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https://finance.yahoo.com/news/cannadips-relaunches-across-california-exclusive-140000904.html
HERBL to distribute Cannadips' new formulation of THC-infused pouches in California
HUMBOLDT, Calif., Nov. 8, 2021 /PRNewswire/ -- Cannadips, the original smokeless cannabis and hemp dip pouch have relaunched their THC line across California exclusively with HERBL, California's largest cannabis supply chain company. HERBL's distribution network will support the relaunch of Cannadips' THC product line in California beginning November 8th and will provide immediate access to all licensed retailers across the state.
Let’s Toke Business-Ted Ohashi
https://4495825a-d729-4d8f-ade8-e78f828e1c8d.usrfiles.com...
Lexaria Bioscience (NASDAQ: LEXX) (NASDAQ: LEXXW) (CSE: LXX) announced a new study that will
compare the effectiveness of DehydraTECH-CBD to Epidiolex for reducing seizures. Epidiolex is an FDA
approved formulation developed by GW Pharmaceuticals. It uses CBD medication to treat seizures associated with two rare forms of pediatric epilepsy. GW Pharma was acquired by Jazz Pharmaceuticals
(NASDAQ: JAZZ) earlier this year for US $7.6 billion paid approximately 90% in cash and 10% in shares of
JAZZ. The study is named EPIL-A21-1 and early-stage preparatory work has begun. Results are expected
by the third quarter of 2022.
I think this is a very promising and exciting idea. Epidiolex is the only CBD-based, FDA approved medication
on the market. Without downgrading anything GW Pharma accomplished, the Epidiolex formulation is relatively simple and most of the science is in the public domain. Basically, it is CBD, sesame seed oil, dehydrated alcohol, sucralose and strawberry flavouring. For clarity, dehydrated alcohol is often used to promote
dissolving materials into a solution and sucralose is commercially known as the artificial sweetener Splenda.
In other words, there is no real “secret formula” or “technological black box” associated with Epidiolex. Essentially the information relating to Epidiolex becomes available through regulatory processes such as FDA
filings and patent applications including data on bioavailability and speed of delivery.
From LEXX’s point of view, given the work they have done with CBD and the data they have collected that
I am aware of, they should have reason to believe their DehydraTECH-CBD formulation will be at least as
good as if not better than the Epidiolex product. As results not only with CBD but also with THC and nicotine
have shown, the results from EPIL-A21-1 could be substantially better. If this is the case, the next step with
a big pharma company such as JAZZ is obvious.
Conclusion: There are a couple of things worth noting that make this announcement a little different from
previous press releases. First, Epidiolex is a CBD-based, FDA approved drug and this is the first time LEXX
has worked with one.
If the results of testing
are positive, that is,
there is an improvement in amount or
speed of delivery, the
next step will be a nobrainer. At that point,
LEXX has a DehydraTECH-CBD product that is superior to an FDA approved CBD-based product.
Second, there was stability in the trading of LEXX immediately following the announcement. Certainly the
price did pop in early trading but it wasn’t the unsustainable kind of price increase on unbelievable volume
that has occurred a few of times in the past. In addition, in the past LEXX has frequently not been able to
sustain its gains on day one. In other words, in the past the stock has increased more and declined even
more in the first day of trading. This time, it has traded modestly higher but maintained that gain over the
first day of trading.
13
I think this means the market is waking up to the fact that LEXX is grossly undervalued. This case gives me
the opportunity to draw some broad conclusions if DehydraTECH-CBD is equal to or better than Epidiolex.
First, GW Pharma was acquired for US $7.6 billion and FDA approved Epidiolex was its major asset. What
would DehydraTECH-CBD be worth equal to or better but unapproved? 50%? 25%? 10%? 5%? If it was
worth 5%, that could make LEXX a 10-bagger. Cut it in half again and its still a prospective 5X return. And
that assumes no value on the potential in hypertension treatment, nicotine and THC delivery.
I have often described LEXX’s investment potential as explosive. The latest announcement is just another
example of how this can happen. LEXX is one of the top positions in the Investor’s Hub model portfolio.
Shouldn’t it be one of your top holdings too?
4495825A-D729-4D8F-ADE8-E78F828E1C8D.USRFILES.COM
4495825a-d729-4d8f-ade8-e78f828e1c8d.usrfiles.com
Thanks, I see John Docherty is speaking on day 1 at 12:45 on Track 2A. this should draw some attention as every big name pharma company in North America is attending.
https://www.newsfilecorp.com/redirect/zW7gQu1jRE
Lexaria THC Test Results Come in as MORE Act Gains Momentum in Congress
2021-10-20 08:31 ET - News Release
New York, New York--(Newsfile Corp. - October 20, 2021) - PCG Digital -- Lexaria Bioscience Corp, developers of the revolutionary DehydraTECH™ drug delivery technology, is in the news again this week. On October 13th, the British Columbia-based pharmaceutical company released study results on THC-A21-1, a THC oral format.
The study revealed that Lexaria's DehydraTECH™ THC delivers THC levels to blood-plasma at a rate that is roughly three times faster than standard MCT-based THC. Oral ingestion required just fifteen minutes to reach comparable levels that the "coconut-oil" formulations took forty-five minutes to achieve. By the six-hour mark, as THC was leaving the system, the levels were equal and demonstrated the fast-on, fast-off performance.
One of the key goals of this trial was to advance DehydraTECH™ THC as a medicinal solution, but CEO Chris Bunka is looking at a broader market. "THC consumers today include… medicinal and pharmaceutical users. Our objective is to provide them rapid onset and high bioavailability without harmful delivery mechanisms like smoking."
MORE Act Passes Another Congressional Hurdle
The DehydraTECH™ THC test results are timely because the House Judiciary Committee passed the MORE Act with a 26-15 majority vote just last week. There are still several hurdles to overcome, including final Senate approval, but the movement for federal legalization of cannabis in the United States appears to be gathering momentum again.
Canada (2018) and Mexico (2021) already have legalized cannabis on a national level. That includes medical marijuana. Eighteen US states, the District of Columbia, and Guam have also passed laws decriminalizing the use of cannabis and THC. The legal market for DehydraTECH™ THC in the US is estimated at 145 million Americans, based on US Census Bureau data.
With an increasing market size and a slim Senate majority in favor of national legalization, Lexaria's work in this area is critical. "The cannabis industry continues to use outdated formulations and processes," Chris Bunka said. "Our study demonstrated the rapid, safe THC delivery that is consistent with the wants and needs of today's THC consumers."
Medicinal Uses for THC Should Push Legislation Forward
The stigma of recreational THC use remains a stumbling block for Congressional action, but the documented benefits of using THC as a medical solution for pain relief should push legislation forward. According to the CDC, 93,331 people died from drug overdoses during the 2020 pandemic, many of them from pharmaceutical and synthetic opioids.
In recent years, the FDA has approved THC-based dronabinol (Marinol®) and nabilone (Cesamet®) as anti-nausea drugs for patients undergoing chemo treatments or suffering from AIDS-related wasting syndrome. The UK and Canada, along with several other European countries, are using THC/CBD formulations to treat neuropathic pain.
Lexaria is already well down the path to NDA filing for DehydraTECH™ CBD as an anti-hypertensive solution. That market is estimated at $30 billion. According to Grand View Research, the global legal cannabis market, which includes medicinal and recreational THC, was at $9.1 billion in 2020 and expected to grow at the rate of 26.7% from 2021 to 2028.
Exactly! I don't give a rat's ass about animal tests anymore and neither does the rest of the market.
They got some rats stoned quicker than the competition! Halleluiah!
Chris, Please give us some new news.
https://podcast.stock2me.com/
IBN (InvestorBrandNetwork) Announces Latest Episode of Stock2Me Podcast Featuring Lexaria Bioscience Corp. Chairman & CEO Chris Bunka
2021-10-12 08:17 ET - News Release
LOS ANGELES, Oct. 12, 2021 (GLOBE NEWSWIRE) -- via InvestorWire -- IBN (InvestorBrandNetwork), a multifaceted communications organization engaged in connecting public companies to the investment community, is pleased to announce the release of the latest episode of The Stock2Me Podcast as part of its sustained effort to provide specialized content distribution via widespread syndication channels.
The Stock2Me Podcast features a fascinating array of companies and individuals, many of whom are actively revolutionizing age-old business practices within their respective markets. Stock2Me’s latest podcast features Chris Bunka, Chairman & CEO of Lexaria Bioscience Corp. (NASDAQ: LEXX), a global innovator in drug delivery platforms.
To begin the interview, Bunka provided a summary of Lexaria’s business model, which is focused on leveraging the company’s proprietary DehydraTECH™ drug delivery technology.
“[Lexaria has] developed a drug delivery technology that’s quite unique,” Bunka said. “What our technology does is it allows people to swallow any number of various drugs or active pharmaceutical ingredients (APIs) and basically allow a larger proportion of the drug to … get into the bloodstream and reach the site of action. That is what our technology is focused on, and, because we’re so good at it, we’re actually seeing applications in all sorts of different business sectors, be it cannabidiol, nicotine for oral delivery, antiviral drugs and others. … We do not sell any drugs ourselves, but we do sell or ‘rent’ our technology.”
Bunka then discussed his professional background and the team behind Lexaria.
“I’ve been in a number of different industry sectors over what is now a 40-year career – construction and real estate development, natural resources and technology. … I’ve been with Lexaria a long time. My president, John Docherty, and I are the two people who are mostly responsible for the current business lines,” he added. “I’m delighted to be able to work on my final project of my career, which will be Lexaria. It’s the most exciting thing I’ve ever worked on in my life, and I’m really, really fortunate to be part of the team that we have at Lexaria, which has some incredible scientists and businesspeople involved in the company.”
Bunka next highlighted Lexaria’s recent transformative steps to position itself for accelerated growth.
“Our company kind of had a rebirth in January 2021. … We completed a 1-for-30 reverse stock split,” Bunka explained. “That was really hard, and just so you all know, I was the biggest shareholder. I am still the biggest shareholder. I took a big hit on my own holdings, but we had to do that to make the company attractive for future shareholders. … We got listed on Nasdaq in January and completed an $11 million financing. That was the biggest financing in the history of the company, and it transformed us. … We were able to step on the gas pedal and basically work on our research and development and our commercial studies at a 5-10x higher pace than anything we could do in the past. Therefore, this year, we’ve done more work than we did in the five years previous – all put together.”
Join IBN’s Stuart Smith and Chris Bunka, Chairman & CEO of Lexaria Bioscience Corp. (NASDAQ: LEXX), as they explore Lexaria’s accelerated development efforts in recent months and the company’s ambitious goals for the remainder of 2021 and beyond.
To hear the whole podcast and subscribe for future episodes, visit https://podcast.stock2me.com.
The latest installment of The Stock2Me Podcast continues to reinforce IBN’s commitment to the expansion of its robust network of brands, client partners, followers and the growing IBN Podcast Series. For more than 15 years, IBN has leveraged this commitment to provide unparalleled distribution and corporate messaging solutions to 500+ public and private companies.
To learn more about IBN’s achievements and milestones via a visual timeline, visit: https://IBN.fm/TimeLine
About Lexaria Bioscience Corp.
Lexaria Bioscience Corp.'s patented drug delivery technology, DehydraTECH™, improves the way active pharmaceutical ingredients (APIs) enter the bloodstream by promoting more effective oral delivery. Since 2016, DehydraTECH has repeatedly demonstrated the ability to increase bio-absorption with cannabinoids and nicotine by up to 5-10x, reduce time of onset from 1-2 hours to minutes and mask unwanted tastes; it is also being evaluated for orally administered anti-viral drugs, non-steroidal anti-inflammatory drugs (NSAIDs) and more. DehydraTECH has also evidenced an ability to deliver some drugs more effectively across the blood brain barrier. Lexaria operates a licensed in-house research laboratory and holds a robust intellectual property portfolio with 21 patents granted and over 50 patents pending worldwide. For more information, visit the company’s website at www.lexariabioscience.com.
About IBN
IBN (InvestorBrandNetwork) consists of financial brands introduced to the investment public over the course of 15+ years. With IBN, we have amassed a collective audience of millions of social media followers. These distinctive investor brands aim to fulfill the unique needs of a growing base of client-partners. IBN will continue to expand our branded network of highly influential properties, leveraging the knowledge and energy of specialized teams of experts to serve our increasingly diversified list of clients.
Through NetworkNewsWire (“NNW”) and its affiliate brands, IBN provides: (1) access to a network of wire solutions via InvestorWire to reach all target markets, industries and demographics in the most effective manner possible; (2) article and editorial syndication to 5,000+ news outlets; (3) enhanced press release solutions to ensure maximum impact; (4) full-scale distribution to a growing social media audience; (5) a full array of corporate communications solutions; and (6) a total news coverage solution.
For more information, please visit https://www.InvestorBrandNetwork.com.
Please see full terms of use and disclaimers on the InvestorBrandNetwork website, applicable to all content provided by IBN wherever published or re-published: http://IBN.fm/Disclaimer
Forward-Looking Statements
This release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All forward-looking statements are inherently uncertain as they are based on current expectations and assumptions concerning future events or future performance of the company. Readers are cautioned not to place undue reliance on these forward-looking statements, which are only predictions and speak only as of the date hereof. In evaluating such statements, prospective investors should review carefully various risks and uncertainties identified in this release and matters set in the company's SEC filings. These risks and uncertainties could cause the company's actual results to differ materially from those indicated in the forward-looking statements.
Corporate Communications
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Ted Ohashi Oct 8 Let's Toke Business
https://4495825a-d729-4d8f-ade8-e78f828e1c8d.usrfiles.com/ugd/449582_3ab1fdc0e7744e519b8ced762f6a4486.pdf
Lexaria Bioscience (NASDAQ: LEXX) (NASDAQ: LEXXW) (CSE: LXX) announced its recent oral
nicotine absorption study NIC-A21-1 results in which nicotine delivery peaked in the bloodstream 10X to 20X faster than controls and peak levels achieved were up to 10X higher. This
means DehydraTECHTM-nicotine delivered via the oral pouch product format in animals required only
2 to 4 minutes to deliver nicotine levels in blood plasma comparable to levels achieved at 45 minutes
with concentration-matched controls. In fact, just four minutes after the pouch was placed in the mouth,
the DehydraTECH-nicotine had reached a higher delivery
level than the generic oral pouch achieved at any point during
the study.
DehydraTECH-nicotine also reached statistically significant
peak blood plasma levels up to 10-fold higher overall than
controls while still clearing from blood virtually as quickly as
the controls. This is important because it means DehydraTECH-nicotine will not result in a buildup of nicotine in the body. This would be a concern to regulators. The chart above right illustrates these findings graphically: the more rapid delivery, the higher
delivery and the evacuation of nicotine using DehydraTECH-nicotine.
It is also worth noting that this test was based primarily on mucosal absorption, that is, the nicotine was
introduced into the body primarily through the mucous membranes located in the mouth and not the
digestive system. I say “primarily” because it is unavoidable for some nicotine to pass into the saliva
which is then swallowed and digested. This is another first for DehydraTECH as it adds mucosal absorption to its delivery platforms for active pharmaceutical ingredients. DehydraTECH does not function
with cigarettes or with vape devices that can cause unnecessary harm. Instead, it is focused on providing less harmful nicotine dosing methods via oral mucosal absorption.
Lexaria believes that these findings support the world’s fastest-acting nicotine oral mucosal
absorption, offering a safer nicotine alternative for the world’s 1.1 billion smokers.
“We are extremely pleased with the performance of our latest DehydraTECH-2.0 nicotine oral pouch
formulations in this study,” said Chris Bunka, CEO of Lexaria. “Our technology was ten to twenty times
faster in delivering comparable levels of nicotine into bloodstream than the peak of the concentrationmatched controls and went on to far exceed their total delivery, which should provide much greater
consumer satisfaction.” Bunka went on to say these results could render “…pulmonary administration
practices like smoke and vaping as obsolete.”
I spoke to Bunka and the next step is a larger investigation in human volunteers to compare its DehydraTECH-nicotine pouch performance to that of existing leading brands such as products including Zyn
(Swedish Match) and ON! (Altria). Although Bunka could not be specific, it appears the human study
will be started in approximately two months with some results available in the first or second quarter of
8
2022. An earlier 2021 subjective human testing utilizing DehydraTECH-nicotine formulations demonstrated the onset of initial nicotine effectiveness in as little as 1.5 to 4 minutes after an oral dose.
The global nicotine oral pouch market is among the fastest growing nicotine sectors in the world with
revenues estimated at $2.3 billion in 2020 and forecast to grow to $21.8 billion by 2027. Lexaria believes DehydraTECH-nicotine is ideally suited for the oral nicotine pouch sector and that this product
format, if empowered with DehydraTECH-nicotine for rapid and more complete nicotine delivery, could
revolutionize the nicotine industry as the first practical, reduced risk category to successfully challenge
smoking tobacco. In October 2019, the Food and Drug Administration for the first time ever, authorized
reduced risk claims for certain nicotine oral pouches stating that these products “…put you at lower risk
of mouth cancer, heart disease, lung cancer, stroke, emphysema and chronic bronchitis.” compared to
cigarettes.
Conclusion: In recent months, Chris Bunka and I have spent some discussing the fact that LEXX and
LEXXW does not appear to respond to news as an experienced investor would expect. The investor
reaction to this news is a good example. These results indicate the potential exists that Dehydra-TECHnicotine in conjunction with an
oral nicotine
pouch product
could challenge
smoking tobacco. There are
still many hurdles to overcome and scientific work to be done but these results are indicative of an enormous potential for LEXX in the smokeless nicotine delivery sector.
As a result, I was surprised that on the day of the announcement, October 5. 2021. LEXX traded only
406,900 shares on the NASDAQ in an unexpectedly tight price range of $6.30 to $6.71 per share. The
volume is from NASDAQ so to make it comparable to the reporting form other major exchanges, the
406,900 should be reduced to around 203,000 shares. Yahoo Finance reports the average daily volume of LEXX as 1,141,613 shares. So this news did not even generate an average level of trading.
It is also interesting to note that very shortly after the market close on October 5, 2021, LEXX rallied
up to a high of $7.19 per share in after-hours trading. This is the period from 4:15 p.m. to 3:30 a.m. the
following day. Pre-market hours are from 4:15 a.m. to 7:30 a.m. the following day. All hours are Eastern
time. By the start of pre-market activity, the LEXX stock price had dropped back down again. As afterhours and pre-market trading data are typically not reported by the usual Internet suppliers of such
information, most investors would be unaware of this activity.
In the meantime, there was an interesting report on Lexaria BioScience recently by Zacks Small-Cap
Research titled ‘An Investment That’s Easy to Swallow’ that values LEXX at US $15.00 per share.
(to read this report Ctrl-Click here) A shorter article titled DehydraTECH™ Nicotine Pouches Could
9
Make Smoking Obsolete provides an excellent summary of what these nicotine results could lead to.
(to read this article Ctrl-Click here)
I’ve said it before and I’ll say it again, Lexaria Bioscience (NASDAQ: LEXX) (NASDAQ: LEXXW)
(CSE: LXX) is my top pick for a potentially explosive market response. LEXX now has two major applications for its DehydraTECH technology to pursue: hypertension and nicotine. After the hypertension
results, I said there was potential for more and now we have nicotine. Again, now that we have hypertension and nicotine, I think there is still potential for more to come. At a market cap of under US $40
million, I feel Zack’s estimate is conservative.
For a detailed explanation of the warrants see page 5 of Ted Ohashi's report.
https://4495825a-d729-4d8f-ade8-e78f828e1c8d.usrfiles.com/ugd/449582_99bc794020214b5d9054f4cc98bcb0d0.pdf
I believe that Altria has given up the right to purchase Lexaria Nicotine along with their exclusive access to DehydraTECH.
"The company also said that Altria has not exercised its first warrant tranche to invest a further staged payment into Lexaria Nicotine and as a result that warrant had expired along with Altria's former exclusive access to DehydraTECH for the US market, at 11:59 pm on October 8, 2020."
Will we see Altria return? How much cash would they have to put up to regain exclusive license rights? They previously got a steal of a deal.
Altria owns 16.67% of Lexaria Nicotine and one seat of its board in connection with Altria's funding of Lexaria's nicotine research & development (R&D) program in 2019, while Lexaria owns the remaining 83.33% stake.
The company, which specializes in innovative drug delivery platforms, said Altria now has non-exclusive license rights to use DehydraTECHTM drug delivery technology for both the US and worldwide markets under a predefined royalty structure payable to Lexaria Nicotine.
$7.18 now in after market
Traded as high as 6.9899 as soon as soon the regular market closed.
I you look at the dissolution profile for the ON pouch they don't reach near 100% dissolution and plateau until the 40 min mark and only have about 40% after 10 min, so yes I believe you're right, we will have a far superior product. Nicotine users want their fix now not in 10 or 40 minutes.
I'm not sure why they just didn't start with a human trial, animal trials don't impress anyone! That being said this next trial should be a defining one if we can show superior performance over ON and Zyn. I believe both these products may use nicotine polacrilex, I see Juul uses nicotine benzoate.
Dissolution Testing of Nicotine Release from OTDN Pouches:
Product Characterization and Product-to-Product Comparison
The percent of total release profiles of nicotine from the on!®More rapid nicotine dissolution was
observed for all five products with a total percent release of ~80% in the profile region
between zero and 20 min. The total percent of release for all products (>95%) was achieved
within 40 min before the nicotine dissolution profiles reached a plateau.
https://www.mdpi.com/2297-8739/8/1/7
"....independently funded with existing capital."
Lexaria is no longer bragging about their former deals with BAT and Altria.
Some of it is old material and some of it is new
And there's also the possibility of better sleep performance with CBD DehydraTECH.
Ted Ohashi
https://4495825a-d729-4d8f-ade8-e78f828e1c8d.usrfiles.com/ugd/449582_99bc794020214b5d9054f4cc98bcb0d0.pdf
"The first release provided initial results from human clinical study HYPER-H21-2 evaluating DehydraTECHTM-processed cannabidiol (CBD) for potential application against hypertension. For example,
work is still being conducted for signs of oxidation, oxidative stress and inflammation. In addition, the
scientists are looking for molecules that would occur when there is stiffness in the vascular walls. If
such evidence is found, it is possible that DehydraTECHTM-CBD can reduce inflammation in the arteries. We know the ability of CBD to reduce inflammation has been found in other applications. This could
indicate not only a BP reduction but possible treatment and cure of cardiovascular disease. This is
highly speculative and well beyond what the results are showing so far but there are indications that
point to the value of further testing."
Great news! I have no doubt that Gilead is working on an oral version of Remdesivir. The question is, are they looking at Lexaria's DehydraTECH?
Why do you say that? It's rising with the market, up .16 or 2.6%.
Some anti-viral pills for Covid-19, clinical trails are already underway.
https://www.cnn.com/2021/09/27/health/covid-treatment-pill-khn-partner/index.html
Interesting, all of a sudden the volume doubled!
Yes, Lexaria is working with Remdesivir and other anti-viral drugs.
Lexaria Summarizes Successful Antiviral Drug Studies and Ongoing Strategy
2021-07-22 07:05 ET - News Release
All objectives evaluating DehydraTECH™ drug delivery platform successfully achieved
KELOWNA, BC / ACCESSWIRE / July 22, 2021 / Lexaria Bioscience Corp. (NASDAQ:LEXX)(NASDAQ:LEXXW) (the "Company" or "Lexaria"), a global innovator in drug delivery platforms is pleased to review its successful 2021 antiviral drug program to date and summarize expected next steps.
Lexaria's objectives in its 2021 antiviral drug examination program thus far have been to determine whether:
DehydraTECH processing of compounds from leading classes of antiviral drugs for SARS-CoV-2/COVID-19, HIV/AIDS and other infectious diseases could exhibit evidence of superior oral absorption relative to controls,
DehydraTECH processing of those compounds would preserve expected viral inhibitory performance upon efficacy testing in infected mammalian cells, and
DehydraTECH does not alter nor degrade the drug molecules chemically as to create new molecular entities that could be challenging to guide through the regulatory approval process.
All three of these objectives have been met.
Lexaria has successfully tested and published summary results on five compounds from three antiviral drug classes, and in each of these drug classes has evidenced significant gains with up to a three-fold increase in oral drug delivery into the bloodstream ("Area Under the Curve" or "AUC") upon animal testing when processed with DehydraTECH:
Drug
Drug Class
AUC DehydraTECH Delivery Improvement (hr·ng/mL)
Efavirenz
RTI
42% (p=0.028)
Darunavir
PI
54% (p=0.036)
Remdesivir
(GS-441524)
RTI
82% (p=0.12)
Colchicine
TPMI
167% (p=0.0028)
Ebastine
PI
204% (p=0.027)
Protease Inhibitors ("PI"): Darunavir and Ebastine (AKA an antihistamine and 3CL or SARS-CoV-2 main protease "MPro" inhibitor)
Reverse Transcriptase Inhibitors ("RTI"): Efavirenz (AKA a non-nucleoside RTI or "NNRTI") and Remdesivir (AKA a nucleotide RTI or "NtRTI"; quantified in its nucleoside analogue metabolite form GS-441524)
Tubulin Polymerization and Microtubule Inhibitor ("TPMI"): Colchicine (AKA an anti-inflammatory)
Lexaria believes that the absorption gains it has demonstrated with the above compounds from their respective antiviral drug classes could have significant commercial potential given the fact that many antiviral drugs exhibit diminished oral bioavailability in their available forms today due to poor intestinal uptake and/or significant liver biotransformation. The DehydraTECH delivery system is designed to overcome this bioavailability issue.
For example, drugs like colchicine in its currently available oral form demonstrate bioavailability of about 45%, and are also known to have a narrow therapeutic index, meaning that the distinction between toxic and non-toxic doses is marginal. There could be significant benefits in allowing its dosing to be reduced while maintaining therapeutic delivery levels. DehydraTECH formulations of antiviral compounds such as colchicine have the potential to lead to significantly improved bioavailability while allowing for lower overall dosing requirements and improved safety and tolerability. The majority of drugs that are currently delivered via injection could also experience lower costs of administration and larger market potential if delivery characteristics were enhanced sufficiently to allow for oral dosing.
The next steps in Lexaria's DehydraTECH antiviral drug testing program are expected to include, but not be limited to, larger in vivo efficacy evaluations in animals infected with SARS-CoV-2, HIV or other infectious disease-causing viruses, which Lexaria is planning, subject to further investigation to select lead compounds based on our work to-date for this effort. The Company will release further plans and results related to these upcoming studies as they become available.
Lexaria is working diligently on a comprehensive, multi-pronged program that is intended to demonstrate pivotal proof-of-concept safety, efficacy and formulation/scalability feasibility data to prospective pharmaceutical industry partners with a view to creating opportunities for expanded, collaborative product development. The Company is interested in pursuing strategic collaboration opportunities with established pharmaceutical industry partners who may be interested in incorporating DehydraTECH technology with antiviral drugs including and/or similar to those that are currently being investigated. Lexaria would like to evidence that DehydraTECH works to enhance the oral delivery characteristics of the drugs mentioned above and potentially others which are used to fight many virus triggered diseases, including but not limited to shingles, influenza and viral forms of gastroenteritis, hepatitis, meningitis, and pneumonia.
Antiviral Drug Background and DehydraTECH Formulation Strategy
The first antiviral drug was approved for use in the USA in 1963, and over 90 additional antiviral drugs have been approved since, with thousands of other antiviral inhibitors having been proposed. Eleven of the approved drugs are used to treat more than one infectious disease, illustrating that some of these drugs are effectively used for multiple applications.
Antiviral drugs treat those who have been infected and try to preserve life; whereas antiviral vaccines are administered to those who are not infected in an effort to prevent or lessen the severity of subsequent infection.
Of note, "antiviral drugs from the same drug group share similar mechanisms of drug action to inhibit viral reproduction during the viral life cycle." This phenomenon is a crucial component to Lexaria's strategy of evidencing that DehydraTECH improves the delivery characteristics of many drugs from the classes Lexaria has investigated, potentially assisting in their efficacy for both their original approved use, as well as for use treating additional health indications if/when that delivery performance has been enhanced.
For example, there are six main classes of antiviral drugs used to treat HIV, including drugs from the PI and RTI classes, above. There are 37.7 million people currently known to be infected with HIV and 36.3 million people have died from HIV/AIDS since the beginning of the epidemic, roughly equal to the entire population of Canada. There are over 200 drugs approved by the FDA to treat HIV/AIDS. Because of the massive regulatory and scientific response to the onset of HIV, this disease is thankfully killing fewer people now than in the past, although significant demand remains for safe and effective HIV/AIDS therapies that can be used on a chronic treatment basis to preserve life.
Influenza is caused by viruses even though vaccines have been widely available for years and remain the #1 recommended method to prevent infection. Despite that, between 290,000 and 650,000 people die every year from seasonal influenza. The 1918-19 influenza epidemic is thought to have killed up to 50 million people, and the 1958 and 1968 influenza epidemics are thought to have killed between 1 and 4 million people each. There are only 4 drugs approved by the FDA to treat influenza; three of them belong to the Neuraminidase Inhibitors class and must be administered by injection, and one belongs to the PA endonucleases inhibitor class and is taken as an oral tablet.
Over 189 million people have been infected by SARS-CoV-2 in the current global epidemic, and over 4 million have died to date. It is not known today if or when infections and deaths will stop. Many drugs are being investigated for use in treatment of SARS-CoV-2, including but not limited to compounds from each of the PI, RTI, and TPMI drug classes. Only remdesivir has received emergency use authorization from the FDA for treatment of SARS-CoV-2.
Regardless of the efficacy and availability of vaccines to prevent many viral infections including influenza vaccines that have been widely available since 1945, thousands of people die every year because they are infected with viruses while unvaccinated, or live in large areas of the world where vaccines are not available. It is currently estimated that over 99% of the over 200,000 deaths in the US since January 1, 2021 from SARS-CoV-2 have occurred in unvaccinated victims, demonstrating the vital current need for successful treatment options for those who are unvaccinated.
Based on all these facts, the need and demand for effective antiviral drugs via oral delivery that are available to all, has never been more profound than today. Lexaria has progressed significantly in evidencing that its DehydraTECH delivery technology can sufficiently enhance the usable fraction of known antiviral drugs that reach the bloodstream so that they can safely and more effectively do what they are designed to accomplish. Lexaria continues to evaluate the data generated from its 2021 antiviral drug program and will make an announcement regarding next steps as soon as possible.
The Company is not making any express or implied claims that its products have the ability to eliminate, cure or contain the COVID-19 pandemic (or SARS-CoV-2 or novel Coronavirus) or any other virally induced diseases at this time.
He's said that for a long time, I don't know if he ever owned any.
Well written and informative IR material and a good use of the company's resources, IMHO.
Sure, lots of companies have successfully dissolved cannabis oils in a clear liquid using commercially available Nano-emulsion technology,(MCT formulation) but they do not come close to what DehydraTECH can do.
"One of our latest DehydraTECH 2.0 formulations gave us the strongest absorption enhancement results we've ever recorded, at 2,708% more CBD into bloodstream during the study period than the representative industry standard MCT control formulation."
https://ir.lexariabioscience.com/news-events/press-releases/detail/131/lexarias-newest-dehydratechtm-2-0-formulation-tested-in
IN HYPER-H21-1 this was demonstrated with a quick onset and reduction in BP followed by a quick off-set.
In HYPER-H21-2 because of the quick off-set the dosage was changed to three 150 mg doses to successfully moderate BP throughout a 24 hr. period.
High bioavailability results in the need for a lower dose and less side effects.
You're mistaken. The bioavailability of CBD is very low, thus the need for better delivery systems to avoid gastrointestinal problems and liver toxicity.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6275223/
CBD is highly lipophilic, and it is usually supplied as an oil preparation. Since the oral bioavailability of CBD is known to be approximately 6% in humans [1], CBD is commonly administered via the sublingual route.
https://www.karger.com/Article/Fulltext/497361
I believe they have a proprietary method of emulsifying the CBD oil so that they have a clear liquid with no suspended solids. Lexaria also has a proprietary emulsification method-DehydraTECH.
It's interesting to note that one of the common side effects of Epidiolex is diarrhea and stomach upset, so we may actually have a better delivery mechanism, though this is not proven.
https://www.rxlist.com/epidiolex-side-effects-drug-center.htm
Another side effect of Epidiolex is transaminase elevations, which is indicative of liver damage, which suggest that Epidiolex does not avoid first pass liver metabolism as DehydraTECH does.
Furthermore, it's notable that nearly 90% of patients in Dr. Leehey's study had diarrhea;
Cannabidiol Drugs Clinical Trial Outcomes and Adverse Effects
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7053164/
There are other companies investigating CBD for other diseases, but a proper delivery method to avoid gastrointestinal discomfort, speed onset and cross the blood-brain barrier is critical. It's not possible to patent CBD, but it is possible to patent CBD in combination with a delivery mechanism, e.g. Epidiolex.
Human Clinical Study HYPER-H21-1 evidences a rapid and sustained drop in blood pressure with DehydraTECH-CBD and excellent tolerability
Lexaria was also pleased that its DehydraTECH-CBD was well tolerated by all subjects, with no serious adverse events or side effects observed or reported. Ingestion of the concentration-matched, generic CBD control, on the other hand, resulted in unwanted side effects in some of the volunteers, namely gastrointestinal distress including diarrhea. These findings corroborate what Lexaria has previously evidenced in other unrelated studies whereby human volunteers have also experienced reduced side effects with DehydraTECH-processed test articles compared to concentration-matched, generic controls.
As for the small size of these first two human trials, these were designed as dosing trials to determine the optimal dosing required. Now that they've determined what the optimal dosing needed to obtain significant results we can move onto larger studies over a longer period, as was announced.
It's just the way it's done.
This is a question you should pose to Lexaria IR.
But in my opinion, a lot of the leg work has already been done and thus money spent so approval for an investigational-new-drug-ind-application shouldn't take too long and further cost should be contained to whatever they are paying the INDEPENDENT experts that have been hired to advance the application. The NRC has done extensive and comprehensive safety testing, in-vitro testing has been completed and now 2 human clinical studies have been completed with very positive outcomes with no adverse side effects. Also CBD has a known safety profile. As you can see Lexaria, contrary to your opinion, is expending considerable sums on research and development and is not spending just on salaries and promotions.