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Murine Data Show Anavex 3-71 Is Powerful
Might Anavex-facilitated Sleep Prevent Alzheimer’s?
Anavex 2-73 Was Best, First
It’s Not Just Anavex 2-73
Pages 2-8 tell the powerful Anavex science story.
Just read a portion of the just-out 60-page annual report.
Those unfamiliar with the unique, innovative, powerful, proprietary chemistries of Anavex Life Sciences Corp are directed to a close read of pages 2 through 8. It's all laid out there (for those who know a bit about biochemistry and cellular biology).
The future of Anavex Life Sciences Corp is not just Anavex 2-73, by any means.
Voted for all issues. My very moderate share count will not move any of the final votes in any particular direction.
Properly, it would have been "$8."
Gotta watch the order of those financial symbols. Complicated. Not like the profound evidence of Anavex 2-73 inefficacy.
But with some substantial news....
Explain the Market’s MOA
I’m a biologist, I understand the intricacies and details of the unique biochemistry of the Anavex 2-73 sigma-1 receptor agonist.
But I don’t understand how or why or who is creating an Ask Size in the hundreds (172 I see now on my Schwab screen; rather certain that means 172,100 shares are being offered at $2.50).
At this moment, I see these numbers:
Bid/Size 2.46/4 Ask/Size 2.50/172
Who’s wanting to unload large positions at $2.50, for what purpose. Is someone wanting to cap trades today at or below $2.50?
More importantly, will this effort be successful?
Tell, Us, Please....
After all of the previous Anavex presentations at any of various conferences and webinars, we’ve been able to rather soon learn of the company’s errors, misrepresentations, and inadequacies in their presentations. We have such helpful posters here, keeping things on the straight and narrow.
But this presentation looks, to me, pretty solid. Please, tell us of its errors.
Do it quickly. If there are none, the info in the PDF might prompt increased AVXL purchases by an otherwise unknowing public. Keep us safe. Tell us the errors and misrepresentations in today’s conference information. For some, a lot might be at risk.
For the record, the presentation PDF is here:
https://www.anavex.com/wp-content/uploads/2019/02/Anavex-BIO-CEO-Feb-2019-1.pdf
Wish I Could Buy Some More.
Watched, listened to Missling's presentation.
Slides too info-dense to completely comprehend at the rapid rate of his presentation. (But they will be available on the Anavex website.)
Were I a short, I'd be covering this moment.
But, I'm a strong long. I understand the cellular biology of Anavex 2-73. Further affirmed in the presentation.
One last interesting take-away. Missling mentioned upcoming human testing of Anavex 3-71, a proprietary sigma-1 receptor agonist of even better pre-clinical outcomes and applications. I will not be surprised to learn from ensuing human trials of Anavex 3-71 that it will eclipse the positive therapeutic outcomes of Anavex 2-73.
2019. The Year of Anavex.
What’s Up?
Well, big morning volume, and share price up sharply (>4%).
Might some traders have intimations of some sort of price-changing information that might appear later in the day?
Being In The Dark... Really!
My area of greatest professional competency (today, after retiring from my teaching career) is working as a field biologist, advising agencies and land managers on how to restore and re-create native plants environments (at a NASA facility, and numerous state and local natural areas and parks).
For both wildlife (mammals, birds, insects) and plants, things in recent decades have changed dramatically in many respects. One of the greatest (and ominous) has been the universal proliferation of unnatural levels of light; even, now, inside otherwise “dark” forests or wood lots.
All organisms, from microbes to elephants and sequoia trees, are affected by, even controlled by the occurrence, duration, and intensity of light. Today, humans experience intense light for far longer than when light after dark was by oil lamps or candles. My hero, Thomas Edison (his biography, read as a fourth-grader, impelled my desire to become a scientist) changed the world; made life possible as we know it today. And that’s a world undimmed by the natural setting of the sun.
Let me cut to the chase, and tackle the problem. Neither animals, plants, nor humans now experience long, completely dark periods each night. Yep, we turn out the lights and go to bed. But there’s a street light out there illuminating a slit of light on the bedroom wall. No big deal, eh?
WRONG! Without daily 8 to 10 hour periods of absolute, complete darkness, the human pituitary gland (and other parts of the brain and immune system) simply continue to operate as though it were day. Simply, sleep is compromised. Sure, you slept last night, and you thought it was pretty good. But you could not recognize the multiple effects of low-level nocturnal light had in compromising deep sleep, preventing adequate episodes of rapid eye movement sleep (REM). Without adequate REM episodes, your immune system was compromised, and neurons were unable to adequately clear metabolic wastes from nerves and neurons (which is the Anavex/sleep connection).
In recent years the essential roles of sleep have been discovered. In the last century, there was little understanding of the actual functions of sleep. Sure, get little of it and you feel sleepy. But why is sleep so universal in Kingdom Animalia? Now we know. A deep sleep state, of adequate duration, is required for the biochemistry of nerves and neurons to dramatically change (the sleep state), allowing endogenous chemical resources to clear nervous system wastes. If they remain, pathology ensues (Alzheimer’s, Parkinson’s, etiologically at least to some degree?).
I’m 71, have slept well all my life (or, I thought so). But had to be in the Cleveland Clinic for a surgical procedure (wonderfully resolved). While recuperating, I couldn’t sleep well. Regulations required that the hospital room that I slept in have the door open all night. The hall lights and sounds kept me from sleeping deeply. I mentioned this to a nurse. And, as nurses so often do, she solved my problem. She went to her floor office and came back and said, “Here, use this. We like to give these to our patients. This will solve your sleep problems here; and probably at home, too. Take it with you. Now, sleep tight!”
A cheap, 98-cent fabric sleep mask. “This is crazy. But, I’ll try it.”
Couldn’t believe it the next morning. I awakened entirely refreshed, mentally eager to start the day. Dreamed well (the REM thing). Thought I had just come back from a vacation in a national park (where I used to sleep at night in my tent, with not even any moon light.) Nerves got cleared there with that natural night darkness. I thought it was the delight of experiencing the deep woods. Nope. The magic of complete darkness.
Went home from the hospital (about two years ago), and have slept every night with a cheap fabric night mask. I feel, now, like I’m mentally in my fifties. No day-time grogginess. Just feel healthy. For a third of the day, I’m in the dark. In my waking hours, I see the light, all of it — especially the enlarging glimmer from Anavex Life Sciences Corp.
Ya, But....
Complete Failure In All Three Trials?
Blarcamesine, The Name
https://adisinsight.springer.com/drugs/800033840
Ok, how shall it be pronounced, the new trade name for Anavex 2-73?
blarc-AM-es-een
blarc-AIM-es-een
blarc-AM-es-eyne
blarc-AIM-es-eyne
blarca-MESS-see
blarca-MESS-eyne
I prefer the first one. When the drug is sold by pharmacists, the included information sheet will tell people how to pronounce it. One of the pronunciations above will be presented and mandated.
A company’s creation of trade names of proprietary drugs (such as Claritin, Benadryl, Lipitor, Vicodin), is not haphazard. A very deliberate, detailed process. Read about it here:
https://www.statnews.com/2017/02/08/drug-names-process/
As a biologist familiar with the multitude of Greek and Latin phrases used to create medical and biological terms, their names are self-revealing. When I taught high school biology, I required my students over a year to memorize several hundred Latin and Greek prefixes and suffixes. With that knowledge, they could then decipher the meanings of just about any scientific or medical term they happened upon. (Many students came back from college, telling me that the science vocabulary I taught them put them way out in front of fellow students ignorant of Latin and Greek terminology.)
So, I looked at “Blarcamesine” to see what it meant. Appears to be entirely contrived. No Greek, Latin, or any other language’s phraseology within. A complete contrivance — which is the standard practice of pharmaceutical companies.
Is Anavex Life Sciences Corp blarking up the right tree?
“Say, doctor, about that trial going on?”
Now what spouse of an Australian with Alzheimer’s would skip reading that article? And after that, would the family’s doctor be queried, “Doctor, I see they are doing a test of a promising new Alzheimer’s drug over at the hospital. How can I get my spouse in on that?”
Is it really going to be hard to enlist 450 Aussies for the Anavex 2-73 Phase 3 clinical trial down there?
But, Then, Alzheimer's.
Anavex 2-73 for Parkinson's:
Congress Legislates $100 million for Alzheimer’s Measures. Sure.
The Parkinson’s Plague
Yea, Wherefrom?
Read the Patent Application
Anavex Life Sciences Corp starts the year with a new patent application. Very fine.
The details needn’t be commented upon. Those unable to discern their implications from a straight read of the application itself wouldn’t have a more useful understanding with anyone’s more detailed elaboration. I won’t provide any analysis. Not needed. Not useful.
Simply, ponder the several (well, many) new therapeutic applications and outcomes.
Marked reduction in seizures and sleep problems are particularly noteworthy; with great implications.
How would the general public weigh an Anavex autism therapy?
(But, no. Any sort of market reaction increasing the demand for AVXL shares is not likely to emerge solely on the basis of this patent application. Anyone can file an application. I have one pending myself. But should the patent be granted, things might change a bit for Anavex. Let’s watch.)
Ok, glyphosate used as a wheat desiccant, too.
Looks like it'll be rice chex. Don't see any glyphosate used on that grain.
I Don’t Eat Oat-type Breakfast Cereals Anymore
New Alzheimer’s Blood Test
https://www.eurekalert.org/pub_releases/2019-01/d-gc-epo011719.php
Germans have a new test, from a blood sample, for Alzheimer’s. Allows, perhaps, early detection to a degree; or monitoring of progression in a therapy test:
How Will Vaccination Work?
Ok, virtually everyone over 50 (before Alzheimer's onset) is to get vaccinated.
How will that work? Will GPs do the shots? Or, will people have to line up at hospital infusion centers?
About 300 million Americans live here now. How many millions will be getting the prophylactic vaccinations? How often? Or, will it be a one-shot-and-done thing?
Anavex Solely Dependent on an Alzheimer’s Fix?
Ok, what if the new Alzheimer’s vaccine a) really works; prevents the disease, b) has double-blind, placebo-controlled Phase III clinical trials that happen quickly (within a year), and then, c) becomes the new standard of care (well, prevention) of Alzheimer’s, what would Anavex Life Sciences Corp be left with?
1. A Rett syndrome therapy (very small market for such).
2. A Parkinson’s dementia therapy (a gigantic market).
3. A Fragile-X therapy (market size undetermined; small).
4. An insomnia therapy (gigantic market).
Others yet to be tested in the Anavex pipeline.
Too Hard For Investors To Understand
After teaching high school biology for 30 years (biology I, biology II, advanced placement; plus conduct of extensive student science research program [many awards, scholarships]), and also having done a good deal of technical science writing for lay audiences on my other areas of biological expertise, I can affirm that the details of the mechanism(s) of action of the Anavex molecules in dysfunctioning neurons simply will not be conveyed to lay audiences.
Telling that a “Alzheimer’s vaccine” shows early good results resonates quickly with readers of all competencies. Makes sense. Entirely plausible — therefore must be so.
But trying to convey the mechanism of action any of the Anavex sigma-1 receptor agonists in a simple word or phrase can’t happen; is beyond comprehension by lay audiences. Too hard to tell about. Too hard to understand. Therefore, probably just phony science gibberish and doesn’t really work. Some obscure “scientists” trying, once again, to snooker investors with high-sounding biological verbiage. Nice try. We are too smart to believe (or understand) any of it.
But, a vaccine? Yea! That’s what’s needed. Where can I get some shares of that?
We can jabber all we want about the current state of Anavex Life Sciences Corp and its science and depressed share price (the major posting topics here for months). But nothing is going to increase the price of an AVXL share until things the general public can understand appear. And those will be reports of Anavex 2-73 efficacies against any of the three conditions being tested in the clinical trials. Nothing hard to understand. Little girls with Rett syndrome have mothers telling how much better the girls are. Some Parkinson’s patients walk with reduced spasticity and increased motor control. Some Alzheimer’s patients begin to sleep soundly.
At worst, nothing is known for the investment public to act on until at least one of the trials is completed and formal results are announced. More likely, preliminary positive “results” (anecdotes) will “leak” with tangential news reports, perhaps from Australia.
Until either of those appear, formal or anecdotal reports of patient responses to Anavex 2-73, it’ll be more of the same on this message board. I follow the postings here each day. But none of them (with perhaps the exception of this one itself — ha) portends any accurate AVXL future in the near term.
Can only wait....
Not For My Cat
Ok, An Alzheimer’s Vaccine
Did a quick review of the company’s announcement.
(https://www.marketwatch.com/press-release/united-neuroscience-announces-positive-top-line-results-from-phase-2a-clinical-study-of-ub-311-vaccine-in-patients-with-alzheimers-disease-2019-01-16).
Early results (Phase 2a) appear promising. The vaccine apparently induces immunological action against beta-amyloid, perhaps with detectable improvements in cognition. All well and good.
Many questions yet, however.
Will suppression of beta-amyloids also prohibit subsequent or consequent accumulations of tau protein wastes? Those, too, cause Alzheimer’s symptoms.
How enduring is the vaccine? There is an oblique reference to repeated immunizations or dosings. How many, how often, in what form? Pills or IV infusions?
The bigger question is duration. Many vaccines need “booster” shots to maintain strength. Will the vaccine lose efficacy after many months or years?
Even if all the above turns out positive, the Anavex therapy is preferable, inasmuch as it fixes neuron biochemistry malfunctions at their base; upstream, as it were. It prevents the accumulation of waste proteins (both beta-amyloids and tau tangles) early on, with restoration of other healthful cellular functions.
Anavex 2-73 is administered orally; no injections. A distinct therapeutic advantage.
Lastly, there is a pile of evidence (murine, presently) showing that the Anavex sigma-1 receptor agonist is either prophylactic or therapeutic for a diversity of central nervous system pathologies. Not so for the United Neuroscience vaccine.
I’m maintaining my moderate AVXL position.
Na, The Piano Playing Is Just Placebo Effect
[Sarc…]
Sure, Placebo Effect.
Right, the improved sleep of the people in the Alzheimer's Phase One study in Australia could have been only a placebo effect. The study was not double-blinded; the unfortunate blokes down there with Alzheimer's stupidly thought the pills they were taking were really something good and effective. Really good things were gonna happen. It allowed them to think themselves to sleep. Aunt Matilda said, "Finally. I got me a pill that will fix me up, mate. I'm gonna sleep well tonight, aye!"
The placebo effect, pure and simple. Happens all the time with Alzheimer's disease and new drugs being tested for it. Look at all the placebo outcomes with the amyloid drugs. (Wait...?)
Sure, the placebo effect is a real problem in testing Alzheimer's drug efficacies. (And because they are down under, Australians have to hang on to the dirt, so they don't slide off the globe. Hope the new trial finishes before they all do that. Alzheimer's people have tough time holding on.)
Will It Take 48 Weeks To Know?
The things to be assessed to determine efficacy of Anavex 2-72 in the Australian clinical study have been announced:
Early Revelation of Anavex 2-73 Rett Efficacy
If Anavex 2-73 yields any level of symptomatic improvement in little Rett girls, those favorable treatment outcomes will not be subtle, discerned only with biochemical analyses by medical technicians. Check out the symptoms of Rett syndrome, here:
https://www.mayoclinic.org/diseases-conditions/rett-syndrome/symptoms-causes/syc-20377227
Which of these will be hard for a non-medical person to quickly detect an improvement in?
Anavex 2-73 efficacy against Rett syndrome may be discovered early in the clinical trial; by both medical people and professional care-givers, and especially by family members.
Mothers know precisely the status of their children’s health. Any improvements, such as improved movement and coordination, increased communication skills, reduction in aberrant hand movements, normalized eye control, reduction in breathing problems, reduced irritability or crying, improved cognition, reduced frequencies or severities of seizures, improved sleep patterns, (and others), will be easily detected and noted. The required blindedness of the clinical trial (where no one, patients, medical people, staff, etc. knows what patients are getting a starch pill or the actual drug) will not be sufficient to keep any positive clinical outcomes unrevealed before the trial ends.
With any sort of even moderate treatment efficacies, stories will be told. Knowing how drug trials are to be blinded to all, just who would share those stories when first discovered? Mothers and nurses are typically silent, keeping health observations to themselves, right? Ha.
Wasn't My First Purchase
No, I made larger (but not giant) purchases 2 years ago; based upon the Anavex science I knew then (and hence affirmed).
As earlier, spending only moderate discretionary funds. Can ford to lose it all --- but don't expect to.
Made First 2019 Buy
Checked in this morning, saw both the new Scientific Advisory Board Member and the sharply ascending AVXL price. Had some funds sitting in my Schwab account; bought a few dozen. Have a nice paper gain.
I first wondered what created all of the buy-in interest. Then saw the addition of the new guy on the Anavex SAB. I’m a biologist (retired biology teacher; now a researcher with an Ohio university research foundation on a really significant new biotechnology, not related to medical technology, however).
Clear to me guys like Dr. Kaufman don’t align themselves with start-up new biotechs unless they are certain that their participation in the company’s Scientific Advisory Board (SAB) wouldn’t in any way diminish or compromise their otherwise sterling record.
No doubt, before Kaufman signed on with Anavex he scrutinized all of the back of the lab data and information Anavex has about their sigma-1 receptor agonists. With an understanding of those data, Dr. Kaufman signed on. He knows more about the science and prospects of Anavex Life Sciences Corp than any of us outsiders. He determined that his new position with Anavex is not a career risk; rather, an opportunity.
Understanding all of that, I made my AVXL purchase this morning. Will be holding until 2023, at least.
Fine way to start the Anavex 2019 year, for both Dr. Kaufman and those of us who have taken new 2019 AVXL positions.
My Conjecture Exactly
Thanks for the Correction
Yes, there were some dose interruptions. Very well.
Eager to see how this might work in the upcoming Phase 3 trials.
Interrupted Anavex 2-73 Dosing
On the recent patent application, it was noted that various dosing regimens involved interruption, temporary termination of Anavex 2-73. Very interesting; inasmuch I find no indication that this occurred in any of the previous human Anavex dosings. It appears that in both the initial Phase 1 dosage and tolerability study in Australia, and with the consequent continuance of that study for many months thereafter the drug was continuously dosed. No interruptions.
Why, now, is the new patent application claiming patent protection for interrupted dosings (at various frequencies and durations)? Why was interrupted dosing not a part of the original Phase 1 study in Australia?
Having no access to all of the relevant pharmacokinetics and pharmacodynamics of the matter, the following is only speculation. But worthy of pondering.
Has it been discovered that, in fact, Anavex 2-73 (and its intracellular metabolites, perhaps) do persist and remain therapeutically active for some time after initial dose loading periods? Does this unique sigma-1 receptor agonist bind to good-fit receptor sites in the neuron and remain both attached and remain active for some time thereafter?
If that is so, there is no need for continuous, daily dosings. Administer a loading dose, which chemically binds to appropriate receptors, where it remains active for some time. Then, re-dose only after the loading dose is slowly cleared or lost.
If this is, indeed, the now-best administration routine of Anavex 2-73, what might be the implications? The next big question is the duration of activity of initial, loading doses. Might, perhaps, those extend for not days, but both in lengthy periods of weeks or months?
Then, might activity periods increase with subsequent dosings? Finally, after a course of interrupted dosings, at increasing intervals, might Anavex 2-73 so effectively restore homeostatic processes that subsequent doses are unneeded? Neuron organelle architecture and protein and enzyme chemistry are rather permanently restored?
This can make sense with the understanding that Parkinson’s and Alzheimer’s are both (except in rare cases) geriatric in onset. Takes decades for things to go wrong in the affected neurons. Twenty-three year olds seldom get either disease (and when they do, aberrant genetics are involved). It can take decades for neurons to “wear out,” or otherwise become malfunctioning. Can Anavex 2-73 put things back together in youthful, healthful configuration, allowing lengthy periods of subsequent un-dosed therapy? The functionality of interrupted dosing (as in the patent application) implies that such is the case — at least for short periods.
As with all of the other exteriorly unknowns about the Anavex molecules, this surely has been examined on transgenic, aged lab rats with genes for Parkinson’s and Alzheimer’s. Might such murine data have prompted the patent application; gaining further intellectual property protection for Anavex Life Sciences Corp.?
Bought Some Myself Today
Had a few dollars left in my budget, discretionary funds. Bought a few hundred AVXLs this morning; have for the day a 12.6% on-paper gain.
In my target year (2023), let's see how those turn out.
1.28% Of All Shares Today
My sometimes questionable arithmetic shows about 1.28% of all AVXL shares were traded today. Uncharacteristically large percentage.
And the day-long trend was generally upward.
Next week, too?
Have the majority of shareholders with doubts now liquidated their positions, leaving only us long-and-strongs holding the bag (as it were)?