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Hello Pfizer we have just the drug for you!
https://financialpost.com/pmn/business-pmn/pfizer-shares-drop-after-axing-twice-daily-weight-loss-pill
Hello Novo Nordisk, guess what?
"This Study is not complete and additional results will be reported, likely in two tranches: Lexaria has also collected blood glucose data and expects to release those interim results imminently. Then, once the cross-over Study visit as described below has been conducted, final results from the Study should be available in late December or early January."
Substantial reductions in Blood Glucose will be a real impetus for this stock!
MD&A
"During fiscal 2023, Lexaria has been working diligently with its third-party regulatory and clinical advisors in the development of its IND study protocol, has interviewed and selected its contract research organization, InClin Inc. as announced on April 24, 2023, and has been developing its clinical trial DehydraTECH-CBD drug product in order to obtain the stability data needed for its IND application to the FDA. As announced in its news release august 30, 2023, Lexaria is waiting on one of its third-party material suppliers to complete certain analytical and stability testing, which we expect to be completed prior to the end of the calendar year, to be followed with the filing of our IND application with the FDA."
Canadian health experts call for immediate suspension of sales of nicotine pouches. Physicians for Smoke-Free Canada Executive Director Cynthia Callard called on federal health authorities to place an immediate suspension of the sale of nicotine pouches “until measures can be put in place to protect children in the nicotine market,”
This was posted recently on the Lexaria Bioscience Investors Group Facebook page by a member.
"No rumours at all that I know of. There is a couple big hitters that are buying in right now. Friends of a friend of mine. Between my friend, myself and our friends there will probably be a bit more than 15% ownership in good hands.. My hope is that there won't be enough stock out there to mess around with. Naked shorts could easily get caught chasing 🤞
But when they are done buying will there be a big pullback? That's the question I want answered lol"
Someone knows something, and of course, we're in the dark.
Nice push through the 200 DMA.
Run LEXXY run, See LEXXY run!
In January lexaria brought on board Julian Gangolli.
"Kelowna, BC - TheNewswire - 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."
"At the other end of the scale was Lexaria Bioscience (NASDAQ: LEXX) which gained +28.3% last week perhaps because of a story pointing out the links between LEXX and Jazz Pharma leading to a question of whether we could see a commercial agreement using DehydraTECH™ and Epidiolex®. "
https://www.letstoke.biz/_files/ugd/449582_895d661d4a4e41b3b7efe884ea437d57.pdf
Here's what Evgen was going to get in the deal that Juvenescence canceled in August. They found a better product apparently, DeydraTECH. "The license is for exclusive rights to leverage certain patents and know-how for all non-pharmaceutical applications in the United States, with options for the other major markets namely, Europe, Asia and Rest of World. Evgen will receive upfront and milestone payments of up to $10.5m, and in addition, royalties on sales of the commercialized product."
https://juvlabs.com/blogs/news/juvenescence-announces-licensing-agreement-with-evgen-pharma-plc
Although sulforaphane has good bioavailability and can cross the blood-brain barrier it's not very stable and this is probably why SulfoSyn has sought out LEXX.
"The use of such extracts, though effective, is complicated by the fact that sulforaphane is only moderately stable over time, especially in aqueous solution. The reactivity of sulforaphane is exacerbated by the fact that lyophilized extracts are hygroscopic, and as water is adsorbed during protracted storage or formulation, their useful shelf-life is limited unless chemically stabilized, kept cold, or made frequently during the study."
Or treated with DehydraTECH!
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4629881/
Sulforaphane has excellent bioavailability and can also cross the blood-brain barrier.
https://www.bing.com/search?FORM=SNAPST&q=Sulforaphane+Life+cycle&filters=fcid:%220-4dff8d45-70f5-6d88-8af0-34e9bdebcf8b%22+sid:%22c4a11db6-e59c-a3be-4984-514cfe2e8592%22
I think it's very bullish that Juvenescence prefers to develop a Sulforathane product with LEXX and canceled an existing deal with Evgen, which cost them some money. They must have tried their Sulforathane product with DehydraTECH and saw much better bioavailability, which would be a great endorsement of the technology.
Thanks again to pieinthesky for leading us down this trail!
Great work, thanks
I see that Gillian Dines, Chief Science Officer of Juvenescence, once worked for Jazz Pharma. Jazz Pharma now owns Epidiolex which may benefit from using DehydraTECH to improve the bioavailability.
'Before joining Juvenescence she was Senior Vice President and Head of Research and Early Development at Jazz Pharmaceuticals. In this role she led integration and organisational restructuring to build a novel pipeline and capabilities in R&D following the acquisition of GW Pharma where she was Head of R&D Operations.'
https://www.letstoke.biz/_files/ugd/449582_1c661256c4774033a329a25b488a57ca.pdf
I had a quick contact with Chris Bunka, CEO of Lexaria Bioscience (NASDAQ: LEXX). Here is a brief summary of what I learned: (a) I was happy to note that the delay in the Investigational New Drug (IND) application is being taken very seriously. LEXX has been in regular touch with the contractor and I would look for some explanation shortly. (b) The stock closed at U.S. $1.00 per share which I understand restarts the NASDAQ 30-day clock and relieves some of the pressure of a possible need for a rollback. Conclusion: Clearly if Lexaria Bioscience (NASDAQ: LEXX) is able to get the IND application back on track, the stock performance should improve significantly. As the accompanying chart illustrates, LEXX has traded in a remarkably narrow range since the early spring of this year. The delay in the IND application is an unexpected bump in the road but LEXX is a company with many irons in the fire. Recently, they added a plan to investigate a diabetes application to the list of projects. I anticipate a sharp move higher and for that to be timed with a full explanation of the IND delay. Hopefully we will have that information within a period of weeks.
https://www.letstoke.biz/_files/ugd/449582_1104ee8d97d94d478426416087d07513.pdf
Sometimes, being an investment analyst is like being a detective. You’re looking small clues that others have missed. Each clue brings you closer to the solving the case you are working on. Such is the
case of Lexaria Bioscience (NASDAQ: LEXX). Last week, I pointed out that LEXX shares performed very well following its announcement to pursue a diabetes application for its DehydraTECH™
technology. The stock was “only” up +7.5% during a very poor week for the stock markets in general.
Many investors “missed” the fact that LEXX’s performance was actually very positive given the circumstances.
This past week, LEXX announced a private placement with a single healthcare-focused institutional
investor for gross proceeds of $1.6 million. LEXX stock was up on the day of this announcement. I
don’t know the last time I watched a small cap, cannabis-technology company announce a financing
with the stock closing up on the day.
Not only that, LEXX shareholders are a little confused and concerned about the delay in the Investigational New Drug (IND) application. After seeing this investment, a question I would ask is would a
healthcare-focused institutional investor commit $1.6 million if they were concerned about the IND
application delay? That was also unusual and positive. Next, if we remember the NASDAQ rule
means a listed company will not be in compliance if it trades below $1.00 per share for 30 consecutive days. This is the rule that has led to companies reverse splitting their shares to get back over
$1.00 per share. the stock closed last week at US $0.9999 per share. I don’t know if the NASDAQ
rounds up to decide if a stock trades for 30 days below $1.00 per share which would start the thirty
day counter over again. If it does not, then LEXX is about as close as you can get. So keep an eye on
LEXX next week.
Conclusion: Despite the fact that Lexaria Bioscience (NASDAQ: LEXX) has encountered a delay
in its Investigational New Drug (IND) application, the Company continues to show the market it is undervalued at current levels. At a price of US $1.00 per share, LEXX’s market
cap is just over US $8 million which I think is a gross undervaluation for a company with so many prospects. Again, as
the chart shows, the stock has traded down since the financing fiasco early in the spring of 2023. The clues I have
identified and reported to readers indicate there is quiet accumulation of the stock at current levels. At current levels I would much rather join the buyers than
participate with any sellers.
Ted Ohashi
https://letstoke.us19.list-manage.com/track/click?u=f2e0706764f99154e3a11feb5&id=c6535d835f&e=9cbb5a4bc7
Last week, I spoke to Chris Bunka, CEO of Lexaria Bioscience (NASDAQ: LEXX) to get some
clarification of the delay in submitting the Investigational New Drug (IND) application. Whether it
was the wording or the way I parsed the words, I was left with he impression that LEXX wasn’t taking
the problem with the urgency I would have expected.
Here is what Bunka had to say:
(a) While some shareholders and observers did not believe a press release was necessary, Bunka
believes it is important to keep shareholders up to date.
(b) The problem rests with an American service provider whose input is required to proceed with
the IND application.
(c) Unlike my interpretation of the news, Bunka has been in regular contact with the third party by
phone call or email probably once or twice a week for the past two months. But LEXX has not
received a completely acceptable reason for the delay.
(d) The responses are more like excuses and leaves Bunka wondering if there is an underlying
issue. He has said if the problem is finances, LEXX is willing to try to work out a solution. He
has also threatened to confront them at their offices.
(e) The specific issue is the Drug Master File (DMF) which is used to provide confidential and
detailed information to the Food and Drug Administration (FDA). It enables parties to reference
material in the DMF without disclosing the contents.
(f) The DMF must be updated annually and this has caused the delay. Updating is mainly clerical
but some scientific data might be required from time to time. The third party has not provided
an update and the IND cannot be submitted without it.
(g) The next steps involve raising the pressure on the third party. To date, LEXX has not disclosed
the name of the service provider and neither CEO Chris Bunka or President John Docherty has
gone down for a person-to-person meeting.
(h) In the worst case scenario, I suppose legal action is possible but this seems to be a “lose-lose”
option. The other worse case might be a critical problem with the third party but that seems
doubtful as well. As is most often the case, the final result will fall somewhere between the best
and worst cases.
Conclusion: if the issue is resolved in a few weeks, the lasting impact of the delay should be minimal.
If it stretches into a month or two without further information,
it becomes more problematic. In the meantime, the market
took the news well although it looks like it has stopped the
streak of consistent price increases that had been building.
My sense of it is that it is not a serious problem or “show
stopper” but it is a situation that bears watching. Rest
assured, I will be watching.
Lexaria Discovers that DehydraTECH-CBD Treatment in Hypertension Study HYPER-H21-4 Resulted in Reduction in Pro-Inflammatory Biomarkers
2023-05-23 09:06 ET - News Release
(via TheNewswire)
Lexaria Bioscience Corp.
DehydraTECH-CBD offers distinctive mechanistic benefits related to its growing therapeutic utility
Kelowna, BC - TheNewswire - May 23, 2023 - Lexaria Bioscience Corp. (Nasdaq:LEXX) (Nasdaq:LEXXW) (the “Company” or “Lexaria”) , a global innovator in drug delivery platforms is pleased to announce additional findings from last year’s human clinical study HYPER-H21-4 (“the Study”) demonstrating significant reductions in several pro-inflammatory biomarkers known to be linked to cardiovascular disease (“CVD”) and a host of other conditions.
After five weeks of treatment with the patented DehydraTECH-processed cannabidiol (“CBD”) capsule formulation, blood-plasma levels of interleukin (“IL”) 8, 10, and 18 were reduced by ~ 19%, ~ 27%, and ~ 43%, respectively. Those persons receiving five weeks of placebo experienced no significant changes in their IL levels as shown with the black bars in the graph below. The differences evidenced relative to baseline and/or placebo with pro-inflammatory biomarkers IL 8, 10 and 18 were statistically significant (p<0.05).
Blood Plasma Levels (pg/mL) of Pro-Inflammatory Biomarkers IL-8, IL-10 and IL-18
*Solid bars are at baseline and hollow bars are at end of five weeks of treatment
“ There is some pre-clinical evidence for the anti-inflammatory actions of CBD, but this is likely the most convincing evidence in humans that I have ever seen ,” said Dr. Philip Ainslie, Cardiovascular Advisor to Lexaria and Lead Investigator of Study HYPER-H21-4. “ The bigger picture is that inflammation is the key basis of atherosclerosis, and several pro-inflammatory agents have been examined as potential mediators of the biochemical pathways of lesion formation. Other ‘common’ diseases or disorders associated with chronic inflammation include fatty liver disease; Type 1 & 2 diabetes mellitus; inflammatory bowel disease; asthma; lung diseases chronic kidney disease; rheumatoid arthritis and obesity. Part of the reason why many of these diseases lead to cardiovascular disease is via chronic inflammation .”
There is clear scientific evidence for the involvement of IL-8 in the establishment and preservation of the inflammatory microenvironment of the vascular wall in instances of CVD. In cardiovascular risk estimation, several reports have indicated that increased serum levels of IL-8 are correlated with an increased risk of CVD or acute cardiovascular events.
IL-10 and IL-18 are also considered anti-atherosclerotic cytokines with evidence for IL-8 and IL-18 perhaps being even stronger in CVD. In addition , IL-10 levels are known to increase along with the reduction of kidney function ; and higher serum IL-10 levels have been associated with the risk of cardiovascular events during follow-up . Similarly, IL-18 is an independent predictor of cardiovascular events in patients with metabolic syndrome . In large population-based studies, circulating IL-18 is prospectively and independently associated with CVD risk .
Lexaria previously announced that the primary efficacy and safety objectives of the Study were successfully achieved, with resting blood pressure significantly reduced in hypertensive patients, and sustained over the full 5-weeks of dosing with zero serious adverse events being reported throughout the Study. Lexaria is aware of only a handful of other published research studies , mostly in young, healthy and normotensive volunteers, that have investigated whether a sustained decrease in resting blood pressure is possible following multiple weeks of oral CBD dosing; none of which have been successful in achieving this.
I n addition, Lexaria also previously announced data from the Study revealing potentially a unique mechanistic benefit upon cardiovascular regulation via catestatin modulation with DehydraTECH-CBD treatment that has not previously been demonstrated with testing of CBD for blood pressure reduction to its knowledge. This finding together with today’s announcement of improvements in pro-inflammatory biomarker levels related to cardiovascular and related disease states further strengthens the case for DehydraTECH-CBD offering distinctive mechanistic benefits related to its growing therapeutic utility . These reductions in inflammation also provide an mechanistic additional pathway by which DehydraTECH-CBD may act to lower blood pressure.
The Food and Drug Administration (“FDA”) has laid out clear guidelines for sponsors who seek to develop new anti-hypertensive drugs, specifically defining the need for medications that offer complementary modes of action. Lexaria believes that its latest results, detailed below and already peer-reviewed and published in the respected journal, “ Biomedicine and Pharmacotherapy ” , may support DehydraTECH-CBD qualification within these FDA guidelines .
DehydraTECH’s Relationship to the Hypertension Market
Over 100 million adult Americans have high blood pressure, but only one in four of those have the condition under control. Many patients stop taking their medications because of troublesome side effects: some diuretics can cause excessive urination, beta blockers can cause erectile dysfunction, calcium-channel blockers can cause leg swelling, and ACE inhibitors can lead to persistent cough. Lexaria believes that its DehydraTECH-CBD may introduce a more tolerable anti-hypertensive treatment option that may be used alone or in combination with other medications, to reduce blood pressure with fewer discouraging and unwanted side effects.
There is a clear medical and market need for alternative anti-hypertensive therapies, especially in the case of patients with so-called resistant hypertension who fail to adequately control their high blood pressure with combinations of existing medications. Of note, the decreases in blood pressure evidenced in the Study were similar in both those hypertensive patients on standard of care blood pressure medications and those who were untreated for their hypertension upon Study entry. Therefore, Lexaria’s findings indicate that Lexaria’s DehydraTECH-CBD has the potential to offer complementary and additive blood pressure reduction benefits on top of any degree of improvements the standard of care medications provided. This additive improvement of DehydraTECH-CBD as an adjunct therapy, perhaps related to its pronounced effectiveness in modulating catestatin and pro-inflammatory cytokine levels, could become a significant value enhancer should it eventually enter the marketplace as an approved hypertension treatment.
Study HYPER-H21-4 together with four previous human clinical studies in hypertension Lexaria conducted from 2018 through 2022 are integral to successful filing and review of its upcoming Phase 1b investigational New Drug (“IND”) application to the U.S. Food and Drug Administration (“FDA”) for purposes of its planned U.S. study HYPER-H23-1. Lexaria’s five foundational human clinical studies to-date in this area have been carried out in an aggregate total of 134 healthy and hypertensive persons and have evidenced significant reductions in resting blood pressure over both acute and multi-week dosing regimens while producing zero serious adverse events.
Additional endpoint analyses from HYPER-H21-4 as described in the complete study protocol are still underway and any relevant material findings will be reported upon as these findings become available.
Study 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 study 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. Lexaria anticipates filing the IND this summer with hoped-for FDA authorization within 60 days thereafter.
About DehydraTECH-CBD
DehydraTECH-CBD is a unique CBD formulation Lexaria has developed and is optimizing based on its patented and proprietary DehydraTECH drug delivery technology. DehydraTECH is designed to improve the way active molecules enter the bloodstream upon oral ingestion. DehydraTECH has also demonstrated enhanced delivery of certain active molecules including CBD into brain tissue, which Lexaria believes to be of particular importance for the effectiveness of its DehydraTECH-CBD specifically against hypertension because of the significant influence of central mediation upon blood pressure. Lexaria has also developed DehydraTECH-CBD formulations for other applications demonstrating superior bio-absorption when administered intraorally and topically.
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 30 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.