DehydraTECH-CBD has the potential to have broad therapeutic utility.
As indicated at the FDA website, “once the IND is submitted, the sponsor must wait 30 calendar days before initiating any clinical trials. During this time, FDA has an opportunity to review the IND for safety to assure that research subjects will not be subjected to unreasonable risk.”
Lexaria looks forward to commencing clinical trial HYPER-H23-1 as soon as possible following IND effectiveness, subject to certain conditions including funding. The IND review process when successfully concluded will be an important milestone achievement for Lexaria demonstrating that its DehydraTECH technology has met high level formal regulatory scrutiny towards prospective future pharmaceutical commercial registration.
About Planned Clinical Trial HYPER-H23-1
Clinical trial HYPER-H23-1 is entitled ‘A Phase 1b Randomized, Double-Blind, Placebo-Controlled Study of the Safety, Pharmacokinetics, and Pharmacodynamics of DehydraTECH-CBD in Subjects with Stage 1 or Stage 2 Hypertension’. The primary objective of the trial will be to evaluate safety and tolerability in hypertensive patients, and secondary objectives will include efficacy evaluation in reducing blood pressure together with detailed pharmacokinetic testing.
All clinical, laboratory and analysis procedures for study HYPER-H23-1 are to be performed entirely by U.S.-based, third-party independent contract service providers.
About Lexaria Bioscience Corp. & DehydraTECH
DehydraTECH™ is Lexaria’s patented drug delivery formulation and processing platform technology which improves the way active pharmaceutical ingredients (APIs) enter the bloodstream through oral delivery. Since 2016, Lexaria has developed and investigated DehydraTECH with a variety of beneficial molecules in oral and topical formats. DehydraTECH has repeatedly demonstrated the ability to increase bio-absorption and has also evidenced an ability to deliver some drugs more effectively across the blood brain barrier, which Lexaria believes to be of particular importance for centrally active compounds. Lexaria operates a licensed in-house research laboratory and holds a robust intellectual property portfolio with 38 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
Time to get in while the getting's good! Filing coming very soon and acceptance shouldn't be much more than a month following. Trials should begin right after that. Get your tickets now!
Well on it's way there?
They haven't even filed the IND paperwork yet, let alone begun even phase 1 clinical trials. At best they are many years and lots of capital raises away from an "approved pharmaceutical." With lexaria it seems like there are so many great study results but no "big fish" company willing to bite on the tech. What do they know that we don't? I'm willing to take a chance on lexaria but it seems like it's just never ending "just around the corner" stories with this company.
Going to stay optimistic...but I thought for sure that this would have held $1.50, at the lowest, knowing that FDA IND news is any day now. I found the CEO letter a little wishy-washy compared to the date deadline provided in the quarterly report. Just hoping the slow regression is not an indication that the "on or before January 31, 2024" is getting pushed back.
Bashing is not Pumping! LEXX has done a great deal of amazing research and development that has shown nothing but good to excellent results. Success is closer everyday. Bunka and the team have made some choices that didn't work out but that's how companies grow, by learning from both successes and failures. There are many reasons pathways don't work out that have virtually nothing to do with the companies themselves. The US decision to not allow CBD in food or drinks is a huge reason LEXX had to change course from pushing CPG's in the US. Other countries are still wrestling with this as well.
If LEXX can get approved for a pharmaceutical approved CBD product for Hypertension or Diabetes or other and get a drug code for prescribing these products then sales will grow exponentially. This is not a pipe dream. LEXX is well on it's way there!
Also looking at the way TPST, ALT ,KALA etc have gone up by 20-30X on news and even retained more than half of their gains is what keeps me around. I think if this company surely does something +ve, this is will fly probably 30-40X of current PPS.
I don't have to , Bumka is very much following this board. As I said earlier, I want him to deliver results. So far "NOTHING" has been delivered.
The Poviva tea, Vegan/CBD bars , or Gummies or what no, nothing has worked. The only and final hope is Biotech arm or the Nicotine Arm that could act as Pivot.
Otherwise this company is going Bankrupt.
As someone had mentioned in the post earlier too, this is probably is his "Last Chance", the IND application and GLP-1 trials and if he sooner does not find partners willing to work with him, it is going to be very bad for existing shareholders.
It still baffles me that none of the Big Tobacco is working with Lexxy.
Why waste money in trials using offshore laboratories when they are not credited enough for Big Pharma/Big Tobacco to partner.
Why not just call him then. You are constantly posting impossible questions that only Bunka knows the answers to. That's what the rest of us do!
I am not going to Pump a stock just to get an exit or make some dough. I genuinely want Bumka to work his ASS OFF and full fill the promises or narratives that he has been showing folks. That guy is taking 300k salary and another 200k+ of free stock and options, the least I expect him is to deliver.
Its not funny, it is good to call it out, as I sure Bumka is going through these messages. So just addressing them in shareholder letter is not going to cut it out.
If you truly do own a bagful and you want the SP to go up, you sure have a funny way of showing it!
My advice is to try be more positive. lol
Ok if that was the case, u agree Bumka conned us into believing institutional investors have lined up. Folks r willing to partner etc.
So unless results are from.credited labs, it is also manipulated?
Hard to believe none from Big pharma or Big Tobacco jumping on it unless IND approval brings legitimacy to these trials
Doing trials offshore with a different set surely has its disadvantages.
You pose some fair questions re: why no one big has jumped on board yet. I think it's a matter of scale and proof. There is plenty of evidence from studies involving up to over a hundred people at a time but that number needs to be larger. When we have success with clinical trials with American laboratories more well known by Big Pharma then the risk factor for getting on board will become a no brainer. It is tough to wait. I've been a shareholder for over 6 years so I know but I'm still a believer. Call me crazy!
Completely agree that Bumka is focusing on Biotech and not CPG's. But the thing is that CPG was a way to fund biotech's trails and not dilute the shit out of shareholders. I have been holding bag and clearly frustrated with Bumka and find it hard to trust his narratives.
For me as a layman if DHT which seems to be "The thing" and the best one as per results published so far, why are biotech's not investing at this low mcap. Its a chump change for Biotech or Tobacco companies to partner at this stage with Lexx instead of waiting out.
This shareholder letter is also visible to other's from Big Pharma / Big Tobacco, how come they are not jumping up and down on their seats looking al the human trials of Nicotine or GLP-1 or CBD or Antiviral or any of those. Cause I believe, we have increase the bioavailability in each of the cases and non of the results from any of the previously taken trials had anything to suggest anything negative abt it.
There are too many +ve streams , but none of them is materializing , so it is very frustrating. This stock should have been $30-40 and mcap of 300-400 mil when the revenue potential is in few billions at the least. Hard to explain the market or rather Market know's it that we long terms don't
Bunka doesn't need to make excuses for deals that aren't making money. The licensees are not his businesses. Good that he's going to focus on Pharma moving ahead instead of CPG companies that aren't even able to use our excellent tech because of their countries antiquated laws with CBD.
Going forward, things are looking good for attracting some big fish. Possibly there are some on the line right now. Someone may have said "As soon as you get accepted for trials we will be your partner!" That could be in a month and a half from now. Worth waiting for in my opinion.
Seems like Bunka is having time to go through board messages , can he then also address the failures. The whole Japan co deal worth 4.5 mil would have sponsored some of the R&D expense, but having little to no revenue even after all these years of proving how "DHT" is better than what they are using now does not add much to the confidence of existing shareholders.
Nicotine pouch / Tobacco industry is bigger than Diabetes/Hypertension combined, still with very positive results, not a single taker on anything to do with DHT.
How come Bumka is not able to explain these gaps that I can clearly see between vision and its execution in this shareholder letter.
The failures have not been explained to give enough confidence whether the newer initiatives will yield any +ve results.
There are small biotech's that have gone up 30x like TPST, KALA or ALT etc, especially knowing that DHT is better than the one Novo got for 1.8 bil, not sure why its competitors are not pursuing joint trails using DHT
With such low mcap, for companies that big and having to sponsor these planned trials is chump change of few mil 5-10mil and acquire 25-30% of Lexx biotech subsidiary. That's what is baffling ,why none of the big ones are approaching Bumka
From the letter to shareholders Jan 24, 2024
"On January 19, 2024, we filed a Form S-8 Registration Statement with a reoffer prospectus (the "S8"), in order to effectively register the additional shares issuable under our Incentive Equity Plan (the "Plan") as approved by our shareholders on May 9, 2023 and to allow our insiders the ability to trade any shares currently issuable to them under the Plan. The filing of an S8 does not mean that insider selling is imminent! In fact, Lexaria has had a valid S8 in place since our listing on the Nasdaq and to date no insider has sold any shares pursuant to it. Every situation is unique, but as a rule, paying much heed to the "short and distort" community is not a smart way to manage your investments".
There's nothing makes me think any of them are willing to dump any shares at this point. But if the SP takes off with the FDA application and Clinical trials then an employee may wish to sell some options on the open market. Not rocket science. Everyone needs a little money! I'd be happy if no one sells any until we at least have a partner to help with financing.
Yes, I agree it is for future sales of 396k shares . Can u explain why is bumka.and others are willing to dump them if they r so confident about the prospects.of this company technology.
"This reoffer prospectus has been prepared for the purposes of registering the Shares under the Securities Act to allow for future sales by the Selling Stockholders on a continuous or delayed basis to the public without restriction".
https://fintel.io/doc/sec-lexaria-bioscience-corp-1348362-s8-2024-january-18-19740-9160?utm_source=stocktwits.com&utm_medium=referral&utm_campaign=filing
I think this S8 is one of not offering new securities, but rather selling by employees. They're dumping 396502 shares as reoffer, and giving themselves additional thru this S8
Here's the latest insider info. No one's selling. https://www.sec.gov/edgar/browse/?CIK=0001348362
Go to Ownership Disclosures...All Insider Transactions. You're welcome.
LEXX is just registering securities as part of their stock benefits plan. Likely in the next few days you'll see more stock options handed out to employees.
https://www.investopedia.com/terms/s/sec-form-s-8.asp
They're currently not selling any. Bunka has never sold any shares. Eventually they may want to like all of us.
As far as Big Tobacco goes, a deal could happen at any time. Too bad we haven't seen it yet but the future is wide open.
Can you explain the S-8 where insiders are dumping shares. I think Bumka now only owns 5% of shares and not 10%.
As I mentioned earlier, all the news is planned around dumping more shares in open market.
If the earlier test were not enough to get BigP interested in technology, why do you think this time things will be any different.
I agree Diabetes and HighBP is much bigger market, but still much less than Tobacco and it is hard to believe that after proving and publishing human trials and still none of Big Tobacco has not shown any interest, including the one who owns 12% (MO)
He didn't do it because it was trending. He did it because he saw LEXX had a technology that could help a current health problem. It's unfortunate there's so much govt. red tape that he couldn't get the anti-viral improvements fast tracked. With Hypertension and Diabetes, these are serious illnesses that aren't going away anytime soon and hopefully BP will be able to use DehydraTECH. It's extremely versatile as far as being able to be combined with virtually any drug. Just a matter of time as you likely know!
Surprising, just sometime back someone was saying bumka does not test whats trending, but it is clear he did test covid 19 antiviral , I think I saw more than 1 press release in past.
He did it for epidolex and also for anything that's out there by other pharma Co. But none of its competitors are going after lexx to bring competitive products through dehydratech
https://ir.lexariabioscience.com/news-events/press-releases/detail/139/lexaria-completes-successful-antiviral-drug-molecular
"The NRC has successfully confirmed Lexaria's study objectives, demonstrating DehydraTECH™ processing and formulation technology does not create a covalently bonded new molecular entity ("NME") and that each drug tested remained stable and did not undergo change in chemical structure. The five drugs studied were remdesivir, ebastine, bepridil, rupintrivir and colchicine, which have antiviral effects through a variety of different modes of action."
My understanding is that both phase 1 and phase 2 studies will be run concurrently.
Pretty sure this fact is why LEXX was pre-approved by the FDA to put their application in a 505(b)(2) format.
"A 505(b)(2) application is an NDA that contains full reports of investigations of safety and effectiveness, where at least some of the information required for approval comes from studies not conducted by or for the applicant, and for which the applicant has not obtained a right of reference or use, including, for example, the Agency’s finding of safety and/or effectiveness for a listed drug or published literature".
https://www.fda.gov/drugs/cder-small-business-industry-assistance-sbia/abbreviated-approval-pathways-drug-product-505b2-or-anda
In this case of LEXX using CBD with DehydraTECH, a fair amount of the CBD studies have been done through previous FDA studies when GW Pharma did their FDA clinical trials for the CBD drug Epidiolex. It's my understanding, this information does not need to be re-tested.
Of course it would follow that we could use this format for other drugs that have already been FDA approved! It's definitely going to be interesting to see how the abbreviated pathway speeds up the clinical trials!
When I was speaking to IR a few months ago this was mentioned so I'm assuming true.
Shawking & Abundance88,
Do either of you remember, years ago, LEXX saying that they received confirmation from the FDA stating that DehydraTECH does not alter the carrier drug? I remember it being mentioned, but I can't find it anywhere. I am trying to confirm the information, and have written IR as well as Chris on LinkedIn (still awaiting a response). I remember it being conveyed to us as critical because it means that DehydraTECH can be added to any existing FDA approved drug without the drug company redoing all of FDA Drug Approval process. If my memory serves me correctly, this information is obviously BULLISH and needs to be broadcasted.
GLP-1. Everyone wants a piece of this market and they're all trying for an oral application.
https://www.msn.com/en-ca/money/markets/the-weight-loss-drug-market-may-soon-get-more-crowded-here-are-the-companies-trying-to-enter-the-booming-space/ar-AA1n8L4O?ocid=msedgntp&pc=DCTS&cvid=2511223d8cbd440b87eab90fa48408c5&ei=199
I see some shares traded as high as 1.73 in after hours!
I just hope Bunka gets Big Pharma / Big Tobacco as interested in his vision and mission as he has got bunch of Long term share holders holding bags while he continues to profit from their HOPE
Sounds like you should sell!
Bumka at his best, running con game with help of Ted and news wire, creating hope and anticipation of some big tobacco or big pharma will one day buy it out or seriously partner instead of TIEing their hands 😃
Looks like all the news are planned around shitty 10-Q
Ted has dropped another letter justifying why Altria has bought 12% of lexx nicotine and tied their hands , so that they can continue to use other product , but not the superior lexxy pouches .
It gets more interesting that now for next 6 months a new HOPE of GLP-1 study and data is created just like last year of hypertension ind application
Let's see if things will be done in 6 months or he will drag it to 1yr+ as he did for hypertension
https://4495825a-d729-4d8f-ade8-e78f828e1c8d.usrfiles.com/ugd/449582_fda7c9d8647a468d856ddc51e5413803.pdf
“LEXX has shown many great results regarding the enhancements their technology can provide. Why do you think drug, tobacco and supplement companies aren't knocking each other
out of the way to get at this? Only one small supplement company has come knocking.”
DG
I think that up to now, it has been a question of size. I will use Altria (NYSE: MO) as an example since
most of us know it is one of the world’s largest producers and marketers of tobacco, cigarettes, and
related products. MO has a market cap of $73.1 billion. Lexaria (NASDAQ: LEXX), the company we all
know, has a market cap of $15.5 million. This means that if MO acquired LEXX and LEXX increased in
value tenfold that would be an outstanding return in most cases. Having said that, a tenfold increase in
the value of their investment in LEXX might translate into an increase in MO’s market cap of 0.2%.
Of course, LEXX’s DehydraTECH™ could improve the delivery of nicotine in MO’s product which would
boost their sales. That is why I was excited when Altria invested in Lexaria Nicotine. But that is yet to
develop into a business. I can only say, that sometimes multibillion corporations play defense. If they see
something with potential down the road, they will tie it up for a few million dollars to prevent anyone
else from getting at it.
I see the Investigational New Drug (IND) application for hypertension as completely different. Assuming
the application is accepted and approved by the U.S. Food and Drug Administration, it will be the most
advanced development of an application that LEXX has carried forward under their control. At this
point, I can see big pharma trying to acquire this interest. I look at GW Pharmaceuticals' development of Epidiolex® using a CBD base for the treatment of childhood seizures, a relatively small area of
medical treatment compared with hypertension. However, GW Pharma was acquired by Jazz PharmaCeuticals for $7.2 billion. That’s a number large enough to have an impact on any large-cap company
assuming the successful development of the IND into an FDA-approved drug. And the hypertension market
is exponentially larger than the childhood seizures market.
Conclusion: I alerted you to the fact that I thought LEXX was under accumulation starting last fall. The
LEXX market action has certainly borne this out in successive months as seen in the chart below. I suspect that there have been a lot of questionable trades
in LEXX, especially if you go back to the Robin Hood days
when LEXX traded multiple of its market cap in one session. I have also accepted that those trades will never be
properly sorted out. What I’m saying is I like the current pattern of trading much better: without spectacular price
changes in one session where prices move sharply higher,
then just as sharply lower and close unchanged on ridiculously high volume. I believe trading today is based on fundamentals where the recovery takes place
gradually over time. When news is announced such as submission of the IND application or approval
of the IND by the FDA, there will be strong jumps in the stock price in my opinion but off a stronger
base. I would continue to participate in the accumulation pattern with buy and hold being the key
LEXARIA BIOSCIENCE CORP.
FORM 10-Q
(Quarterly Report)
Filed 01/12/24 for the Period Ending 11/30/23
https://www.otcmarkets.com/filing/conv_pdf?id=17182679&guid=xFJ-kW-KetqjJth
if you look at their investor presentation, essentially all of their most important data has been generated in the last 3 years. as much as it must frustrate people who have been around for longer (I totally get it), the company is going to be made or broken based on this recent stretch and the significance of that data (e.g. is the data from the hypertension or GLP-1 programs good enough to attract BP or large biotech interest?).
I guess there is someone who is able to call out A spade a spade.
Can Bunka clear all the questions I have raised. If the test were carried out offshore to save $, why us there need to raise so much $.
Why can't Bumka focus on one thing and keeps on doing Animal studies for anything and everything.
He has proven his technique delivers better than GW pharma epidolex, but that didn't change the perception of big pharma
Similarly, for remesidivor or now glp-1
Or nicotine pouches
What is the catch or gap that we shareholders and warrant holders are not able to see and are constantly buying into narratives set by Ted and NewsWire
And are willingly holding bags for Home Run
Even if lexx follows TPST profile where it went up 30x on some approval or KALA 20x on IND approval, it is still going to be below $75 pps pre split high
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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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