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Even better....
The Name. What will it be?
When approved for sale and therapeutic use, "blarcamesine" will not be the name on the pill bottle label from the pharmacy. Prescription drugs actually have three names. First is the actual chemical name. Blarcamesine, among chemists, is tetrahydro-N,N-dimethyl-2,2-diphenyl-3-furanemethanamine. Not too many will call it that.
Then (and now), the generic working name of the drug is blarcamesine. But when approved for sale, it will have another name assigned, the commercial product name.
For example, ever heard of anyone taking atorvastatin? How about clopidogrel? Oxycodone? Those are the generic working names of Lipitor, Plavix, and Oxycontin.
Some clever marketing people engaged by Anavex will come up with a new, final commercial name for blarcamesine. It will have just a few syllables; be easy to pronounce and remember.
In a few months after the name is assigned and the new drug is prescribed, it will be heard often in news reports; for all of the obvious reasons.
Of no consequence whatsoever.
Just a canoe.
Anavex, to the heart of a problem?
A very interesting new study (https://pubmed.ncbi.nlm.nih.gov/33010304/). Thanks for posting this.
In summary, treatment with a sigma-1 receptor agonist, fluvoxamine, produced favorable treatment outcomes in rats that had myocardial infarctions, heart attacks from decreased blood flow through the heart. For Anavex, this presents another, new disease target. Until now, most of those have been in the central nervous system. Now, the cardiovascular system — heart attacks. Are those a problem for anyone?
The sigma-1 receptor agonist in this rat study was fluvoxamine, an on-the-market selective serotonin re-uptake inhibitor, SSRI drug, used mostly as an antidepressant and anxiolytic, for depression. In comparison to the Anavex sigma-1 receptor agonists, fluvoxamine is not as active or strong. Don't you suppose Anavex right now is arranging for a replication of this study, but using blarcamesine or Anavex 3-71?
Another Anavex what-if. What if, indeed, chronic (continuous) dosing of either blarcamesine or Anavex 3-71 does in humans what it did in the rats? Might there be a market for such human therapies. How many Americans have myocardial infarctions (heart attacks) each year? How many might benefit from prophylactic (preventative, before it happens) dosings of an Anavex drug?
Cardiologists are eager to prophylactically prescribe any of the several statin drugs to those they think at risk of having a heart attack. Fine and dandy. But given the extremely tiny fraction of heart attacks actually prevented by statin dosings, if those are the SOC, standard of care, in regard to pharmaceutic prevention of heart attacks, what are the chances that the Anavex drugs could beat it?
Will an Anavex drug replace the statins? Pfizer, with it's Lipitor statin, took in $1.9 billion last year. https://www.statista.com/statistics/254341/pfizers-worldwide-viagra-revenues-since-2003/
The key? Write, then re-write.
My thanks for the comments on my postings here. But, understand; they don't spontaneously leap off my fingers on to my keyboard. Here's how I create my postings here --- and encourage others to try the same.
First, I read carefully (several times) any posting I think I might have something useful to comment about. Then, on my word processing program (I prefer Word Perfect) I type out a first draft. A good start, but still with amateurish mistakes.
Next, just like your English teacher taught you (Remember her?), I go back and re-write the paragraphs. Try to make them make clear, interesting presentations.
Then I copy and paste my text onto the iHub screen. I search diligently for missing punctuation marks, checking to see how the stuff reads. I make more corrections.
Then, I hit the green Preview button. That's what readers will read. But I do another re-read. Almost always I find awkward phrases, missing commas, etc. Once again, I re-write awkward or unclear text.
Only then do I hit the Submit Post button. Now, I have but 15 minutes to do any final fixes or corrections. Time and again, after I've posted what I thought were pretty good deliberations I find errors. Before the allowed correction time runs out, I go back and make final corrections.
With all of that, my postings are both clear and grammatically correct. Takes a wee bit of time and effort, but both Anavex and I are worthy of such efforts. No one is going take a poorly packaged or damaged drug. Few are going to consider my comments unless they are structurally equivalent to and as accurate as the actual things I'm writing about.
Try it. Write. Re-write. Then do a final-fix re-write. Such posts will be superb, in every regard.
Yes, thanks so much.
Exactly
It's the Iceberg Thing.
Ok, then, blarcamesine for all, early.
Science Features Neurodegeneration
Today's Science magazine, the house organ of AAAS, the American Association for the Advancement of Science, highlights the problem of neurodegeneration.
In the second paragraph in the lead article, it is stated, "Much fundamental research has led to a greater understanding of the pathophysiological processes involved in neurodegeneration and has revealed that accumulation of misfolded, toxic proteins is frequently a cause of neurodegeneration."
The "accumulation of misfolded, toxic proteins is frequently a cause of neurodegeneration." Will the Anavex sigma-1 receptor agonists treat or prevent protein misfolding? Strong evidence that they do, by optimizing the biochemical processes in endoplasmic reticula, the cellular location of protein folding.
An article made this claim: "Disrupted sleep often occurs before or in the early stages of neurogenerative disease. An important function of sleep is to allow waste products — including misfolded proteins associated with neurodegeneration — to be cleared from the brain via the glymphatic system."
It is noted that improved sleep has been a clinical outcome of those taking blarcamesine in early clinical trials.
The article elaborates on the crucial importance of functional autophagy, the ability of neurons to collect and reprocess waste proteins. Facilitated, optimized autophagy has been noted with blarcamesine.
Note the diseases referred to in this statement: "In addition to the deterioration of sleep architecture in aging, the neurodegenerative diseases — including AD, Parkinson’s disease, Huntington’s disease, the multisystem atrophies, and the FTDs — are all associated with sleep disturbances." Anavex is targeting AD (Alzheimer's disease), a form of Parkinson's disease, and FTD, frontotemporal dementia.
It will be an error to discount or dismiss the ability of blarcamesine to improve sleep.
The issue has many pages discussing the aggregation of the pathogenic proteins of Parkinson's disease, Alzheimer's disease, and other CNS diseases. Doubtless, the aggregation of these proteins cause their associated diseases. But I didn't find any discussion of how neurons might be treated so as to prevent waste protein aggregation. That's where blarcamesine will come into play, with it's ability of facilitate and promote normalized sigma-1 receptor protein functions; which include proper folding of proteins (enzymes) that clear waste proteins in earlier, more healthy stages of life.
An article deliberated on the genetics of Alzheimer's disease. But I note that except in some rather rare forms of Alzheimer's, the disease is late-onset. Until late middle age or later, even with "bad genes," the disease is not present. Can blarcamesine maintain a more youthful, functional status in nerves, preventing the geriatric onset of the disease? Let's see how the Alzheimer's clinical trial turns out.
In a few years, I expect another issue of Science to be devoted to neurodegeneration: "Sigma-1 Receptor Activation Terminates Neurodegeneration."
No. Off by 66.6%.
Who'da thought?
Anavex will succeed because of its science, not the timing of its prospective announcements. Announcements don't control or affect cellular biology. Now that it's Q4 (fourth quarter), those who invest based upon corporate announcements, absent the underlying, supportive actual cellular chemistry, have good reason (for them) now to look elsewhere. Best wishes.
But those of us who have taken AVXL positions because of our knowledge of the unique Anavex science will wait patiently. The three clinical trials coming to completion have not fallen off the calendar now that September has past. Results, favorable for at least one of the CNS conditions being addressed, we believe will be positive. Worth waiting for.
Molecules and calendars.
Well, it's 1 October (30 September has passed). For some, it seems that blarcamesine can no longer bind to the sigma-1 receptor protein.
It's new, never-known chemistry; how the timing of pronouncements (or their absence or variances) from corporate leadership can so precisely change cellular biology.
Awaiting the pronouncement, "Unfortunately, it has been discovered in our labs that after 30 September 2020, the sigma-1 receptor protein no longer accepts or binds to blarcamesine, our lead drug in development. Henceforth, all calendars and digital references to calendar dates will be scrupulously removed from our labs and test sites, so as to allow normalized sigma-1 receptor function to resume."
Very clear.
Exceptional Article
If so, I'll be first in line.
The Anavex box score in the Rett game.
No, the regular season hasn't start.
Thanks. Keeping Right to Try in mind.
Then, hereditary spastic paraplegia (HSP).
But, too, safety.
Consider health care changes for both.
Ok, what happens if a quick, safe, effective treatment or preventative for COVID-19 appears? COVID-19 deaths are averted.
Likewise, what happens if blarcamesine proves to be both safe and effective against several central nervous system (CNS) diseases or conditions?
"Whoa. Ya can't be making either claim. No Phase 3 randomized, controlled clinical trials in either case. Pure speculation."
Sure. Let's wait and see. Indeed, if either situation turns out positive what in health care, health insurance, and a diversity of other social realms will change? How much? In what ways,.
Thinking minds think.
And, of course, vitamin D deficiency.
The role of bradykinins in causing many of the lethal symptoms of advanced COVID-19 cases is well described in that article.
I noted with affirming interest this paragraph:
There are no degrees of uniqueness.
Yes, I, too, will chase it.
Sleep and Alzheimer's onset, re blarcamesine.
Some AVXL arithmetic.
As a curious diversion (not investment advice), here is some Anavex arithmetic to ponder.
What are the ranges of various Anavex metrics, regarding, among other things, potential corporate revenues? When investing in a stock equity, it is advisable to conduct "DD," so-called due diligence. (I prefer to call DD "determining diligence;" more accurate.)
Here are some Anavex determining diligence numbers to consider. (Then, where you disagree, run your own. Simple eighth-grade arithmetic.)
First, how many AVXL shares are in trade, "outstanding?" Presently, $60,190,00 shares are listed. I prefer to be conservative, so for my calculations I'll presume the eventual, continuing number of AVXL shares in trade will be 75,000,000.
Then, how many patients will be treated each year with blarcamesine?
For Alzheimer's, various data sources I discovered claimed that about 5 million Americans have the disease. With eventual FDA approval for treatment with blarcamesine, I'll presume that all of these patients will be on blarcamesine therapy each year in the US.
For simple convenience (very conservative), I'll also assume that in the rest of the world another 5 million with Alzheimer's will be treated each year.
In total, conservatively 10 million patients will be treated with blarcamesine globally.
The other big disease, Parkinson's, has about a half million cases in the US. I'll presume an equivalent number elsewhere, bringing the total annual treatments to one million.
Therefore, conservatively, about 11,000,000 patients worldwide will be treated with blarcamesine each year.
Then, to be conservative, I'll assume Anavex will have sales to only 10,000,000 patients each year. Eventually, that number could be much larger. But, here, I'll use 10 million.
Now, the real question. What will a year's treatment with blarcamesine cost?
At $5 a day, $1825
At $10 a day, $3650
At $50 a day, $18,250
At $100 a day, $36,500.
With these baseline numbers, here are annual Anavex revenues:
With a $5/per day treatment cost, it's $1825 x 10,000,000 = $18,250,000,000 ($18.25 billion).
Per share, that would be $18,250,000,000/75,000,000 = $243 per share.
At a very conservative 10:1 price/earnings ratio, the AVXL share price would be $2430.
With a $10/per day treatment cost, $3650 x 10,000,000 = $36,500,000,000 ($36.5 billion).
Per share, that would be $36,500,000,000/75,000,000 = $487 per share.
At a very conservative 10:1 price/earnings ratio, the AVXL share price would be $4870.
With a $50/per day treatment cost, $18,250 x 10,000,000 = $182,500,000,000 ($182.5 billion).
Per share, that would be 182,500,000,000/75,000,000 = $2433 per share.
At a very conservative 10:1 price/earnings ratio, the AVXL share price would be $24,330
With a $100/per day treatment cost, $3650 x 10,000,000 = $365,000,000,000 ($365 billion).
Per share, that would be 365,000,000,000/75,000,000 = $4867 per share.
At a very conservative 10:1 price/earnings ratio, the AVXL share price would be $48,670.
All of these data are conservative. Actual numbers may be turn out to be much larger.
Or, if Anavex fails to gain sales authority for blarcamesine, if all three of the clinical trials fail, revenues and the share price will be $0.00.
In reality, I think it unreasonable to assume the $100/day treatment cost. Most reasonable are the $5 or $10 a day treatment costs. At $10 a day, $3650 per year, insurance companies and governments are likely to cover that cost; so much cheaper than any other maintenance costs with a disease otherwise continuing.
Personally, I like a cheap $5 a day cost. With that, individuals without insurance can pay for it. The market then involves virtually everyone with any sort of disease for which blarcamesine proves efficacy, not just Alzheimer's or Parkinson's.
I've long contended that because of the drug's unique mechanisms of action (MOA), restoring or favorably modifying a number of diverse pathologies, blarcamesine will eventually prove to be a very safe and effective prophylactic (disease preventer) for a multitude of late-onset, geriatric diseases and conditions. Punch your own numbers for what happens when every American reaching age 50 is prescribed a daily, $5 dose of blarcamesine, to be taken for the rest of his or her then much longer and healthier life.
Today, about 60 million Americans are over 55. If only half were to spend $5 a day on prophylactic blarcamesine, Anavex would take in annually $54.75 billion. Double that to include Europeans and the rest of the world; $109.5 billion. That would be $1460 per Anavex share. A 10/1 price earnings ratio would mark a share of AVXL at $14,600.
Blarcamesine is a rather simple molecule, not difficult to synthesize. A daily dose can surely be made for less than $2.
A more complete description of how I suppressed my Meniere's can be found here:
https://menieres.org/forums/threads/antivirals-and-fullness.3777/page-2#post-85870
But this PDF (which I wrote) is a bit out of date. It claims that vinpocetine is no longer available in the US. Not so. A number of vendors offer it. Do an online search.
--John of Ohio (Falconer)
Blarcamesine for tinnitus.
What? Murine mitochondria different from human mitochondria?
There's a reason.
Anavex, mitochondrial dysfunction, and mental health.
It is being discovered that malfunctioning mitochondria may play crucial etiological roles in various mental health problems. Details in this article:
https://www.quantamagazine.org/mitochondria-may-hold-keys-to-anxiety-and-mental-health-20200810/
It is very clear that the Anavex sigma-1 receptor agonists modulate or facilitate normalized mitochondrial processes, some of which now appear to be important for mental health. Like so many other potential new applications for the Anavex drugs, this is something that would first be checked in murine (lab rodent) studies.
But, were I making the decision at Anavex Life Sciences Corp (I'm not), I'd elect to hold as trade secrets the results of such murine studies at least until the results of the three human clinical trials are announced; and perhaps until blarcamesine (Anavex 2-73) attains regulatory approval for therapeutic sales and use somewhere in the world. Then, the notion that this proprietary class of new drugs might work for a diversity of Central Nervous System neurological pathologies would be more difficult to dismiss.
Actually, not likely.
The likelihood of such a corporate announcement (positive clinical results from both the Rett syndrome and Parkinson's disease dementia trials at the same time) are not high; for any number of reasons.
However, were such an announcement made it would focus the public's and media's attention on one unique matter. A single drug successfully treated two very different central nervous system diseases. Writers and commenters would have to try to explain that. How could this happen?
Regardless of any explanation by the media, the possibility that the drug might also then provide therapeutic applications for Alzheimer's would not be so summarily dismissed (the present perception).
Finally, a subsequent media release might be published telling of positive Alzheimer's results in the then concluded trial. Completion of the Anavex clinical results trifecta. After that, think that Anavex discussion topics, here and elsewhere, might be a bit different?
What if...
...the results of both the Rett syndrome clinical trial and those of the Parkinson's disease dementia trial get released on the same day, in a single media release:
"Anavex Life Sciences Corp announces positive results from two clinical trials involving two different CNS diseases...."
Another new SARS-CoV-2 mouse.
It appears that blarcamesine may provide favorable therapeutic outcomes for people with advanced cases of COVID-19 disease, caused by the SARS-CoV-2 virus.
https://hub.bio.org/system/files/2020-04/AV2-73%20Sigma-1%20Receptor%20COVID-19%20April%202020.pdf
But to affirm safety and efficacy, the drug has to be first tested in mice that can be thoroughly infected and diseased with the virus. Another new mouse for this has been bred, and will be available for the testing of new COVID-19 therapeutics, including blarcamesine.
https://eurekalert.org/pub_releases/2020-08/uonc-msm082720.php
Australia to lead in medical tourism?
Look it up: https://en.wikipedia.org/wiki/Medical_tourism
If blarcamesine becomes generally available in Australia, it might then become a medical tourism destination. People would travel there to get treated with the drug. Perhaps?
Prenatal blarcamesine?
In 2016 it was announced that Anavex 2-73 (blarcamesine) might have therapeutic efficacy for a form of autism.
https://www.anavex.com/anavex-announces-positive-preclinical-results-with-anavex-2-73-in-fragile-x-autism-related-disorders/
A new study shows that autism can begin before birth, in embryonic development. "A new study now shows in human brain cells that the atypical development starts at the very earliest stages of brain organization, at the level of individual brain cells."
https://eurekalert.org/pub_releases/2020-08/e-apn082120.php
This is, I believe, a new potential application of blarcamesine therapy. Prenatal (before birth) dosing, to prevent autism, and perhaps the occurrence of other diseases prenatally.
I know of no published studies on this, either in murines or humans. But it surely is an interesting phenomenon worthy of investigation (at least in lab rats and mice, murines).
Might blarcamesine taken by a mother cross the placental barrier and thereafter modulate or facilitate optimized neuron, nerve, or brain development in the embryo and fetus?
Just what was Anavex thinking back then?
Toutain was brought on board March 2018: